Page last updated: 2024-11-12

ganirelix

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Cross-References

ID SourceID
PubMed CID16130957
CHEMBL ID1251
CHEBI ID135910
SCHEMBL ID19712192
MeSH IDM0169271

Synonyms (40)

Synonym
ganirelix
lhrh,n-ac-2-nal(1)-4-cl-phe(2)-3-pal(3)-et2-harg(6,8)-alanh2(10)-
ganirelixum [inn-latin]
gnrh, n-ac-2-nal(1)-4-cl-phe(2)-3-pal(3)-et2-harg(6,8)-alanh2(10)-
n-ac-(2-naphthyl)ala-2-(4-cl-phe)-3-(3-pyridinyl-ala)-6,8-et2-harg-10-alanh2-lhrh
lhrh, n-acetyl-2-naphthylalanyl(1)-(4-chlorophenylalanyl)(2)-3-pyrdinylalanyl(3)-diethylhomoarginyl(6,8)-alaninamide(10)-
d-alaninamide, n-acetyl-3-(1-naphthalenyl)-d-alanyl-4-chloro-d-phenylalanyl-3-(3-pyridinyl)-d-alanyl-l-seryl-l-tyrosyl-n6-(bis(ethylamino)methylene)-d-lysyl-l-leucyl-n6-(bis(ethylamino)methylene)-l-lysyl-l-prolyl-
ganirelix [inn:ban]
CHEMBL1251 ,
124904-93-4
D08010
orgalutran (tn)
ganirelix (inn)
ac-d-nal-[d-(pcl)phe]-d-pal-ser-tyr-d-har(et2)-leu-har(et2)-pro-dala-nh2
bdbm50102454
123246-29-7
ganirelixum
unii-ix503l9wn0
ix503l9wn0 ,
d-24598
d 24598
Y-100038
ganirelix [inn]
ganirelix [vandf]
ganirelix [who-dd]
ganirelix [mi]
ganirelix [ema epar]
DB06785
CHEBI:135910
GJNXBNATEDXMAK-PFLSVRRQSA-N
SCHEMBL19712192
Q5521314
d-alaninamide, n-acetyl-3-(2-naphthalenyl)-d-alanyl-4-chloro-d-phenylalanyl-3-(3-pyridinyl)-d-alanyl-l-seryl-l-tyrosyl-n6-[bis(ethylamino)methylene]-d-lysyl-l-leucyl-n6-[bis(ethylamino)methylene]-l-lysyl-l-prolyl-
cid 16134406
DTXSID401027283
EN300-19652012
h01cc01
ganirelixum (inn-latin)
GLXC-26188
ac-d-2nal-d-phe(4-cl)-d-3pal-ser-tyr-d-harg(et,et)-leu-harg(et,et)-pro-d-ala-nh2 3 acoh

Research Excerpts

Overview

Ganirelix is a gonadotrophin-releasing hormone (GnRH) antagonist. Used for the prevention of premature LH surge during ovarian stimulation. administered via the subcutaneous route.

ExcerptReferenceRelevance
"Ganirelix is a synthetic decapeptide linked with nine different amino acids. "( Determination of Amino Acid Composition of Ganirelix Acetate in an Injectable Formulation by Pre-column Derivatization with 6-Aminoquinolyl-N-hydroxysuccinimidyl Carbamate.
Kumar, JVS; Ummiti, K, 2020
)
2.26
"Ganirelix is a gonadotrophin-releasing hormone (GnRH) antagonist used for the prevention of premature LH surge during ovarian stimulation. "( The effect of a GnRH antagonist on follicle maturation in normal women.
Anifandis, G; Dafopoulos, K; Daponte, A; Georgoulias, P; Messini, CI; Messinis, IE; Pousias, S; Sveronis, G, 2019
)
1.96
"Ganirelix is a synthetic third generation gonadotropin-releasing hormone (GnRH) antagonist that is administered via the subcutaneous route. "( Ganirelix.
Balfour, JA; Faulds, D; Gillies, PS; Perry, CM, 2000
)
3.19

Treatment

Ganirelix treatment rapidly decreased serum levels of gonadotropins and E2 after both 1 and 2 mg administration. Treatment with ganireLix effectively prevents premature LH rises, luteinization in subjects undergoing stimulated IUI.

