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menotropins

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Description

Menotropins: Extracts of urine from menopausal women that contain high concentrations of pituitary gonadotropins, FOLLICLE STIMULATING HORMONE and LUTEINIZING HORMONE. Menotropins are used to treat infertility. The FSH:LH ratio and degree of purity vary in different preparations. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID21888462
SCHEMBL ID1784550
MeSH IDM0013384

Synonyms (12)

Synonym
61489-71-2
human menopausal gonadotrophin
menotrophin
menotropin
menotropins
AKOS013847259
SCHEMBL1784550
6,6-dimethylheptanal
CBUWTGCATVNMJE-UHFFFAOYSA-N
gonadotropin from human menopausal urine
EN300-1838362
187244-57-1

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" In conclusion, low-dose FSH administration seems a safe stimulation regimen with a satisfactory conception rate even in PCOS women with a previous record of multifollicular ovarian development."( Polycystic ovary syndrome: low-dose follicle stimulating hormone administration is a safe stimulation regimen even in previous hyper-responsive patients.
Abyholm, T; Dale, PO; Haug, E; Tanbo, T, 1992
)
0.28
"An analysis was performed on the cumulative conception rates, cumulative live birth rates and adverse effects of ovulation induction in patients with anovulatory infertility attending a single unit over an 11-year period."( Cumulative conception and live birth rates after the treatment of anovulatory infertility: safety and efficacy of ovulation induction in 200 patients.
Balen, AH; Braat, DD; Jacobs, HS; Patel, A; West, C, 1994
)
0.29
"Our goal was to determine if the addition of norethindrone acetate (NETA) to leuprolide acetate (LA) has an adverse effect on controlled ovarian stimulation (COH) during in vitro fertilization (IVF)."( The addition of norethindrone acetate to leuprolide acetate for ovarian suppression has no adverse effect on ovarian stimulation.
Ditkoff, EC; Lindheim, S; Prosser, R; Sauer, MV; Zimmermann, RC, 1997
)
0.3
"No adverse effect on ovarian stimulation was evident on the addition of NETA to LA."( The addition of norethindrone acetate to leuprolide acetate for ovarian suppression has no adverse effect on ovarian stimulation.
Ditkoff, EC; Lindheim, S; Prosser, R; Sauer, MV; Zimmermann, RC, 1997
)
0.3
" A maximum of 3 cycles were offered unless conception or severe adverse reaction occurred."( A prospective, open, randomized clinical study to assess the efficacy and safety of two gonadotropin preparations administered in WHO Group II anovulatory subfertile women.
Ernest, NH; Flora, TO; Ho, PC; William, SW, 1998
)
0.3
"This clinical study shows that in WHO Group II anovulatory patients Metrodin HP administered subcutaneously by self-injection is as safe and effective as Metrodin administered intramuscularly in inducing ovulation."( A prospective, open, randomized clinical study to assess the efficacy and safety of two gonadotropin preparations administered in WHO Group II anovulatory subfertile women.
Ernest, NH; Flora, TO; Ho, PC; William, SW, 1998
)
0.3
" This FDA approved case series suggest that nasal route of Menopur administration seems to be safe at a very low doses and it constitutes a potential novel approach for ovarian stimulation."( Safety data for the use of nasal human menopausal gonadotropins: a potential novel approach for fertility treatment.
Merhi, Z; Zhang, J, 2019
)
0.51

Pharmacokinetics

ExcerptReferenceRelevance
"We performed a pharmacodynamic comparison of human urinary follicle-stimulating hormone (hFSH) and human menopausal gonadotropin (hMG) to characterize differences in the bioavailability of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to compare estrogen responses in normal women and those with polycystic ovary syndrome (PCOS)."( A pharmacodynamic comparison of human urinary follicle-stimulating hormone and human menopausal gonadotropin in normal women and polycystic ovary syndrome.
Anderson, RE; Chang, RJ; Cragun, JM; Lobo, RA; Stanczyk, FZ, 1989
)
0.28
" After the last gonadotrophin injection, blood samples were collected more frequently to determine pharmacokinetic parameters of FSH."( Pharmacodynamics and pharmacokinetics after repeated subcutaneous administration of three gonadotrophin preparations.
Coelingh Bennink, HJ; Duijkers, IJ; Klipping, C; Mulders, TM; Out, HJ; Vemer, HM, 1997
)
0.3
"To characterize the pharmacokinetics of recombinant-human follicle stimulating hormone (r-hFSH) and urinary-human follicle stimulating hormone (u-hFSH) using population pharmacokinetic analysis and deconvolution techniques."( The population pharmacokinetics of recombinant- and urinary-human follicle stimulating hormone in women.
Karlsson, MO; Loumaye, E; Munafo, A; Wade, JR, 1998
)
0.3
" After a rapid distribution phase with an initial half-life of 1 hour, both recombinant human LH and urinary human LH were eliminated with a terminal half-life of 10-12 hours."( Clinical pharmacology of recombinant human luteinizing hormone: Part I. Pharmacokinetics after intravenous administration to healthy female volunteers and comparison with urinary human luteinizing hormone.
Beltrami, V; le Cotonnec, JY; Munafo, A; Porchet, HC, 1998
)
0.3
"Retrospective pharmacokinetic study."( Pharmacokinetics of exogenous gonadotropin and ovarian response in in vitro fertilization.
Honjou, K; Inoue, Y; Kawarabayashi, T; Nagata, Y; Sonoda, M; Sumii, Y, 1999
)
0.3
" However, both endogenous and exogenous LH have a relatively short terminal half-life and studies have reported normal serum LH, but abnormal urinary LH and emphasized that early morning urinary measurements are more informative than those in serum because they reflect nocturnal LH secretion."( A pharmacokinetic and endocrine comparison of recombinant follicle-stimulating hormone and human menopausal gonadotrophin in polycystic ovary syndrome.
Balasch, J; Casamitjana, R; Fábregues, F; Peñarrubia, J; Vanrell, JA,
)
0.13

Compound-Compound Interactions

ExcerptReferenceRelevance
"Gamete intra-Fallopian transfer (GIFT) was combined with a diagnostic laparoscopy on a routine operating list in a district general hospital."( Gamete intra-fallopian transfer combined with diagnostic laparoscopy: a treatment for infertility in a district hospital.
Bolton, VN; Campbell, S; Pampiglione, JS; Parsons, JH, 1989
)
0.28
"The response of female mice of F1 hybrids (CBA x C57/BL) to superovulatory doses of human menopausal gonadotropin (hMG) or pure follicle-stimulating hormone (FSH) in combination with human chorionic gonadotropin (hCG) was studied."( Superovulation of mice with human menopausal gonadotropin or pure follicle-stimulating hormone in combination with human chorionic gonadotropin and the effects of oocyte aging on in vitro fertilization.
Chia, CM; Edirisinghe, WR; Law, HY; NG, SC; Ratnam, SS, 1986
)
0.27
", Welwyn Garden City, England) superovulation, and 22 (group 3) underwent Pergonal superovulation combined with IUI."( Unexplained infertility--the value of Pergonal superovulation combined with intrauterine insemination.
Katz, M; Little, V; Serhal, PF; Woronowski, H, 1988
)
0.27
" This action combined with treatment with human menopausal gonadotropins (hMG) has been exploited in programmes of induction of follicular growth in infertile women for both in vivo and in vitro fertilisation."( The use of GnRH analogues in combination with exogenous gonadotropins in infertile women.
Black, WP; Coutts, JR; Fleming, R; Hamilton, MP; Jamieson, ME; Macnaughton, MC, 1988
)
0.27
"The luteal phase was studied in 12 polycystic ovary syndrome (PCOS) patients following ovulation induction using exogenous gonadotrophins combined with a gonadotrophin-releasing hormone agonist (GnRH-a)."( Luteal function following ovulation induction in polycystic ovary syndrome patients using exogenous gonadotrophins in combination with a gonadotrophin-releasing hormone agonist.
de Jong, FH; Donderwinkel, PF; Fauser, BC; Hop, WC; Pache, TD; Schoot, DC, 1993
)
0.29
"The use of ovulation induction combined with intrauterine insemination (IUI) as a treatment for subfertility in women with patent Fallopian tubes has increased in recent years."( Ovulation induction combined with intrauterine insemination in women 40 years of age and older: is it worthwhile?
Corsan, G; Kemmann, E; Trias, A; Trout, S, 1996
)
0.29
"This study analyses the influence of female and male patient age and human menopausal gonadotrophin (HMG) requirements on clinical pregnancy rates and live birth rates with ovulation stimulation using HMG in combination with intrauterine insemination (IUI)."( Female and male partner age and menotrophin requirements influence pregnancy rates with human menopausal gonadotrophin therapy in combination with intrauterine insemination.
Brzechffa, PR; Buyalos, RP, 1997
)
0.3
" The early cessation of GnRHa combined with high doses of gonadotrophins permitted the retrieval of a significantly higher number of oocytes."( High doses of gonadotrophins combined with stop versus non-stop protocol of GnRH analogue administration in low responder IVF patients: a prospective, randomized, controlled trial.
Garcia-Velasco, JA; Isaza, V; Landazábal, A; Martínez-Salazar, FJ; Pellicer, A; Remohí, J; Requena, A; Simón, C, 2000
)
0.31
" (2) A recombinant LH, lutropin alfa, has now been licensed for this use, in combination with recombinant FSH (follitropin alfa or follitropin beta)."( Lutropin alfa: new preparation. Combined with follitropin for follicular development: no better than menotropin.
, 2003
)
0.32
"A prospective randomized feasibility study was carried out on 10 patients undergoing IVF treatment using a single-dose LHRH antagonist protocol (cetrorelix, Cetrotide) with clomiphene citrate in combination with either human menopausal gonadotrophin (HMG) (n = 5) or recombinant human FSH (rFSH) (n = 5)."( Single dose application of cetrorelix in combination with clomiphene for friendly IVF: results of a feasibility study.
Blanchet, V; Engel, JB; Fanchin, R; Frydman, N; Frydman, R; Le Dû, A; Olivennes, F, 2003
)
0.32
"To assess embryo implantation rate (IR) and pregnancy rate (PR) in women who received Bushen Wengong Decoction (BSWGD), a Chinese herbal formula, combined with low dose of human menopausal gonadotropin (hMG) prior to frozen-thawed embryo transfer (FET)."( Effect of traditional Chinese herbs combined with low dose human menopausal gonadotropin applied in frozen-thawed embryo transfer.
Cao, L; Gu, DY; Jia, XF; Shi, HJ; Wang, L; Yan, B; Zhang, HQ; Zhao, HX, 2006
)
0.33
"A programmed cycle of BSWGD combined with low dose of hMG could improve the embryo IR and PR of FET."( Effect of traditional Chinese herbs combined with low dose human menopausal gonadotropin applied in frozen-thawed embryo transfer.
Cao, L; Gu, DY; Jia, XF; Shi, HJ; Wang, L; Yan, B; Zhang, HQ; Zhao, HX, 2006
)
0.33
" The aim of the study was to evaluate the effectiveness and efficacy of letrozole and clomiphene citrate (CC) combined with human menopausal gonadotropin (HMG) in CC-resistant infertile women with PCOS."( Use of letrozole and clomiphene citrate combined with gonadotropins in clomiphene-resistant infertile women with polycystic ovary syndrome: a prospective study.
Liu, S; Lu, X; Mao, H; Xi, W; Xue, X; Yang, Y, 2015
)
0.42
"Letrozole in combination with HMG is an effective protocol for reducing the risks of hyperstimulation for ovarian induction in CC-resistant women with PCOS."( Use of letrozole and clomiphene citrate combined with gonadotropins in clomiphene-resistant infertile women with polycystic ovary syndrome: a prospective study.
Liu, S; Lu, X; Mao, H; Xi, W; Xue, X; Yang, Y, 2015
)
0.42
" Especially little is known about efficacy and safety of letrozole (LTZ) combined with low-dose highly purified human menopausal gonadotropin (Hp-HMG) in women with polycystic ovary syndrome (PCOS)."( Letrozole combined with low dose highly purified HMG for ovulation induction in clomiphene citrate-resistant infertile Chinese women with polycystic ovary syndrome: a prospective study.
Mueck, AO; Ruan, X; Zhao, Y, 2017
)
0.46
" All patients got LTZ on day 3 for 5 d in combination with Hp-HMG, starting with 75 IU from cycle day 7 and maintained for up to 3 d."( Letrozole combined with low dose highly purified HMG for ovulation induction in clomiphene citrate-resistant infertile Chinese women with polycystic ovary syndrome: a prospective study.
Mueck, AO; Ruan, X; Zhao, Y, 2017
)
0.46
"LTZ combined with low-dose Hp-HMG is an effective and safe choice for reducing hyperstimulation and increasing pregnancy rate in CC-resistant women with PCOS."( Letrozole combined with low dose highly purified HMG for ovulation induction in clomiphene citrate-resistant infertile Chinese women with polycystic ovary syndrome: a prospective study.
Mueck, AO; Ruan, X; Zhao, Y, 2017
)
0.46
"To evaluate endocrine characteristics and clinical outcomes in normal ovulatory patients undergoing controlled ovarian hyperstimulation (COH) with the use of a Duphaston and hMG protocol during in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) treatments in combination with frozen-thawed embryo transfer (FET) compared with the characteristics and outcomes of patients undergoing an Utrogestan and hMG protocol."( Duphaston and human menopausal gonadotropin protocol in normally ovulatory women undergoing controlled ovarian hyperstimulation during in vitro fertilization/intracytoplasmic sperm injection treatments in combination with embryo cryopreservation.
Fu, Y; Ye, H; Zhu, X, 2017
)
0.46
"To ask lots of questions and try to find the truth about the medicine-based effectiveness of letrozole (LE) combined with human menopausal gonadotropin (HMG) in the treatment of inability to have children crops patients with endocrine (things that are different from what is usually expected and the effect on ovulation-related chemicals produced by the body)."( Efficacy of Letrozole Combined with Urinary Gonadotropin for Ovulation Induction in Endocrine Abnormal Infertility Patients: A Retrospective Single-Center, Case-Control Study.
Luo, S; Mao, J; Peng, H; Wang, J; Yuan, B, 2022
)
0.72
" After being combined with human menopausal gonadotropin treatment, the follicle development and ovulation of patients are significantly improved, and infertility is improved to a certain extent."( Efficacy of Letrozole Combined with Urinary Gonadotropin for Ovulation Induction in Endocrine Abnormal Infertility Patients: A Retrospective Single-Center, Case-Control Study.
Luo, S; Mao, J; Peng, H; Wang, J; Yuan, B, 2022
)
0.72
"To compare the effects of human menopausal gonadotropin (HMG) combined with letrozole (LE) to HMG only for ovarian stimulation on pregnancy outcome of infertile patients undergoing artificial insemination by husband (AIH) due to unexplained or mild male factors."( Retrospective analysis: The application of human menopausal gonadotropin combined with letrozole for IUI in patients undergoing artificial insemination by husband due to unexplained or mild male factors.
Chen, JQ; Chen, XW; Li, HQ; Lu, XP; Pan, XL; Su, NJ, 2022
)
0.72
" The patients were divided into two groups according to the ovarian stimulation schemes they received, namely HMG combined with LE or HMG only."( Retrospective analysis: The application of human menopausal gonadotropin combined with letrozole for IUI in patients undergoing artificial insemination by husband due to unexplained or mild male factors.
Chen, JQ; Chen, XW; Li, HQ; Lu, XP; Pan, XL; Su, NJ, 2022
)
0.72
" The univariate analysis showed that the clinical pregnancy rate of the HMG combined with LE group was 24."( Retrospective analysis: The application of human menopausal gonadotropin combined with letrozole for IUI in patients undergoing artificial insemination by husband due to unexplained or mild male factors.
Chen, JQ; Chen, XW; Li, HQ; Lu, XP; Pan, XL; Su, NJ, 2022
)
0.72
"Ovarian stimulation using HMG combined with LE can increase the clinical outcomes (live birth and clinical pregnancy) among infertile patients undergoing AIH due to explained or mild male factors."( Retrospective analysis: The application of human menopausal gonadotropin combined with letrozole for IUI in patients undergoing artificial insemination by husband due to unexplained or mild male factors.
Chen, JQ; Chen, XW; Li, HQ; Lu, XP; Pan, XL; Su, NJ, 2022
)
0.72

Bioavailability

ExcerptReferenceRelevance
"We performed a pharmacodynamic comparison of human urinary follicle-stimulating hormone (hFSH) and human menopausal gonadotropin (hMG) to characterize differences in the bioavailability of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to compare estrogen responses in normal women and those with polycystic ovary syndrome (PCOS)."( A pharmacodynamic comparison of human urinary follicle-stimulating hormone and human menopausal gonadotropin in normal women and polycystic ovary syndrome.
Anderson, RE; Chang, RJ; Cragun, JM; Lobo, RA; Stanczyk, FZ, 1989
)
0.28
"To determine the difference in FSH bioavailability from IM and SC injection sites."( Differences in serum follicle-stimulating hormone uptake after intramuscular and subcutaneous human menopausal gonadotropin injection.
Dobbs, KE; Dumesic, DA; Dumesic, JA; Shapiro, SS, 1994
)
0.29
" Computed absorption rate constants for FSH after IM and SC injection differed significantly."( Differences in serum follicle-stimulating hormone uptake after intramuscular and subcutaneous human menopausal gonadotropin injection.
Dobbs, KE; Dumesic, DA; Dumesic, JA; Shapiro, SS, 1994
)
0.29
"Empty follicle syndrome is associated with very low bioavailability of beta-hCG and can be predicted by measuring serum beta-hCG level 36 hours after IM hCG administration."( Predicting empty follicle syndrome.
al-Hassan, S; Dowell, K; Fishel, S; Hunter, A; Ndukwe, G; Thornton, S, 1996
)
0.29

