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cetrorelix

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Description

cetrorelix: LHRH antagonist [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

cetrorelix : A synthetic ten-membered oligopeptide comprising N-acetyl-3-(naphthalen-2-yl)-D-alanyl, 4-chloro-D-phenylalanyl, 3-(pyridin-3-yl)-D-alanyl, L-seryl, L-tyrosyl, N(5)-carbamoyl-D-ornithyl, L-leucyl, L-arginyl, L-prolyl, and D-alaninamide residues coupled in sequence. A gonadotrophin-releasing hormone (GnRH) antagonist, it is used for treatment of infertility and of hormone-sensitive cancers of the prostate and breast. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID25074887
CHEMBL ID1200490
CHEBI ID59224
SCHEMBL ID61331
SCHEMBL ID19712202
MeSH IDM0173811

Synonyms (55)

Synonym
cetrorelixum
n-acetyl-3-(naphthalen-2-yl)-d-alanyl-4-chloro-d-phenylalanyl-3-(pyridin-3-yl)-d-alanyl-l-seryl-l-tyrosyl-n(5)-carbamoyl-d-ornithyl-l-leucyl-l-arginyl-l-prolyl-d-alaninamide
chebi:59224 ,
gtpl1190
ac-d-nal(2)-d-phe(pcl)-d-pal(3)-ser-tyr-d-cit-leu-arg-pro-d-ala-nh2
cetrotide
sb 75
n-acetyl-3-(2-naphthyl)-d-alanyl-p-chloro-d-phenylalanyl-3-(3-pyridyl)-d-alanyl-l-seryl-l-tyrosyl-n(sup 5)-carbamoyl-d-ornithyl-l-leucyl-l-arginyl-l-prolyl-d-alaninamide
sb-075
cetrorelix [inn]
cetrorelixum [inn-latin]
n-acetyl-1-(3-(2-naphthyl)alanine)-2-(4-chlorophenylalanine)-3-(3-(3-pyridyl)alanine)-6-citrulline-10-alanine-lhrh
lhrh, n-ac-1-nal(2)-2-phe(pcl)-3-pal(3)-6-cit-10-ala-
lhrh, n-acetyl-1-(3-(2-naphthyl)alanyl)-2-(4-chlorophenylalanyl)-3-(3-(3-pyridyl)alanyl)-6-citrulline-10-alanine-
cetrorelix (inn)
D07665
120287-85-6
cetrorelix
DB00050
cetrotide (tn)
n-acetyl-3-(2-naphthyl)-d-alanyl-4-chloro-d-phenylalanyl-3-(3-pyridyl)-d-alanyl-l-seryl-l-tyrosyl-n5-carbomoyl-d-ornithyl-l-leucyl-l-prolyl-d-alaninamide
CHEMBL1200490
ac-(d-ala[3-(2-naphthyl)])-[d-phe(4-cl)]-(d-ala[3-(3-pyridyl)])-ser-tyr-(d-cit)-leu-arg-pro-d-ala-oh
AKOS015994648
unii-oon1hfz4ba
oon1hfz4ba ,
hsdb 7696
cetrorelix [inn:ban]
bdbm50369965
130143-01-0
SCHEMBL61331
HS-2008 ,
Y-100040
AC-28734
cetrorelix [who-dd]
cetrorelix [orange book]
cetrorelix [mi]
cetrorelix [vandf]
cetrorelix [hsdb]
cetrorelix [ema epar]
DTXSID7040996 ,
NCGC00485296-01
SCHEMBL19712202
Q5065704
NCGC00481544-01
d-alaninamide,n-acetyl-3-(2-naphthalenyl)-d-alanyl-4-chloro-d-phenylalanyl-3-(3-pyridinyl)-d-alanyl-l-seryl-l-tyrosyl-n5-(aminocarbonyl)-d-ornithyl-l-leucyl-l-arginyl-l-prolyl-
VEA28785
EN300-19768591
n-acetyl-3-(2-naphthalenyl)-d-alanyl-4-chloro-d-phenylalanyl-3-(3-pyridinyl)-d-alanyl-l-seryl-l-tyrosyl-n5-(aminocarbonyl)-d-ornithyl-l-leucyl-l-arginyl-l-prolyl-d-alaninamide
CS-0012400
HY-P0009
n-acetyl-3-(2-naphthyl)-d-alanyl-p-chloro-d-phenylalanyl-3- (3-pyridyl)-d-alanyl-l-seryl-l-tyrosyl-n(sup 5)-carbamoyl-d- ornithyl-l-leucyl-l-arginyl-l-prolyl-d-alaninamide
dtxcid5020996
cetrorelixum (inn-latin)
h01cc02

Research Excerpts

Overview

Cetrorelix (CET) is a potent luteinizing hormone-releasing hormone (LH-RH) antagonist. It is used to prevent premature ovulation in IVF (in vitro fertilization) procedures.

ExcerptReferenceRelevance
"Cetrorelix is a GnRH antagonist of the third generation. "( Modification of the in vitro release profile of Cetrorelix by complexation with biophilic partners.
Engel, J; Lang, A; Naumann, W; Rattei, T; Rischer, M, 2008
)
2.04
"Cetrorelix (CET) is a potent luteinizing hormone-releasing hormone (LH-RH) antagonist and is used to prevent premature ovulation in IVF (in vitro fertilization) procedures. "( Pharmacokinetic/pharmacodynamic modeling of luteinizing hormone (LH) suppression and LH surge delay by cetrorelix after single and multiple doses in healthy premenopausal women.
Derendorf, H; Erb, K; Hermann, R; Klipping, C; Locher, M; Nagaraja, NV; Pechstein, B, 2003
)
1.98
"Cetrorelix is a novel agent offering important advantages in ovarian stimulation."( An evaluation of the multiple dose protocol of cetrorelix in single ovary women.
al-Hasani, S; Asimakopoulos, B; Diedrich, K; Nikolettos, N,
)
1.11
"Cetrorelix is a very potent new GnRH antagonist. "( A single injection of a gonadotropin-releasing hormone (GnRH) antagonist (Cetrorelix) postpones the luteinizing hormone (LH) surge: further evidence for the role of GnRH during the LH surge.
Bouchard, P; Brailly-Tabard, S; d'Acremont, M; de Mouzon, J; Frydman, R; Leroy, I, 1994
)
1.96
"Cetrorelix is a potent luteinizing hormone-releasing hormone (LH-RH) antagonist and is used for the prevention of the premature ovulation indicated by an LH surge in in vitro fertilization. "( Pharmacokinetic and pharmacodynamic modeling of cetrorelix, an LH-RH antagonist, after subcutaneous administration in healthy premenopausal women.
Derendorf, H; Erb, K; Hermann, R; Klipping, C; Nagaraja, NV; Niebch, G; Pechstein, B, 2000
)
2.01

Effects

ExcerptReferenceRelevance
"Cetrorelix has been applied in single and multiple dose protocols, while Ganirelix has until now only been used in the multiple dose protocol."( Ovarian stimulation for in-vitro fertilization/intracytoplasmic sperm injection with gonadotrophins and gonadotrophin-releasing hormone analogues: agonists and antagonists.
Diedrich, K; Felberbaum, R, 1999
)
1.02

Treatment

Cetrorelix treatment of leiomyoma cells for 6 hours showed an increase in fibronectin protein production (3.14 ± 0.09-fold) Cetro Relix pretreated with OCs resulted in similar number of oocytes retrieved compared with a long buserelin protocol.

ExcerptReferenceRelevance
"Cetrorelix treatment caused a decrease in FSH and LH concentrations by 8 and 16 h, respectively, and an obliteration of the response to exogenous GnRH given 24h after treatment onset."( Administration of a gonadotropin-releasing hormone antagonist to mares at different times during the luteal phase of the estrous cycle.
Alexander, SL; Evans, MJ; Irvine, CH; Kitson, NE; Taylor, TB, 2011
)
1.09
"Cetrorelix treatment of leiomyoma cells for 6 hours showed an increase in fibronectin protein production (3.14 ± 0.09-fold)."( Gonadotropin-releasing hormone (GnRH) agonist leuprolide acetate and GnRH antagonist cetrorelix acetate directly inhibit leiomyoma extracellular matrix production.
Britten, JL; Catherino, WH; Levy, G; Malik, M; Mendoza, M, 2012
)
1.32
"Cetrorelix pretreated with OCs resulted in similar number of oocytes retrieved compared with a long buserelin protocol. "( Cetrorelix in an oral contraceptive-pretreated stimulation cycle compared with buserelin in IVF/ICSI patients treated with r-hFSH: a randomized, multicentre, phase IIIb study.
Braat, DM; Fischl, F; Hugues, JN; Huirne, JA; Lambalk, CB; Obruca, A; Pirard, C; Pouly, JL; Sage, JC; van Loenen, AC, 2006
)
3.22
"Cetrorelix-rFSH treatment caused a mid-luteal suppression of PR protein expression in the endometrial stroma, surface epithelium and glands, although expression in the glands of control samples was variable. "( Mid-luteal endometrial intracrinology following controlled ovarian hyperstimulation involving use of a gonadotrophin releasing hormone antagonist.
Critchley, HO; Mason, JI; McDonald, SE; Thong, KJ; Vani, S; Williams, AR, 2007
)
1.78
"Treatment with Cetrorelix inhibited growth and colony-forming ability of myeloma cells, including cell lines resistant to arsenic trioxide, bortezomib, or lenalidomide."( Luteinizing Hormone-Releasing Hormone (LHRH)-I antagonist cetrorelix inhibits myeloma cell growth in vitro and in vivo.
Bjorklund, CC; Chang, CC; Feng, Y; Liao, B; O'Hare, J; Orlowski, RZ; Schally, AV; Shi, ZZ; Wang, M; Wen, J; Zu, Y, 2011
)
0.95
"Pre-treatment with cetrorelix or saline was given as a single slow intravenous dose 2 hours before intramuscular administration of either GnRH or OIF."( Cetrorelix suppresses the preovulatory LH surge and ovulation induced by ovulation-inducing factor (OIF) present in llama seminal plasma.
Adams, GP; Guerra, M; Letelier, C; Ratto, MH; Silva, ME; Smulders, JP; Valderrama, XP, 2011
)
2.13
"Treatment with Cetrorelix pamoate depot led to a 75-80% decrease in the levels of 5.0- and 4.5-kilobase forms of LHRH receptor mRNA compared to those in the control group."( Chronic administration of the luteinizing hormone-releasing hormone (LHRH) antagonist cetrorelix decreases gonadotrope responsiveness and pituitary LHRH receptor messenger ribonucleic acid levels in rats.
Groot, K; Halmos, G; Jungwirth, A; Kakar, SS; Lamharzi, N; Pinski, J; Schally, AV; Vadillo-Buenfil, M, 1996
)
0.86
"Treatment with Cetrorelix decreased the expression of IGF-II mRNA by 78% (p < 0.01) as compared with controls."( Luteinizing hormone-releasing hormone (LH-RH) antagonist Cetrorelix inhibits growth of DU-145 human androgen-independent prostate carcinoma in nude mice and suppresses the levels and mRNA expression of IGF-II in tumors.
Koppán, M; Lamharzi, N; Schally, AV, 1998
)
0.88
"Treatment with cetrorelix produced a decline of 52.9% (P < 0.0001) in IPSS, a 46% improvement in the Quality of Life score (P < 0.001), a rapid reduction of 27% (P < 0.006) in prostatic volume, and an increase in peak urinary flow rates by 2.86 mL/s."( Efficacy and safety of luteinizing hormone-releasing hormone antagonist cetrorelix in the treatment of symptomatic benign prostatic hyperplasia.
Brannan, W; Colcolough, M; Comaru-Schally, AM; Monga, M; Schally, AV, 1998
)
0.87
"Treatment with cetrorelix reversibly suppressed testosterone to castrate levels for three weeks in group C + C and for one week in group C + P."( Effects of testosterone suppression in young men by the gonadotropin releasing hormone antagonist cetrorelix on plasma lipids, lipolytic enzymes, lipid transfer proteins, insulin, and leptin.
Assmann, G; Behre, HM; Büchter, D; Chirazi, A; Kliesch, S; Nieschlag, E; von Eckardstein, A, 1999
)
0.86
"Treatment with Cetrorelix, but not [D-Trp6]LH-RH, caused about 60% reduction (p<0."( Down-regulation and change in subcellular distribution of receptors for luteinizing hormone-releasing hormone in OV-1063 human epithelial ovarian cancers during therapy with LH-RH antagonist Cetrorelix.
Halmos, G; Kahan, Z; Schally, AV, 2000
)
0.84