ExcerptReferenceRelevance
"The ganirelix treatment was continued until the day of human chorionic gonadotropin (hCG) injection."( Clinical efficacy of the gonadotropin-releasing hormone antagonist, ganirelix, in Korean women undergoing controlled ovarian hyperstimulation for in vitro fertilization and embryo transfer with recombinant follicle-stimulating hormone.
Choi, YM; Jee, BC; Kim, JG; Kim, SH; Kim, SM; Ku, SY; Moon, SY; Suh, CS, 2005
)
1.04
"Ganirelix treatment rapidly decreased serum levels of gonadotropins and E2 after both 1 and 2 mg administration. "( Suppression of follicular phase pituitary-gonadal function by a potent new gonadotropin-releasing hormone antagonist with reduced histamine-releasing properties (ganirelix).
Fujimoto, VY; Jaffe, RB; Monroe, SE; Nelson, LR, 1995
)
1.93
"Treatment with ganirelix effectively prevents premature LH rises, luteinization in subjects undergoing stimulated IUI. "( Treatment with the GnRH antagonist ganirelix prevents premature LH rises and luteinization in stimulated intrauterine insemination: results of a double-blind, placebo-controlled, multicentre trial.
Andersen, AN; Avril, C; Belaisch-Allart, J; Fluker, MR; Ingerslev, J; Khalaf, Y; Lambalk, CB; Leader, A; Mannaerts, B; Olivennes, F; Roulier, R, 2006
)
0.96
"Treatment with ganirelix started on day 6 of stimulation, whereas treatment with triptorelin started on menstrual cycle day 21 to 24 of the previous cycle (i.e."( Comparable clinical outcome using the GnRH antagonist ganirelix or a long protocol of the GnRH agonist triptorelin for the prevention of premature LH surges in women undergoing ovarian stimulation.
, 2001
)
0.9

Toxicity

ExcerptReferenceRelevance
" Evaluation of all safety data indicated that the ganirelix regimen was safe and well tolerated."( Treatment with the gonadotrophin-releasing hormone antagonist ganirelix in women undergoing ovarian stimulation with recombinant follicle stimulating hormone is effective, safe and convenient: results of a controlled, randomized, multicentre trial. The Eu
Borm, G; Mannaerts, B, 2000
)
0.8
" 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
"Cumulative vital pregnancy rate per-patient by treatment group, cumulative live-birth rate per-patient by treatment group, and occurrence of adverse events in (pregnant) women and their fetuses/infants and the incidence of congenital malformations in the infants."( Efficacy and safety of frozen-thawed embryo transfer in women aged 35 to 42 years from the PURSUE randomized clinical trial.
Boostanfar, R; Gates, D; Gordon, K; Guan, Y; McCrary Sisk, C; Stegmann, BJ, 2016
)
0.43