Dosage Studied

ExcerptRelevanceReference
" Daily 24 hours urinary total estrogen excretion rates were measured and HMG daily dosage was varied according to levels obtained."( Ovulation induction with human menopausal gonadotrophins: an evaluation of a variable daily dosage regimen.
Arronet, GH; Webb-Wilson, GJ, 1977
)
0.26
"Radioimmunological methods have been used to assay the plasma concentrations of gonadotropins, androgens (expressed as the sum of testosterone and dihydrotestosterone) and 17beta-oestradiol in 98 patients suffering from dysspermia of variable etiology, after stimulation with GnRH, Clomiphene, L-Dopa, Cyclophenyl, HCG in various dosage schemes, and HMG."( [Dynamic tests with GnRH, L-dopa, clomiphene, cyclophenyl, HCG and HMG in 98 cases of dysspermia due to a variety of causes].
De Aloysio, D; Farello, P; Flamigni, C; Fronticelli, A; Nardi, M; Venturoli, S, 1977
)
0.26
" Three dosage schemes have been compared: a single dose of LH-RH, multiple doses of LH-RH, and LH-RH used in combination with human menopausal gonadotrophins (HMG)."( The use of synthetic luteinizing hormone-releasing hormone to induce ovulation.
Block, B; Kort, HI, 1977
)
0.26
" Parallel dose-response curves were obtained for hMG and rhesus monkey pituitary gonadotropin."( Bioassay of circulating luteinizing hormone in the rhesus monkey: comparison with radioimmunoassay during physiological changes.
Catt, KJ; Dufau, ML; Goodman, AL; Hodgen, GD, 1977
)
0.26
" The dosage schedules used for the patients should be considered conservative, insofar as the amount of HMG and HCG administered per treatment cycle is concerned."( Observations on 320 infertile patients treated with human gonadotropins (human menopausal gonadotropin/human chorionic gonadotropin).
Comninos, AC; Tsapoulis, AD; Zourlas, PA, 1978
)
0.26
" A wide range of hCG dosage was used to induce ovulation, but three subjects conceived following 5000 IU of hCG on 2 successive days."( Isolated hypogonadotropic hypogonadism: induction of ovulation with exogenous gonadotropins.
Ben-Aderet, N; Bercovici, B; Jaffe, H; Polishuk, W; Rosen, E; Spitz, IM, 1977
)
0.26
" The two groups of normo- and hyper-prolactinemic patients showed no significant difference in the required dosage and duration or hMG treatment, plasma estradiol-17 beta response, and ovulatory and pregnancy outcome."( Plasma prolactin changes during the administration of human menopausal gonadotropins in nonovulatory women.
Beinert, WC; Beling, CB; GEMZELL, CA; Jones, JR; Kemmann, E, 1977
)
0.26
" Ovarian over-stimulation was directly related to the dosage of clomiphene, and the increased levels of 17 alpha-hydroxyprogesterone thus produced persisted into the seventh week of pregnancy."( Corpus luteum function during pregnancies of previously infertile women.
Gentry, WC; Karow, WG, 1976
)
0.26
"Coagulation and fibrinolytic profiles have been studied in two groups of sterility patients receiving low dosage regimens of human gonadotropins for ovarian stimulation."( Studies of the coagulation and fibrinolytic systems in hyperstimulation syndrome after administration of human gonadotropins.
Gladstone, W; Phillips, LL; vande Wiele, R, 1975
)
0.25
" Six mature female monkeys were treated with HMG-HCG for at least 2 control ovulatory cycles at dosage levels adjusted to induced ovulation while avoiding superovulation."( The effect of indomethacin of HMG-HCG induced ovulation in the phesus monkey.
Cruz, A; Hunt, J; Stevens, VC; Wallach, EE; Wright, KH, 1975
)
0.25
" Duration and dosage can be determined on the basis of daily plasma estrogen levels."( Plasma estrogen monitoring of ovulation induction.
Wu, CH, 1975
)
0.25
" The dose of GH used in these studies was substantial, and we await the results of a multi-centre trial attempting to establish a dose-response relationship."( Growth hormone and ovulation: is there an indication for treatment of infertile women with growth hormone?
Jacobs, HS, 1992
)
0.28
"Whereas the dose of hMG is significantly correlated with both BMI and BW, commencing the more obese patient on higher hMG doses is not justified in view of the cancellation of cycles from over-responsiveness in the more obese patients started on higher hMG dosage regimens."( Body weight, body mass index, and age: predictors of menotropin dose and cycle outcome in polycystic ovarian syndrome?
Burger, HG; Healy, DL; Kovacs, GT; McClure, N; McDonald, J; McQuinn, B, 1992
)
0.28
"Induction of ovulation using low doses of gonadotrophins with small, stepwise increments in dosage as required."( Association of moderate obesity with a poor pregnancy outcome in women with polycystic ovary syndrome treated with low dose gonadotrophin.
Franks, S; Hamilton-Fairley, D; Kiddy, D; Paterson, C; Watson, H, 1992
)
0.28
" Patients with polycystic ovarian disease are at a high risk of OHSS and therefore a small dose and slow start of HMG is recommended, tailoring the dosage according to the ovarian response."( Ovarian hyperstimulation syndrome after superovulation using GnRH agonists for IVF and related procedures.
Rizk, B; Smitz, J, 1992
)
0.28
"These findings suggest that there is no obvious superiority between the two GnRH-a protocols in the dosage schedule used and that the major advantage of GnRH-a over non-GnRH-a protocols is in decreasing the cancellation rate and increasing the number of oocytes and conceptus obtained."( Prospective randomized study of human menotropin versus a follicular and a luteal phase gonadotropin-releasing hormone analog-human menotropin stimulation protocols for in vitro fertilization.
Bernhisel, M; Emery, M; Maroulis, GB; Saphier, A; Verkauf, BS; Yeko, TR, 1991
)
0.28
" Pretreatment daily gonadotrophin dosage of 8-11 ampoules pre-hCG was reduced to 3-6 ampoules during growth hormone and 3-4 post growth hormone."( Ovarian sensitization to gonadotrophins by human growth hormone. Persistence of the effect beyond the treated cycle.
Burger, HG; Colman, P; Harrop, M; Healy, DL; Kovacs, GT; McCloud, PI; McDonald, J; Polson, DM, 1991
)
0.28
"Growth hormone causes persisting ovarian sensitization to gonadotrophin and may produce a substantial lowering of gonadotrophin requirement for ovulation induction in patients with large dosage needs."( Ovarian sensitization to gonadotrophins by human growth hormone. Persistence of the effect beyond the treated cycle.
Burger, HG; Colman, P; Harrop, M; Healy, DL; Kovacs, GT; McCloud, PI; McDonald, J; Polson, DM, 1991
)
0.28
" In receptor displacement and in vitro bioassay studies recFSH provided dose-response curves parallel to those of pituitary and urinary FSH references."( Comparative in vitro and in vivo studies on the biological characteristics of recombinant human follicle-stimulating hormone.
de Leeuw, R; Geelen, J; Kloosterboer, H; Mannaerts, B; Schuurs, A; Van Ravestein, A; Van Wezenbeek, P, 1991
)
0.28
"This study assesses the effects of attempts to optimize human menopausal gonadotropin (hMG) dosage in 271 patients who had at least two hyperstimulation cycles for in vitro fertilization or gamete intrafallopian transfer."( Increasing the human menopausal gonadotropin dose--does the response really improve?
Johnston, I; Pantos, C; Speirs, AL; Thornton, SJ, 1990
)
0.28
" We thus conclude that very low E2 levels after 5 days of gonadotropin therapy are predictive of low response in that cycle, and that in cycles with day 8 E2 of 51 to 150 pg/mL, increasing the dosage of hMG on day 8 and beyond does not alter the course of the cycle."( The predictive value and the management of cycles with low initial estradiol levels.
Asis, MC; DeCherney, AH; Diamond, MP; Hershlag, A; Lavy, G, 1990
)
0.28
"The use of Pergonal at a fixed dosage was evaluated in 200 women."( Practice management for ovulation induction.
Bonaventura, LM, 1989
)
0.28
" With the first protocol, 28 women (group 1) were treated with an hMG dosage which was increased stepwise."( Manipulating the follicular phase in IVF cycles: a comparison of two hMG stimulation protocols.
Bar-Hava, I; Laufer, N; Lewin, A; Rabinowitz, R; Schenker, JG; Simon, A, 1989
)
0.28
" All were given the same dosage of gonadotropins as in previous cancelled cycles (6-17 ampules/cycle of menofollitropin; 34-80 ampules/cycle of human menopausal gonadotropin) plus a standard dosage of GH (0."( Ovarian response to combined growth hormone-gonadotropin treatment in patients resistant to induction of superovulation.
Artini, PG; Barreca, A; Coukos, G; Genazzani, AR; Giordano, G; Minuto, F; Volpe, A, 1989
)
0.28
" It is concluded that the first ovulation-induction course should be regarded as a preventive or preparatory one, where an optimum drug dosage is adjusted while the gonads and target organs are getting ready for the ovulation."( [Comparative analysis of fertile and infertile cycles during stimulation of ovulation with pergonal in patients with hypo- gonadotropic amenorrhea].
Manuilova, IA; Nazarenko, TA; Shchedrina, RN; Sotnikova, EI; Torganova, IG; Zykin, BI, 1989
)
0.28
" Pregnant and nonpregnant patients were compared with regard to their age, the total dosage of hMG, the cycle day at oocyte retrieval, the E2 levels 48 and 24 hours before laparoscopy, the E2 rise, the number of retrieved oocytes, and the cleavage rate."( Factors influencing successful in vitro fertilization and embryo transfer: a matched pair study.
Deutinger, J; Fischl, F; Janisch, H; Müller-Tyl, E; Reinthaller, A; Riss, P, 1986
)
0.27
" This dosage is continued until the leading follicle reaches a diameter of 14 mm."( [Ovulation induction for in vitro fertilisation at the Tygerberg Hospital].
Kruger, TF; Lombard, CJ; Muller, LM; van der Merwe, JP, 1987
)
0.27
" The different responses are not related to total dosage of HLG administered."( A lesson from IVF endocrinology: the importance of the follicular phase to success and failure in non-IVF cycles.
Buytaert, P; Delbeke, L; Desmedt, E; Gerris, J; Van Gaal, L,
)
0.13
" Buserelin was infused subcutaneously in a dosage of 400 micrograms/d for 26-44 days using a portable external osmotic minipump system."( [Stimulation of ovarian function with gonadotropins following suppression of endogenous gonadotropin secretion by long-term infusion of the LHRH analog buserelin].
Bliefert, R; Breckwoldt, M; Geisthövel, F; Geyer, H; Sandow, J, 1987
)
0.27
" The initial HMG dosage was 1 ampoule per day."( [Gonadotrophin induction of ovulation monitored by ultrasonic studies of the ovary].
van Schouwenburg, JA, 1985
)
0.27
" Based on the size and number of follicles, the peripheral levels of estradiol, and the rate of follicular growth and increase in estradiol, human menopausal gonadotropin was continued at a dosage of 1 to 3 ampules/day through the day of human chorionic gonadotropin administration."( Preliminary experience with a combination of clomiphene and variable dosages of menopausal gonadotropins for enhanced follicular recruitment.
Beauchamp, PJ; Berkowitz, AS; Maklad, NF; Quigley, MM; Schmidt, CL; Wolf, DP, 1985
)
0.27
" The increased dosage of hCG used in this series is considered to be a decisive factor in the induction of ovulation and the maintenance of pregnancies through the abundant steroid production it induced."( Induction of ovulation and pregnancy in twenty-six patients with primary hypogonadotropic amenorrhea.
Batrinos, ML; Panitsa-Faflia, C, 1980
)
0.26
" The dosage of hMG required was found to be significantly higher in this group."( Transient hyperprolactinaemia in human menopausal gonadotropin induction of ovulation.
Ho, PC; Tang, GW; Tang, LC, 1984
)
0.27
" A significant difference was observed in the dosage of human menopausal gonadotropins (hMG) over various days of treatment, but not in the mean dosage of hMG and human chorionic gonadotropin (hCG) administered per cycle."( Regulation of ovarian follicular and luteal function during treatment with exogenous gonadotropins in anovulatory infertility.
Cannon, W; Sy, L; Yuen, BH, 1981
)
0.26
" Serum E2 and progesterone responses were inversely related to the amount of hMG, indicating a patient sensitivity rather than a dosage relationship."( Human menopausal gonadotropin/human chorionic gonadotropin follicular maturation for oocyte aspiration: phase I, 1981.
Acosta, AA; Garcia, JE; Jones, GS; Wright, G, 1983
)
0.27
"Either to induce ovulation in anovulatory infertility patients or to enhance ovulation in patients with mild endometriosis or luteal phase inadequacy, we utilized a sequential regimen of low-dose clomiphene citrate (CC) followed by human menopausal gonadotropin (hMG) injections on alternate days; duration and dosage of menotropin therapy was individualized by using serum estradiol levels for monitoring until the time of administration of human chorionic gonadotropins."( Sequential clomiphene citrate-menotropin therapy for induction or enhancement of ovulation.
Jones, JR; Kemmann, E, 1983
)
0.27
" In six of these patients this approach was used because of suboptimal response of serum estradiol levels to standard hMG therapy, and all six patients had an increase in estradiol response with infusion therapy; therapy duration and total dosage of hMG were similar in both treatment modalities."( The initial experience with the use of a portable infusion pump in the delivery of human menopausal gonadotropins.
Brandeis, VT; Kemmann, E; Nosher, JL; Shelden, RM, 1983
)
0.27
" Serial dilutions of active material from IEF preparations demonstrated a dose-response relationship in the bioassay."( Identification of a porcine follicular fluid fraction which suppresses follicular response to gonadotropins.
Campeau, JD; diZerega, GS; Kling, OR; Nakamura, RM; Nishimura, K; Roche, PC, 1984
)
0.27
"When clomiphene citrate is used for enhanced follicular recruitment in an in vitro fertilization and embryo transfer program, the usual dosage is 150 mg/day, although we recently reported comparable follicular development (size and number) with 50 mg/day."( Clomiphene citrate in an in vitro fertilization program: hormonal comparisons between 50- and 150-mg daily dosages.
Berkowitz, AS; Gilbert, SA; Quigley, MM; Wolf, DP, 1984
)
0.27
" These patterns allow a good diagnostic presumption before the following missing menses, which can be useful when dealing with women treated for infertility and when plasmatic dosage of hCG or beta hCG cannot be rapidly available."( [Urinary estrone and estradiol levels in the diagnostic presumption of pregnancy (author's transl)].
Chikhaoui, Y; Crastes de Paulet, A; Cristol, P; Descomps, B; Durand, G; Hedon, B; Viala, JL, 1980
)
0.26
" Non-parallelism of dose-response curves between serial dilutions of individual male as well as female sera and LH standards was caused by damage to incubated interstitial cells in the presence of human serum."( Biological and immunological potencies of lutropin (LH) in human serum: comparative studies using different standard preparations.
Bettendorf, G; Graesslin, D; Lichtenberg, V; Pahnke, VG, 1982
)
0.26
" (i) On the basis of E2 values measured every 3 days, HMG dosage was adjusted."( [A new method of ovulation induction with HMG-HCG by a E2 rapid radioimmunoassay (author's transl)].
Matsuyama, A; Minaguchi, H; Namiki, T; Oomori, J; Shirasu, K; Uemura, T, 1982
)
0.26
"Forty-nine patients in whom clomiphene citrate failed to induce ovulation were treated for 177 cycles with a fixed low dosage of menotropin."( A life-table analysis of pregnancy yield in fixed low-dose menotropin therapy for patients in whom clomiphene citrate failed to induce ovulation.
Goldfarb, AF; Mansi, ML; Schlaff, S, 1982
)
0.26
" The increased incidence of twinning appears to be related to the type and dosage of medication used, and the patient's underlying problem."( Twin pregnancies following induction of ovulation: a literature review.
Lamont, JA, 1982
)
0.26
" In the present study, the relationship between the dosage of injected HMG and the superovulatory response including fertilization rate was studied."( Superovulation induction by human menopausal gonadotrophin in rabbits.
Endo, T; Kanayama, K; Nariai, K; Sankai, T, 1995
)
0.29
" The extent of suppression of the adenohypophysis, as expressed by the different reactions on GnRH test, can be modulated by the dosage administered."( Preserved pituitary response under ovarian stimulation with HMG and GnRH antagonists (Cetrorelix) in women with tubal infertility.
al Hasani, S; Bauer, O; Diedrich, C; Diedrich, K; Felberbaum, RE; Küpker, W; Reissmann, T, 1995
)
0.29
" In each patient, the initial dosage of 300 IU daily, adopted for the first 9 days, was modified subsequently according to the ovarian morphology, as shown by serial echographic examinations and by serum estradiol levels."( Induction of follicle maturation and ovulation by gonadotropin administration in women with beta-thalassemia.
Cavagnini, F; Danesi, L; Dubini, A; Maiolo, AT; Miragoli, AM; Pincelli, AI; Polli, EE; Scacchi, M, 1994
)
0.29
" All findings were independent of the total hMG dosage used and the body mass index of the patients."( Total renin after gonadotropin stimulation in polycystic ovarian disease.
Aalto, M; Anttila, L; Irjala, K; Jaatinen, TA; Koskinen, P; Matinlauri, I; Nikkanen, V, 1995
)
0.29
"A randomized prospective study was undertaken to compare low and standard luteinizing hormone-releasing hormone agonist (LHRHa) dosage used in combination with gonadotrophins in ovarian stimulation for in-vitro fertilization (IVF)."( A comparison between a standard and reduced dose of D-Trp-6-luteinizing hormone-releasing hormone administered after pituitary suppression for in-vitro fertilization.
Benshushan, A; Dorembus, D; Laufer, N; Lewin, A; Shushan, A; Simon, A; Zajicek, G, 1994
)
0.29
" The treatment schedule involved ovulation induction after treatment with a gonadotrophin-releasing hormone (GnRH) agonist, using standard doses of human menopausal gonadotrophin (HMG) for 4 days, and further stepwise increments in dosage as required."( Anthropometric indicators and response to gonadotrophin for ovulation induction.
Crosignani, PG; Lombroso, G; Parazzini, F; Perotti, L; Ragni, G; Wyssling, H, 1994
)
0.29
"Intranasal nafarelin at a dosage of 200 micrograms twice daily or LA at a dose of 1 mg/d SC was administered."( Comparison between nafarelin and leuprolide acetate for in vitro fertilization: preliminary clinical study.
Asch, RH; Balmaceda, JP; Dantas, ZN; Stone, SC; Vicino, M, 1994
)
0.29
"Human menopausal gonadotrophin was self-administered subcutaneously in two dosage regimens to patients requiring (a) fertility (Group I), 37."( Self-administered subcutaneous human menopausal gonadotrophin for the stimulation of testicular growth and the initiation of spermatogenesis in hypogonadotrophic hypogonadism.
Darne, JF; Jones, TH, 1993
)
0.29
" No differences were observed for days of stimulation, peak oestradiol attained, total dosage of exogenous gonadotrophins, or number of aspirated oocytes."( A combination of norethindrone acetate and leuprolide acetate blocks the gonadotrophin-releasing hormone agonistic response and minimizes cyst formation during ovarian stimulation.