Toxicity

ExcerptReferenceRelevance
" Our study demonstrates that in patients with symptomatic BPH, treatment with cetrorelix is safe and produces long term improvement."( Efficacy and safety of luteinizing hormone-releasing hormone antagonist cetrorelix in the treatment of symptomatic benign prostatic hyperplasia.
Brannan, W; Colcolough, M; Comaru-Schally, AM; Monga, M; Schally, AV, 1998
)
0.76
" Taken together, the use of GnRH antagonists are safe with regard to children's health."( Safety aspects of gonadotrophin-releasing hormone antagonists in ovarian stimulation procedures: ovarian hyperstimulation syndrome and health of children born.
Diedrich, K; Felberbaum, RE; Katalinic, A; Ludwig, M, 2002
)
0.31
"Gonadotrophin-releasing hormone antagonists are effective and safe in preventing premature LH surges, a leading cause of cycle cancellation or failure during assisted conception."( Safety and efficacy of a 3 mg dose of the GnRH antagonist cetrorelix in preventing premature LH surges: report of two large multicentre, multinational, phase IIIb clinical experiences.
Diedrich, K; Felberbaum, RE; Frydman, R; Howles, CM; Olivennes, F, 2003
)
0.56
" The main outcome measures were the number of metaphase II (MII) oocytes retrieved; secondary efficacy end-points; adverse events (AE) and other safety measures."( Comparative efficacy and safety of cetrorelix with or without mid-cycle recombinant LH and leuprolide acetate for inhibition of premature LH surges in assisted reproduction.
Frishman, GN; Sauer, MV; Schoolcraft, W; Thornton, MH, 2004
)
0.6
"GnRH antagonists are an effective, safe and well tolerated alternative to agonists for COS."( A randomised study of GnRH antagonist (cetrorelix) versus agonist (busereline) for controlled ovarian stimulation: effect on safety and efficacy.
Calejo, L; Gamboa, C; Martinez-de-Oliveira, J; Nunes, A; Silva, J; Stevenson, D; Xavier, P, 2005
)
0.6
" The safety endpoints included ovarian hyperstimulation syndrome, and adverse events related to injections including local tolerability."( Safety and efficacy of mixing cetrorelix with follitropin alfa: a randomized study.
Chang, Y; Hsieh, BC; Hwang, JL; Lin, YH; Seow, KM; Tzeng, CR; Wen, YR, 2010
)
0.65
" Pregnancy outcomes and adverse events were observed and compared."( Efficacy and Safety of gonadotropin-releasing hormone (GnRH) Agonists Triptorelin Acetate and Cetrorelix Acetate in Assisted Reproduction.
Gao, S; Jiang, J; Xu, J, 2018
)
0.7
" We concluded that early administration of cabergoline is a safe and potentially more effective approach for prophylaxis against OHSS in high risk cases."( Early onset of cabergoline therapy for prophylaxis from ovarian hyperstimulation syndrome (OHSS): A potentially safer and more effective protocol.
El Maghraby, HA; El-Gezary, D; Gaafar, S, 2019
)
0.51

Pharmacokinetics

Cetrorelix acetate (CET) is a luteinising hormone-releasing hormone (LH-RH) antagonist. The pharmacodynamic response on testosterone production was investigated in rats and dogs.

ExcerptReferenceRelevance
" After single administration of each dose, maximum Cetrorelix concentrations (Cmax) were reached after 1 h, and Cmax and area under curve (AUC) increased linearly with the dose."( Single and multiple dose pharmacokinetics and pharmacodynamics of the gonadotrophin-releasing hormone antagonist Cetrorelix in healthy female volunteers.
Duijkers, IJ; Hermann, R; Klipping, C; Krone, D; Niebch, G; Schneider, E; Willemsen, WN, 1998
)
0.76
"Population models for the pharmacokinetic-pharmacodynamic relationship for cetrorelix (CET), a luteinising hormone-releasing hormone (LH-RH) antagonist, and the pharmacodynamic response on testosterone production were investigated in rats and dogs."( Population pharmacokinetic/pharmacodynamic modeling of cetrorelix, a novel LH-RH antagonist, and testosterone in rats and dogs.
Derendorf, H; Nagaraja, NV; Schwahn, M, 2000
)
0.78
"A population pharmacokinetic model was developed to explain the dissolution rate limited absorption from the injection site."( Population pharmacokinetic/pharmacodynamic modeling of cetrorelix, a novel LH-RH antagonist, and testosterone in rats and dogs.
Derendorf, H; Nagaraja, NV; Schwahn, M, 2000
)
0.55
"To investigate the pharmacodynamic effects and plasma pharmacokinetics of single subcutaneous doses of cetrorelix acetate in healthy premenopausal women."( Pharmacodynamic effects and plasma pharmacokinetics of single doses of cetrorelix acetate in healthy premenopausal women.
Duijkers, I; Erb, K; Hermann, R; Klipping, C; Pechstein, B; Schueler, A, 2001
)
0.76
"The purpose of this study was the development of pharmacokinetic and pharmacodynamic models for the luteinizing hormone (LH) suppression and subsequent shift in LH surge and follicle-stimulating hormone by cetrorelix in women."( Pharmacokinetic and pharmacodynamic modeling of cetrorelix, an LH-RH antagonist, after subcutaneous administration in healthy premenopausal women.
Derendorf, H; Erb, K; Hermann, R; Klipping, C; Nagaraja, NV; Niebch, G; Pechstein, B, 2000
)
0.75
" The pharmacokinetic and pharmacodynamic relationship for the suppression and the shift in the LH surge has not yet been established."( Pharmacokinetic and pharmacodynamic modeling of cetrorelix, an LH-RH antagonist, after subcutaneous administration in healthy premenopausal women.
Derendorf, H; Erb, K; Hermann, R; Klipping, C; Nagaraja, NV; Niebch, G; Pechstein, B, 2000
)
0.56
"Cetrorelix pharmacokinetics were described by a 2-compartment model with a terminal half-life of 56."( Pharmacokinetic and pharmacodynamic modeling of cetrorelix, an LH-RH antagonist, after subcutaneous administration in healthy premenopausal women.
Derendorf, H; Erb, K; Hermann, R; Klipping, C; Nagaraja, NV; Niebch, G; Pechstein, B, 2000
)
2.01
"A pharmacokinetic and pharmacodynamic model was developed for the transient initial suppression of LH and the subsequent shift in the LH surge after 3 single subcutaneous doses of cetrorelix without ovarian stimulation."( Pharmacokinetic and pharmacodynamic modeling of cetrorelix, an LH-RH antagonist, after subcutaneous administration in healthy premenopausal women.
Derendorf, H; Erb, K; Hermann, R; Klipping, C; Nagaraja, NV; Niebch, G; Pechstein, B, 2000
)
0.75
" On average, Cmax was nearly doubled after single and multiple doses, and AUC(tau) was increased by about 50% after single doses and about 30% after multiple doses of 10 mg CET/glu as compared to 10 mg CET/wat."( Novel formulations of cetrorelix acetate in healthy men: pharmacodynamic effects and noncompartmental pharmacokinetics.
Derendorf, H; Erb, K; Hermann, R; Junge, K; Pechstein, B; Schneider, E, 2002
)
0.63
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" The inductive approximation is applied to three examples, a simple nonlinear pharmacokinetic model with Michaelis-Menten elimination (E1), an integrated glucose-insulin model and an HIV viral load model with recursive feedback systems (E2 and E3, respectively)."( Exploring inductive linearization for pharmacokinetic-pharmacodynamic systems of nonlinear ordinary differential equations.
Duffull, SB; Hasegawa, C, 2018
)
0.48

Compound-Compound Interactions

ExcerptReferenceRelevance
"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
)
0.82
"The objective was to verify the outcome of intracytoplasmic sperm injection (ICSI) with ovulation induction performed with GnRH antagonists, comparing the use of recombinant follicle-stimulating hormone (r-FSH) alone and in combination with recombinant luteinizing hormone (r-LH) in a prospective and randomized trial."( Recombinant gonadotrophins associated with GnRH antagonist (cetrorelix) in ovarian stimulation for ICSI: comparison of r-FSH alone and in combination with r-LH.
Bulletti, C; Cavagna, M; Levi-Setti, PE, 2006
)
0.58
"To evaluate the appropriate controlled ovarian hyperstimulation (COH) protocol in poor responders, we compared the stimulation characteristics of 21 cycles, which included the ultrashort gonadotropin-releasing hormone (GnRH) agonist combined with the flexible multidose GnRH antagonist, to the patients' previous failed in vitro fertilization attempts."( Ultrashort gonadotropin-releasing hormone agonist combined with flexible multidose gonadotropin-releasing hormone antagonist for poor responders in in vitro fertilization/embryo transfer programs.
Anteby, EY; Kruchkovich, J; Meltcer, S; Orvieto, R; Rabinson, J; Zohav, E, 2008
)
0.35
"To evaluate the appropriate controlled ovarian hyperstimulation (COH) protocol in patients with repeated IVF failures and poor embryo quality we compared the stimulation characteristics of ten cycles which included ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist with the patients' earlier failed IVF attempts."( Ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist for patients with repeated IVF failures and poor embryo quality.
Anteby, EY; Gemer, O; Meltcer, S; Nahum, R; Orvieto, R; Rabinson, J, 2009
)
0.35
"Ovarian stimulation with FSH combined with an appropriate period of FSH withdrawal (coasting) before ovum pick-up now appears to be a successful way to obtain oocytes with high developmental competence in bovine."( Gene expression analysis of bovine oocytes at optimal coasting time combined with GnRH antagonist during the no-FSH period.
Blondin, P; Labrecque, R; Sirard, MA; Vigneault, C, 2014
)
0.4
"The results suggest that corifollitropin alfa/GnRH antagonist protocol can be used in PCOS patients, in combination with GnRHa triggering and embryo cryopreservation."( Feasibility of corifollitropin alfa/GnRH antagonist protocol combined with GnRH agonist triggering and freeze-all strategy in polycystic ovary syndrome patients.
Chang, CH; Chen, HF; Chen, HJ; Chen, SU; Hwang, JL; Lin, YH; Seow, KM; Tzeng, CR; Yang, YS, 2018
)
0.48

Bioavailability

ExcerptReferenceRelevance
" bioavailability was calculated as 75."( Systemic delivery of the GnRH antagonist cetrorelix by intratracheal instillation in anesthetized rats.
Borchard, G; Klenner, T; Lehr, CM; Lizio, R; Reissmann, T; Romeis, P; Sarlikiotis, AW, 2000
)
0.57
" The purpose of this study was to evaluate the pharmacokinetics and absolute bioavailability of 3 mg intravenously and subcutaneously administered CET in healthy male and female volunteers and to develop a pharmacokinetic-pharmacodynamic (PK-PD) model to link the plasma concentrations of CET to the T and LH suppression in males."( Pharmacokinetic-pharmacodynamic modeling of testosterone and luteinizing hormone suppression by cetrorelix in healthy volunteers.
Derendorf, H; Hermann, R; Locher, M; Nagaraja, NV; Pechstein, B; Romeis, P, 2000
)
0.53
"Absolute bioavailability of cetrorelix was 100% in rats and 97% in dogs."( Population pharmacokinetic/pharmacodynamic modeling of cetrorelix, a novel LH-RH antagonist, and testosterone in rats and dogs.
Derendorf, H; Nagaraja, NV; Schwahn, M, 2000
)
0.85
" Compared to CET/wat, bioavailability and duration of suppression were increased with CET/glu."( Novel formulations of cetrorelix acetate in healthy men: pharmacodynamic effects and noncompartmental pharmacokinetics.
Derendorf, H; Erb, K; Hermann, R; Junge, K; Pechstein, B; Schneider, E, 2002
)
0.63
" Increasing bioavailability of melatonin in the brain may improve outcomes during cholestatic liver disease."( Melatonin inhibits hypothalamic gonadotropin-releasing hormone release and reduces biliary hyperplasia and fibrosis in cholestatic rats.
Alpini, G; DeMorrow, S; Giang, T; Glaser, S; Grant, S; Greene, JF; Jefferson, B; Kyritsi, K; McMillin, M; Meng, F; Venter, J; Wu, N; Zhou, T, 2017
)
0.46
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

The lowest effective dosage of cetrorelix for pituitary desensitization during COH luteolysis is 0.3 mg once weekly over 8 weeks in the case of endometriosis. Administration every 4th day for a time span of 2-4 weeks for fibroids creates a new opportunity for medical treatment.