Pharmacokinetics

ExcerptReferenceRelevance
" We also examined the pharmacokinetic characteristics of RS-26306 by quantifying serum levels of the drug by RIA."( Endocrine effects and pharmacokinetic characteristics of a potent new gonadotropin-releasing hormone antagonist (Ganirelix) with minimal histamine-releasing properties: studies in postmenopausal women.
Jaffe, RB; Monroe, SE; Nerenberg, C; Rabinovici, J; Rothman, P, 1992
)
0.49
"Randomized, crossover, pharmacokinetic study."( Pharmacokinetic and pharmacodynamic characteristics of ganirelix (Antagon/Orgalutran). Part I. Absolute bioavailability of 0.25 mg of ganirelix after a single subcutaneous injection in healthy female volunteers.
Kleijn, HJ; Mannaerts, BM; Oberyé, JJ; Timmer, CJ, 1999
)
0.55
" The mean (+/- SD) peak concentration and time of occurrence after SC administration were 14."( Pharmacokinetic and pharmacodynamic characteristics of ganirelix (Antagon/Orgalutran). Part I. Absolute bioavailability of 0.25 mg of ganirelix after a single subcutaneous injection in healthy female volunteers.
Kleijn, HJ; Mannaerts, BM; Oberyé, JJ; Timmer, CJ, 1999
)
0.55
"To assess the dose-proportionality and pharmacodynamic properties of multiple doses of ganirelix (Antagon/Orgalutran; NV Organon, Oss, the Netherlands)."( Pharmacokinetic and pharmacodynamic characteristics of ganirelix (Antagon/Orgalutran). Part II. Dose-proportionality and gonadotropin suppression after multiple doses of ganirelix in healthy female volunteers.
Huisman, JA; Mannaerts, BM; Oberyé, JJ; Timmer, CJ, 1999
)
0.77
"Randomized, parallel, pharmacokinetic, and pharmacodynamic study."( Pharmacokinetic and pharmacodynamic characteristics of ganirelix (Antagon/Orgalutran). Part II. Dose-proportionality and gonadotropin suppression after multiple doses of ganirelix in healthy female volunteers.
Huisman, JA; Mannaerts, BM; Oberyé, JJ; Timmer, CJ, 1999
)
0.55
" Additionally, the pharmacodynamic effect was evaluated."( Local tolerance, pharmacokinetics, and dynamics of ganirelix (Orgalutran) administration by Medi-Jector compared to conventional needle injections.
Huisman, J; Mannaerts, B; Oberyé, J; Timmer, C, 2000
)
0.56

Compound-Compound Interactions

ExcerptReferenceRelevance
"The aim of this prospective paired cohort study is to elucidate the impact of ovarian stimulation with recombinant follicle-stimulating hormone in combination with gonadotropin-releasing hormone antagonist on the endometrial transcriptome."( The impact of ovarian stimulation with recombinant FSH in combination with GnRH antagonist on the endometrial transcriptome in the window of implantation.
Fauser, BC; Giudice, LC; Hamilton, A; Macklon, NS; van der Gaast, MH, 2008
)
0.35

Bioavailability

Ganirelix is absorbed rapidly and extensively after SC administration, resulting in a high absolute bioavailability of >90%.

ExcerptReferenceRelevance
"To assess the absolute bioavailability of ganirelix (Antagon/Orgalutran; NV Organon, Oss, the Netherlands) after a single SC injection."( Pharmacokinetic and pharmacodynamic characteristics of ganirelix (Antagon/Orgalutran). Part I. Absolute bioavailability of 0.25 mg of ganirelix after a single subcutaneous injection in healthy female volunteers.
Kleijn, HJ; Mannaerts, BM; Oberyé, JJ; Timmer, CJ, 1999
)
0.82
" Mean (+/- SD) AUC0-infinity (area under the concentration-time curve) values of 105+/-11 ng/mL x hours and 96+/-12 ng/mL x hours were calculated for IV administration and SC administration, respectively, resulting in an absolute mean (+/- SD) bioavailability of 91."( Pharmacokinetic and pharmacodynamic characteristics of ganirelix (Antagon/Orgalutran). Part I. Absolute bioavailability of 0.25 mg of ganirelix after a single subcutaneous injection in healthy female volunteers.
Kleijn, HJ; Mannaerts, BM; Oberyé, JJ; Timmer, CJ, 1999
)
0.55
"Ganirelix is absorbed rapidly and extensively after SC administration, resulting in a high absolute bioavailability of >90%."( Pharmacokinetic and pharmacodynamic characteristics of ganirelix (Antagon/Orgalutran). Part I. Absolute bioavailability of 0.25 mg of ganirelix after a single subcutaneous injection in healthy female volunteers.
Kleijn, HJ; Mannaerts, BM; Oberyé, JJ; Timmer, CJ, 1999
)
1.99