Ditkoff, EC; Sauer, MV, 1996
)
0.29
"Sixty-four Japanese Black parous cows were divided into 5 dosage groups (I, II, III, IV, V) and administered either human menopausal gonadotrophin (hMG) or FSH by intramuscular injection."( Effects of human menopausal gonadotrophin (hMG) for superovulation in Japanese Black cattle.
Ohsaki, J; Sato, N; Sugano, M; Takano, T; Watanabe, S, 1995
)
0.29
" There were also no statistical differences in the HMG dosage (26."( Subcutaneous low dose leuprolide acetate depot versus leuprolide acetate for women undergoing ovarian stimulation for in-vitro fertilization.
Chang, CC; Chen, CM; Lo, HY; Tsai, HD, 1995
)
0.29
" No significant differences were noted between the two dosage protocols with respect to the other outcome measures."( A randomized clinical trial to evaluate the clinical effects of split- versus single-dose human menopausal gonadotropins in an assisted reproductive technology program.
Clarke, RN; Fox, JH; Friedman, AJ; Hornstein, MD; Jackson, KV; Rein, MS, 1996
)
0.29
" The dosage necessary for sufficient suppression of the pituitary gland is not yet defined."( Hormone profiles under ovarian stimulation with human menopausal gonadotropin (hMG) and concomitant administration of the gonadotropin releasing hormone (GnRH)-antagonist Cetrorelix at different dosages.
Al-Hasani, S; Bauer, O; Diedrich, C; Diedrich, K; Felberbaum, R; Küpker, W; Reissmann, T; Schill, T; Zoll, C, 1996
)
0.29
" Regarding fertilization rates and use of hMG, the lower dosage seems to be the most favorable."( Hormone profiles under ovarian stimulation with human menopausal gonadotropin (hMG) and concomitant administration of the gonadotropin releasing hormone (GnRH)-antagonist Cetrorelix at different dosages.
Al-Hasani, S; Bauer, O; Diedrich, C; Diedrich, K; Felberbaum, R; Küpker, W; Reissmann, T; Schill, T; Zoll, C, 1996
)
0.29
" Dosage is standardised on a mg/kg basis."( In vitro fertilisation. A review of drug therapy and clinical management.
Jennings, JC; Moreland, K; Peterson, CM, 1996
)
0.29
" No differences were noted in days of stimulation, peak estradiol (E2) level attained, peak E2-to-oocyte ratio, dosage of exogenous gonadotropins, number of aspirated oocytes, fertilization rate, or oocyte and preembryo quality."( The addition of norethindrone acetate to leuprolide acetate for ovarian suppression has no adverse effect on ovarian stimulation.
Ditkoff, EC; Lindheim, S; Prosser, R; Sauer, MV; Zimmermann, RC, 1997
)
0.3
"All patients received individualized dosing of hMG after 5 days of CC."( Sonographic assessment of endometrial pattern and thickness in patients treated with clomiphene citrate, human menopausal gonadotropins, and intrauterine insemination.
Ananth, CV; Bohrer, MK; Hock, DL; Kemmann, E, 1997
)
0.3
"The population analysis indicates that the variability in CL/F is moderate, consequently, so would be the variability in exposure, given a fixed dosage regimen."( The population pharmacokinetics of recombinant- and urinary-human follicle stimulating hormone in women.
Karlsson, MO; Loumaye, E; Munafo, A; Wade, JR, 1998
)
0.3
" All patients underwent FSH dosage on cycle day 3 prior to stimulation."( In vitro fertilization outcome according to age and follicle-stimulating hormone levels on cycle day 3.
Bassil, S; Donnez, J; Gillerot, S; Godin, PA; Verougstraete, JC, 1999
)
0.3
"A fixed hMG dosage was initiated on cycle days 5-9 in both of the study cycles."( Attenuation of ovarian response by low-dose ketoconazole during superovulation in patients with polycystic ovary syndrome.
Barr, I; Diamant, YZ; Eldar-Geva, T; Gal, M; Margalioth, EJ; Orly, J, 1999
)
0.3
"The hCG ratio decreased with the total dosage of hMG and increased with the serum E2 level, the number of oocytes recovered, and the number of oocytes fertilized."( Pharmacokinetics of exogenous gonadotropin and ovarian response in in vitro fertilization.
Honjou, K; Inoue, Y; Kawarabayashi, T; Nagata, Y; Sonoda, M; Sumii, Y, 1999
)
0.3
" After gonadotropin releasing hormone analogue pituitary desensitization, patients were randomized to receive either Fostimon or Metrodin HP at the initial dosage of 225 IU for 6 days."( A prospective, randomized, controlled clinical study of a new subcutaneous, purified, urinary FSH preparation for controlled ovarian hyperstimulation in in vitro fertilization.
Anserini, P; Costa, M; Remorgida, V; Venturini, PL, 2000
)
0.31
" Prediction of ovarian responses prior to stimulation is useful in counselling patients and helpful in tailoring the dosage of gonadotrophin to individual patients."( The significance of the number of antral follicles prior to stimulation in predicting ovarian responses in an IVF programme.
Ho, PC; Ng, EH; Tang, OS, 2000
)
0.31
" The trials included 1,014 women (nafarelin n = 597) in protocols employing three different dosage regimens, long and short stimulation protocols, and three comparative GnRH agonists (buserelin n = 348; triptorelin n = 14, and leuprolide n = 55)."( Efficacy of nafarelin in assisted reproductive technology: a meta-analysis.
Forrest, KA; Gersh, GE; Kennedy, SH; Snabes, SZ; Wong, JM; Zhao, SZ,
)
0.13
" The antral follicle count correlated significantly with the patient age, dosage of gonadotropins, serum estradiol concentration, number of antral follicles (> or = 13 mm) while receiving hCG injections, number of oocytes retrieved, and, later, number of embryos transferred."( Determination of the efficiency of controlled ovarian hyperstimulation in the gonadotropin-releasing hormone agonist-suppression cycle using the initial follicle count during gonadotropin stimulation.
Chang, HW; Chang, SY; Huang, FJ; Kung, FT; Tsai, MY; Wu, JF, 2001
)
0.31
"There were no significant differences in the duration of COH, the total dosage of gonadotropins used for COH, the serum E2 concentration on day of hCG administration, the number of follicles on the day of hCG administration, the number of oocytes retrieved or fertilized in vitro, and the number of embryos transferred between their respective PI1, PI2, and API values."( Clinical significance of transvaginal color Doppler ultrasonography of the ovarian artery as a predictor of ovarian response in controlled ovarian hyperstimulation for in vitro fertilization and embryo transfer.
Jee, BC; Kim, SH; Ku, SY; Lee, JY; Moon, SY; Suh, CS, 2002
)
0.31
") total dosage of hMG (ampoules) (37."( Clinical evaluation of three different gonadotrophin-releasing hormone analogues in an IVF programme: a prospective study.
Al-Mizyen, E; Al-Shawaf, T; Bhide, M; El-Nemr, A; Gillott, C; Grudzinskas, JG; Khalifa, Y; Lower, AM, 2002
)
0.31
" Daily hMG was stopped and the GnRH dosage was changed from 10 microg to 20 microg when the follicle diameter reached 11-13 mm."( A modified hMG-GnRH method for the induction of ovulation in infertile women with severe hypogonadotropic amenorrhea.
Hirahara, F; Ishikawa, M; Kondoh, Y; Murase, M; Uemura, T; Yokoi, N, 2002
)
0.31
" There was no evidence of dose-response correlations in all three gonadotropin experiments."( Effect of gonadotropins on human endometrial stromal cell proliferation in vitro.
Choi, YM; Kim, JG; Kim, SH; Ku, SY; Lee, JY; Moon, SY; Suh, CS, 2002
)
0.31
" Such trials should preferably (1) use a consistent long GnRHa protocol and (2) use a fixed dose of gonadotrophin such to prevent potentially subjective decisions of the clinician in dosing and (3) take live birth as primary endpoint."( Human menopausal gonadotropin versus recombinant follicle stimulation hormone for ovarian stimulation in assisted reproductive cycles.
Bossuyt, PM; Van der Veen, F; Van Wely, M; Westergaard, LG, 2003
)
0.32
" r-hLH therefore provides the clinician with the opportunity for precise and consistent dosing within the therapeutic window for patients requiring exogenous LH, without the risk of LH overexposure that is associated with hCG."( Comparison of recombinant human luteinising hormone (r-hLH) and human menopausal gonadotropin (hMG) in assisted reproductive technology.
Baer, G; Loumaye, E, 2003
)
0.32
"A significant reduction in both ovarian weight and the number of oocytes was found as the ANP dosage increased."( Atrial natriuretic peptide inhibits ovarian functions in female mice.
Chang, Y; Lee, JN; Lee, TT; Li, S; Tsai, EM; Yang, YY, 2005
)
0.33
" During the dosing period, the ovarian follicle diameter and count were measured by transvaginal ultrasonography."( Ovarian follicular development stimulated by leuprorelin acetate plus human menopausal gonadotropin in chimpanzees.
Hayasaka, I; Honda, R; Ide, Y; Mori, Y; Nakagata, N; Nakashima, T; Okamura, H; Shimoda, K; Torii, R; Yoshikawa, Y; Yoshimoto, N, 2005
)
0.33
"Many studies on gonadotropin treatment in idiopathic OAT have produced inconsistent (75 IU FSH + 75 IU LH) at the dosage of 3 ampoules a week for 90 days in 18 patients with idopathic OAT and testicular volume 12-15 ml."( Menotropin (hMG) and idiopathic oligoastenoteratozoospermia (OAT): effects on seminal fluid parameters and on results in ICSI cycles.
Beretta, G; Dilena, M; Fino, E; Sibilio, L, 2005
)
0.33
" But these results, except the dosage of FSH, were not statistically significant."( [Influence of exogenous supplementation with luteinizing hormone during controlled ovarian hyperstimulation on the results of IVF cycle].
Hredzák, R; Ostró, A; Potoceková, D; Toporcerová, S; Zdilová, V, 2005
)
0.33
"Patients were randomized to receive either highly purified hMG or rFSH in a fixed dosage of 150 IU/d after GnRH-agonist suppression (long protocol)."( Effectiveness of highly purified human menopausal gonadotropin vs. recombinant follicle-stimulating hormone in first-cycle in vitro fertilization-intracytoplasmic sperm injection patients.
Broekmans, FJ; Hompes, PG; Hoozemans, DA; Schats, R, 2008
)
0.35
"Compared with rFSH, highly purified hMG did not result in superiority in ongoing pregnancy rates in first-cycle IVF-intracytoplasmic sperm injection patients who were treated with a fixed dosage of 150 IU of gonadotropin per day."( Effectiveness of highly purified human menopausal gonadotropin vs. recombinant follicle-stimulating hormone in first-cycle in vitro fertilization-intracytoplasmic sperm injection patients.
Broekmans, FJ; Hompes, PG; Hoozemans, DA; Schats, R, 2008
)
0.35
" Since the ploidy of embryos changes with female age, patients were matched for age and dosage of the respective gonadotropin."( The impact of LH-containing gonadotropins on diploidy rates in preimplantation embryos: long protocol stimulation.
Barad, D; Brannath, W; Cekleniak, N; Chen, S; Cohen, J; Garrisi, M; Gleicher, N; Munné, S; Tomkin, G; Weghofer, A, 2008
)
0.35
" When serum prolactin was controlled at normal levels, we decreased the dosage of bromocriptine step by step (1."( [Analysis of therapeutic outcomes of polycystic ovary syndrome patients with hyperprolactinemia].
Chen, ZJ; Gao, Q; Liu, H; Ma, ZX; Sheng, Y; Shi, YH; Yan, JH, 2008
)
0.35
"Bromocriptine administration before the stimulated ovulation therapy can decrease the total dosage and treatment course of ovulating drugs."( [Analysis of therapeutic outcomes of polycystic ovary syndrome patients with hyperprolactinemia].
Chen, ZJ; Gao, Q; Liu, H; Ma, ZX; Sheng, Y; Shi, YH; Yan, JH, 2008
)
0.35
" These results suggest that the perceived required dosage with rFSH is currently over-estimated, and the higher unit cost of rFSH may be offset by a lower required dosage compared with hMG-HP."( In vitro fertilisation with recombinant follicle stimulating hormone requires less IU usage compared with highly purified human menopausal gonadotrophin: results from a European retrospective observational chart review.
Blackmore, S; Brown, AP; Clewlow, C; Gillard, S; O'Donohoe, P; Trew, GH; Wasiak, R, 2010
)
0.36
" Such trials should preferably (1) use a consistent long GnRHa protocol and (2) use a fixed dose of gonadotrophin such to prevent potentially subjective decisions of the clinician in dosing and (3) take live birth as primary endpoint."( WITHDRAWN: Human menopausal gonadotropin versus recombinant follicle stimulation hormone for ovarian stimulation in assisted reproductive cycles.
Bossuyt, PM; Van der Veen, F; van Wely, M; Westergaard, LW, 2011
)
0.37
"CONCLUSIONSs: Our study showed that rFSH is more powerful and more applicable in individualized dosing then HP-hMG and brings better results from COS (more oocytes, more matured oocytes)."( Recombinant FSH versus HP-HMG for controled ovarian stimulation in intracitoplasmic sperm injection cycles.
Aydin, B; Balkanov, T; Dimitrov, G; Hadzi-Lega, M; Lazarova, A; Matevski, V; Petanovska, E; Petanovski, Z; Saltirovski, S; Sotirovska, V; Stojkovska, S; Suslevski, D, 2011
)
0.37
" The letrozole group had lower dosage of HMG (P<0."( Sequential use of letrozole and gonadotrophin in women with poor ovarian reserve: a randomized controlled trial.
Chan, CC; Ho, PC; Lee, VC; Ng, EH; Yeung, WS, 2011
)
0.37
" ≥2 embryos on IVF pregnancy chances; (iii) correlation of anti-Müllerian hormone (AMH) levels to embryo ploidy (iv) effect of gonadotropin dosage used in stimulation on available embryos for transfer; and (v) in form of a 1:1 case control study, compared 33 elective PGS cycles with matched control cycles without PGS, performed in couples with either prior tubal ligations and/or severe male factor infertility as indication of IVF."( Lessons from elective in vitro fertilization (IVF) in, principally, non-infertile women.
Barad, DH; Gleicher, N; Kim, A; Weghofer, A, 2012
)
0.38
"001) and gonadotropin dosage used in ovarian stimulation (P = 0."( Lessons from elective in vitro fertilization (IVF) in, principally, non-infertile women.
Barad, DH; Gleicher, N; Kim, A; Weghofer, A, 2012
)
0.38
" Despite wide use of recombinant gonadotropins in clinical practice, the efficacy of urinary gonadotropins and the dosage of LH component have not yet been elucidated."( Effects of urinary and recombinant gonadotropins on in vitro maturation outcomes of mouse preantral follicles.
Choi, YM; Jung, KC; Kim, JG; Kim, SH; Kim, YJ; Kim, YY; Ku, SY; Liu, HC; Moon, SY; Park, KE, 2013
)
0.39
"7% lower human menopausal gonadotropin (hMG) dosage than the long protocol but surprisingly the number of oocytes retrieved was also smaller."( Estradiol Valerate Pretreatment in Short Protocol GnRH-Agonist Cycles versus Combined Pretreatment with Oral Contraceptive Pills in Long Protocol GnRH-Agonist Cycles: A Randomised Controlled Trial.
Jakiel, G; Kuczynski, W; Kunicki, M; Liss, J; Lukaszuk, K; Pastuszek, E; Plociennik, L; Zabielska, J; Zielinski, K, 2015
)
0.42
" However, the use of MPA may lead to stronger pituitary suppression and thus may require a higher dosage of hMG and a longer duration of ovarian stimulation than that of conventional ovarian stimulation protocol."( New application of dydrogesterone as a part of a progestin-primed ovarian stimulation protocol for IVF: a randomized controlled trial including 516 first IVF/ICSI cycles.
Ai, A; Chang, HY; Gao, H; Kuang, Y; Liu, Y; Long, H; Lyu, Q; Quan, X; Yu, S; Zhu, J, 2018
)
0.48
" Treatment with proper dosage of ovulation induction drugs may enhance the number of normal sized oocytes."( The influence of ovarian hyperstimulation drugs on morphometry and morphology of human oocytes in ICSI program.
Alemzadeh Mehrizi, A; Halvaei, I; Khalili, MA; Taheri, F, 2018
)
0.48
" Single-use pens were associated with the lowest risk of dosing errors."( Qualitative risk assessment of follicle stimulating hormone injectable products.
Jenkins, J; Kendrew, H; Mathur, R; Steinke, DT; Zarroug, OH, 2020
)
0.56
"The study identifies differences in the risks for both sharps injuries and dosing errors between FSH delivery options that practitioners should consider when making a treatment choice."( Qualitative risk assessment of follicle stimulating hormone injectable products.
Jenkins, J; Kendrew, H; Mathur, R; Steinke, DT; Zarroug, OH, 2020
)
0.56
"To evaluate the safety profile and the number of usable blastocysts on day 5 and on day 6 after treatment with an individualized dosing regimen of a follitropin delta and highly purified human menopausal gonadotropin (HP-hMG) for controlled ovarian stimulation."( Individualized ovarian stimulation for in vitro fertilization: a multicenter, open label, exploratory study with a mixed protocol of follitropin delta and highly purified human menopausal gonadotropin.
Bissonnette, F; Kadoch, IJ; Librach, C; Minano Masip, J; Sampalis, J; Yuzpe, A, 2021
)
0.62
"Follitropin delta coadministered with HP-hMG, with follitropin delta dose fixed according to an established algorithm and HP-hMG dose at 75 IU when the follitropin delta starting dosage was <12 μg; 150 IU when follitropin delta dosage was 12 μg and weight <100 kg, and 225 IU when follitropin delta dosage was 12 μg and weight ≥100 kg (dosage adjustments confined to HP-hMG only)."( Individualized ovarian stimulation for in vitro fertilization: a multicenter, open label, exploratory study with a mixed protocol of follitropin delta and highly purified human menopausal gonadotropin.
Bissonnette, F; Kadoch, IJ; Librach, C; Minano Masip, J; Sampalis, J; Yuzpe, A, 2021
)
0.62
"Optimizing the ovarian response during in vitro fertilization employing a mixed protocol of individualized dosing of follitropin delta and HP-hMG resulted in a statistically significant number of usable blastocysts on days 5 and 6 with an increased risk of mild OHSS, which did not require medical intervention or hospitalization."( Individualized ovarian stimulation for in vitro fertilization: a multicenter, open label, exploratory study with a mixed protocol of follitropin delta and highly purified human menopausal gonadotropin.
Bissonnette, F; Kadoch, IJ; Librach, C; Minano Masip, J; Sampalis, J; Yuzpe, A, 2021
)
0.62
"To determine whether serum human follicle-stimulating hormone (FSH) levels after single subcutaneous dosing of highly purified human menopausal gonadotropins (HP-hMG) in a liquid formulation and a powder formulation are bioequivalent."( First pre-filled pen device with highly purified human menopausal gonadotropin (HP-hMG, Menopur) in liquid is shown to be bioequivalent to powder for reconstitution.
Buur Rasmussen, B; Jonker, DM; Koch, M; Larsson, P; Mannaerts, B; Ravi, A; Speer, R, 2021
)
0.62
"The aim of the study was to evaluate dosing of recombinant human luteinizing hormone (r-hLH) or human menopausal gonadotrophin (hMG)-derived medications with LH activity in ovarian stimulation (OS) cycles for in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI)."( Dosing Characteristics of Recombinant Human Luteinizing Hormone or Human Menopausal Gonadotrophin-Derived LH Activity in Patients Undergoing Ovarian Stimulation: A German Fertility Database Study.
Allignol, A; Bühler, K; Fischer, R; Hubbard, J; Lispi, M; Longobardi, S; Schertz, J; Strezsak, V; Verpillat, P, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (2,998)