ExcerptRelevanceReference
" On the basis of a dose-response curve, a dose of 100 micrograms/kg/d of Cetrorelix was determined as sufficient for a full antitumor response."( Treatment of experimental DMBA induced mammary carcinoma with Cetrorelix (SB-75): a potent antagonist of luteinizing hormone-releasing hormone.
Comaru-Schally, AM; Engel, J; Harleman, JH; Hilgard, P; Reissmann, T; Schally, AV, 1992
)
0.76
" 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
)
0.51
" Dose-response experiments showed that lower concentrations (10(-9) mol/L) of the agonist decreased the proliferation to 80 +/- 1% for the HEC-1A line and 71 +/- 2% of controls for the Ishikawa line after 6 days."( High affinity binding and direct antiproliferative effects of luteinizing hormone-releasing hormone analogs in human endometrial cancer cell lines.
Emons, G; Ortmann, O; Schally, AV; Schröder, B; Schulz, KD; Westphalen, S, 1993
)
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
)
0.49
" 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
)
0.49
" Surgery was done after 6 or 8 weeks of treatment, depending on second dosage administration."( Treatment of uterine fibroids with a slow-release formulation of the gonadotrophin releasing hormone antagonist Cetrorelix.
Bauer, O; Buttge, I; Diedrich, K; Engel, J; Felberbaum, RE; Germer, U; Heise, S; Ludwig, M; Reissmann, T; Riethmüller-Winzen, H, 1998
)
0.51
" Patients were randomised for a second dosage of 60 mg or 30 mg to be injected on day 21 or day 28 of treatment according to the degree of estradiols' suppression (< 50 pg/mL)."( [Medical treatment of uterine fibroids with the LHRH antagonist: Cetrorelix].
Diedrich, K; Felberbaum, RE; Ludwig, M, 1999
)
0.54
" The 22 patients included in group B were administered recombinant FSH alone at the same dosage for 27 cycles."( Comparison of luteal phase profile in gonadotrophin stimulated cycles with or without a gonadotrophin-releasing hormone antagonist.
Arnoldi, M; Baroni, E; Colombo, M; Crosignani, PG; Lombroso, G; Ragni, G; Vegetti, W, 2001
)
0.31
" The stimulation regimen was simplified by reducing the total treatment period, the dosage and duration of gonadotrophin."( Use of gonadotrophin releasing hormone (GnRH) antagonist (cetrotide) during ovarian stimulation for in-vitro fertilization treatment: multiple doses and single dose.
Ho, PC; Ng, EH, 2001
)
0.31
" Pituitary cells were prepared and after 3-4 days incubation, loaded onto columns and given four pulses of GnRH (at 0, 30, 60 and 90 min; dose-response study)."( Effectiveness of an antagonist to gonadotrophin releasing hormone on the FSH and LH response to GnRH in perifused equine pituitary cells, and in seasonally acyclic mares.
Alexander, SL; Evans, MJ; Irvine, CH; Kitson, NE; Livesey, JH; Perkins, NR; Turner, JE, 2002
)
0.31
" Sequential administration of the GnRH antagonist cetrorelix (Cetrotide) in a 3 mg dosage once weekly over 8 weeks creates a new opportunity for medical treatment of symptomatic endometriosis."( Use of GnRH antagonists in the treatment of endometriosis.
Diedrich, K; Felberbaum, RE; Krapp, M; Küpker, W; Malik, E; Schill, T,
)
0.38
" Sequential administration of the GnRH antagonist cetrorelix (Cetrotide), in a 3 mg dosage once weekly over 8 weeks in the case of endometriosis or administration every 4th day for a time span of 2-4 weeks for fibroids, creates a new opportunity for medical treatment."( Will GnRH antagonists assist in the treatment of benign gynaecological diseases?
Diedrich, K; Felberbaum, RE; Küpker, W, 2002
)
0.57
"This observation indicates that no rationale exists of increasing the daily FSH dosage concomitantly to the GnRH-antagonist administration to compensate for a drop of endogenous FSH."( FSH time-concentration profiles before and after administration of 0.25 mg cetrorelix in the gnRH-antagonist multiple-dose protocol for ovarian hyperstimulation.
Alisch, A; Dafopoulos, K; Diedrich, K; Felberbaum, R; Finas, D; Griesinger, G; Roiha, K; Schröder, AK; Schultze-Mosgau, A, 2004
)
0.55
" In other words, rFSH was administered in the new cycle according to the dosage and the step-up or step-down modalities used during the previous cycle, independently of ultrasound findings and serum estradiol (E(2)) levels."( Comparison of GnRH agonists and antagonists in assisted reproduction cycles of patients at high risk of ovarian hyperstimulation syndrome.
Brigante, C; Crosignani, PG; Engl, B; Ragni, G; Riccaboni, A; Vegetti, W, 2005
)
0.33
" In terms of follicular development, the SD protocol requires further modification, including flexible scheduling or possibly a small reduction of the dosage of the administered cetrorelix."( Ovarian response and follicular development for single-dose and multiple-dose protocols for gonadotropin-releasing hormone antagonist administration.
Chen, HF; Chen, MJ; Ho, HN; Lee, TH; Wu, MY; Yang, YS, 2005
)
0.52
" Cetrorelix shifted the EC50s of the GnRH dose-response curve to the right."( Actions of gonadotropin-releasing hormone analogues in pituitary gonadotrophs and their modulation by ovarian steroids.
Diedrich, K; Emons, G; König, SJ; Ortmann, O; Polack, S; Schulz, KD; Weiss, JM, 2006
)
1.24
"To assess the efficacy and safety of different dosing schedules of cetrorelix acetate as a short term treatment for 4 weeks prior to surgery in patients with uterine fibroids."( Presurgical short term treatment of uterine fibroids with different doses of cetrorelix acetate: a double-blind, placebo-controlled multicenter study.
Audebert, A; Diedrich, K; Engel, JB; Frydman, R; Zivny, J, 2007
)
0.8
" There were no statistical differences between the two groups when comparing gonadotropin dosage and OHSS."( Preliminary report on the effect of a lower dose of gonadotropin-releasing hormone antagonist (cetrorelix) on ovarian hyperstimulation in lower-weight Asian women.
Chang, YL; Hsieh, YY; Tsai, HD, 2006
)
0.55
" To determine the proper dosage for a GnRH-antagonist (Cetrorelix), 12 animals in three groups of four female marmosets were treated with two different dosages and a sham dosage."( GnRH-antagonist mediated down-regulation of the estrous cycle in marmosets.
Kuhlmann, M; Luetjens, CM; Wesselmann, R, 2006
)
0.58
"To determine whether a low initial dosage of cetrorelix acetate could prevent a premature luteinizing hormone (LH) surge in women undergoing controlled ovarian stimulation."( Effect of a lower-dose cetrorelix acetate protocol on in-vitro fertilization outcome.
Chen, HJ; Hsieh, BC; Huang, LW; Hwang, JL; Lin, YH; Tzeng, CR, 2008
)
0.92
"Pilot studies with daily dosing suggested the use of the luteinizing hormone-releasing hormone antagonist cetrorelix (CET) for the treatment of symptoms from benign prostatic hyperplasia (BPH)."( Placebo-controlled dose-ranging phase 2 study of subcutaneously administered LHRH antagonist cetrorelix in patients with symptomatic benign prostatic hyperplasia.
Arustamov, DL; Debruyne, F; Gres, AA, 2008
)
0.78
"To assess efficacy and safety of three dosing schemes of CET in patients with symptomatic BPH."( Placebo-controlled dose-ranging phase 2 study of subcutaneously administered LHRH antagonist cetrorelix in patients with symptomatic benign prostatic hyperplasia.
Arustamov, DL; Debruyne, F; Gres, AA, 2008
)
0.57
" All dosage regimens were well tolerated."( Placebo-controlled dose-ranging phase 2 study of subcutaneously administered LHRH antagonist cetrorelix in patients with symptomatic benign prostatic hyperplasia.
Arustamov, DL; Debruyne, F; Gres, AA, 2008
)
0.57
"At all dosage regimens tested, CET was safe and effective in patients with symptomatic BPH, with a trend towards a more rapid onset of effect for the CET 10mg/wkx4 regimen."( Placebo-controlled dose-ranging phase 2 study of subcutaneously administered LHRH antagonist cetrorelix in patients with symptomatic benign prostatic hyperplasia.
Arustamov, DL; Debruyne, F; Gres, AA, 2008
)
0.57
" The optimum (possibly higher) dosage of cetrorelix for this purpose has not yet been established."( A randomised controlled trial comparing GnRH antagonist cetrorelix with GnRH agonist leuprorelin for endometrial thinning prior to transcervical resection of endometrium.
Bentick, B; Bhatia, K; Doonan, Y; Giannakou, A, 2008
)
0.86
"To compare the efficacy of 4 dosage regimens of cetrorelix pamoate, a sustained release formulation that allows for more convenient dosing, in patients with symptomatic benign prostatic hyperplasia (BPH)."( Dose-ranging study of the luteinizing hormone-releasing hormone receptor antagonist cetrorelix pamoate in the treatment of patients with symptomatic benign prostatic hyperplasia.
Altarac, S; Debruyne, F; Geavlete, PA; Tzvetkov, M, 2010
)
0.84
" In all dosage groups, the symptomatic improvement was paralleled by an increase in uroflow."( Dose-ranging study of the luteinizing hormone-releasing hormone receptor antagonist cetrorelix pamoate in the treatment of patients with symptomatic benign prostatic hyperplasia.
Altarac, S; Debruyne, F; Geavlete, PA; Tzvetkov, M, 2010
)
0.59
" A shorter duration of stimulation, a lower dosage of recombinant FSH consumption and a thinner endometrium on the day of human chorionic gonadotropin administration were all observed in the GnRH antagonist group."( Low-dose GnRH antagonist protocol is as effective as the long GnRH agonist protocol in unselected patients undergoing in vitro fertilization and embryo transfer.
Chen, CK; Huang, HY; Huang, SY; Lee, CL; Soong, YK; Wang, HS; Yu, HT, 2011
)
0.37
" However, since Inhibin B was only decreased at the end of the Dosing Phase and not at the Recovery Phase, when the onset of testicular pathology occurred, it is unclear if monitoring Inhibin B would provide sufficient advanced warning for the onset of testicular pathology."( Assessment of inhibin B as a biomarker of testicular injury following administration of carbendazim, cetrorelix, or 1,2-dibromo-3-chloropropane in Wistar han rats.
Her, LS; Knight, BL; Mineo, AM; Moffit, JS; Phillips, JA; Thibodeau, MS, 2013
)
0.61
" In accordance with the higher gonadotropin requirements for obese women undergoing ART, weight-based dosing of GnRH antagonists may be required."( Evidence of GnRH antagonist escape in obese women.
Allshouse, AA; Bradford, AP; Bradshaw-Pierce, EL; Chosich, J; Lesh, J; Polotsky, AJ; Roth, LW; Santoro, N, 2014
)
0.4
" Prior to initiating stimulation (T-0), 17-β-estradiol (E(2)) and TSH serum values were dosed in all women and repeated on T-5 (day 5 of COS) and subsequently every 2 days until T-ov-ind (ovulation induction day) and T-pick-up (oocytes retrieval day)."( The Potential Role of GnRH Agonists and Antagonists in Inducing Thyroid Physiopathological Changes During IVF.
Alviggi, C; Andrisani, A; D'Antona, D; Esposito, F; Gangemi, M; Gizzo, S; Nardelli, GB; Noventa, M; Plebani, M; Quaranta, M; Venturella, R; Vitagliano, A, 2016
)
0.43
"Should the number of oocytes retrieved being higher in letrozole group might indicate that letrozole might contribute to successful ovarian stimulation with a lower dosage of gonadotropins."( Controlled ovarian hyperstimulation with sequential letrozole co-treatment in normo/high responders.
Caglar, GS; Ecemis, T; Tasci, Y, 2016
)
0.43
" Although increasing the dosage of gonadotropins for ovarian hyper stimulation treatment in patients with poor ovarian response is beneficial with respect to retrieved oocytes, meiosis II oocytes and number of embryos, the increased dosage does not provide a statistically significant increase in clinical pregnancy rates."( A comparison of treatment results of the different treatment protocols in patients with poor ovarian response.
Bilgic, BE; Incebiyik, A; Kutlu, HT; Sanverdi, I, 2018
)
0.48
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
GnRH antagonistA chemical substance which inhibits the function of gonadotrophin-releasing hormone (GnRH).
antineoplastic agentA substance that inhibits or prevents the proliferation of neoplasms.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (1)