Dosage Studied

ExcerptRelevanceReference
" Blood samples were obtained during dosing as well as before and after cessation of dosing."( Suppression of follicular phase pituitary-gonadal function by a potent new gonadotropin-releasing hormone antagonist with reduced histamine-releasing properties (ganirelix).
Fujimoto, VY; Jaffe, RB; Monroe, SE; Nelson, LR, 1995
)
0.49
" Estradiol remained suppressed (mean levels < 26 pg/mL) on all subsequent 7 days of ganirelix dosing in both groups."( Suppression of follicular phase pituitary-gonadal function by a potent new gonadotropin-releasing hormone antagonist with reduced histamine-releasing properties (ganirelix).
Fujimoto, VY; Jaffe, RB; Monroe, SE; Nelson, LR, 1995
)
0.71
" Mean serum LH levels were suppressed by > or = 35% relative to baseline from 2 to 12 hours after dosing in both groups."( Dose-related suppression of serum luteinizing hormone in women by a potent new gonadotropin-releasing hormone antagonist (Ganirelix) administered by intranasal spray.
Downey, D; Fujimoto, VY; Jaffe, RB; Monroe, SE; Nelson, LR, 1997
)
0.5
" Corresponding mean values for the area under the curve over one dosing interval (24 hours) were 33 ng x h/mL, 77."( Pharmacokinetic and pharmacodynamic characteristics of ganirelix (Antagon/Orgalutran). Part II. Dose-proportionality and gonadotropin suppression after multiple doses of ganirelix in healthy female volunteers.
Huisman, JA; Mannaerts, BM; Oberyé, JJ; Timmer, CJ, 1999
)
0.55
" The pen device is used for the subcutaneous injection of a pre-mixed ready-to-use solution of follitropin beta from a multiple-dose cartridge, and has flexible dosing capabilities."( Administration of recombinant human FSH (solution in cartridge) with a pen device in women undergoing ovarian stimulation.
Givens, C; Kaplan, B; Karande, V; Pang, S; Sacks, P; Scott, R; Westphal, LM, 2003
)
0.32
" Linear regression of the 18 individual estimates of LH-Te feedforward dose-response slopes on age disclosed a strongly negative relationship (r = -0."( Age-specific changes in the regulation of LH-dependent testosterone secretion: assessing responsiveness to varying endogenous gonadotropin output in normal men.
Iranmanesh, A; Liu, PY; Roebuck, PD; Takahashi, PY; Veldhuis, JD, 2005
)
0.33
" Clinical and biochemical pregnancy rates, fertilization and implantation rates, as well as the number of oocytes retrieved, the number of mature oocytes present, the stimulation period and the gonadotrophin dosage were not significantly different between the two groups compared."( Flexible GnRH antagonist versus flare-up GnRH agonist protocol in poor responders treated by IVF: a randomized controlled trial.
Kolibianakis, EM; Lainas, GT; Lainas, TG; Papanikolaou, EG; Petsas, GK; Sfontouris, IA; Zorzovilis, JZ, 2008
)
0.35
"The objective of this prospective study was to identify predictors of ovarian response in ovulatory patients treated with low-dose recombinant FSH (rFSH), gonadotrophin-releasing hormone antagonist and intrauterine insemination (IUI), and to develop an rFSH dosage nomogram based on the findings."( Predictors of ovarian response in intrauterine insemination patients and development of a dosage nomogram.
Andersen, AN; Bangsboll, S; Bogstad, J; Bredkjaer, HE; Budtz-Jørgensen, E; Freiesleben, NL; Loft, A; Lossl, K; Pinborg, A; Toft, B, 2008
)
0.35
" Analytical estimation of pulsatile rhLH-T dose-response measures revealed higher T secretory sensitivity and greater rhLH potency (lower EC₅₀) after exposure to 1-h than 2-h rhLH pulses."( Dynamic testosterone responses to near-physiological LH pulses are determined by the time pattern of prior intravenous LH infusion.
Keenan, DM; Liu, PY; Takahashi, PY; Veldhuis, JD, 2012
)
0.38
" Such considerations include dosing conditions and use of concomitant medications."( Practical guidance for use of oral semaglutide in primary care: a narrative review.
Morales, J; Shubrook, JH; Skolnik, N, 2020
)
0.56
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
polypeptideA peptide containing ten or more amino acid residues.
[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 (1)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Gonadotropin-releasing hormone receptorHomo sapiens (human)IC50 (µMol)0.00360.00010.12895.2000AID74279
[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)Kd0.00050.00010.00090.0025AID74429
[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 (2)