TimeframeStudies, This Drug (%)All Drugs %
pre-19901264 (42.16)18.7374
1990's1119 (37.32)18.2507
2000's373 (12.44)29.6817
2010's196 (6.54)24.3611
2020's46 (1.53)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 69.09

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index69.09 (24.57)
Research Supply Index8.21 (2.92)
Research Growth Index4.31 (4.65)
Search Engine Demand Index124.41 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (69.09)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials496 (15.65%)5.53%
Reviews199 (6.28%)6.00%
Case Studies315 (9.94%)4.05%
Observational15 (0.47%)0.25%
Other2,144 (67.66%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (65)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Open Randomized Study Comparing Clinical Efficacy of Corifollitropin Alfa (Elonva) in Combination With Menotropin (Merional) With Follitropin and Lutropin Alfa (Pergoveris) for Ovarian Stimulation in Expected Suboptimal Responders [NCT03177538]Phase 432 participants (Actual)Interventional2017-09-04Completed
Influence of Ovarian Stimulation With hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF [NCT01365936]Phase 480 participants (Actual)Interventional2008-01-31Completed
Prospective Randomized Trial Comparing Ovarian Stimulation in IVF-patients With Corifollitropin Alfa in Combination With Hp-FSH Versus Corifollitropin Alfa in Combination With Low Dose hCG [NCT03208972]Phase 4107 participants (Actual)Interventional2014-10-31Completed
Cumulative Pregnancy Rate With Lower and Higher Dose of Gonadotropin During Controlled Ovarian Hyperstimulation During IVF Among Expected Poor Responders: a Prospective, Randomized Controlled Trial [NCT05103228]700 participants (Anticipated)Interventional2021-12-02Recruiting
Phase 4 Study Comparing Recombinant Follicle Stimulating Hormone (rFSH) or Ultra-pure to HMG in Patients Submitted to IVF Using Gnrh Antagonist [NCT02412904]Phase 4188 participants (Actual)Interventional2014-01-31Completed
Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in the Treatment of Male Patients With Isolated Hypogonadotropic Hypogonadism: an Open, Randomized Controlled Study [NCT03687606]Phase 4210 participants (Anticipated)Interventional2018-10-18Recruiting
[NCT01569945]371 participants (Actual)Interventional2004-09-30Completed
A Prospective, Open Label, Randomised, Parallel Group, Comparative Pilot Study to Study the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant FSH (Follitropin Alfa) Administered Subcutaneously to Subfertile Female Patients Undergoing I [NCT00257556]Phase 480 participants (Actual)Interventional2005-10-31Completed
A Prospective Randomized Trial to Study the Effect of Luteal Progesterone Support on Pregnancy Rates in Combined Clomiphene Citrate and Gonadotropin Ovulation Induction Protocol With Intrauterine Insemination. [NCT02510534]Phase 1520 participants (Actual)Interventional2015-07-31Terminated(stopped due to unable to enroll participants who meet the criteria)
Prediction of Metaphase II Oocytes According to Different Levels of Serum AMH in Poor Responders Using the Antagonist Protocol [NCT03484611]179 participants (Anticipated)Interventional2013-01-31Recruiting
Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct and GnRH Agonist Trigger for Egg Bank Donation [NCT02069808]Phase 438 participants (Actual)Interventional2014-04-30Completed
Prospective Randomized Trial on the Effect of DHEA Administration in Women With Poor Ovarian Reserve Undergoing Controlled Ovarian Stimulation for IVF. Impact on Stimulation Characteristics and and Pregnancy Outcome. [NCT02099916]Phase 2/Phase 350 participants (Anticipated)Interventional2014-10-31Not yet recruiting
[NCT02158689]80 participants (Anticipated)Interventional2014-06-30Completed
Effect of GnRH Agonist (Long Protocol) vs GnRH Antagonist (Flexible Protocol) on Oocyte Morphology in Polycystic Ovary Syndrome Patients During IVF/ICSI [NCT04727684]Phase 450 participants (Actual)Interventional2020-08-22Completed
Effect of GnRH Agonist (Long Protocol) vs GnRH Antagonist (Flexible Protocol) on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients. [NCT04727671]Phase 450 participants (Actual)Interventional2019-12-22Completed
Effect of GnRH Agonist (Long Protocol) vs GnRH Antagonist (Flexible Protocol) on Oocyte Morphology During IVF/ICSI [NCT04724486]Phase 450 participants (Actual)Interventional2020-08-22Completed
Effect of GnRH Agonist (Long Protocol) vs GnRH Antagonist (Flexible Protocol) on IVF/ICSI Outcomes. [NCT04724343]Phase 450 participants (Actual)Interventional2019-12-22Completed
Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility [NCT01250821]Phase 475 participants (Actual)Interventional2010-12-31Completed
"An Observational Study FOLLITROPIN Comparing the Efficacy of Follitropin Alpha Biosimilar: the Real-world Data" [NCT04854707]5,484 participants (Actual)Observational2020-01-12Completed
Randomized, Controlled Trial to Assess the Efficacy of Human Menopausal Gonadotrophin Stimulation and Hormone Replacement Therapy for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe Intrauterine Adhesion Patients [NCT03578172]186 participants (Actual)Interventional2018-07-18Completed
A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in Polycystic Ovarian Syndrome (PCOS) Patients [NCT00805935]Phase 4110 participants (Actual)Interventional2009-01-31Completed
Progestin-primed Ovarian Stimulation Protocol Versus GnRH Antagonist Protocol in Polycystic Ovary Syndrome Patients Undergoing IVF/ICSI Cycles [NCT05112692]200 participants (Anticipated)Interventional2021-11-30Not yet recruiting
A Prospective, Randomized, Controlled Trial Comparing Highly Purified hMG With Recombinant FSH + Recombinant LH in Women Undergoing Intrauterine Insemination: Ovarian Response and Clinical Outcomes. [NCT00820482]Phase 480 participants (Anticipated)Interventional2009-01-31Completed
Lipid Profile and Oxidative Stress Parameters of Patients With Idiopathic Hypogonadotropic Hypogonadism and the Change of These Parameters With Gonadotropin Replacement Therapy [NCT02728440]30 participants (Actual)Observational2010-05-31Completed
Influence of Ovarian Stimulation With 200 IU of hCG, (Administered in the Late Follicular Phase Among ICSI Patients Undergoing a GnRH-antagonist Protocol), on the Endometrium on the Day of Oocyte Pick-up [NCT00976651]Phase 430 participants (Anticipated)Interventional2009-01-31Completed
Highly Purified Human Menopausal Gonadotropin Versus Recombinant Follicle Stimulating Hormone in Ovarian Hyperstimulation With Gonadotropin Releasing Hormone Antagonists. A Randomized Study. [NCT00669786]Phase 30 participants InterventionalCompleted
Protocol to Minimize Injections and Blood Draws for Women Undergoing Controlled Ovarian Hyperstimulation for in Vitro Fertilization [NCT02865681]4 participants (Actual)Interventional2016-07-01Completed
A Randomized, Open-label, Assessor-blind, Parallel Groups, Multicentre Trial Comparing the Efficacy of MENOPUR Versus Recombinant FSH in Controlled Ovarian Stimulation Following a GnRH Antagonist Protocol and Single Embryo Transfer [NCT00884221]Phase 3749 participants (Actual)Interventional2009-07-31Completed
Effect of a Higher Than Maximum 450IU Gonadotropin Dose on Patient Outcomes in an In-Vitro Fertilization Setting: a Randomized Controlled Non-infertility Trial [NCT00971152]Phase 3366 participants (Actual)Interventional2009-09-30Completed
A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in GnRH Antagonist Cycles [NCT00802360]Phase 4173 participants (Actual)Interventional2008-12-31Completed
Low Dose GnRHa Early Luteal Phase Down Regulation Versus GnRHa Ultra-short Protocol for Poor Ovarian Response: a Randomized Control Trial [NCT02940535]200 participants (Anticipated)Interventional2016-12-31Not yet recruiting
[NCT02018159]738 participants (Actual)Observational2014-01-31Completed
Randomized, Multicentric and Prospective Clinical Trial to Check the Cost-effectiveness of Corifollitropin Alfa vs. Recombinant FSH and/or HP-hMG [NCT02213627]Phase 4300 participants (Anticipated)Interventional2014-10-31Recruiting
A Randomized, Assessor-blind Trial Comparing MENOPUR® (Menotropins for Injection) and Recombinant FSH (Follicle Stimulating Hormone) in a GnRH Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population [NCT02554279]Phase 4620 participants (Actual)Interventional2015-08-31Completed
Human Menopausal Gonadotropin Combining With Human Chorionic Gonadotropin is Superior to Human Chorionic Gonadotropin in Therapeutic Efficacy in Adolescent Boys With Congenital Hypogonadotropic Hypogonadism [NCT02880280]Phase 440 participants (Anticipated)Interventional2016-08-31Recruiting
Assessing the Relation Between Hormone Receptors Gene Polymorphism and Ovarian Stimulation Response in In Vitro Fertilization (IVF) Program [NCT02640976]Early Phase 1216 participants (Actual)Interventional2013-06-30Completed
Effect of Highly Purified Menotrophin and Recombinant Follicle Stimulating (rFSH, Follitrophin Alpha) in Subfertile Female Patients Undergoing IVF on Progesterone Serum Levels During the Follicular Phase and Their Possible Use as Predictors for the Succes [NCT01225835]Phase 4124 participants (Actual)Interventional2010-10-31Completed
Non-Interventional Clinical Study on Efficacy and Safety of Highly Purified Human Menopausal Gonadotrophin (HP-hMG) Menopur® Multidose in Korean Female Patients With Infertility [NCT02835469]412 participants (Actual)Observational2016-06-30Completed
Prospective Randomised Clinical Study on Pharmacogenetics of Gonadotropin Receptors in Relation to Pregnancy and Life Birth Rate as Well as Unwanted Side Effects Such as Ovarian Hyper Stimulation Syndrome During Assisted Reproduction. [NCT03737253]Phase 4796 participants (Actual)Interventional2016-09-01Completed
Relationship Between antimüllerian Hormone Measured by a Fully Automated Assay and the Initial Dose of HP-hMG (Menopur®) Prescribed for Infertile Women Undergoing Their First IVF/ICSI Cycle. [NCT02935335]297 participants (Actual)Observational2016-10-31Completed
Sonographic and Laboratory Predictors of Ovarian Reserve in Infertile Women [NCT02896023]Phase 4100 participants (Anticipated)Interventional2016-09-30Recruiting
The Impact of Overweight and Obesity on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles [NCT03457233]185 participants (Anticipated)Interventional2015-01-03Recruiting
Natural Cycle Versus Stimulation With Human Menopausal Gonadotropin in Cycles With Cryopreserved Embryos [NCT00492934]300 participants (Anticipated)Interventional2004-01-31Active, not recruiting
Soft Versus Conventional Protocol in Ovarian Stimulation in Intracytoplasmic Sperm Injection Cycles for Poor Responders [NCT04193930]0 participants (Actual)Interventional2021-01-01Withdrawn(stopped due to no women were recruited)
A Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Combination of Menopur® and Bravelle® With Menopur® Alone in Subjects Undergoing Assisted Reproductive Technology (ART) [NCT01417195]Phase 4122 participants (Actual)Interventional2011-07-31Completed
Follicular Fluid, Serum Endocrine Profile Following Stimulation With Recombinant Gonadotropins or Highly Purified Human Menopausal Gonadotropin During GnRH-antagonist Protocol [NCT02992808]Phase 4100 participants (Anticipated)Interventional2016-12-31Not yet recruiting
A Phase IV, Multicenter, Open-label, Randomized Study to Compare the Safety and Efficacy of Cetrotide® 3 mg Versus Antagon™ in the Inhibition of a Premature LH Surge in a r-hFSH/hMG Stimulation Cycle With OCP Programming in Women Undergoing Ovarian Stimul [NCT00298025]Phase 4185 participants (Actual)Interventional2003-09-30Completed
The Effect of LH-Priming During Early Follicular Phase on Ovarian Response and Pregnancy Outcome in GnRHa Down-Regulated Women, Stimulated With Exogenous Gonadotrophins in IVF Treatment [NCT00334425]Phase 4150 participants Interventional2006-04-30Recruiting
Prospective Randomized Open Label Study to Compare the Efficacy and Safety of Ovarian Stimulation With Pergoveris® and Menopur® in Women With Severe Luteinizing Hormone (LH) and Follicular Stimulating Hormone (FSH) Deficiency. [NCT01623570]40 participants (Actual)Interventional2011-03-31Completed
Effects of Single Nucleotide Polymorphism of GnRH Receptor Genes on Clinical Response to Pituitary Down Regulation in IVF Patients [NCT02979886]1,500 participants (Anticipated)Interventional2017-01-31Enrolling by invitation
Effect of GnRH Antagonist Protocol vs Agonist Long Protocol During Controlled Hyperstimulation (COH)for Assisted Reproduction on IVF Outcome, Peak Estradiol Level, and Duration of Stimulation. [NCT01669291]43 participants (Actual)Interventional2012-07-31Completed
SHOview Observational Study. Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old. [NCT01703728]455 participants (Actual)Observational2012-11-30Completed
[NCT01784380]1,159 participants (Actual)Observational2006-10-31Completed
Safety and Efficacy Study Comparing a New hMG Formulation (hMG-IBSA) to a Reference Product (Menopur®) in Patients Undergoing Ovarian Stimulation for in Vitro Fertilisation (IVF) [NCT01312766]Phase 3270 participants (Actual)Interventional2011-02-28Completed
Human Menopausal Gonadotropin as a Novel Addition to Luteal Phase Support in Down-regulated ICSI Cycles (RCT) [NCT03209687]Phase 4600 participants (Anticipated)Interventional2017-07-06Recruiting
A Prospective, Randomized Trial to Compare Mono-menotropins Protocol for Controlled Ovarian Stimulation (COS) Versus Recombinant Follicle Stimulating Hormone (rFSH) Protocol on Embryo Quality Parameters in IVF Patients [NCT02418533]109 participants (Actual)Interventional2015-03-31Completed
Retrospective Analysis of Real-world Data From Medical Records on the Use of Gonadotropin for Infertility Treatment to Describe the Treatment Patterns and to Understand the Clinical Impact [NCT04814940]0 participants (Actual)Observational2022-09-01Withdrawn(stopped due to Based on company decision to close the project)
Type of Gonadotropin During Controlled Ovarian Stimulation Affects the Endocrine Profile in Follicular Fluid and Apoptotic Rate in Granulose Cells [NCT02437032]Phase 4100 participants (Actual)Interventional2009-04-30Completed
A Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of s.c. Administration of IVF-M HP Inj. Versus Menopur® Inj. in Infertility Women Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Technologies [NCT02458768]Phase 4112 participants (Actual)Interventional2013-07-31Completed
An Open-label, Randomised, 2-way Crossover, Single-dose, Bioequivalence Trial Comparing MENOPUR Solution for Injection in Pre-filled Pen and MENOPUR Powder and Solvent for Solution for Injection, After Subcutaneous Administration in Healthy Women [NCT04902131]Phase 195 participants (Actual)Interventional2021-11-02Completed
Double Ovarian Stimulation in Cases of Preimplantation Genetic Testing: Comparison of Embryo Quantity and Embryonic Quality Using MitoScore [NCT03291821]136 participants (Actual)Interventional2017-12-01Completed
A Randomized, Double-blind Double-dummy Trial Comparing MENOPUR Solution for Injection in a Pre-filled Pen and MENOPUR Powder and Solvent for Solution for Injection (Menotropins for Injection) in a GnRH Agonist Cycle in Women Aged 18-42 Years Undergoing a [NCT04163458]Phase 3405 participants (Actual)Interventional2019-10-25Completed
Ovarian Response to Controlled Ovarian Stimulation Measured Through the Follicular Output Rate (FORT) [NCT04416607]300 participants (Actual)Interventional2018-06-15Completed
In Vitro Fertilization Versus Gonadotropin Therapy in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome [NCT02458963]Phase 40 participants (Actual)Interventional2016-01-31Withdrawn