ClassDescription
oligopeptideA peptide containing a relatively small number of amino acids.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (2)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency3.54810.009610.525035.4813AID1479145
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Gonadotropin-releasing hormone receptorHomo sapiens (human)IC50 (µMol)0.00420.00010.12895.2000AID74279
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Gonadotropin-releasing hormone receptorHomo sapiens (human)Kd0.00070.00010.00090.0025AID1681581; AID74429
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (4)

Processvia Protein(s)Taxonomy
gonadotropin secretionGonadotropin-releasing hormone receptorHomo sapiens (human)
cellular response to gonadotropin-releasing hormoneGonadotropin-releasing hormone receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayGonadotropin-releasing hormone receptorHomo sapiens (human)
cellular response to hormone stimulusGonadotropin-releasing hormone receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (2)

Processvia Protein(s)Taxonomy
peptide bindingGonadotropin-releasing hormone receptorHomo sapiens (human)
gonadotropin-releasing hormone receptor activityGonadotropin-releasing hormone receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (3)

Processvia Protein(s)Taxonomy
plasma membraneGonadotropin-releasing hormone receptorHomo sapiens (human)
membraneGonadotropin-releasing hormone receptorHomo sapiens (human)
plasma membraneGonadotropin-releasing hormone receptorHomo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (29)

Assay IDTitleYearJournalArticle
AID74429Competitive antagonism of GnRH-induced response in the reporter gene assay2001Journal of medicinal chemistry, Feb-01, Volume: 44, Issue:3
GnRH antagonists: a new generation of long acting analogues incorporating p-ureido-phenylalanines at positions 5 and 6.
AID1681551Inhibition of Tag-lite green-labeled agonist binding to terbium fluorophore-labeled human N-terminal SNAP-tag GnRh receptor expressed in HEK293 cells assessed as association rate constant by TR-FRET assay
AID195405Compound was tested for histamine release at a concentration of 10 ug/mL2001Journal of medicinal chemistry, Feb-01, Volume: 44, Issue:3
GnRH antagonists: a new generation of long acting analogues incorporating p-ureido-phenylalanines at positions 5 and 6.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID195404Compound was tested for histamine release at a concentration of 1 ug/mL2001Journal of medicinal chemistry, Feb-01, Volume: 44, Issue:3
GnRH antagonists: a new generation of long acting analogues incorporating p-ureido-phenylalanines at positions 5 and 6.
AID195408Compound was tested for histamine release at a concentration of 3 ug/mL2001Journal of medicinal chemistry, Feb-01, Volume: 44, Issue:3
GnRH antagonists: a new generation of long acting analogues incorporating p-ureido-phenylalanines at positions 5 and 6.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID195401Effective dose for histamine release was determined2001Journal of medicinal chemistry, Feb-01, Volume: 44, Issue:3
GnRH antagonists: a new generation of long acting analogues incorporating p-ureido-phenylalanines at positions 5 and 6.
AID104506Compound was tested for inhibition of Leutenizing hormone release at 72 hours (long duration) in castrated male rat assay2001Journal of medicinal chemistry, Feb-01, Volume: 44, Issue:3
GnRH antagonists: a new generation of long acting analogues incorporating p-ureido-phenylalanines at positions 5 and 6.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1681552Inhibition of Tag-lite green-labeled agonist binding to terbium fluorophore-labeled human N-terminal SNAP-tag GnRh receptor expressed in HEK293 cells assessed as dissociation rate constant by TR-FRET assay
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1681550Inhibition of Tag-lite green-labeled agonist binding to terbium fluorophore-labeled human N-terminal SNAP-tag GnRh receptor expressed in HEK293 cells assessed as residence time by TR-FRET assay
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1681544Suppression of ovariectomized-induced increase in plasma luteinizing hormone level in Wistar Han rat at 0.1 mg/kg, sc measured up to 24 hrs
AID1681580Inhibition of Tag-lite green-labeled agonist binding to terbium fluorophore-labeled human N-terminal SNAP-tag GnRh receptor expressed in HEK293 cells assessed as dissociation constant by TR-FRET assay
AID74279Antagonism of human GnHR receptor, determined in a reporter gene assay in HEK293 cells2001Journal of medicinal chemistry, Feb-01, Volume: 44, Issue:3
GnRH antagonists: a new generation of long acting analogues incorporating p-ureido-phenylalanines at positions 5 and 6.
AID1681581Inhibition of Tag-lite green-labeled agonist binding to terbium fluorophore-labeled human N-terminal SNAP-tag GnRh receptor expressed in HEK293 cells assessed as equilibrium dissociation constant by TR-FRET assay
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347159Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347160Primary screen NINDS Rhodamine qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1346002Human GnRH1 receptor (Gonadotrophin-releasing hormone receptors)2007Endocrinology, Feb, Volume: 148, Issue:2
Pharmacological characterization of a novel nonpeptide antagonist of the human gonadotropin-releasing hormone receptor, NBI-42902.
AID1346002Human GnRH1 receptor (Gonadotrophin-releasing hormone receptors)1995European journal of biochemistry, Aug-01, Volume: 231, Issue:3
Selection and characterization of mammalian cell lines with stable over-expression of human pituitary receptors for gonadoliberin.
AID1346002Human GnRH1 receptor (Gonadotrophin-releasing hormone receptors)1997Analytical biochemistry, Aug-15, Volume: 251, Issue:1
Characterization of gonadotropin-releasing hormone analogs based on a sensitive cellular luciferase reporter gene assay.
AID1346002Human GnRH1 receptor (Gonadotrophin-releasing hormone receptors)2002Endocrinology, Mar, Volume: 143, Issue:3
GnRH and GnRH receptor genes in the human genome.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (592)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's104 (17.57)18.2507
2000's306 (51.69)29.6817
2010's160 (27.03)24.3611
2020's22 (3.72)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 58.96