Processvia Protein(s)Taxonomy
plasma membraneGonadotropin-releasing hormone receptorHomo sapiens (human)
membraneGonadotropin-releasing hormone receptorHomo sapiens (human)
plasma membraneGonadotropin-releasing hormone receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (9)

Assay IDTitleYearJournalArticle
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.
AID195409Compound was tested for histamine release at a concentration of 30 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.
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.
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.
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.
AID195406Compound was tested for histamine release at a concentration of 100 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.
AID194294Compound was tested for inhibition of Leutenizing hormone release at 48 hours (intermediate 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.
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.
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.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (235)

TimeframeStudies, This Drug (%)All Drugs %
pre-19901 (0.43)18.7374
1990's16 (6.81)18.2507
2000's126 (53.62)29.6817
2010's78 (33.19)24.3611
2020's14 (5.96)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 71.81

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 Index71.81 (24.57)
Research Supply Index5.81 (2.92)
Research Growth Index6.23 (4.65)
Search Engine Demand Index121.44 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (71.81)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials92 (38.33%)5.53%
Reviews30 (12.50%)6.00%
Case Studies17 (7.08%)4.05%
Observational1 (0.42%)0.25%
Other100 (41.67%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (63)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Multi-center, Open-label, Randomized Trial in India to Investigate the Efficacy and Safety of a Single Injection of MK-8962 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation Using Daily Recombinant FSH as a [NCT01599494]Phase 30 participants (Actual)Interventional2014-03-31Withdrawn
A Phase II, Open Label, Prospective, Randomized, Comparative Clinical Trial to Investigate the Appropriate Dose of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Proto [NCT00702806]Phase 299 participants (Actual)Interventional2001-07-01Completed
A Phase III, Randomized, Double-Blind, Active-Controlled, Non-Inferiority Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulat [NCT00696800]Phase 31,509 participants (Actual)Interventional2006-06-27Completed
Post-Marketing Surveillance Orgalutran (Ganirelix)® [NCT01304511]711 participants (Actual)Observational2005-02-28Completed
A Phase III, Randomized, Double-blind, Active-controlled, Equivalence Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of 100 µg Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimu [NCT00702845]Phase 3397 participants (Actual)Interventional2006-12-28Completed
Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct and GnRH Agonist Trigger for Egg Bank Donation [NCT02069808]Phase 438 participants (Actual)Interventional2014-04-30Completed
GnRH Antagonist Prevention of Premature Luteinization in Patients Undergoing IUI [NCT00780858]662 participants (Actual)Observational2008-10-31Completed
A Multicenter, Double-blind, Non-inferiority, Phase 3 RCT Comparing GenSci094 and Recombinant FSH During the First Seven Days of Ovarian Stimulation in Chinese ART Patients [NCT06091436]Phase 3176 participants (Anticipated)Interventional2023-03-24Recruiting
A Phase III, Multi-center, Open-label, Randomized Study to Assess the Efficacy and Safety of Org 37462 Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for IVF or ICSI, Using a Long Protocol of Triptorelin as a Reference Treatment. [NCT00725491]Phase 3259 participants (Actual)Interventional2007-05-31Completed