AMH and Dosing Regimens for Initial IVF Stimulation Protocols [NCT03098199]78 participants (Actual)Interventional2015-10-22Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00257556 (11) [back to overview]Mean Endometrial Thickness
NCT00257556 (11) [back to overview]Mean Estradiol Level
NCT00257556 (11) [back to overview]Mean Number of Days Stimulated With Gonadotrophins
NCT00257556 (11) [back to overview]Number of Participants With an Ongoing Pregnancy
NCT00257556 (11) [back to overview]Percentage of Participants With an Ongoing Pregnancy
NCT00257556 (11) [back to overview]Participants With Varying Numbers of Embryos Frozen
NCT00257556 (11) [back to overview]Participants With Varying Numbers of Embryos Transferred
NCT00257556 (11) [back to overview]Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters
NCT00257556 (11) [back to overview]Participants With Varying Numbers of Oocytes Retrieved
NCT00257556 (11) [back to overview]Participants With Varying Numbers of Pronuclear Stage Oocytes
NCT00257556 (11) [back to overview]Pregnancy Outcomes
NCT00802360 (10) [back to overview]Participants With Clinical Pregnancy at Week 7
NCT00802360 (10) [back to overview]Participants With Biochemical Pregnancy at Day 38
NCT00802360 (10) [back to overview]Number of Oocytes Retrieved at Day 18
NCT00802360 (10) [back to overview]Number of Follicles Observed at Day 15
NCT00802360 (10) [back to overview]Number of Embryos Frozen at Day 24
NCT00802360 (10) [back to overview]Number of Embryos Transferred at Three Stages of Development
NCT00802360 (10) [back to overview]Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
NCT00802360 (10) [back to overview]Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle
NCT00802360 (10) [back to overview]Percentage of Participants With Ongoing Pregnancy at Week 8
NCT00802360 (10) [back to overview]Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved
NCT00805935 (13) [back to overview]Estradiol Levels at Day 6
NCT00805935 (13) [back to overview]Percentage of Participants With Biochemical Pregnancy at Approximately Day 38
NCT00805935 (13) [back to overview]Percentage of Participants With Clinical Pregnancy at Week 7
NCT00805935 (13) [back to overview]Percentage of Participants With Ongoing Pregnancy at Week 9
NCT00805935 (13) [back to overview]Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration
NCT00805935 (13) [back to overview]Number of Embryos Transferred at Three Stages of Development Before Implantation
NCT00805935 (13) [back to overview]Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3
NCT00805935 (13) [back to overview]Participants With Treatment Emergent Adverse Events
NCT00805935 (13) [back to overview]Number of Embryos Frozen
NCT00805935 (13) [back to overview]Number of Follicles Observed at Day 15
NCT00805935 (13) [back to overview]Number of Oocytes Retrieved at Day 18
NCT00805935 (13) [back to overview]Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved
NCT00805935 (13) [back to overview]Human Chorionic Gonadotropin (hCG) Levels at Day 6
NCT00884221 (16) [back to overview]Endocrine Profile (Progesterone), Intention-to-treat (ITT) Analysis Set
NCT00884221 (16) [back to overview]Endocrine Profile (Prolactin), Intention-to-treat (ITT) Analysis Set
NCT00884221 (16) [back to overview]Endocrine Profile (Sex Hormone Binding Globulin), Intention-to-treat (ITT) Analysis Set
NCT00884221 (16) [back to overview]Endocrine Profile (Testosterone), Intention-to-treat (ITT) Analysis Set
NCT00884221 (16) [back to overview]Fertilization, Intention-to-treat (ITT) Analysis Set
NCT00884221 (16) [back to overview]Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set
NCT00884221 (16) [back to overview]Number of Oocytes Retrieved in Each Participant, Intention-to-treat (ITT) Analysis Set
NCT00884221 (16) [back to overview]Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set
NCT00884221 (16) [back to overview]Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set
NCT00884221 (16) [back to overview]Blastocyst Quality, Intention-to-treat (ITT) Analysis Set
NCT00884221 (16) [back to overview]Number of Follicles of >= 12mm, 12-14 mm, 15-16 mm and >= 17 mm in Each Participant, Intention-to-treat (ITT) Analysis Set
NCT00884221 (16) [back to overview]Cumulative Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh and 1 Year Frozen Embryo Replacement Cycles, Intention-to-treat (ITT) Analysis Set
NCT00884221 (16) [back to overview]Endocrine Profile (Estradiol), Intention-to-treat (ITT) Analysis Set
NCT00884221 (16) [back to overview]Endocrine Profile (Free Androgen Index), Intention-to-treat (ITT) Analysis Set
NCT00884221 (16) [back to overview]Endocrine Profile (FSH), Intention-to-treat (ITT) Analysis Set
NCT00884221 (16) [back to overview]Endocrine Profile (Luteinizing Hormone), Intention-to-treat (ITT) Analysis Set
NCT01225835 (18) [back to overview]Number of Days Stimulated With Gonadotrophins
NCT01225835 (18) [back to overview]Number of Cumulus-oocyte Complexes Retrieved
NCT01225835 (18) [back to overview]Number of Ampoules of Gonadotrophins Used
NCT01225835 (18) [back to overview]Estradiol (E2) Levels on Day of hCG Administration
NCT01225835 (18) [back to overview]Endometrial Thickness on Day of hCG Administration
NCT01225835 (18) [back to overview]Number of Embryos Transferred
NCT01225835 (18) [back to overview]Number of Follicles at hCG Administration
NCT01225835 (18) [back to overview]Number of Frozen Oocytes at Pronuclear Stage
NCT01225835 (18) [back to overview]Number of Pronuclear Oocytes
NCT01225835 (18) [back to overview]Percentage of Participants With Clinical Pregnancy 6 Weeks After the First Positive Pregnancy Test
NCT01225835 (18) [back to overview]Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration
NCT01225835 (18) [back to overview]Percentage of Participants With Ongoing Pregnancy
NCT01225835 (18) [back to overview]Summary of Pregnancy Outcome
NCT01225835 (18) [back to overview]Receiver Operating Characteristic (ROC) Analysis of Progesterone as Predictor for Ongoing Pregnancy Rate at Day 7 and Day of hCG Administration
NCT01225835 (18) [back to overview]Percentage of Participants With Successful Embryo Transfer
NCT01225835 (18) [back to overview]Number of Participants With Pronuclear Stage Oocytes at Each Quality Grade
NCT01225835 (18) [back to overview]Best Quality of an Embryo Transferred
NCT01225835 (18) [back to overview]Average Follicle Diameter at hCG Administration
NCT01312766 (13) [back to overview]Clinical Pregnancy Rate,
NCT01312766 (13) [back to overview]Controlled Ovarian Stimulation Duration (Days)
NCT01312766 (13) [back to overview]Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)
NCT01312766 (13) [back to overview]Implantation Rate
NCT01312766 (13) [back to overview]Live Birth Rate
NCT01312766 (13) [back to overview]Mean hMG Dose (Total);
NCT01312766 (13) [back to overview]Number of Mature (Grade III Metaphase II) Oocytes Retrieved.
NCT01312766 (13) [back to overview]Positive b-hCG Test
NCT01312766 (13) [back to overview]Ratio Mature/Total Number of Oocytes Retrieved.
NCT01312766 (13) [back to overview]Total Number of Inseminated Oocytes (IVF and ICSI)
NCT01312766 (13) [back to overview]Total Number of Oocytes Retrieved
NCT01312766 (13) [back to overview]Number of Cleaved Embryos
NCT01312766 (13) [back to overview]17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;
NCT01417195 (6) [back to overview]Summary of Assessor Questionnaire on Day 1
NCT01417195 (6) [back to overview]Summary of Assessor Questionnaire on Day 6
NCT01417195 (6) [back to overview]Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1
NCT01417195 (6) [back to overview]Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6
NCT01417195 (6) [back to overview]Fertilization Rate
NCT01417195 (6) [back to overview]Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
NCT02458768 (1) [back to overview]Number of Retrieved Oocytes
NCT02554279 (12) [back to overview]Quality of Embryos
NCT02554279 (12) [back to overview]Clinical Pregnancy Rate
NCT02554279 (12) [back to overview]Early Pregnancy Loss
NCT02554279 (12) [back to overview]Fertilization Rate
NCT02554279 (12) [back to overview]Number of Metaphase II Oocytes
NCT02554279 (12) [back to overview]Number of Oocytes Retrieved
NCT02554279 (12) [back to overview]Positive β-human Chorionic Gonadotropin (hCG) Rate
NCT02554279 (12) [back to overview]Quality of Blastocysts
NCT02554279 (12) [back to overview]Follicular Development as Assessed by TVUS
NCT02554279 (12) [back to overview]Follicular Development as Assessed by TVUS
NCT02554279 (12) [back to overview]Quality of Embryos
NCT02554279 (12) [back to overview]Ongoing Pregnancy Rate
NCT04163458 (54) [back to overview]Proportion of Participants With Ovarian Hyperstimulation Syndrome (OHSS)
NCT04163458 (54) [back to overview]Proportion of Participants With Treatment-induced Anti-MENOPUR Antibodies. Overall as Well as With Neutralizing Capacity
NCT04163458 (54) [back to overview]Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters
NCT04163458 (54) [back to overview]Serum Anti-Müllerian Hormone (AMH) Concentration
NCT04163458 (54) [back to overview]Serum Follicle-stimulating Hormone (FSH) Concentration
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Alanine Aminotransferase
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Aspartate Aminotransferase
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Blood Urea Nitrogen
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Calcium
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Chloride
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Creatinine
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr African American
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr Non-afr. American
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Gamma Glutamyl Transferase
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Glucose
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Potassium
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Sodium
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils/Leukocytes
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils/Leukocytes
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Erythrocytes
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hematocrit
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hemoglobin
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Leukocytes
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes/Leukocytes
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes/Leukocytes
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils/Leukocytes
NCT04163458 (54) [back to overview]Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Platelets
NCT04163458 (54) [back to overview]Clinical Pregnancy Rate
NCT04163458 (54) [back to overview]Early Pregnancy Loss
NCT04163458 (54) [back to overview]Fertilization Rate
NCT04163458 (54) [back to overview]Frequency of Adverse Events (AEs)
NCT04163458 (54) [back to overview]Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period
NCT04163458 (54) [back to overview]Number of Fertilized (2 Pronuclei [2PN]) Oocytes
NCT04163458 (54) [back to overview]Number of Metaphase II (MII) Oocytes
NCT04163458 (54) [back to overview]Number of Oocytes Retrieved
NCT04163458 (54) [back to overview]Number of Participants With Potential Technical Malfunctions of the Administration Pen
NCT04163458 (54) [back to overview]Number of Stimulation Days
NCT04163458 (54) [back to overview]Ongoing Pregnancy Rate
NCT04163458 (54) [back to overview]Positive Beta Human Chorionic Gonadotropin (βhCG) Rate
NCT04163458 (54) [back to overview]Total Gonadotropin Dose
NCT04163458 (54) [back to overview]Estradiol (E2) Concentration
NCT04163458 (54) [back to overview]Follicular Development on Last Day of Stimulation
NCT04163458 (54) [back to overview]Follicular Development on Stimulation Day 6
NCT04163458 (54) [back to overview]Human Chorionic Gonadotropin (hCG) Concentration
NCT04163458 (54) [back to overview]Intensity of AEs
NCT04163458 (54) [back to overview]Intensity of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period
NCT04163458 (54) [back to overview]Luteinizing Hormone (LH) Concentration
NCT04163458 (54) [back to overview]Number of Blastocysts and Number of Good-Quality Blastocysts 5 Days After Oocyte Retrieval
NCT04163458 (54) [back to overview]Progesterone (P4) Concentration
NCT04854707 (5) [back to overview]Number of Mature Oocytes
NCT04854707 (5) [back to overview]Number of Oocytes Retrieved
NCT04854707 (5) [back to overview]Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer
NCT04854707 (5) [back to overview]Total Dose of Follitropin Alpha Biosimilar Protocol, IU
NCT04854707 (5) [back to overview]Number of Fertilized Oocytes

Mean Endometrial Thickness

Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction. (NCT00257556)
Timeframe: Day 7 or 9 or 11 or 13

Interventionmillimeters (Mean)
Menotrophin11.7
Follitropin Alfa11.0

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Mean Estradiol Level

Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction. (NCT00257556)
Timeframe: Day 7 or 9 or 11 or 13

Interventionpicomoles / liter (Mean)
Menotrophin6706.6
Follitropin Alfa6268.3

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Mean Number of Days Stimulated With Gonadotrophins

Number of days stimulated with study drug until participant met the criteria for ovulation induction. Ovulation induction criteria is three follicles greater than or equal to 17 mm diameter as shown by pelvic ultrasound examination. (NCT00257556)
Timeframe: study days 1 - 13

Interventiondays (Mean)
Menotrophin9.2
Follitropin Alfa8.9

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Number of Participants With an Ongoing Pregnancy

Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test. (NCT00257556)
Timeframe: Approx week 13; 9 weeks or more after the 1st positive pregnancy test

Interventionparticipants (Number)
Menotrophin14
Follitropin Alfa13

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Percentage of Participants With an Ongoing Pregnancy

Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action. (NCT00257556)
Timeframe: Approx week 13; 9 weeks or more after the first positive pregnancy test

Interventionpercentage of participants (Number)
Menotrophin37.8
Follitropin Alfa33.3

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Participants With Varying Numbers of Embryos Frozen

Number of participants with different categories of number of embryos frozen. (NCT00257556)
Timeframe: Approximately study day 17

,
Interventionparticipants (Number)
0 embryos frozen1 embryo frozen2 embryos frozen3 embryos frozen4 embryos frozen5 embryos frozen6-8 embryos frozen9 embryos frozen10 embryos frozen
Follitropin Alfa2201422011
Menotrophin1612140000

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Participants With Varying Numbers of Embryos Transferred

Number of participants with various categories of numbers of embryos transferred. (NCT00257556)
Timeframe: Approximately study day 17

,
Interventionparticipants (Number)
0 embryos transferred1 embryo transferred2 embryos transferred3 embryos transferred
Follitropin Alfa11283
Menotrophin03210

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Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters

The criterion for ovulation induction was three follicles ≥ 17 mm diameter as shown by pelvic ultrasound examination. Patients were assessed by pelvic ultrasound on the morning (prior to menotrophin or follitropin alfa administration) of Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) until the criterion was met. (NCT00257556)
Timeframe: Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)