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 Index58.96 (24.57)
Research Supply Index6.64 (2.92)
Research Growth Index4.61 (4.65)
Search Engine Demand Index99.78 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (58.96)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials157 (25.78%)5.53%
Reviews48 (7.88%)6.00%
Case Studies13 (2.13%)4.05%
Observational6 (0.99%)0.25%
Other385 (63.22%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (84)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian During Controlled Ovarian Stimulation(COH) for In Vitro Fertilisation(IVF) [NCT01109888]Phase 1/Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to there was no percipitant enrolled)
Effect of GnRH Agonist (Long Protocol) vs GnRH Antagonist (Flexible Protocol) on IVF/ICSI Outcomes. [NCT04724343]Phase 450 participants (Actual)Interventional2019-12-22Completed
Progesterone Primed Ovarian Stimulation Protocol (PPOS) VS GnRH Antagonist Protocol in Patients With Expected High Ovarian Response Undergoing ICSI Cycles: a Prospective Randomized Controlled Trial [NCT05951400]Phase 2/Phase 3200 participants (Anticipated)Interventional2023-08-20Not yet recruiting
GnRH Antagonist Pre-treatment in the Early Follicular Phase for Resolution of a Baseline Functional Ovarian Cyst - A Proof-of-concept Pilot Study [NCT04993924]Phase 415 participants (Anticipated)Interventional2021-05-01Recruiting
A Randomized Controlled Study on the Short-term Intervention of Acupuncture in the Freeze-all IVF Cycle to Improve Pregnancy Rate [NCT04931355]90 participants (Anticipated)Interventional2023-06-01Recruiting
A Randomised Controlled Pilot Trial of the Use of GnRH-antagonist Pituitary Suppression During Medicated Frozen-thawed Embryo Transfer (FET) Cycles [NCT03763786]Phase 4300 participants (Anticipated)Interventional2018-12-13Enrolling by invitation
Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders [NCT04537078]Phase 390 participants (Actual)Interventional2020-09-01Completed
GnRH Antagonist in the Luteal Phase Compared to Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS) in Whom All Embryos Are Cryopreserved [NCT02392520]40 participants (Anticipated)Interventional2015-05-31Not yet recruiting
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
Can Antagonist Protocol be the Protocol of Choice in in Vitro Fertilization Patients? [NCT02335736]Phase 2200 participants (Anticipated)Interventional2015-01-31Recruiting
A Prospective, Observational Study on the Use of Cetrotide (GnRH Antagonist) With GONAL-f in Assisted Reproductive Technologies (ART) [NCT01109654]2,175 participants (Actual)Observational2008-09-30Completed
Fixed Versus Flexible GnRH Antagonist Initiation [NCT01005784]Phase 4146 participants (Actual)Interventional2005-06-30Completed
Exploring the Role of Testosterone on Neurovascular Control in Humans [NCT04819204]20 participants (Anticipated)Interventional2021-06-30Not yet recruiting
Clomiphene Citrate Plus Gonadotropins and GnRH Antagonist Versus Flexible GnRH Antagonist Protocol Versus Microdose GnRH Agonist Protocol in Poor Responders Undergoing IVF: a Randomized Study [NCT02201914]Phase 4250 participants (Anticipated)Interventional2014-01-31Recruiting
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
Efficacy of Growth Hormone Supplementation With Gonadotrophins in IVF/ICSI for Poor Responders; a Randomized Controlled Trial [NCT03759301]Phase 4156 participants (Actual)Interventional2018-12-20Completed
Clinical Pharmacological Study of NS75A for Healthy Adult Women [NCT00628121]31 participants (Actual)Interventional2006-04-30Completed
Comparison Between Effects of Dydrogesterone, Cetrorelix Acetate and Triptorelin on Intra Cytoplasmic Sperm Injection Outcomes [NCT05972902]Phase 3387 participants (Anticipated)Interventional2023-07-15Recruiting
The Effect of the Type of Ovarian Stimulation Protocol on PGD Results: a Prospective Randomised Trial [NCT01888744]Phase 4120 participants (Actual)Interventional2010-09-30Completed
Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Women With Infertility Problems [NCT04071574]Phase 1/Phase 2200 participants (Actual)Interventional2018-02-01Completed
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
Usefulness of GnRH Antagonist Administration in the Treatment of Early Ovarian Hyperstimulation Syndrome [NCT01268761]Phase 3100 participants (Actual)Interventional2012-04-30Completed
Comparative Study Between Single Versus Dual Trigger for Poor Responders in GnRH-antagonist ICSI Cycles. A Randomized Controlled Study [NCT04008966]Phase 4160 participants (Actual)Interventional2016-07-20Completed
[NCT00633347]Phase 4570 participants (Actual)Interventional2007-01-31Completed
Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial [NCT00667758]Phase 2104 participants (Actual)Interventional2008-05-31Completed
Coasting Versus Gonadotrophin-Releasing Hormone Antagonist Administration in Patients at High Risk of Ovarian Hyperstimulation Syndrome and Its Impact on the Embryos Quality and the Outcome of ICSI [NCT03996434]Phase 4300 participants (Actual)Interventional2019-07-01Completed
Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: an Open-Labeled Safety and Efficacy Assessment Study [NCT00670306]Phase 3528 participants (Actual)Interventional2008-03-31Completed
A Phase IIIb Randomized Open-label Study to Compare the Estradiol Level on the Releasing Day in Two Regimen of Cetrotide® 0.25 mg Used From Day 1 or From Day 7 of the Menstrual Cycle (Day 0 or Day 6 of Stimulation) in Polycystic Ovarian (PCO) Women in ART [NCT01185704]Phase 3136 participants (Actual)Interventional2008-11-30Completed
'A Multicentre, Prospective Randomized Study to Assess the Effect When GnRH Antagonist is Started Either on Stimulation Day 1 and Day 6 vs. Conventional GnRH Agonist Long Protocol in Patients With Polycystic Ovary Syndrome Undergoing IVF-ET [NCT01402336]Phase 343 participants (Actual)Interventional2011-06-30Completed
Biological Mechanisms of Vascular Dysfunction With Age and Estrogen Deficiency [NCT02042196]Early Phase 1100 participants (Anticipated)Interventional2013-12-31Completed
Lutropin Alfa (Luveris®) in Women at Risk of Poor Response Suppressed With Cetrorelix: an Exploratory Trial [NCT01112358]Phase 258 participants (Actual)Interventional2005-12-07Completed
Cetrorelix Pamoate Intermittent Intramuscular (IM) Dosage Regimens in Patients With Symptomatic BPH: a 1 Year Placebo-controlled Efficacy Study and Long-term Safety Assessment [NCT00449150]Phase 3667 participants (Actual)Interventional2007-03-31Terminated(stopped due to Trial did not meet primary efficacy endpoint for double blind phase.)
The Comparison of Effect of Four Different Treatment Protocols: Antagonist/Letrozole Protocol, Microdose Flare-up Protocol, Antagonist/Clomiphene Protocol, Antagonist on IVF Outcomes in Poor Responders Undergoing in Vitro Fertilization; a Prospective Rand [NCT01948804]Phase 4100 participants (Anticipated)Interventional2014-01-31Not yet recruiting
A Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Duration of Effect of a Single Administration of Various Doses of Cetrorelix SR in Subjects With Histologically Confirmed Endometri [NCT00244452]Phase 20 participants Interventional2005-11-30Completed
Study on the Effect of GnRH Antagonist on hCG Day on Outcomes of Controlled Ovarian Hyperstimulation With GnRH Antagonist Flexible Multiple-dose Protocols [NCT00571870]80 participants (Anticipated)Interventional2007-11-30Completed
Progesterone-Primed Ovarian Stimulation Might be a Safe and Effective Alternative to GnRH-antagonist Protocol for Controlled-Ovarian Stimulation of Infertile PCOS Women [NCT05939284]238 participants (Actual)Interventional2021-06-01Completed
An Innovative Controlled Ovarian Hyperstimulation (COH) Protocol That Combines Large Oocyte Availability and Physiologic Estrogenic Environment for Good Prognosis In Vitro Fertilization and Embryo Transfer (IVF-ET) Patients [NCT02892942]Phase 4129 participants (Actual)Interventional2017-01-13Completed
The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy [NCT04308343]120 participants (Anticipated)Interventional2020-03-30Not yet recruiting
Novel Magnetic Resonance Imaging Strategies as a Non-invasive Biomarker of Vascular and Extracellular Matrix Morphology in Women With Uterine Fibroids. [NCT00746031]Phase 430 participants (Actual)Interventional2008-12-31Completed
Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: a Double-blind Placebo-controlled Efficacy Study [NCT00663858]Phase 3420 participants (Actual)Interventional2008-03-31Completed
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
Lutropin Alfa (Luveris®) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age: Phase II Clinical Trial [NCT01079949]Phase 293 participants (Actual)Interventional2007-11-30Terminated(stopped due to Trial was terminated due to low recruitment rate)
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
Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome - a Randomized Controlled Trial [NCT02784457]Phase 284 participants (Actual)Interventional2014-06-30Completed
CLASSICAL ANTAGONIST PROTOCOL IN COMPARISON WITH AGONIST STOP PROTOCOL IN Polycystic Ovary Symdrome WOMEN UNDERGOING Intra-cytoplasmic Injection TRIAL: a Randomized Controlled Trial [NCT04094467]Phase 4150 participants (Anticipated)Interventional2019-12-07Recruiting
Synchronization of Follicle Wave Emergence and Ovarian Stimulation in Women With a History of Poor Ovarian Response to Treatment [NCT00439829]Phase 480 participants (Anticipated)Interventional2007-02-28Completed
[NCT00505817]Phase 40 participants InterventionalCompleted
The Impact of Overweight and Obesity on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles [NCT03457233]185 participants (Anticipated)Interventional2015-01-03Recruiting
Use of GnRH Antagonist (Cetrotide) Protocol, Instead of Agonist, to Prepare Recipients for Embryo Transfer [NCT00460642]130 participants (Anticipated)Interventional2007-01-31Completed
A Randomised, Controlled, Open Label, Parallel Group, Multicentre Trial Comparing the Efficacy and Safety of Individualised FE 999049 (Follitropin Delta) Dosing, Using a Long GnRH Agonist Protocol and a GnRH Antagonist Protocol in Women Undergoing Control [NCT03809429]Phase 3437 participants (Actual)Interventional2019-04-29Completed
Prospective, Multicenter,Randomized Controlled Trial Towards Identifying the Optimal GnRH Antagonist Treatment Protocol [NCT00866034]Phase 4617 participants (Actual)Interventional2009-02-28Terminated(stopped due to Due to limited rate of patient inclusion)
A Randomized, Double-blind, Open for Active Comparator, Parallel, Multi-center Phase II Study to Explore the Efficacy, Safety and Tolerability of BG2109 Compared With Cetrorelix During COH in Female Subjects Undergoing ART Procedures [NCT05738382]Phase 2240 participants (Anticipated)Interventional2023-08-31Not yet recruiting
A Randomized Controlled Study of Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patients in Intracytoplasmic Sperm Injection Cycles [NCT05847660]210 participants (Anticipated)Interventional2023-06-01Not yet recruiting
Mechanism and Modulation of Sex Differences in Myocardial Steatosis Induced Left Ventricular Dysfunction [NCT04671966]Phase 4100 participants (Anticipated)Interventional2018-09-13Recruiting
Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in Patients With Polycystic Ovary Syndrome Undergoing Intra-Cytoplasmic Sperm Injection [NCT05751681]79 participants (Anticipated)Interventional2023-02-20Recruiting
[NCT01636505]Phase 3200 participants (Anticipated)Interventional2012-09-30Not yet recruiting
Is it Possible to Obtain Higher Yield of Mature M2 Oocytes by Establishing Appropriate Levels of LH During Controlled Ovarian Hyperstimulation (COH) in Antagonist Cycles for In-vitro Fertilization-embryo Transfer (IVF-ET)/ Intracytoplasmic Sperm Injection [NCT01595334]300 participants (Anticipated)Interventional2012-04-30Recruiting
The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome in Oocyte Donors [NCT00867659]20 participants (Actual)Interventional2009-03-31Completed
Suppression of Endogenous Luteinizing Hormone (LH) Surge With Progesterone vs GnRH Antagonist in Freeze-all IVF Cycles. A Prospective Equivalence Study With Repeated Ovarian Stimulation Cycles. [NCT04108039]44 participants (Actual)Interventional2019-09-25Completed
Effect of Ovarian Stimulation Using Recombinant FSH and GHRH Antagonist in Alternate Days on ICSI Outcomes [NCT01468441]96 participants (Actual)Interventional2011-09-30Completed
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
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
Use of Long Acting GnRH Antagonist to Prevent Ovarian HyperStimulation Syndrome (OHSS) in PCOS Women Undergoing COH for IVF [NCT01709942]Phase 380 participants (Actual)Interventional2012-11-30Completed
Assessment of Implantation Potential of Embryos Cultured by Time-lapse Technology (Embryoscope) Before Transfer in In-vitro Fertilization (IVF) / Intracytoplasmic Sperm Injection (ICSI) Cycles: A Randomized Control Study. [NCT01760278]Phase 4200 participants (Anticipated)Interventional2012-12-31Active, not recruiting
Subcutaneous Versus Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles: Which is the Preference Expressed by the Patients? [NCT03181685]Phase 460 participants (Actual)Interventional2016-12-20Terminated(stopped due to 27 couples were recruited. This unexpected poor recruitment was due to more clinical pregnancies (for a better patients' selection) and more freeze-all cycles.)
Comparison of Cetrorelix, Medroxyprogesterone Acetate and Dydrogesterone for Preventing Premature Ovulation in Ovarian Stimulation Cycles [NCT05767086]297 participants (Anticipated)Interventional2023-03-15Recruiting
Vascular Disease, Inflammation and Hormones in Women With Type 1 Diabetes [NCT04418908]40 participants (Actual)Interventional2010-11-24Completed
A Randomized Controlled Study on the Short-term Intervention of Traditional Chinese Medicine Herbs in the Freeze-all IVF Cycle to Improve Pregnancy Rate [NCT04935073]Phase 390 participants (Anticipated)Interventional2021-06-15Not yet recruiting
Prospective Randomized Study Comparing Ovarian Stimulation With Pergoveris Supported by a GnRH Agonist in a Long Protocol Versus Multidose GnRH Antagonist Regimen in Young Infertile Women Treated With ICS [NCT01565265]5 participants (Actual)Interventional2012-04-30Completed
Dysregulation of Follicle Stimulating Hormone (FSH) in Obesity: Functional and Statistical Analysis [NCT02478775]99 participants (Actual)Interventional2015-07-31Completed
Sequential E2 Levels Not Ovarian Maximal Diameter Estimates Were Correlated With Outcome of Cetrotide Therapy for Management of Women at High-risk of Ovarian Hyperstimulation Syndrome [NCT02823080]Phase 2/Phase 348 participants (Actual)Interventional2014-10-31Active, not recruiting
A Randomized Control Trial to Compare the Euploid Rate of Blastocyst Between the PPOS (Progestin-primed Ovarian Stimulation) Protocol and the Gonadotropin-releasing Hormone (GnRH) Antagonist Protocol in Women With PCOS (Polycystic Ovary Syndrome) Undergoi [NCT05326087]Phase 3204 participants (Anticipated)Interventional2023-12-01Not yet recruiting
A Randomized Control Trial to Compare the Euploid Rate of Blastocyst Between the Progestin-primed Ovarian Stimulation Protocol and the GnRH Antagonist Protocol in Patients Undergoing PGT-A [NCT04414748]Phase 3400 participants (Anticipated)Interventional2020-06-10Recruiting
A Randomized Comparison of the Live Birth Rate Between the Progestin-primed Ovarian Stimulation Protocol and the Gonadotrophin Releasing Hormone Antagonist Protocol in Patients Undergoing in Vitro Fertilization [NCT03680053]784 participants (Anticipated)Interventional2020-04-10Recruiting
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 Controlled Study on Sequential Therapy of Kidney Tonifying and Blood Regulating Herbs to Improve the Success Rate of IVF-ET in Patients With Ovarian Reserve Dysfunction [NCT04842825]Phase 3200 participants (Anticipated)Interventional2021-04-15Recruiting
Effectiveness of Generic Cetrorelix Acetate Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a GnRH Antagonist Protocol in Women Undergoing IVF: A Multicenter Non-inferiority, Randomised Controlled Trial [NCT06023602]1,338 participants (Anticipated)Interventional2023-12-01Not yet recruiting
A Randomized Control Trial to Compare the Live Birth Rate Between the Progestin-primed Ovarian Stimulation Protocol and the GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response Undergoing IVF [NCT04414761]Phase 3784 participants (Actual)Interventional2020-06-04Completed
Reproductive Hormonal Alterations in Obesity, AIMS #1 & #2 [NCT01457703]62 participants (Actual)Interventional2010-06-30Completed
Cetrorelix and Ganirelix Flexible Protocol for In Vitro Fertilization: a Prospective Randomized Trial [NCT03477929]Phase 4100 participants (Anticipated)Interventional2017-11-15Recruiting
Delayed Start vs Conventional Antagonist Protocol in Poor Responders Pretreated by Estradiol in Luteal Phase. [NCT02333253]Phase 360 participants (Actual)Interventional2015-01-31Completed
Long Protocol and Freeze All Embryos vs Antagonist Protocol With Fresh Embryo Transfer in PCOS Patients Undergoing ICSI [NCT03118830]Phase 4204 participants (Actual)Interventional2017-04-21Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00449150 (2) [back to overview]International Prostate Symptoms Score (IPSS)
NCT00449150 (2) [back to overview]Time Course of Quality of Life
NCT00663858 (1) [back to overview]International Prostate Symptom Score (IPSS)
NCT00670306 (1) [back to overview]IPSS Change From Baseline
NCT00866034 (2) [back to overview]Cumulative Ongoing Pregnancy Rate
NCT00866034 (2) [back to overview]Live Birth Rate Per Started Cycle and Live Birth From Cryopreserved Embryos Originating From, and Occurring Within 6 Months of the Initial Treatment Cycle Will be Included in the Total Live Birth Rate Per Started Cycle.
NCT00867659 (2) [back to overview]Volume of Ascites in the Abdomen is Indicative of the Severity of OHSS
NCT00867659 (2) [back to overview]Ovarian Volumes as a Predictor of OHSS Severity
NCT01079949 (19) [back to overview]Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day
NCT01079949 (19) [back to overview]Number and Quality of Embryos
NCT01079949 (19) [back to overview]Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)
NCT01079949 (19) [back to overview]Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)
NCT01079949 (19) [back to overview]Number of Participants With Clinical Pregnancies
NCT01079949 (19) [back to overview]Number of Participants in Whom Recombinant Human Chorionic Gonadotropin (r-hCG) Was Not Administered Due to Poor Response
NCT01079949 (19) [back to overview]Number of Ovarian Stimulation Days
NCT01079949 (19) [back to overview]Number of Oocytes Retrieved
NCT01079949 (19) [back to overview]Number of Fertilized Oocytes at Stage 2 Pronuclei (2PN) or Higher Than 2PN
NCT01079949 (19) [back to overview]Number of Fertilized Oocytes (2 Pronuclei [PN])
NCT01079949 (19) [back to overview]Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)
NCT01079949 (19) [back to overview]Follicular Levels of Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and Human Chorionic Gonadotropin (hCG) at Ovum Pick up (OPU)
NCT01079949 (19) [back to overview]Implantation Rate
NCT01079949 (19) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01079949 (19) [back to overview]Follicular Levels of Testosterone (T) at Ovum Pick up (OPU)
NCT01079949 (19) [back to overview]Endometrial Thickness on Recombinant Human Choriogonadotropin (r-hCG) Day
NCT01079949 (19) [back to overview]Estradiol (E2) Levels on r-hCG Day
NCT01079949 (19) [back to overview]Follicular Levels of Estradiol (E2) at Ovum Pick up (OPU)
NCT01079949 (19) [back to overview]Number of Mature Oocytes Retrieved
NCT01112358 (16) [back to overview]Number of Participants With Positive Pregnancy Test
NCT01112358 (16) [back to overview]Plasma Level of Estradiol
NCT01112358 (16) [back to overview]Plasma Levels of LH
NCT01112358 (16) [back to overview]rFSH Cumulative Dose
NCT01112358 (16) [back to overview]Number of Embryos by Quality
NCT01112358 (16) [back to overview]Duration of Ovarian Stimulation
NCT01112358 (16) [back to overview]Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled
NCT01112358 (16) [back to overview]Implementation Rate
NCT01112358 (16) [back to overview]Number of Embryos Transferred by In Vitro Fertilization (IVF)
NCT01112358 (16) [back to overview]Fertilization Rate
NCT01112358 (16) [back to overview]Endometrial Thickness
NCT01112358 (16) [back to overview]Oocyte Nuclear Maturity Rate
NCT01112358 (16) [back to overview]Number of Oocytes Retrieved
NCT01112358 (16) [back to overview]Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter
NCT01112358 (16) [back to overview]Number of Participants With Clinical Pregnancy
NCT01112358 (16) [back to overview]Oocytes Recovery Rate
NCT01185704 (15) [back to overview]Number of Embryos
NCT01185704 (15) [back to overview]Number of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Day
NCT01185704 (15) [back to overview]Number of Transferred Embryos
NCT01185704 (15) [back to overview]Percentage of Fertilized Oocytes Retrieved
NCT01185704 (15) [back to overview]Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels
NCT01185704 (15) [back to overview]Percentage of Participants With Clinical Pregnancy
NCT01185704 (15) [back to overview]Serum Estradiol (E2) Levels
NCT01185704 (15) [back to overview]Serum Progesterone (P4) Levels
NCT01185704 (15) [back to overview]Number and Quality of Oocytes Retrieved
NCT01185704 (15) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01185704 (15) [back to overview]Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)
NCT01185704 (15) [back to overview]Anti Mullerian Hormone (AMH) Levels
NCT01185704 (15) [back to overview]Estradiol (E2) Levels on r-hCG Day
NCT01185704 (15) [back to overview]Implantation Rate
NCT01185704 (15) [back to overview]Number of Blastocysts
NCT01225835 (18) [back to overview]Number of Cumulus-oocyte Complexes Retrieved
NCT01225835 (18) [back to overview]Number of Days Stimulated With Gonadotrophins
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]Percentage of Participants With Ongoing Pregnancy
NCT01225835 (18) [back to overview]Number of Ampoules of Gonadotrophins Used
NCT01225835 (18) [back to overview]Best Quality of an Embryo Transferred
NCT01225835 (18) [back to overview]Number of Participants With Pronuclear Stage Oocytes at Each Quality Grade
NCT01225835 (18) [back to overview]Percentage of Participants With Successful Embryo Transfer
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]Summary of Pregnancy Outcome
NCT01225835 (18) [back to overview]Endometrial Thickness on Day of hCG Administration
NCT01225835 (18) [back to overview]Estradiol (E2) Levels on Day of hCG Administration
NCT01225835 (18) [back to overview]Average Follicle Diameter at hCG Administration
NCT01225835 (18) [back to overview]Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration
NCT01457703 (5) [back to overview]Changes in Pregnanediol Glucuronide (PdG) (Aim 2)
NCT01457703 (5) [back to overview]Changes in Follicle Stimulating Hormone (FSH) (Aim 1)
NCT01457703 (5) [back to overview]Changes in Follicle Stimulating Hormone (FSH) (Aim 2)
NCT01457703 (5) [back to overview]Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1)
NCT01457703 (5) [back to overview]Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2)
NCT02478775 (3) [back to overview]Difference Between Peak Inhibin B
NCT02478775 (3) [back to overview]Peak Inhibin B Per Subject
NCT02478775 (3) [back to overview]Peak E2 Per Subject
NCT02823080 (7) [back to overview]Daily Hematocrits Value
NCT02823080 (7) [back to overview]Daily Maximal Ovarian Diameter
NCT02823080 (7) [back to overview]Daily Numerical Pain Visual Analogue Scale Score
NCT02823080 (7) [back to overview]Daily Serum E2 Levels
NCT02823080 (7) [back to overview]Daily Total Leucocytic Count
NCT02823080 (7) [back to overview]Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
NCT02823080 (7) [back to overview]Ultrasound Detected Severity Grades of Ascites From Days 0-8
NCT04537078 (14) [back to overview]the Implantation Rate
NCT04537078 (14) [back to overview]the Fertilization Rate
NCT04537078 (14) [back to overview]the Difference in the Ongoing Pregnancy Rate in Both Protocols.
NCT04537078 (14) [back to overview]the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Total Dosage of Gonadotropins Used in the Controlled Ovarian Hyperstimulation
NCT04537078 (14) [back to overview]the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Total Days of Controlled Ovarian Hyperstimulation
NCT04537078 (14) [back to overview]the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Resultant Embryos Number
NCT04537078 (14) [back to overview]the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Number of M2 Oocytes Retrieved
NCT04537078 (14) [back to overview]the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Fertilization Rate.
NCT04537078 (14) [back to overview]the Clinical Pregnancy Rate.
NCT04537078 (14) [back to overview]Assessing the Difference Between the Follicular Phase of the Progestin Primed Double Stimulation Protocol and the First Round of the Conventional GnRH Antagonist Protocol Regarding the Fertilization Rate.
NCT04537078 (14) [back to overview]Assessing the Difference Between the Follicular Phase of the Progestin Primed Double Stimulation Protocol and the First Round of the Conventional GnRH Antagonist Protocol Regarding the Resultant Embryos Number.
NCT04537078 (14) [back to overview]Assessing the Difference Between the Follicular Phase of the Progestin Primed Double Stimulation Protocol and the First Round of the Conventional GnRH Antagonist Protocol Regarding the Number of M2 Oocytes Retrieved .
NCT04537078 (14) [back to overview]the Resultant Embryos Number
NCT04537078 (14) [back to overview]the Number of M2 Oocytes Retrieved