An Open-label, Observational Trial to Monitor the Incidence of Congenital Malformations in Infants of Women With an Ongoing Pregnancy After Controlled Ovarian Hyperstimulation Using Puregon® (recFSH)/Orgalutran® (Ganirelix) Followed by IVF/ICSI, or a Long [NCT00724789]2,066 participants (Actual)Observational2000-11-30Completed
Prospective Randomized Study for the Evaluation of Controlled Ovarian Stimulation With Corifollitropin Alpha in Patients With Expected or Poor Ovarian Response in IVF Cycles [NCT02118051]Phase 3234 participants (Actual)Interventional2013-09-30Completed
A Randomized Study to Analysis the Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response Patient [NCT03300518]552 participants (Actual)Interventional2017-11-15Completed
Efficacy of Single Dose Ganirelix in Gonadotropin Ovulation Induction Cycles [NCT01286051]80 participants (Actual)Interventional2011-01-31Completed
Polymorphisms of FSH Receptor, LH Receptor, LH and Ovarian Response to FSH in Controlled Ovarian Stimulation Using a GnRH Antagonist Protocol [NCT01206803]294 participants (Actual)Observational2010-09-30Completed
Evaluation of the Efficacy of Micronized Natural Progesterone (Seidigestan®) vs GnRH Antagonist (Astarté®) in the Prevention of LH Peak During Controlled Ovarian Stimulation: a Randomized Clinical Trial. [NCT05954962]Phase 4150 participants (Anticipated)Interventional2023-10-23Not yet recruiting
To Compare the Efficacy and Safety of Oral SHR7280 Tablets With Ganirelix Acetate Injection in Female Subjects With Infertility Receiving Controlled Ovarian Hyperstimulation Therapy: A Multi-center, Randomized, Parallel-Group, Double-Blind, Dual-Simulatio [NCT05994378]Phase 3316 participants (Anticipated)Interventional2023-08-29Recruiting
Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 38819 [NCT00702273]344 participants (Actual)Observational2006-04-19Completed
Follicle-Stimulating Hormone (FSH) and the Onset of Puberty [NCT00734279]Early Phase 111 participants (Actual)Interventional2006-03-31Completed
Administration of GnRH Antagonist to Oocyte Donation Recipients During Endometrial Preparation. [NCT00635258]100 participants (Actual)Observational2004-01-31Completed
A RCT Study to Evaluate the Safety and Efficacy of the Fixed Day-5 Antagonist Protocol Versus the Flexible Antagonist Protocol for the Controlled Ovarian Stimulation in Chinese Women With Predicted High Ovarian Response [NCT02635607]200 participants (Anticipated)Interventional2016-01-31Not yet recruiting
Compromised Microcirculation in Women With Polycystic Ovary Syndrome [NCT00757185]Early Phase 128 participants (Actual)Interventional2008-02-29Completed
A Randomized Controlled Trial of Treatment Protocols to Optimize Outcomes in Poor Responder In Vitro Fertilization (IVF) Patients: E2 Patch/Antagonist Protocol Versus OCP/Microdose Lupron Protocol [NCT00826839]Phase 40 participants (Actual)Interventional2009-01-31Withdrawn(stopped due to poor enrollment)
A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in GnRH Antagonist Cycles [NCT00802360]Phase 4173 participants (Actual)Interventional2008-12-31Completed
Comparison Between GnRH Agonist Long Protocol And GnRH Antagonist Protocol In Outcome Of The First Cycle ART [NCT00823602]Phase 32 participants (Anticipated)Interventional2008-03-31Recruiting
GnRH Antagonist /Letrozole Versus Microdose GnRH Agonist Flare Protocol in Poor Responders Undergoing in Vitro Fertilization [NCT00823004]Phase 1/Phase 2120 participants (Actual)Interventional2008-06-30Completed
Short-term GnRH- Antagonist Treatment to Lower LH Pulsatility in Women With PCOS Aiming to Improve Hormonal Functions [NCT05751252]Early Phase 120 participants (Anticipated)Interventional2023-07-31Not yet recruiting
The Effect of the Type of Ovarian Stimulation Protocol on PGD Results: a Prospective Randomised Trial [NCT01888744]Phase 4120 participants (Actual)Interventional2010-09-30Completed
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
Luteal Phase Recombinant FSH vs. Follicular Phase Recombinant FSH for IVF Stimulation in the Poor Responder [NCT00225433]Phase 420 participants (Actual)Interventional2005-09-30Completed