,
Interventionparticipants (Number)
Did not meet criterion3 follicles ≥ 17 mm in diameter4 follicles ≥ 17 mm in diameter5 follicles ≥ 17 mm in diameter6 follicles ≥ 17 mm in diameter7 follicles ≥ 17 mm in diameter8 follicles ≥ 17 mm in diameter9 follicles ≥ 17 mm in diameter10 follicles ≥ 17 mm in diameter11-14 follicles ≥ 17 mm in diameter15 follicles ≥ 17 mm in diameter16 follicles ≥ 17 mm in diameter
Follitropin Alfa311101010300010
Menotrophin10117240101001

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Participants With Varying Numbers of Oocytes Retrieved

Number of participants with grouped by the number of oocytes retrieved. Oocytes were retrieved following ovulation induction by subcutaneous administration of human chorionic gonadotrophin (hCG) in the form of choriogonadotropin alfa at a dose of 250 micrograms once participants reached the criteria of at least three follicles with >= 17mm in diameter. (NCT00257556)
Timeframe: Approximately study day 15

,
Interventionparticipants (Number)
0 oocytes retrieved1 oocyte retrieved2 oocytes retrieved3 oocytes retrieved4 oocytes retrieved5 oocytes retrieved6 oocytes retrieved7 oocytes retrieved8 oocytes retrieved9 oocytes retrieved10 oocytes retrieved11 oocytes retrieved12 oocytes retrieved13 oocytes retrieved14 oocytes retrieved15 oocytes retrieved16 oocytes retrieved17-18 oocytes retrieved19 oocytes retrieved20 oocytes retrieved21 oocytes retrieved22 oocytes retrieved23 oocytes retrieved
Follitropin Alfa01112542423041032020001
Menotrophin11332242221000101010100

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Participants With Varying Numbers of Pronuclear Stage Oocytes

Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination. (NCT00257556)
Timeframe: Approximately study day 15

,
Interventionparticipants (Number)
1 pronuclear stage oocyte2 pronuclear stage oocytes3 pronuclear stage oocytes4 pronuclear stage oocytes5 pronuclear stage oocytes6 pronuclear stage oocytes7 pronuclear stage oocytes8 pronuclear stage oocytes9 pronuclear stage oocytes10 pronuclear stage oocytes11 pronuclear stage oocytes12 pronuclear stage oocytes13 pronuclear stage oocytes14-16 pronuclear stage oocytes17 pronuclear stage oocytes
Follitropin Alfa063770221104101
Menotrophin181241221120000

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Pregnancy Outcomes

Long term follow-up to determine the outcome of the pregnancy. (NCT00257556)
Timeframe: Approximately 10 months

,
Interventionparticipants (Number)
MiscarriagePre-term: 1 live birthPre-term: 2 live birthsPre-term stillbirthFull term: 1 live birthFull term: 2 live births
Follitropin Alfa413162
Menotrophin412073

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Participants With Clinical Pregnancy at Week 7

Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination. (NCT00802360)
Timeframe: approximately week 7

Interventionparticipants (Number)
Menopur/Endometrin19
Menopur/Progesterone in Oil19
Follistim/Endometrin18
Follistim/Progesterone in Oil20

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Participants With Biochemical Pregnancy at Day 38

Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer. (NCT00802360)
Timeframe: approximately day 38 (Day 14 post embryo transfer)

Interventionparticipants (Number)
Menopur/Endometrin21
Menopur/Progesterone in Oil20
Follistim/Endometrin22
Follistim/Progesterone in Oil23

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Number of Oocytes Retrieved at Day 18

The mean number of oocytes retrieved within 34-36 hours of human chorionic gonadotropin (hCG) administration. (NCT00802360)
Timeframe: Approximately Day 18

Interventionoocytes (Mean)
Menopur11.5
Follistim13.8

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Number of Follicles Observed at Day 15

The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase. (NCT00802360)
Timeframe: Day 15

Interventionfollicles (Mean)
Menopur15.6
Follistim16.2

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Number of Embryos Frozen at Day 24

The number of embryos that were not transferred but instead were frozen for future use. (NCT00802360)
Timeframe: Approximately Day 24

Interventionembryos (Mean)
Menopur1.9
Follistim1.6

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Number of Embryos Transferred at Three Stages of Development

The number of embryos, morula and blastocytes transferred to the study participant on either day 3 or day 5 following fertilization. (NCT00802360)
Timeframe: Approximately Day 24

,
Interventionembryos (Mean)
Number of Embryos transferredNumber of Morula transferredNumber of Blastocytes transferred
Follistim2.40.10.9
Menopur2.10.00.9

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Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)

"Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale:~mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable)~Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable.~Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly." (NCT00802360)
Timeframe: Day 1 - week 12

,,,
Interventionparticipants (Number)
With at least one adverse eventMild or moderate adverse eventSevere adverse eventSerious adverse eventUnrelated or unlikely adverse eventPossibly or probably related adverse event
Follistim/Endometrin181821177
Follistim/Progesterone in Oil2121001415
Menopur/Endometrin2020101510
Menopur/Progesterone in Oil181801138

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Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle

A count of participants whose discontinuation was clearly documented on the study completion/termination form as 1) due to cycle cancelled or 2) cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS). (NCT00802360)
Timeframe: Day 1 to Day 24

Interventionparticipants (Number)
Menopur/Endometrin0
Menopur/Progesterone in Oil1
Follistim/Endometrin1
Follistim/Progesterone in Oil2

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Percentage of Participants With Ongoing Pregnancy at Week 8

The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound. (NCT00802360)
Timeframe: Week 8 (Week 6 of gestation)

Interventionpercentage of participants (Number)
Menopur/Endometrin45.2
Menopur/Progesterone in Oil45.2
Follistim/Endometrin42.9
Follistim/Progesterone in Oil48.7

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Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved

The proportion of the number of oocytes inseminated (fertilized) of the total number of oocytes retrieved. (NCT00802360)
Timeframe: Approximately Day 19

Interventionproportion of oocytes retrieved (Mean)
Menopur0.3
Follistim0.3

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Estradiol Levels at Day 6

Estradiol monitoring during fertility therapy assesses follicular growth and is useful in monitoring the treatment. Blood tests sent to a central laboratory to obtain estradiol levels. (NCT00805935)
Timeframe: Day 6

Interventionpg/mL (Mean)
Menotropin/Progesterone Vaginal Insert354.6
Menotropin/Progesterone in Oil268.2
Follitropin Beta/Progesterone Vaginal Insert617.5
Follitropin Beta/Progesterone in Oil550.5

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Percentage of Participants With Biochemical Pregnancy at Approximately Day 38

Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer. (NCT00805935)
Timeframe: approximately day 38 (Day 14 post embryo transfer)

InterventionPercentage of participants (Number)
Menotropin/Progesterone Vaginal Insert60.0
Menotropin/Progesterone in Oil55.6
Follitropin Beta/Progesterone Vaginal Insert60.7
Follitropin Beta/Progesterone in Oil73.3

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Percentage of Participants With Clinical Pregnancy at Week 7

Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination. (NCT00805935)
Timeframe: approximately Day 52

InterventionPercentage of participants (Number)
Menotropin/Progesterone Vaginal Insert56.0
Menotropin/Progesterone in Oil33.3
Follitropin Beta/Progesterone Vaginal Insert46.4
Follitropin Beta/Progesterone in Oil66.7

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Percentage of Participants With Ongoing Pregnancy at Week 9

Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination. (NCT00805935)
Timeframe: approximately Day 65

InterventionPercentage of participants (Number)
Menotropin/Progesterone Vaginal Insert48.0
Menotropin/Progesterone in Oil33.3
Follitropin Beta/Progesterone Vaginal Insert46.4
Follitropin Beta/Progesterone in Oil63.3

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Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration

Blood tests were sent to a central laboratory to obtain progesterone levels. (NCT00805935)
Timeframe: approximately day 16

Interventionng/mL (Mean)
Menotropin/Progesterone Vaginal Insert1.3
Menotropin/Progesterone in Oil1.1
Follitropin Beta/Progesterone Vaginal Insert1.7
Follitropin Beta/Progesterone in Oil1.3

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Number of Embryos Transferred at Three Stages of Development Before Implantation

"The number of embryos, morulas and blastocysts transferred to the study participant on either day 3 or day 5 following fertilization. Embryos represent the earliest development stage and contain 2-8 cells.~Morulas, the next stage, continued cellular cleavage results in a 16-30 cell solid sphere. Morula further develop into blastocyst, which contains 70-100 cells in a hollow spherical shape." (NCT00805935)
Timeframe: approximately day 24

,
InterventionEmbryos (Mean)
Number of embryos transferredNumber of morula transferredNumber of blastocyst transferred
Follitropin Beta2.00.11.1
Menotropin2.00.00.8

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Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3

A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS). (NCT00805935)
Timeframe: weeks 1-3

,,,
InterventionParticipants (Number)
YesNo
Follitropin Beta/Progesterone in Oil030
Follitropin Beta/Progesterone Vaginal Insert127
Menotropin/Progesterone in Oil027
Menotropin/Progesterone Vaginal Insert124

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Participants With Treatment Emergent Adverse Events

"Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale:~mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable.~Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly." (NCT00805935)
Timeframe: Week 1 to week12

,,,
InterventionParticipants (Number)
With at least one adverse eventWith at least one mild or moderate adverse eventWith at least one severe adverse eventWith at least one serious adverse eventWith at least one unrelated or unlikely AEWith at least one possibly or probably related AE
Follitropin Beta/Progesterone in Oil141400136
Follitropin Beta/Progesterone Vaginal Insert151510128
Menotropin/Progesterone in Oil121121117
Menotropin/Progesterone Vaginal Insert990083

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Number of Embryos Frozen

The number of embryos that were not transferred but instead were frozen for future use. (NCT00805935)
Timeframe: approximately day 24

InterventionEmbryos (Mean)
Menotropin1.9
Follitropin Beta1.9

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Number of Follicles Observed at Day 15

The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase. (NCT00805935)
Timeframe: approximately day 15

InterventionFollicles (Mean)
Menotropin27.7
Follitropin Beta30.5

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Number of Oocytes Retrieved at Day 18

The mean number of oocytes retrieved approximately 36 hours after hCG (Novarel®) administration and fertilized (by insemination or intra cytoplasmic sperm injection (ICSI)) according to site-specific procedures. (NCT00805935)
Timeframe: approximately day 18

InterventionOocytes (Mean)
Menotropin13.0
Follitropin Beta15.6

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Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved

The fertilization rate for each participant was the percentage of the number of oocytes inseminated of the total number of oocytes retrieved. (NCT00805935)
Timeframe: approximately day 19

InterventionPercentage of oocytes retrieved (Number)
Menotropin17.1
Follitropin Beta24.8

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Human Chorionic Gonadotropin (hCG) Levels at Day 6

Blood tests were sent to a central laboratory to obtain hCG levels. (NCT00805935)
Timeframe: Day 6

InterventionmIU/ml (Mean)
Menotropin/Progesterone Vaginal Insert1.0
Menotropin/Progesterone in Oil1.0
Follitropin Beta/Progesterone Vaginal Insert1.0
Follitropin Beta/Progesterone in Oil1.0

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Endocrine Profile (Progesterone), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn (NCT00884221)
Timeframe: On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

Interventionnmol/L (Mean)
Highly Purified Menotrophin3.1
Recombinant FSH3.1

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Endocrine Profile (Prolactin), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn (NCT00884221)
Timeframe: On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

Interventionpmol/L (Mean)
Highly Purified Menotrophin1544
Recombinant FSH1410

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Endocrine Profile (Sex Hormone Binding Globulin), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn (NCT00884221)
Timeframe: On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

Interventionnmol/L (Mean)
Highly Purified Menotrophin111
Recombinant FSH107

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Endocrine Profile (Testosterone), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn (NCT00884221)
Timeframe: On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

Interventionnmol/L (Mean)
Highly Purified Menotrophin2.5
Recombinant FSH2.1

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Fertilization, Intention-to-treat (ITT) Analysis Set

Fertilized oocytes with 2 pronuclei were regarded as correctly fertilized. Fertilization was estimated as (Number of oocytes with 2 pronuclei / number of metaphase II oocytes)*100 (NCT00884221)
Timeframe: 1 day after oocyte retrieval (19 h post-insemination)

InterventionPercentage of metaphase II oocytes (Mean)
Highly Purified Menotrophin75
Recombinant FSH76

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Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set

(NCT00884221)
Timeframe: Post-trial information

InterventionPercentage of participants (Mean)
Highly Purified Menotrophin28
Recombinant FSH26

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Number of Oocytes Retrieved in Each Participant, Intention-to-treat (ITT) Analysis Set

Oocyte retrieval took place 36h (± 2h) after hCG administration. At oocyte retrieval, the number of oocytes retrieved was recorded. (NCT00884221)
Timeframe: 36 h after hCG

InterventionOocytes per participant (Mean)
Highly Purified Menotrophin9.1
Recombinant FSH10.7

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Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set

Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage (NCT00884221)
Timeframe: 10-11 weeks after embryo transfer at the blastocyst stage

InterventionPercentage of participants (Mean)
Highly Purified Menotrophin29
Recombinant FSH27

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Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set

Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage (NCT00884221)
Timeframe: 10-11 weeks after embryo transfer at the blastocyst stage

InterventionPercentage of participants (Mean)
Highly Purified Menotrophin30
Recombinant FSH27

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Blastocyst Quality, Intention-to-treat (ITT) Analysis Set

"Blastocyst quality on day 5 was based on the blastocyst expansion and hatching status, inner cell mass grading and trophectoderm grading.~Excellent-quality blastocysts were defined as those with blastocyst expansion and hatching status 4, 5 or 6, inner cell mass grading A, and trophectoderm grading A or B. Good-quality blastocysts were defined as those with blastocyst expansion and hatching status 3, 4, 5 or 6, inner cell mass grading A or B, and trophectoderm grading A or B." (NCT00884221)
Timeframe: 5 days after oocyte retrieval (120h post-insemination)

,
InterventionNumber of blastocysts (Mean)
Blastocyst 1 / 2 pnBlastocyst 2 / 2pnBlastocyst 3 / 2pnBlastocyst 4 / 2pnBlastocyst 5 / 2pnBlastocyst 6 / 2pnBlastocyst 4AA/ 2pnBlastocyst 5AA / 2pn
Highly Purified Menotrophin7710187052
Recombinant FSH7510206052

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Number of Follicles of >= 12mm, 12-14 mm, 15-16 mm and >= 17 mm in Each Participant, Intention-to-treat (ITT) Analysis Set

During the controlled ovarian stimulation, transvaginal ultrasound was performed to count the number of follicles and measure the size of the follicles. (NCT00884221)
Timeframe: Last stimulation day

,
InterventionFollicles per participant (Mean)
>= 12 mm12-14 mm15-16 mm>=17 mm
Highly Purified Menotrophin10.93.32.74.9
Recombinant FSH11.83.82.75.2

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Cumulative Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh and 1 Year Frozen Embryo Replacement Cycles, Intention-to-treat (ITT) Analysis Set

(NCT00884221)
Timeframe: Post-trial information

InterventionPercentage of participants (Mean)
Highly Purified Menotrophin40
Recombinant FSH38

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Endocrine Profile (Estradiol), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn (NCT00884221)
Timeframe: On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

Interventionpmol/L (Mean)
Highly Purified Menotrophin8797
Recombinant FSH7022

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Endocrine Profile (Free Androgen Index), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn. Free androgen index = (testosterone (nmol/L)/ sex hormone binding globulin (nmol/L))*100 (NCT00884221)
Timeframe: On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

InterventionPercentage of participants (Mean)
Highly Purified Menotrophin2.8
Recombinant FSH2.5

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Endocrine Profile (FSH), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn (NCT00884221)
Timeframe: On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

InterventionIU/L (Mean)
Highly Purified Menotrophin15.7
Recombinant FSH12.6

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Endocrine Profile (Luteinizing Hormone), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn (NCT00884221)
Timeframe: On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

InterventionIU/L (Mean)
Highly Purified Menotrophin2.8
Recombinant FSH2.1

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Number of Days Stimulated With Gonadotrophins

Number of days in which gonadotrophins were administered until hCG criteria were met. If hCG criteria were not met by day 13, the participant was withdrawn from the study. (NCT01225835)
Timeframe: Day 1 up to Day 12

Interventiondays (Mean)
Menotrophin8.7
Follitrophin Alpha9.1

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Number of Cumulus-oocyte Complexes Retrieved

Cumulus-oocyte complexes are oocytes with surrounding cumulus cells. (NCT01225835)
Timeframe: approximately day 12 after study start

Interventionoocytes (Mean)
Menotrophin6.8
Follitrophin Alpha10.0

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Number of Ampoules of Gonadotrophins Used

Number of ampoules of gonadotrophins used with the goal of reaching hCG criteria. Each ampoule contained 75 IU of either menotrophin or follitrophin alpha. (NCT01225835)
Timeframe: Day 1 up to Day 12

Interventionampoules (Mean)
Menotrophin20.8
Follitrophin Alpha21.5

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Estradiol (E2) Levels on Day of hCG Administration

(NCT01225835)
Timeframe: approximately day 10

Interventionng/ml (Mean)
Menotrophin1.81
Follitrophin Alpha1.65

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Endometrial Thickness on Day of hCG Administration

Endometrial thickness was assessed by pelvic ultrasound on the day of hCG administration. (NCT01225835)
Timeframe: approximately day 10

Interventionmm (Mean)
Menotrophin10.8
Follitrophin Alpha11.0

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Number of Embryos Transferred