International Prostate Symptoms Score (IPSS)

The International Prostate Symptoms Score (IPSS) score of benign prostata hyperplasia (BPH) symptoms is calculated based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 points (best) to 35 points (worst) (NCT00449150)
Timeframe: Baseline and 52 weeks

InterventionUnits on a scale (Mean)
Cetrorelix 78+78-4.0
Cetrorelix 78+52-3.7
Placebo-3.8

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Time Course of Quality of Life

"The time course of quality of life: assessed by the following disease specific quality of life:If you were to spend the rest of your life with the urinary conditions just the way it is now, how would you feel about that? The rating scale is comprising a range of values from 0 to 6, with = delighted, 1 = pleased, 2 = mostly satisfied, 3 = mixed, 4 = mostly dissatisfied, 5 = unhappy, 6 = terrible." (NCT00449150)
Timeframe: Quality of life assessment in the following weeks: 4,12,26,30,38,46,52

,,
Interventionscore on a scale (Mean)
Week 4Week 12Week 26Week 30Week 38Week 46Week 52
Treatment Group A: Cetrorelix (CET) 78 mg + 78 mg-0.33-0.52-0.48-0.64-0.62-0.71-0.55
Treatment Group B: CET 78 mg + 52 mg-0.42-0.67-0.70-0.71-0.77-0.67-0.62
Treatment Group C: Placebo-0.35-0.47-0.46-0.58-0.59-0.58-0.60

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International Prostate Symptom Score (IPSS)

IPSS score of BPH symptoms based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total overall score range: 0 points (best) to 35 points (worst) (NCT00663858)
Timeframe: Baseline and 52 weeks

InterventionUnits on a scale (Mean)
Cetrorelix 78+78-6.2
CET 78+Placebo-5.1
Placebo-5.7

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IPSS Change From Baseline

International Prostate Symptom Score (IPSS) Patient Questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 - 35 points; absolute change from baseline to Week 26 (NCT00670306)
Timeframe: Baseline and Week 26

InterventionUnits on a scale (Mean)
Cetrorelix 78 mg-5.6

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Cumulative Ongoing Pregnancy Rate

(NCT00866034)
Timeframe: 2 years

Interventioncumulative ongoing pregnancy rate (%) (Number)
Early Start CD227.6
Late Start CD631.4

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Live Birth Rate Per Started Cycle and Live Birth From Cryopreserved Embryos Originating From, and Occurring Within 6 Months of the Initial Treatment Cycle Will be Included in the Total Live Birth Rate Per Started Cycle.

(NCT00866034)
Timeframe: 2 years

InterventionCumulative live birth rate (%) (Number)
Early Start CD226.7
Late Start CD629.9

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Volume of Ascites in the Abdomen is Indicative of the Severity of OHSS

evaluate by ultrasound examination, physical examination and blood work the incidence of ovarian hyperstimulation syndrome in oocyte donors receiving a single injection of 3 mg Cetrotide Acetate. (NCT00867659)
Timeframe: 4 weeks

Interventioncc (volume of ascites) (Mean)
Cetrotide Acetate10

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Ovarian Volumes as a Predictor of OHSS Severity

ultrasound measurements of both ovaries (NCT00867659)
Timeframe: 30 days

Interventioncc (Mean)
Cetrotide Acetate25

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Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day

(NCT01079949)
Timeframe: r-hCG day (end of stimulation cycle [approximately 9 days])

Interventionfollicles (Mean)
r-hFSH + r-hLH8.6
r-hFSH7.4

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Number and Quality of Embryos

Embryos were classified into 5 different grades (1 to 5) based on their capacity of implantation. Grade 1 embryos were those with best capacity of implantation and Grade 5 embryos were those with worst capacity of implantation. (NCT01079949)
Timeframe: Day 2-3 post OPU (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])

,
Interventionembryos (Number)
12345
r-hFSH3935491370
r-hFSH + r-hLH2246561864

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Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)

(NCT01079949)
Timeframe: Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days])

InterventionIU (Mean)
r-hFSH + r-hLH2916.1
r-hFSH2861.7

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Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)

Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. (NCT01079949)
Timeframe: S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])

Interventionparticipants (Number)
r-hFSH + r-hLH0
r-hFSH0

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Number of Participants With Clinical Pregnancies

Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. (NCT01079949)
Timeframe: Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days])

Interventionparticipants (Number)
r-hFSH + r-hLH14
r-hFSH12

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Number of Participants in Whom Recombinant Human Chorionic Gonadotropin (r-hCG) Was Not Administered Due to Poor Response

Poor response was defined as 3 or less follicles of greater than or equal to 12 mm developing following at least 7 days of study treatment. (NCT01079949)
Timeframe: r-hCG day (end of stimulation cycle [approximately 9 days])

Interventionparticipants (Number)
r-hFSH + r-hLH1
r-hFSH3

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Number of Ovarian Stimulation Days

Ovarian stimulation included from first r-hFSH injection (S1) until day on which r-hCG was administered (r-hCG day). (NCT01079949)
Timeframe: Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days])

Interventiondays (Mean)
r-hFSH + r-hLH9.4
r-hFSH8.8

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Number of Oocytes Retrieved

Number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. (NCT01079949)
Timeframe: Ovum pick-up (OPU) day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])

Interventionoocytes (Mean)
r-hFSH + r-hLH10
r-hFSH10

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Number of Fertilized Oocytes at Stage 2 Pronuclei (2PN) or Higher Than 2PN

Oocytes were fertilized using ICSI technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN. Fertilized oocytes at stage higher then 2PN are those oocytes which consist more than 2 pronuclei like oocyte having 3 pronuclei termed as 3PN, oocyte having 4 pronuclei termed as 4PN. (NCT01079949)
Timeframe: Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days])

Interventionoocytes (Number)
r-hFSH + r-hLH210
r-hFSH210

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Number of Fertilized Oocytes (2 Pronuclei [PN])

Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN. (NCT01079949)
Timeframe: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])