Evaluation of Efficacy and Safety of Medroxiprogesterone Acetate (Progevera 10 mg®) Versus GnRh Antagonist (Orgalutran®) in Ovarian Stimulation Cycles of Oocyte Donors [NCT02796105]Phase 4232 participants (Actual)Interventional2016-06-30Completed
The Effects of Estradiol and Progesterone on Arginine Vasopressin Regulation and Serum Sodium Concentration [NCT00589134]26 participants (Actual)Interventional2006-01-31Completed
Randomized Controlled Trial Comparing the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation in Normal Responders [NCT00417183]Phase 4300 participants Interventional2005-09-30Recruiting
Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation [NCT01645241]15 participants (Actual)Interventional2012-07-31Completed
The Impact of the Heterogeneity of the Recruited Cohort of Follicles During Ovarian Hyperstimulation for IVF on Aneuploidy Rates of Generated Embryos. [NCT00866008]Phase 434 participants (Actual)Interventional2008-10-31Terminated(stopped due to Due to a very slow inclusion rate.)
Among IVF Patients Undergoing Fixed Antagonist Protocols With Recombinant FSH, Does Administration of Recombinant FSH From Cycle Day 5 Onwards Compared With Cycle Day 2 Onwards, Yield a Higher Number of Good Quality Embryos? [NCT00823472]Phase 4147 participants (Actual)Interventional2009-01-31Terminated(stopped due to Inclusion of the study didn't go as fast as expected. Expect: 234 patients in 1 year in 2 centers. After 1,5 year only 147 patients were recruited.)
A Novel Approach to Endometrial Preparation in Recipients of Donor Cycles [NCT01424618]20 participants (Anticipated)Interventional2006-01-31Recruiting
Successful Application of Modified Natural Cycle in Poor Responders With High Basal FSH Prior to Oocyte Donation [NCT00417157]135 participants (Actual)Observational2007-01-31Completed
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
Desogestrel Versus GnRH Antagonist (Ganirelix) in IVF/ICSI Patients Undergoing Ovarian Stimulation: a Randomized Controlled Trial [NCT04728659]Phase 4165 participants (Anticipated)Interventional2020-10-01Recruiting
Early Follicular GnRH Antagonist Supplementation Improves Fertilization and Embryo Cleavage Rates in IVF-ET GnRH Antagonist Cycles [NCT00461422]Phase 450 participants (Actual)Interventional2004-01-31Completed
PPOS and CFA for Elective Freeze-all Ovarian Stimulation Cycles: a Prospective Cross-over Study [NCT06175832]Phase 460 participants (Anticipated)Interventional2024-01-01Not yet recruiting
The Rate of Embryo Euploidy in Women Treated With Progestin-primed Ovarian Stimulation Versus Conventional Ovarian Stimulation: a Randomized Controlled Trial [NCT04654741]Phase 4396 participants (Anticipated)Interventional2020-09-01Recruiting
Randomized Controlled Trial Comparing the Effect of GnRH Agonist and Antagonist Ovarian Stimulation Protocols in PCOS Patients [NCT00417144]Phase 4200 participants Interventional2003-11-30Recruiting
The Flexible GnRH Antagonist Protocol Provides Better Results (IVF Outcomes) Than Flare up GnRH Agonist Protocol in Poor Responders [NCT00417066]Phase 4270 participants Interventional2003-09-30Completed
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
[NCT01636505]Phase 3200 participants (Anticipated)Interventional2012-09-30Not yet recruiting
Corifollitropin Alfa Followed by Hp-HMG Versus Recombinant FSH in Young Poor Ovarian Responders. A Multicentre Randomized Controlled Clinical Trial [NCT01816321]Phase 3150 participants (Actual)Interventional2013-03-31Completed
Usefulness of Medroxyprogesterone Acetate in Follicular Phase in Oocyte Donors. [NCT03300960]Phase 3318 participants (Actual)Interventional2017-10-20Completed
Sex Hormones and Orthostatic Tolerance [NCT01153581]Phase 2109 participants (Actual)Interventional2006-02-28Completed
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 107012 for the Development of Org 36286 (Corifollitropin Alfa) [NCT00702624]113 participants (Actual)Observational2007-04-30Completed
A Phase II Bridging Trial of Org 37462 [NCT00988260]Phase 2266 participants (Actual)Interventional2003-02-03Completed