Mean number of embryos transferred 2-3 days following oocyte retrieval. (NCT01225835)
Timeframe: approximately day 14

Interventionembryos (Mean)
Menotrophin2.0
Follitrophin Alpha2.0

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Number of Follicles at hCG Administration

Number of follicles >=17 mm diameter detected by pelvic ultrasound examination at day of hCG administration. (NCT01225835)
Timeframe: approximately day 10

Interventionfollicles (Mean)
Menotrophin8.7
Follitrophin Alpha10.5

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Number of Frozen Oocytes at Pronuclear Stage

No more than three normally developed embryos were transferred 2-3 days after oocyte retrieval. Other normally developed embryos were frozen. (NCT01225835)
Timeframe: approximately day 14

Interventionoocytes (Mean)
Menotrophin1.0
Follitrophin Alpha2.7

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Number of Pronuclear Oocytes

Pronuclear oocytes are fertilized oocytes. (NCT01225835)
Timeframe: approximately day 13 after study start

Interventionoocytes (Mean)
Menotrophin3.7
Follitrophin Alpha5.9

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Percentage of Participants With Clinical Pregnancy 6 Weeks After the First Positive Pregnancy Test

A pelvic ultrasound scan was performed approximately 6 weeks after the first positive pregnancy test and the presence of an active foetal heart action indicated a clinical pregnancy. (NCT01225835)
Timeframe: approximately 2.5 months from start of study, 6 weeks after first positive pregnancy test

Interventionpercentage of participants (Number)
Menotrophin29.2
Follitrophin Alpha31.0

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Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration

Ovulation induction was performed by administration of hCG once three follicles >=17 mm diameter as shown by pelvic ultrasound examination. This outcome compares the serum progesterone level the morning prior to hCG administration across treatment arm, and also by age stratum (<39 years and >=39 years). (NCT01225835)
Timeframe: approximately day 10

Interventionng/ml (Mean)
Menotrophin0.69
Menotrophin: Stratum Age <39 Yrs0.72
Menotrophin: Stratum Age >=39 Yrs0.54
Follitrophin Alpha0.89
Follitrophin Alpha: Stratum Age <39 Yrs0.92
Follitrophin Alpha: Stratum Age >=39 Yrs0.80

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Percentage of Participants With Ongoing Pregnancy

Ongoing pregnancy is defined as having a positive foetal heart action nine or more weeks after the first positive pregnancy test. (NCT01225835)
Timeframe: approximately 3.5 months from study start (at least 9 weeks after first positive pregnancy test)

Interventionpercentage of participants (Number)
Menotrophin29.2
Follitrophin Alpha31.0

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Summary of Pregnancy Outcome

Pregnancy outcomes were reported at the optional long-term follow up visit. (NCT01225835)
Timeframe: up to 10 months

,
Interventionparticipants (Number)
Live birthEctopic pregnancyCongenial abnormality
Follitrophin Alpha1601
Menotrophin1310

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Receiver Operating Characteristic (ROC) Analysis of Progesterone as Predictor for Ongoing Pregnancy Rate at Day 7 and Day of hCG Administration

The influence of the progesterone level on the ongoing pregnancy rate (in relation to all randomized patients) was determined by means of the receiver operating characteristic (ROC) curve. Youden's Index (sensitivity + specificity -1) has a range of 0-1, with 0.5 indicating a random effect. (NCT01225835)
Timeframe: Day 7, approximately Day 10 (hCG Administration)

InterventionYouden's index (Number)
Day 7Day of hCG Administration (approx Day 10)
All Participants0.51890.4944

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Percentage of Participants With Successful Embryo Transfer

(NCT01225835)
Timeframe: approximately day 18

,
Interventionpercentage of participants (Number)
NoYes
Follitrophin Alpha6.993.1
Menotrophin4.295.8

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Number of Participants With Pronuclear Stage Oocytes at Each Quality Grade

"The count of participants with different quality grades of pronuclear stage oocytes is offered. Pronuclear stage oocytes are categorized into seven grades (0A, 0B, 1-5) representing different patterns of pronuclear morphology, according to the German Pronuclear Morphology Study Group. 0A is the highest quality oocyte and grade 5 is the lowest quality.~Participants can have pronuclear stage oocytes of different grades and therefore are counted more than once." (NCT01225835)
Timeframe: approximately day 13

,
Interventionparticipants (Number)
Grade 0AGrade 0BGrade 1Grade 2Grade 3Grade 4Grade 5
Follitrophin Alpha17234025241123
Menotrophin111533158211

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Best Quality of an Embryo Transferred

"Embryo quality was measured by the following grades:~Grade 1: Evenly sized cells, regular cleavage, no fragmentation~Grade 2: Regular or slightly irregular cleavage, <=20% fragmentation~Grade 2.5: Regular or slightly irregular cleavage, >20%and <=50% fragmentation~Grade 3: Irregular cleavage, >50% fragmentation, >1 intact cell~Grade 4: Extensive fragmentation, only 1 cell intact~Grade 5: Totally fragmented, no viable cells.~Grade 1 represents the healthiest embryos and Grade 5 embryos are not viable." (NCT01225835)
Timeframe: approximately day 14

,
Interventionparticipants (Number)
Grade 1Grade 2Grade >2
Follitrophin Alpha26226
Menotrophin22186

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Average Follicle Diameter at hCG Administration

(NCT01225835)
Timeframe: approximately day 10

Interventionmm (Mean)
Menotrophin17.6
Follitrophin Alpha18.1

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Clinical Pregnancy Rate,

defined as a pregnancy showing ultrasound embryonic heart activity at 10 - 11 weeks after embryo transfer; (NCT01312766)
Timeframe: 10 - 11 weeks after embryo transfer

Interventionpercentage of participants (Number)
hMG-IBSA33.3
Menopur37.1

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Controlled Ovarian Stimulation Duration (Days)

(NCT01312766)
Timeframe: up to 23 days after treatment start

Interventiondays (Mean)
hMG-IBSA10.2
Menopur10.6

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Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)

Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded. (NCT01312766)
Timeframe: up to 28 days after treatment start

Interventionpercentage of participants (Number)
hMG-IBSA63.3
Menopur63.3

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Implantation Rate

defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100; (NCT01312766)
Timeframe: 10-11 weeks after embryo transfer

Interventionpercentage of embryos transferred (Mean)
hMG-IBSA29.1
Menopur28.2

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Live Birth Rate

(NCT01312766)
Timeframe: 9 months after treatment

Interventionpercentage of participants (Number)
hMG-IBSA32.6
Menopur36.3

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Mean hMG Dose (Total);

(NCT01312766)
Timeframe: up to 22 days after treatment start

InterventionInternationa Units (IU) (Mean)
hMG-IBSA2171.4
Menopur2303.6

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Number of Mature (Grade III Metaphase II) Oocytes Retrieved.

(NCT01312766)
Timeframe: at the end of the stimulation.

Interventionoocytes (Mean)
hMG-IBSA10.3
Menopur8.2

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Positive b-hCG Test

(NCT01312766)
Timeframe: up to 5 weeks after treatment start

Interventionpercentage of participants (Number)
hMG-IBSA43.7
Menopur45.2

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Ratio Mature/Total Number of Oocytes Retrieved.

Percentage of retrieved oocytes considered to be mature. (NCT01312766)
Timeframe: at the end of the stimulation.

Interventionpercentage of total oocytes retrieved (Number)
hMG-IBSA85
Menopur81

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Total Number of Inseminated Oocytes (IVF and ICSI)

number of oocytes that were inseminated via IVF or injected via ICSI technique. (NCT01312766)
Timeframe: on the day of oocyte retrieval

Interventionoocytes (Mean)
hMG-IBSA10.8
Menopur8.4

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Total Number of Oocytes Retrieved

(NCT01312766)
Timeframe: up to 24 days after treatment start

Interventionnumber of oocytes (Mean)
hMG-IBSA11.6
Menopur9.7

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Number of Cleaved Embryos

(NCT01312766)
Timeframe: two days after insemination

Interventionembryos (Mean)
hMG-IBSA5.8
Menopur4.8

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17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;

(NCT01312766)
Timeframe: up to 23 days after treatment start

Interventionpg/ml (Mean)
hMG-IBSA2613.8
Menopur2364.0

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Summary of Assessor Questionnaire on Day 1

"Participants assigned to the Menopur and Bravelle treatment arm read the Mixing Instructions Guide on how to mix and administer the medications at home. Participants were given enough time to read and understand the instructions and ask any questions. After completing the SCQ, participants prepared and self-administered her assigned first daily dose in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES.~Gonadotropins are referred to as investigational medicinal product (IMP)." (NCT01417195)
Timeframe: Day 1

Interventionparticipants (Number)
Acknowledged understanding of mixing instructionsFilled the syringe with saline solution correctlyMixed the first IMP vial with solution correctlyMixed additional IMP in same syringe correctlyInjected the IMPs correctlyAcknowledged understanding of how to store IMPsDisposed used vials, syringes, needles correctly
Menopur and Bravelle Combination60606060606060

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Summary of Assessor Questionnaire on Day 6

"Participants assigned to the Menopur and Bravelle treatment arm prepared and self-administered her daily dose on Day 6 in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES.~Gonadotropins are referred to as investigational medicinal product (IMP)." (NCT01417195)
Timeframe: Day 6

Interventionparticipants (Number)
Acknowledged understanding of mixing instructionsFilled the syringe with saline solution correctlyMixed the first IMP vial with solution correctlyMixed additional IMP in same syringe correctlyInjected the IMPs correctlyAcknowledged understanding of how to store IMPsDisposed used vials, syringes, needles correctly
Menopur and Bravelle Combination60606060606060

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Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1

Subject comprehension questionnaires were completed on Day 1 only by participants assigned to the Menopur and Bravelle treatment arm. On Day 1, the participant read the Mixing Instructions Guide on how to mix and administer the medications at home. The participant was given enough time to read and understand the instructions and ask any questions. The participant then completed the SCQ which consists of 7 questions with YES/NO answers, to self-gauge their understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP). (NCT01417195)
Timeframe: Day 1

Interventionparticipants (Number)
Overall mixing instructionsHow to fill the syringe with saline solutionHow to mix the first IMP vial with solutionHow to mix additional vials of IMP in same syringeHow to inject the IMPsHow to store the IMPsHow to dispose of used vials, syringes, needles
Menopur and Bravelle Combination60606060606060

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Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6

Subject comprehension questionnaires were repeated on Day 6 after 5 days of combination therapy by participants assigned to the Menopur and Bravelle treatment arm. The SCQ consists of 7 questions with YES/NO answers to self-gauge participants' understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP). (NCT01417195)
Timeframe: Day 6

Interventionparticipants (Number)
Overall mixing instructionsHow to fill the syringe with saline solutionHow to mix the first IMP vial with solutionHow to mix additional vials of IMP in same syringeHow to inject the IMPsHow to store the IMPsHow to dispose of used vials, syringes, needles
Menopur and Bravelle Combination60606060606060

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Fertilization Rate

The fertilization rate was defined for each participant and calculated as the number of 2 pronuclei (fertilized) (2PN) oocytes divided by the total number of oocytes retrieved multiplied by 100. (NCT01417195)
Timeframe: approximately day 13 (16-20 hours post insemination by in vitro fertilization (IVF) insemination or intracytoplasmic sperm injection (ICSI))

Interventionpercentage of oocytes retrieved (Mean)
Menopur and Bravelle Combination63.14
Menopur Alone59.56

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Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)

A treatment-emergent AE was any AE occurring after start of investigational medicinal product (IMP) and within the time of residual drug effect, or a pretreatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. The time of residual drug effect was the estimated period of time after the last dose of the IMP, where the effect of the product was still considered to be present based on pharmacokinetic, pharmacodynamic, or other IMP characteristics. (NCT01417195)
Timeframe: Day 1 up to Day 20

,
Interventionparticipants (Number)
Any TEAEsDrug-related TEAEsSevere TEAEsSerious TEAEsDrug-related Serious TEAEsAny TEAEs resulting in study discontinuationParticipants who diedParticipants with OHSSCycle cancellation due to OHSS
Menopur Alone30131000030
Menopur and Bravelle Combination2990000050

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Number of Retrieved Oocytes

(NCT02458768)
Timeframe: 36 hrs (±3 hrs) after administration of the ovulation stimulant

InterventionOocytes (Mean)
IVF-M HP Inj.13.14
Menopur® Inj.10.29

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Quality of Embryos

Assessed by blastomere uniformity, cell size, the degree of fragmentation, and visual signs of multinucleation. (NCT02554279)
Timeframe: 3 days after oocyte retrieval

,
Interventionpercentage of embryos (Number)
Blastomere uniformity-Equally sized blastomeresCell size classification-Stage specificDegree of fragmentation-≤10%Multinucleation present
Menotropin63.175.581.10.7
Recombinant FSH59.070.881.01.1

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Clinical Pregnancy Rate

Defined as percentage of participants with transvaginal ultrasound (TVUS) showing at least 1 intrauterine gestational sac with fetal heart beat at 6-7 weeks of gestation. (NCT02554279)
Timeframe: 4-5 weeks after blastocyst transfer in the fresh cycle

Interventionpercentage of participants (Number)
Menotropin37.1
Recombinant FSH33.3

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Early Pregnancy Loss

Defined as participants with 2 positive β-hCG tests but no ongoing pregnancy at 10-11 weeks of gestation in the fresh cycle. Percentage of participants with early pregnancy loss is presented. (NCT02554279)
Timeframe: At 10-11 weeks of gestation in the fresh cycle

Interventionpercentage of participants (Number)
Menotropin14.3
Recombinant FSH23.8

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Fertilization Rate

Defined as 100 times the ratio of number of fertilized 2 pronuclei oocytes to the number of oocytes retrieved, for each participant. (NCT02554279)
Timeframe: On day 1 post-insemination

Interventionpercentage of each participant (Mean)
Menotropin55.09
Recombinant FSH59.07

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Number of Metaphase II Oocytes

(NCT02554279)
Timeframe: At oocyte retrieval visit (approximately 36 hours after hCG administration)

Interventionmetaphase II oocytes (Mean)
Menotropin10.1
Recombinant FSH15.9

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Number of Oocytes Retrieved

(NCT02554279)
Timeframe: At oocyte retrieval visit (approximately 36 hours after hCG administration)

Interventionoocytes (Mean)
Menotropin15.1
Recombinant FSH22.2

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Positive β-human Chorionic Gonadotropin (hCG) Rate

Defined as the percentage of participants with 2 positive β-hCG tests within 2 days in serum. (NCT02554279)
Timeframe: First test approximately 10-14 days after blastocyst transfer in the fresh cycle, with a second test approximately 2 days later if first test was positive

Interventionpercentage of participants (Number)
Menotropin40.6
Recombinant FSH39.5

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Quality of Blastocysts

Assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cell). (NCT02554279)
Timeframe: 5 days after oocyte retrieval

,
Interventionpercentage of embryos (Number)
Excellent qualityGood qualityNeitherMissing
Menotropin28.326.545.10.1
Recombinant FSH30.722.545.81.0

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Follicular Development as Assessed by TVUS

Defined as percentage of participants with follicles having a diameter of ≤9 mm, 10-11 mm, 12-14 mm, 15-16 mm, and ≥17 mm. (NCT02554279)
Timeframe: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)

,,,
Interventionpercentage of participants (Number)
Follicle size ≤9 mmFollicle size 10-11 mmFollicle size 12-14 mmFollicle size 15-16 mmFollicle size ≥17 mm
Menotropin, Last Stimulation Day78.482.793.584.9100
Menotropin, Stimulation Day 699.073.850.212.65.2
Recombinant FSH, Last Stimulation Day69.975.796.696.3100
Recombinant FSH, Stimulation Day 696.493.276.124.99.7

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Follicular Development as Assessed by TVUS

Defined as average follicle size and average size of 3 largest follicles. (NCT02554279)
Timeframe: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)

,,,
Interventionmm (Mean)
Average follicle sizeAverage size of 3 largest follicles
Menotropin, Last Stimulation Day12.2021.36
Menotropin, Stimulation Day 65.959.69
Recombinant FSH, Last Stimulation Day13.2821.09
Recombinant FSH, Stimulation Day 67.4512.17

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Quality of Embryos

Assessed by cleavage stage. (NCT02554279)
Timeframe: 3 days after oocyte retrieval

Interventionblastomeres (Mean)
Menotropin7.5
Recombinant FSH7.4

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Ongoing Pregnancy Rate

Defined as the percentage of participants with the presence of at least 1 intrauterine pregnancy with a detectable fetal heartbeat at 10-11 weeks of gestation. (NCT02554279)
Timeframe: 8-9 weeks after blastocyst transfer in the fresh cycle

Interventionpercentage of participants (Number)
Menotropin35.5
Recombinant FSH30.7

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Proportion of Participants With Ovarian Hyperstimulation Syndrome (OHSS)

OHSS was defined as the total of early OHSS with onset ≤9 days after triggering of final follicular maturation, and late OHSS with onset >9 days after triggering of final follicular maturation. (NCT04163458)
Timeframe: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS)

,
InterventionPercentage of participants (Number)
Early OHSSLate OHSS
MENOPUR Liquid3.54.0
MENOPUR Powder3.51.5

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Proportion of Participants With Treatment-induced Anti-MENOPUR Antibodies. Overall as Well as With Neutralizing Capacity

"Measured by presence of anti-MENOPUR antibodies.~95% Clopper-Pearson confidence interval has been reported in this endpoint." (NCT04163458)
Timeframe: Up to 28 days after end of the stimulation period (simulation period up to 20 days)