Intervention2PN oocytes (Number)
r-hFSH + r-hLH203
r-hFSH203

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Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)

Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. (NCT01079949)
Timeframe: S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])

Interventioncycles (Number)
r-hFSH + r-hLH0
r-hFSH0

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Follicular Levels of Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and Human Chorionic Gonadotropin (hCG) at Ovum Pick up (OPU)

(NCT01079949)
Timeframe: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])

,
Interventionmilli international unit (mIU)/mL (Mean)
LH levels at OPUFSH levels at OPUhCG levels at OPU
r-hFSH2.09.0136.2
r-hFSH + r-hLH1.88.3142.2

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Implantation Rate

Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100. (NCT01079949)
Timeframe: Day 35-42 post OPU (34-38 hours post r-hCG day {end of stimulation cycle [approximately 9 days]})

Interventionpercent sacs per embryo (Mean)
r-hFSH + r-hLH30
r-hFSH20

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Number of Participants With Adverse Events (AEs)

An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. (NCT01079949)
Timeframe: S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])

Interventionparticipants (Number)
r-hFSH + r-hLH3
r-hFSH0

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Follicular Levels of Testosterone (T) at Ovum Pick up (OPU)

(NCT01079949)
Timeframe: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])

Interventionnanogram/milliliter (ng/mL) (Mean)
r-hFSH + r-hLH5.9
r-hFSH6.0

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Endometrial Thickness on Recombinant Human Choriogonadotropin (r-hCG) Day

Endometrial thickness measurement was performed on the day of r-hCG administration. (NCT01079949)
Timeframe: r-hCG day (end of stimulation cycle [approximately 9 days])

Interventionmm (Mean)
r-hFSH + r-hLH9.5
r-hFSH8.8

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Estradiol (E2) Levels on r-hCG Day

(NCT01079949)
Timeframe: r-hCG day (end of stimulation cycle [approximately 9 days])

Interventionpicogram/milliter (pg/mL) (Mean)
r-hFSH + r-hLH1813.9
r-hFSH1362.9

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Follicular Levels of Estradiol (E2) at Ovum Pick up (OPU)

(NCT01079949)
Timeframe: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])

Interventionpg/mL (Mean)
r-hFSH + r-hLH454508.0
r-hFSH349605.3

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Number of Mature Oocytes Retrieved

Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The nuclear maturity is assessed based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage or atretic. (NCT01079949)
Timeframe: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])

,
Interventionmature oocytes (Number)
Geminal vesicle (GV)Meta-IMeta-IIAtresic
r-hFSH37262924
r-hFSH + r-hLH604427510

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Number of Participants With Positive Pregnancy Test

The beta Human Chorionic Gonadotropin (beta-hCG) test was used as pregnancy test. (NCT01112358)
Timeframe: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)

InterventionParticipants (Number)
r-FSH + r-hLH3
r-FSH5

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Plasma Level of Estradiol

(NCT01112358)
Timeframe: At the time of r-hCG administration (any days between Day 2 to Day 8)

InterventionPicograms per milliliters (pg/mL) (Mean)
r-FSH + r-hLH1218
r-FSH1029

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Plasma Levels of LH

(NCT01112358)
Timeframe: At the time of r-hCG administration (any days between Day 2 to Day 8)

InterventionIU per liter (IU/L) (Mean)
r-FSH + r-hLH2.8
r-FSH2.1

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rFSH Cumulative Dose

(NCT01112358)
Timeframe: Randomization to Day 8

InterventionIU (Mean)
r-FSH + r-hLH4338
r-FSH4298

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Number of Embryos by Quality

Embryo quality was graded according to morphological classification of Veeck. Grade 1: even blastomeres with no fragmentation; Grade 2: even blastomeres with slight fragmentation (less than 20%); Grade 3: uneven size blastomeres with no fragmentation; Grade 4: even or uneven size blastomeres with moderate fragmentation (20-25%); and Grade 5: unrecognizable blastomeres with severe fragmentation (>50%). (NCT01112358)
Timeframe: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)

,
InterventionEmbroys (Mean)
Grade 1Grade 2Grade 3Grade 4Grade 5
r-FSH0.80.70.60.20.0
r-FSH + r-hLH0.61.41.80.10.1

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Duration of Ovarian Stimulation

Duration of ovarian stimulation was defined as the time from start of study treatment to time of r-hCG administration. (NCT01112358)
Timeframe: Randomization to Day 8

Interventiondays (Mean)
r-FSH + r-hLH4.8
r-FSH4.8

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Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled

(NCT01112358)
Timeframe: Randomization to Day 8

InterventionParticipants (Number)
r-FSH + r-hLH8
r-FSH8

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Implementation Rate

Implementation rate (clinical pregnancy/embryo transferred) was defined as the number of clinical pregnancies divided by number of embryos transferred. (NCT01112358)
Timeframe: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)

InterventionClinical pregnancy/embryo transferred (Number)
r-FSH + r-hLH0.15
r-FSH0.14

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Number of Embryos Transferred by In Vitro Fertilization (IVF)

(NCT01112358)
Timeframe: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)

InterventionEmbroys (Mean)
r-FSH + r-hLH2.0
r-FSH1.6

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Fertilization Rate

The fertilization rate (2 pronuclei [PN] fertilized oocytes per inseminated oocyte) was defined as number of 2 PN fertilized oocytes divided by number of inseminated oocytes. (NCT01112358)
Timeframe: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)

Intervention2PN fertilized oocyte/inseminated oocyte (Mean)
r-FSH + r-hLH0.70
r-FSH0.64

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Endometrial Thickness

(NCT01112358)
Timeframe: At the time of r-hCG administration (any days between Day 2 to Day 8)

Interventionmillimeters (mm) (Mean)
r-FSH + r-hLH12.3
r-FSH11.2

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Oocyte Nuclear Maturity Rate

Oocyte nuclear maturity rate (metaphase II oocytes per retrieved oocyte) is defined as number of metaphase II oocytes divided by total number of oocytes retrieved. (NCT01112358)
Timeframe: At the end of stimulation (Day 2 up to Day 8)

Interventionmetaphase II oocytes/retrieved oocyte (Mean)
r-FSH + r-hLH0.73
r-FSH0.61

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Number of Oocytes Retrieved

(NCT01112358)
Timeframe: At the end of stimulation (Day 2 up to Day 8)

InterventionOocytes (Mean)
r-FSH + r-hLH4.0
r-FSH3.5

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Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter

(NCT01112358)
Timeframe: At the end of stimulation (Day 2 up to Day 8)

InterventionFollicles (Mean)
r-FSH + r-hLH7.2
r-FSH7.0

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Number of Participants With Clinical Pregnancy

A clinical pregnancy is a pregnancy that is confirmed by both pregnancy test (beta-hCG test) and sonographic confirmation of a gestational sac or heartbeat (fetal sac). (NCT01112358)
Timeframe: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)

InterventionParticipants (Number)
r-FSH + r-hLH3
r-FSH5

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Oocytes Recovery Rate

Oocytes recovery rate (oocytes per >14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles >14 mm in diameter. (NCT01112358)
Timeframe: At the end of stimulation (Day 2 up to Day 8)

Interventionoocytes per >14 mm follicle (Mean)
r-FSH + r-hLH0.56
r-FSH0.50

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Number of Embryos

Embryo is defined as the product of the zygote, two or three days after fertilization of the oocytes. (NCT01185704)
Timeframe: Day 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

Interventionembryos (Mean)
Day 1 Protocol3.18
Day 7 Protocol3.60

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Number of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Day

(NCT01185704)
Timeframe: r-hCG day (end of stimulation cycle [approximately 15 days])

Interventionfollicles (Mean)
Day 1 Protocol3.55
Day 7 Protocol2.49

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Number of Transferred Embryos

Embryo transfer is the procedure in which one or more embryos are placed in the uterus. (NCT01185704)
Timeframe: Day 2-3 post Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

Interventiontransferred embryos (Mean)
Day 1 Protocol0.95
Day 7 Protocol1.02

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Percentage of Fertilized Oocytes Retrieved

Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an IVF procedure in which a single sperm is injected directly into an egg under a microscope. (NCT01185704)
Timeframe: Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

Interventionpercent fertilized oocytes (Mean)
Day 1 Protocol46.22
Day 7 Protocol46.86

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Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels

(NCT01185704)
Timeframe: Day 1

,
InterventionInternational unit/liter (IU/L) (Mean)
LH levels (n=58, 62)FSH levels (n=57, 59)
Day 1 Protocol4.874.98
Day 7 Protocol6.846.69

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Percentage of Participants With Clinical Pregnancy

Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy. (NCT01185704)
Timeframe: 10 weeks post r-hCG day (end of stimulation cycle [approximately 15 days])

Interventionpercentage of participants (Number)
Day 1 Protocol20
Day 7 Protocol20

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Serum Estradiol (E2) Levels

(NCT01185704)
Timeframe: Day 1

Interventionpg/mL (Mean)
Day 1 Protocol30.42
Day 7 Protocol68.79

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Serum Progesterone (P4) Levels

(NCT01185704)
Timeframe: Day 1

Interventionnanomolar/liter (nmol/L) (Mean)
Day 1 Protocol0.83
Day 7 Protocol0.97

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Number and Quality of Oocytes Retrieved

Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. Oocytes were classified into 4 different categories based on their quality: mature, fractured, immature and inseminated oocytes. (NCT01185704)
Timeframe: Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

,
Interventionoocytes (Mean)
Total number of oocytesMature oocytesFractured oocytesImmature oocytesInseminated oocytes
Day 1 Protocol7.482.520.090.983.06
Day 7 Protocol8.113.720.111.384.52

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. To avoid the participant/event combination double-count AEs and SAEs are reported separately. (NCT01185704)
Timeframe: Day 1 up to end of study (15 days post last administration of study drug)

,
Interventionparticipants (Number)
AEsSAEs
Day 1 Protocol112
Day 7 Protocol184

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Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)

(NCT01185704)
Timeframe: Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days])

Interventioninternational unit (IU) (Mean)
Day 1 Protocol1462.50
Day 7 Protocol1221.35

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Anti Mullerian Hormone (AMH) Levels

(NCT01185704)
Timeframe: Day 0

Interventionnanogram/milliliter (ng/mL) (Mean)
Day 1 Protocol6.27
Day 7 Protocol7.18

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Estradiol (E2) Levels on r-hCG Day

(NCT01185704)
Timeframe: r-hCG day (end of stimulation cycle [approximately 15 days])

Interventionpicogram/milliliter (pg/mL) (Mean)
Day 1 Protocol1668.86
Day 7 Protocol1672.80

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Implantation Rate

Implantation rate per reporting group was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100. (NCT01185704)
Timeframe: 5 weeks post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

Interventionpercent sacs per embryo (Number)
Day 1 Protocol36.90
Day 7 Protocol32.25

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Number of Blastocysts

Blastocyst is an embryo, five or six days after fertilization, with an inner cell mass, outer layer of trophectoderm and a fluid-filled blastocoele cavity. (NCT01185704)
Timeframe: Day 5-6 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

Interventionblastocysts (Mean)
Day 1 Protocol0.26
Day 7 Protocol0.20

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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 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 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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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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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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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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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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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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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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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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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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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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Average Follicle Diameter at hCG Administration

(NCT01225835)
Timeframe: approximately day 10

Interventionmm (Mean)
Menotrophin17.6
Follitrophin Alpha18.1

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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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Changes in Pregnanediol Glucuronide (PdG) (Aim 2)

Pregnanediol glucuronide (PdG) was collected daily over the course of one menstrual cycle and averaged. (NCT01457703)
Timeframe: Averaged over the length of menstrual cycle

Interventionug/cycle (Mean)
BMI ≥30 kg/m254.1
BMI 18-25 kg/m288.7

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Changes in Follicle Stimulating Hormone (FSH) (Aim 1)

Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. (NCT01457703)
Timeframe: Measured hourly and averaged over the 12 hour study visit

InterventionIU/L (Mean)
BMI ≥30 kg/m23.8
BMI 18-25 kg/m23.3

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Changes in Follicle Stimulating Hormone (FSH) (Aim 2)

Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. (NCT01457703)
Timeframe: Measured hourly and averaged over the 12 hour study visit

InterventionIU/L (Mean)
BMI ≥30 kg/m25.31
BMI 18-25 kg/m26.18

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Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1)

Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. (NCT01457703)
Timeframe: Measured hourly and averaged over the 12 hour study visit

InterventionIU/L (Mean)
BMI ≥30 kg/m24.1
BMI 18-25 kg/m23.6

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Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2)

Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups. (NCT01457703)
Timeframe: Measured hourly and averaged over the 12 hour study visit

InterventionIU/L (Mean)
BMI ≥30 kg/m22.21
BMI 18-25 kg/m24.44

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Difference Between Peak Inhibin B

This is defined as the maximum hormone value during Day 1 of the study subtracted from the maximum hormone value during Day 2. (NCT02478775)
Timeframe: Every 10 minutes over 2 10-hour frequent blood sampling sessions.

Interventionpicograms/mL (Mean)
Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight100.8
Experimental: Frequent Blood Sampling, Cetrorelix: Obese38.8

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Peak Inhibin B Per Subject

Peak inhibin B will be measured every 10 minutes during day 1 and day 2 of the study. The highest inhibin B value will be defined as the peak. (NCT02478775)
Timeframe: Every 10 minutes over 10 hours on Day 1 and Day 2 of the study.

,
Interventionpicograms/mL (Mean)
Day 1 maximumDay 2 maximum
Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight103.5226.5
Experimental: Frequent Blood Sampling, Cetrorelix: Obese87.5126.3

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Peak E2 Per Subject

E2 will be measured every 10 minutes on Day 1 and Day 2 of the study. The highest E2 value will be designated as the peak E2 value. (NCT02478775)
Timeframe: Every 10 minutes over 10 hours of Day 1 and Day 2 of the study.

,
Interventioninternational units/L (Mean)
Day 1Day 2
Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight65.1137.7
Experimental: Frequent Blood Sampling, Cetrorelix: Obese72.599.1

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Daily Hematocrits Value

Blood samples were obtained under complete aseptic condition for determination of hematocrits value (Ht%) (NCT02823080)
Timeframe: 0-8 days.

,
Interventionpercentge (Mean)
Day-0Day-3Day-6Day-8
Cetrotide42.238.737.336.8
no Cetrotide39.838.83837.5

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Daily Maximal Ovarian Diameter

MOD (maximal ovarian diameter in mm) were evaluated daily. (NCT02823080)
Timeframe: 8 days

,
Interventionmm (Mean)
Day-0Day-1Day-2Day-3Day-4Day-5Day-6Day-7Day-8
Cetrotide9.49.39.18.78.57.87.57.37.1
no Cetrotide10.410.29.69.49.298.58.27.9

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Daily Numerical Pain Visual Analogue Scale Score

-All patients were clinically evaluated for the presence of abdominal pain and if present was graduated using a numerical pain visual analogue scale (VAS) with 0 means no pain and 10 means severe intolerable pain . (NCT02823080)
Timeframe: 8 days.

,
Interventionunits on a scale (Mean)
Day-0Day-1Day-2Day-3Day-4Day-5Day-6Day-7Day-8
Cetrotide5.34.33.62.31.60.920.330.170.13
no Cetrotide5.454.94.64.53.72.41.61.1

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Daily Serum E2 Levels

Serum E2 levels (Serum E2 level in picograms/ml) were evaluated daily. (NCT02823080)
Timeframe: 8 days

,
Interventionpicograms/ml (Mean)
Day-0Day-1Day-2Day-3Day-4Day-5Day-6Day-7Day-8
Cetrotide4761339727722067145211731173969902
no Cetrotide500442123620359225701914154412751044

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Daily Total Leucocytic Count

TLC(x 1ooo cells/ml) (NCT02823080)
Timeframe: 0 -8days.

,
Intervention1000 cells/ml (Mean)
Day-0Day-3Day-6Day-8
Cetrotide12.7511.5119.75
no Cetrotide11.611.311.210.1

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Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy

-severity grades of gastrointestinal manifestations determined at Day -0,Day -3 and Day -6. (NCT02823080)
Timeframe: 0-6 days

,
InterventionGI manifestations (Number)
Nil Nausea at Day-0mild Nausea at Day-0moderate Nausea at Day-0severe Nausea at Day-0Nil Nausea at Day-3mild Nausea at Day-3moderate Nausea at Day-3severe Nausea at Day-3Nil Nausea at Day-6mild Nausea at Day-6moderate Nausea at Day-6severe Nausea at Day-6Nil Vomiting at Day-0mild Vomiting at Day-0moderatel Vomiting at Day-0severe Vomiting at Day-0Nil Vomiting at Day-3mild Vomiting at Day-3moderate Vomiting at Day-3severe Vomiting at Day-3Nil Vomiting at Day-6mild Vomiting at Day-6moderat Vomiting at Day-6severe Vomiting at Day-6Nil Abdominal distension at Day-0mild Abdominal distension at Day-0moderate Abdominal distension at Day-0severe Abdominal distension at Day-0Nil Abdominal distension at Day-3mild Abdominal distension at Day-3moderate Abdominal distension at Day-3severe Abdominal distension at Day-3Nil Abdominal distension at Day-6mild Abdominal distension at Day-6moderate Abdominal distension at Day-6severe Abdominal distension at Day-6
Cetrotide5874194102400014721240002400058921581024000
no Cetrotide67651284022200128402040024000471039123020400

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Ultrasound Detected Severity Grades of Ascites From Days 0-8

-US detected severity grades of ascites determined at Day -0, Day -3 and Day -8. (NCT02823080)
Timeframe: 0-8 days

,
InterventionUS detected ascitis (Number)
Low grade ascitis at Day-0Low grade ascitis at Day-3Low grade ascitis at Day-8moderate grade ascitis at Day-0moderate grade ascitis at Day-3moderate grade ascitis at Day-8severe grade ascitis at Day-0severe grade ascitis at Day-3severe grade ascitis at Day-8
Cetrotide818211663000
no Cetrotide613171885032

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the Implantation Rate

it is calculated as the number of intrauterine gestational sacs observed by transvaginal ultrasonography divided by the number of transferred embryos at the 6 th week of pregnancy and then multiplied by 100 (NCT04537078)
Timeframe: at the 6 th week of pregnancy

Interventionpercentage (Median)
the Progestin Primed Double Stimulation Group50
the Flexible GnRh Antagonist Group50

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the Fertilization Rate

percentage transformation of micro injected oocytes into two pronuclei. it is done 16 to 20 hours after microinjection of the oocytes by the sperms (NCT04537078)
Timeframe: 16 to 20 hours after microinjection of the oocytes with the sperms

Interventionpercentage of transformation (Median)
the Progestin Primed Double Stimulation Group71.43
the Flexible GnRh Antagonist Group80.91

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the Difference in the Ongoing Pregnancy Rate in Both Protocols.

Assessing the difference in the ongoing pregnancy rate when the pregnancy had completed ≥20 weeks of gestation (NCT04537078)
Timeframe: At the 20 th week of gestation

Interventionpercentage of participants (Number)
the Progestin Primed Double Stimulation Group6
the Flexible GnRh Antagonist Group5

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the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Total Dosage of Gonadotropins Used in the Controlled Ovarian Hyperstimulation

Assessing the difference between the follicular phase and the luteal phase of the progestin primed double stimulation protocol regarding the total dosage of gonadotropins used in the controlled ovarian hyperstimulation so as to the difference between the two phases (NCT04537078)
Timeframe: From the first day of ovarian stimulation till the last day of ovarian stimulation in each phase ,the follicular and the luteal, of stimulation

InterventionIU (Median)
the Follicular Phase of the Progestin Primed Double Stimulation Group3000
the Luteal Phase of the Progestin Primed Double Stimulation Group3600

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the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Total Days of Controlled Ovarian Hyperstimulation

the total number of days of the controlled ovarian hyperstimulation in both follicular and luteal phase of the progestin primed double stimulation protocol are studied so as to asses the difference between the two phases, the follicular phase and the luteal phase of the progestin primed double stimulation protocol (NCT04537078)
Timeframe: From the first day of ovarian stimulation till the last day of ovarian stimulation in each phase ,the follicular and the luteal, of stimulation

Interventionnumber of days (Median)
the Follicular Phase of the Progestin Primed Double Stimulation Group10
the Luteal Phase of the Progestin Primed Double Stimulation Group12

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the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Resultant Embryos Number

the resultant embryos number are counted day 3 or 4 or 5 after fertilization so as to the difference between the results between the two phases, the follicular phase and the luteal phase of the progestin primed double stimulation protocol (NCT04537078)
Timeframe: the embryos number counted day 3 or 4or 5 after fertilization

Interventionnumber of embryos (Median)
the Follicular Phase of the Progestin Primed Double Stimulation Group1
the Luteal Phase of the Progestin Primed Double Stimulation Group3

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the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Number of M2 Oocytes Retrieved

it is the number of M2 oocytes retrieved that were being assessed after denudation so as to the difference between the results between the two phases, the follicular phase and the luteal phase of the progestin primed double stimulation protocol (NCT04537078)
Timeframe: 1-2 hours after oocyte retrieval

Interventionnumber of oocytes (Median)
the Follicular Phase of the Progestin Primed Double Stimulation Group2
the Luteal Phase of the Progestin Primed Double Stimulation Group4

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the Difference Between the Follicular Phase and the Luteal Phase of the Progestin Primed Double Stimulation Protocol Regarding the Fertilization Rate.

percentage of transformation of micro injected oocytes into two pronuclei at 16 -20 hours after microinjection of the oocytes by the sperms so as to the difference between the results between the two phases, the follicular phase and the luteal phase of the progestin primed double stimulation protocol (NCT04537078)
Timeframe: 16 to 20 hours after microinjection of the oocytes with the sperms

Interventionpercentage (Median)
the Follicular Phase of the Progestin Primed Double Stimulation Group66.67
the Luteal Phase of the Progestin Primed Double Stimulation Group100

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the Clinical Pregnancy Rate.

percentage of cases in which observation of a gestational sac with fetal heart beat by transvaginal ultrasound at 6 weeks of pregnancy (NCT04537078)
Timeframe: at the 6 th weeks of pregnancy

Interventionpercentage of participants (Number)
the Progestin Primed Double Stimulation Group7
the Flexible GnRh Antagonist Group8

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Assessing the Difference Between the Follicular Phase of the Progestin Primed Double Stimulation Protocol and the First Round of the Conventional GnRH Antagonist Protocol Regarding the Fertilization Rate.

it is percentage transformation of micro injected oocytes into two pronuclei.so as to study the effect of the progestin used on the ovarian response and its results in poor ovarian responders, we have compared the follicular phase of the dual stimulation group and first follicular wave of the flexible antagonist group (NCT04537078)
Timeframe: 16 to 20 hours after microinjection of the oocytes by the sperms

Interventionpercentage (Median)
The Follicular Phase of the Double Stimulation Group66.67
the First Round of the Conventional GnRH Antagonist Group91.67

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Assessing the Difference Between the Follicular Phase of the Progestin Primed Double Stimulation Protocol and the First Round of the Conventional GnRH Antagonist Protocol Regarding the Resultant Embryos Number.

it is the number of the resultant embryos counted at day 3 or 4 or 5 after fertilization.so as to study the effect of the progestin used on the ovarian response and the resultant embryos number in poor ovarian responders, we have compared the follicular phase of the dual stimulation group and first follicular wave of the flexible antagonist group (NCT04537078)
Timeframe: at day 3 or 4or 5 after fertilization

Interventionpercentage (Mean)
The Follicular Phase of the Double Stimulation Group1.66
the First Round of the Conventional GnRH Antagonist Group1.69

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Assessing the Difference Between the Follicular Phase of the Progestin Primed Double Stimulation Protocol and the First Round of the Conventional GnRH Antagonist Protocol Regarding the Number of M2 Oocytes Retrieved .

it is the number of M2 oocytes retrieved that were being assessed after denudation.so as to study the effect of the progestin used on the ovarian response in poor ovarian responders, we have compared the follicular phase of the dual stimulation group and first follicular wave of the flexible antagonist group (NCT04537078)
Timeframe: 1-2 hours after oocyte retrieval

Interventionnumber of oocytes (Median)
The Follicular Phase of the Double Stimulation Group2
the First Round of the Conventional GnRH Antagonist Group2

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the Resultant Embryos Number

it is the resultant embryos number counted day 3 or 4 or 5 after fertilization (NCT04537078)
Timeframe: the embryos number counted day 3 or 4or 5 after fertilization

Interventionnumber of embryos (Median)
the Progestin Primed Double Stimulation Group4
the Flexible GnRh Antagonist Group3

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the Number of M2 Oocytes Retrieved

it is the number of M2 oocytes retrieved that were being assessed after denudation (NCT04537078)
Timeframe: 1-2 hours after oocyte retrieval

Interventionoocytes (Median)
the Progestin Primed Double Stimulation Group6
the Flexible GnRh Antagonist Group4.5

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