,
InterventionPercentage of participants (Number)
Treatment-induced anti-MENOPUR antibodies (overall)Treatment-induced anti-MENOPUR antibodies with neutralizing capacity
MENOPUR Liquid1.50
MENOPUR Powder1.50

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Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters

"The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-trial visit values.~It is only parameters with markedly abnormal values at end of stimulation or end of trial visit which are represented. Parameters with normal baseline values and normal end of stimulation and end of trial values are not represented." (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

,
InterventionParticipants (Count of Participants)
Calcium (mmol/L) (End of stimulation)Glucose (mmol/L) (End of stimulation)Erythrocytes (10^12 cells/L) (End of stimulation)Leukocytes (10^9 cells/L) (End of stimulation)Hemoglobin (g/L) (End of stimulation)Hematocrit (RATIO) (End of stimulation)Platelets (10^9 cells/L) (End of stimulation)Basophils/leukocytes ratio (%) (End of stimulation)Lymphocytes/leukocytes ratio (%) (End of stimulation)Alanine Aminotransferase (IU/L) (End of trial)Leukocytes (10^9 cells/L) (End of trial)
MENOPUR Liquid11222211211
MENOPUR Powder00000000001

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Serum Anti-Müllerian Hormone (AMH) Concentration

The concentration of serum AMH was measured. The median and IQR of AMH levels on End of stimulation and End of Trial are presented. (NCT04163458)
Timeframe: At the last day of stimulation (up to 20 stimulation days) and at end-of-trial (up to approximately 6 months from the start of screening)

,
Interventionpmol/L (Median)
End of stimulationEnd of trial
MENOPUR Liquid7.616.5
MENOPUR Powder8.715.5

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Serum Follicle-stimulating Hormone (FSH) Concentration

The concentration of serum FSH was measured. The median and IQR of FSH levels on stimulation day 6, End of stimulation and Oocyte Retrieval visit are presented. (NCT04163458)
Timeframe: At Day 6, last day of stimulation (up to 20 stimulation days) and at oocyte retrieval (up to 22 days after start of stimulation)

,
InterventionIU/L (Median)
Stimulation Day 6End of stimulationOocyte retrieval
MENOPUR Liquid16.717.68.8
MENOPUR Powder14.916.58.4

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Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Alanine Aminotransferase

Blood samples were collected for the analysis of clinical chemistry parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

InterventionIU/L (Mean)
MENOPUR Liquid0.4
MENOPUR Powder-1.0

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Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Aspartate Aminotransferase

Blood samples were collected for the analysis of clinical chemistry parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

InterventionIU/L (Mean)
MENOPUR Liquid-0.9
MENOPUR Powder-2.1

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Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Blood Urea Nitrogen

Blood samples were collected for the analysis of clinical chemistry parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Interventionmmol/L (Mean)
MENOPUR Liquid-0.7
MENOPUR Powder-0.7

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Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Calcium

Blood samples were collected for the analysis of clinical chemistry parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Interventionmmol/L (Mean)
MENOPUR Liquid-0.03
MENOPUR Powder-0.03

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Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Chloride

Blood samples were collected for the analysis of clinical chemistry parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Interventionmmol/L (Mean)
MENOPUR Liquid0.4
MENOPUR Powder0.3

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Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Creatinine

Blood samples were collected for the analysis of clinical chemistry parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Interventionumol/L (Mean)
MENOPUR Liquid-5.498
MENOPUR Powder-5.032

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Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr African American

Blood samples were collected for the analysis of clinical chemistry parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

InterventionmL/min/1.73m2 (Mean)
MENOPUR Liquid7.7
MENOPUR Powder2.4

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Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr Non-afr. American

Blood samples were collected for the analysis of clinical chemistry parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

InterventionmL/min/1.73m2 (Mean)
MENOPUR Liquid6.3
MENOPUR Powder5.9

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Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Gamma Glutamyl Transferase

Blood samples were collected for the analysis of clinical chemistry parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

InterventionIU/L (Mean)
MENOPUR Liquid-0.6
MENOPUR Powder-1.6

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Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Glucose

Blood samples were collected for the analysis of clinical chemistry parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Interventionmmol/L (Mean)
MENOPUR Liquid0.0
MENOPUR Powder-0.1

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Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Potassium

Blood samples were collected for the analysis of clinical chemistry parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Interventionmmol/L (Mean)
MENOPUR Liquid-0.04
MENOPUR Powder-0.05

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Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Sodium

Blood samples were collected for the analysis of clinical chemistry parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Interventionmmol/L (Mean)
MENOPUR Liquid-1.0
MENOPUR Powder-0.8

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Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils

Blood samples were collected for the analysis of haematology parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Interventioncells/uL (Mean)
MENOPUR Liquid1.7
MENOPUR Powder-0.1

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Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils/Leukocytes

Blood samples were collected for the analysis of haematology parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

InterventionBasophils/leukocytes in Percentage (Mean)
MENOPUR Liquid-0.1
MENOPUR Powder-0.2

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Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils

Blood samples were collected for the analysis of haematology parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Interventioncells/uL (Mean)
MENOPUR Liquid-10.6
MENOPUR Powder4.2

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Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils/Leukocytes

Blood samples were collected for the analysis of haematology parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

InterventionEosinophils/leukocytes in percentage (Mean)
MENOPUR Liquid-0.4
MENOPUR Powder-0.1

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Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Erythrocytes

Blood samples were collected for the analysis of haematology parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Intervention10^12 cells/L (Mean)
MENOPUR Liquid-0.169
MENOPUR Powder-0.199

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Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hematocrit

Blood samples were collected for the analysis of haematology parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

InterventionRATIO (Mean)
MENOPUR Liquid-0.02
MENOPUR Powder-0.02

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Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hemoglobin

Blood samples were collected for the analysis of haematology parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Interventiong/L (Mean)
MENOPUR Liquid-4.40
MENOPUR Powder-5.76

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Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Leukocytes

Blood samples were collected for the analysis of haematology parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Intervention10^9 cells/L (Mean)
MENOPUR Liquid1.17
MENOPUR Powder1.11

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Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes

Blood samples were collected for the analysis of haematology parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Interventioncells/uL (Mean)
MENOPUR Liquid-53.2
MENOPUR Powder-4.0

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Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes/Leukocytes

Blood samples were collected for the analysis of haematology parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

InterventionLymphocytes/leukocytes in percentage (Mean)
MENOPUR Liquid-4.5
MENOPUR Powder-3.4

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Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes

Blood samples were collected for the analysis of haematology parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Interventioncells/uL (Mean)
MENOPUR Liquid21.5
MENOPUR Powder36.7

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Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes/Leukocytes

Blood samples were collected for the analysis of haematology parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

InterventionMonocytes/leukocytes in percentage (Mean)
MENOPUR Liquid-0.8
MENOPUR Powder-0.5

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Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils

Blood samples were collected for the analysis of haematology parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Interventioncells/uL (Mean)
MENOPUR Liquid1206.4
MENOPUR Powder1069.0

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Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils/Leukocytes

Blood samples were collected for the analysis of haematology parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

InterventionNeutrophils/leukocytes in percentage (Mean)
MENOPUR Liquid5.7
MENOPUR Powder4.2

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Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Platelets

Blood samples were collected for the analysis of haematology parameters. (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

Intervention10^9 cells/L (Mean)
MENOPUR Liquid22.6
MENOPUR Powder23.7

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Clinical Pregnancy Rate

Clinical pregnancy was based on detection of at least 1 intrauterine gestational sac with fetal heart beat on transvaginal ultrasound. (NCT04163458)
Timeframe: 5-6 weeks after blastocyst transfer (up to approximately 10 weeks after start of stimulation)

InterventionParticipants (Count of Participants)
MENOPUR Liquid94
MENOPUR Powder88

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Early Pregnancy Loss

Number of participants with early pregnancy loss defined as a positive βhCG tests but no ongoing pregnancy. (NCT04163458)
Timeframe: 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)

InterventionParticipants (Count of Participants)
MENOPUR Liquid22
MENOPUR Powder25

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Fertilization Rate

Fertilization rate(%) is the number of 2PN oocytes divided by the number of oocytes retrieved. (NCT04163458)
Timeframe: On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)

InterventionPercentage (Mean)
MENOPUR Liquid57.8
MENOPUR Powder60.0

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Frequency of Adverse Events (AEs)

Any AE occurring after start of IMP and before the end-of-trial visit, or a pre-treatment AE or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint. (NCT04163458)
Timeframe: From the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months)

InterventionPercentage of participants (Number)
MENOPUR Liquid50.0
MENOPUR Powder52.3

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Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period

"Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.~Total Number of events include all categories None, Mild, Moderate and Severe. Percentage of events with injection site reactions as a sum of the categories Mild, Moderate and Severe is presented." (NCT04163458)
Timeframe: Up to 20 stimulation days

InterventionPercentage of events (Number)
MENOPUR Liquid6.3
MENOPUR Powder14.5

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Number of Fertilized (2 Pronuclei [2PN]) Oocytes

Fertilized oocytes with 2PN were regarded as correctly fertilized. (NCT04163458)
Timeframe: On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)

InterventionFertilized oocytes (Mean)
MENOPUR Liquid8.3
MENOPUR Powder6.7

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Number of Metaphase II (MII) Oocytes

Maturity stage was assessed prior to undergoing ICSI. Maturity stage was categorized as germinal vesicle, metaphase I, metaphase II, degenerated or other. (NCT04163458)
Timeframe: On day of oocyte retrieval (up to 22 days after start of stimulation)

InterventionMII Oocytes (Mean)
MENOPUR Liquid10.6
MENOPUR Powder8.9

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Number of Oocytes Retrieved

The number of oocytes retrieved was recorded at the oocyte retrieval visit. (NCT04163458)
Timeframe: On day of oocyte retrieval (up to 22 days after start of stimulation)

InterventionOocytes (Mean)
MENOPUR Liquid14.3
MENOPUR Powder11.4

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Number of Participants With Potential Technical Malfunctions of the Administration Pen

Number of participants With Potential Technical malfunctions of the Administration Pen were recorded. (NCT04163458)
Timeframe: Up to 20 stimulation days

InterventionParticipants (Count of Participants)
MENOPUR Liquid1
MENOPUR Powder1

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Number of Stimulation Days

Calculated by start dates and end dates. (NCT04163458)
Timeframe: Up to 20 stimulation days

InterventionDays (Mean)
MENOPUR Liquid9.6
MENOPUR Powder9.9

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Ongoing Pregnancy Rate

Ongoing pregnancy was based on detection of at least 1 intrauterine viable fetus by transvaginal or abdominal ultrasound (NCT04163458)
Timeframe: 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)

InterventionParticipants (Count of Participants)
MENOPUR Liquid91
MENOPUR Powder85

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Positive Beta Human Chorionic Gonadotropin (βhCG) Rate

A blood serum βhCG test was obtained 10-14 days after blastocyst transfer. If the test was positive according to the local laboratory's reference ranges, this confirmed a positive βhCG. (NCT04163458)
Timeframe: 10-14 days after blastocyst transfer (up to approximately 6 weeks after start of stimulation)

InterventionParticipants (Count of Participants)
MENOPUR Liquid113
MENOPUR Powder110

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Total Gonadotropin Dose

The gonadotropin starting dose was 225 IU for the first 5 days, followed by individual adjustments according to the participant's follicular response. Dose adjustment should be 75 IU per adjustment. Gonadotropin was to be initiated within 3 days of confirmed downregulation. (NCT04163458)
Timeframe: Up to 20 stimulation days

InterventionIU (Mean)
MENOPUR Liquid2265.6
MENOPUR Powder2466.7

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Estradiol (E2) Concentration

The concentration of E2 was measured. The median and IQR of E2 levels on stimulation day 6 and End of stimulation are presented. (NCT04163458)
Timeframe: At stimulation Day 6 and last day of stimulation (up to 20 stimulation days)

,
Interventionpg/mL (Median)
Stimulation Day 6End of stimulation
MENOPUR Liquid518.12720.0
MENOPUR Powder336.42292.0

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Follicular Development on Last Day of Stimulation

The total number of follicles and the number of follicles per size category were reported. (NCT04163458)
Timeframe: At last day of stimulation (up to 20 stimulation days)

,
InterventionFollicles (Mean)
Total number of folliclesFollicles >= 12 mmFollicles >= 15 mmFollicles >= 17 mm
MENOPUR Liquid19.913.18.55.4
MENOPUR Powder19.212.08.15.2

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Follicular Development on Stimulation Day 6

The total number of follicles and the number of follicles per size category were reported. (NCT04163458)
Timeframe: At stimulation Day 6

,
InterventionFollicles (Mean)
Total number of folliclesFollicles >= 12 mmFollicles >= 15 mmFollicles >= 17 mm
MENOPUR Liquid17.01.80.20.0
MENOPUR Powder16.51.50.20.0

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Human Chorionic Gonadotropin (hCG) Concentration

The concentration of hCG was measured. The median and IQR of hCG levels on stimulation day 6 and End of stimulation are presented. (NCT04163458)
Timeframe: At Day 6 and last day of stimulation (up to 20 stimulation days)

,
InterventionIU/L (Median)
Stimulation Day 6End of stimulation
MENOPUR Liquid2.52.7
MENOPUR Powder2.42.7

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Intensity of AEs

The intensity of an AE was classified using the following 3-point scale: Mild = Awareness of signs or symptoms, but no disruption of usual activity. Moderate = Event sufficient to affect usual activity (disturbing). Severe = Inability to work or perform usual activities (unacceptable). (NCT04163458)
Timeframe: From the start of screening until the end-of-trial (up to approximately 6 months)

,
InterventionPercentage of participants (Number)
Mild AEsModerate AEsSevere AEs
MENOPUR Liquid42.123.80.5
MENOPUR Powder40.720.62.0

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Intensity of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period

"Assessed by the participant during the stimulation period as mild, moderate or severe.~Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection." (NCT04163458)
Timeframe: Up to 20 stimulation days

,
InterventionPercentage of events (Number)
Mild injection site reactionModerate injection site reactionSevere injection site reaction
MENOPUR Liquid6.10.20.0069
MENOPUR Powder12.91.40.2

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Luteinizing Hormone (LH) Concentration

The concentration of LH was measured. The median and IQR of LH levels on stimulation day 6 and End of stimulation are presented. (NCT04163458)
Timeframe: At Day 6 and last day of stimulation (up to 20 stimulation days)

,
InterventionIU/L (Median)
Stimulation Day 6End of stimulation
MENOPUR Liquid1.83.3
MENOPUR Powder1.83.1

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Number of Blastocysts and Number of Good-Quality Blastocysts 5 Days After Oocyte Retrieval

The number of blastocysts (total and good-quality) was reported. Blastocyst quality was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cells) (NCT04163458)
Timeframe: On Day 5 after oocyte retrieval (up to 27 days after start of stimulation)

,
InterventionBlastocysts (Mean)
Number of Blastocysts on Day 5Number of Good-quality blastocysts on Day 5
MENOPUR Liquid4.83.0
MENOPUR Powder3.92.6

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Progesterone (P4) Concentration

The concentration of P4 was measured. The median and IQR of P4 levels on stimulation day 6 and End of stimulation are presented. (NCT04163458)
Timeframe: At Day 6 and last day of stimulation (up to 20 stimulation days)

,
Interventionng/mL (Median)
Stimulation Day 6End of stimulation
MENOPUR Liquid0.30.8
MENOPUR Powder0.30.6

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Number of Mature Oocytes

"Mature oocytes (MII stage of development).~Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646)." (NCT04854707)
Timeframe: From date of start of ovarian stimulation with follitropin alpha up to 15 days

InterventionNumber of mature oocytes (Mean)
Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH6.7
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH7.7
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH7.6
Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH6.7
The Overall Protocols6.8

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Number of Oocytes Retrieved

"The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the ovulation inducer (HCG or GnRH-agonist).~Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646)." (NCT04854707)
Timeframe: From date of start of ovarian stimulation with follitropin alpha up to 15 days

InterventionThe total number of retrieved oocytes (Mean)
Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH8.6
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH10.3
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH10.5
Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH9.6
The Overall Protocols9.5

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Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer

"Ongoing clinical pregnancy per embryo transfer (detection of gestational sac and heartbeat from 6 weeks after transfer), n (ongoing pregnancy rate per transfer with known outcome, %).~Due to delayed embryo transfers, the analysed population for Ongoing clinical pregnancy per embryo transfer was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2007 embryo transfers (1542 with known outcome); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2213 embryo transfers (1800 with known outcome); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 1809 embryo transfers (1466 with known outcome) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 404 embryo transfers (334 with known outcome)." (NCT04854707)
Timeframe: At least 6 weeks after embryo transfer

InterventionPercetnage of patients (%) (Number)
Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH39.3
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH37.6
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH37.9
Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH35.9
The Overall Protocols38.4

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Total Dose of Follitropin Alpha Biosimilar Protocol, IU

"Mean dose of follitropin alpha biosimilar for ovarian stimulation.~Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646)." (NCT04854707)
Timeframe: From date of start of ovarian stimulation with follitropin alpha up to 16 days

InterventionIU (International Units) (Mean)
Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH1672
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH1919
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH1952
Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH1711
The Overall Protocols1825

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Number of Fertilized Oocytes

"Fertilization rate (FR) is percentage of transformation of oocytes into two pronuclei (presence of two pronuclei: zygotes with 2PN).~Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646)." (NCT04854707)
Timeframe: From date of start of ovarian stimulation with follitropin alpha up to 16 days

Interventionzygotes with 2PN (Mean)
Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH5.8
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH7.2
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH7.3
Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH5.7
The Overall Protocols6.1

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