Human Cerebral Blood Flow Regulation: Sex, Mechanism, and Stress Differences [NCT04265053]Early Phase 1144 participants (Anticipated)Interventional2021-04-12Recruiting
GnRH Antagonist Pre-treatment in the Early Follicular Phase for the Prevention of Asynchronous Follicular Growth - A Proof-of-concept Pilot Study [NCT05071339]Phase 415 participants (Anticipated)Interventional2021-04-01Recruiting
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 Multicenter, Randomized, Treated-controlled, Parallel, Open Label Study to Compare and Evaluate the Efficacy and Safety of Ganilever PFS and Orgalutran® in Infertility Women for Assisted Reproductive Technologies [NCT03051087]Phase 4255 participants (Actual)Interventional2016-10-31Completed
Hormonal Mechanisms of Sleep Restriction - Axis Study [NCT03142893]Phase 180 participants (Anticipated)Interventional2017-05-08Active, not 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
Delayed Start to Ovarian Stimulation Improves Oocyte Maturation and Quality: A Randomized Trial [NCT01614067]Phase 430 participants (Actual)Interventional2012-05-31Terminated(stopped due to Slow enrollment resulted in withdraw of funding)
Biological Mechanisms of Arterial Stiffening With Age and Estrogen Deficiency [NCT00608062]155 participants (Actual)Interventional2007-03-31Completed
Cetrorelix and Ganirelix Flexible Protocol for In Vitro Fertilization: a Prospective Randomized Trial [NCT03477929]Phase 4100 participants (Anticipated)Interventional2017-11-15Recruiting
Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women [NCT04037605]Early Phase 15 participants (Actual)Interventional2020-02-09Active, not recruiting
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38819 for Org 36286 (Corifollitropin Alfa) [NCT00703014]541 participants (Actual)Observational2006-07-13Completed
Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 107012 [NCT00702546]102 participants (Actual)Observational2006-12-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00608062 (8) [back to overview]Total Antioxidant Status (TAS)
NCT00608062 (8) [back to overview]Supine Brachial Blood Pressures
NCT00608062 (8) [back to overview]Progesterone
NCT00608062 (8) [back to overview]Plasma Norepinephrine
NCT00608062 (8) [back to overview]Estradiol
NCT00608062 (8) [back to overview]Endothelin-1 (ET-1)
NCT00608062 (8) [back to overview]Endothelial Function
NCT00608062 (8) [back to overview]Arterial Stiffness (Carotid Artery Compliance) During Saline
NCT00696800 (23) [back to overview]Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Clinical Pregnancy
NCT00696800 (23) [back to overview]Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Vital Pregnancy
NCT00696800 (23) [back to overview]Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)
NCT00696800 (23) [back to overview]Number of Embryos Obtained on Day 3 Categorized by Quality
NCT00696800 (23) [back to overview]Number of Embryos Transferred on Day 3
NCT00696800 (23) [back to overview]Number of Follicles Categorized by Size on Stimulation Day 1
NCT00696800 (23) [back to overview]Number of Follicles Categorized by Size on Stimulation Day 5
NCT00696800 (23) [back to overview]Number of Follicles Categorized by Size on Stimulation Day 8
NCT00696800 (23) [back to overview]Number of Follicles Categorized by Size on the Day of hCG
NCT00696800 (23) [back to overview]Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI)
NCT00696800 (23) [back to overview]Serum Estradiol (E2) Levels During Stimulation
NCT00696800 (23) [back to overview]Serum FSH Levels During Stimulation
NCT00696800 (23) [back to overview]Serum Inhibin-B Levels During Stimulation
NCT00696800 (23) [back to overview]Serum Luteinizing Hormone (LH) Levels During Stimulation
NCT00696800 (23) [back to overview]Serum Progesterone (P) Levels During Stimulation
NCT00696800 (23) [back to overview]Mean Number of Oocytes Retrieved
NCT00696800 (23) [back to overview]Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1
NCT00696800 (23) [back to overview]Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8
NCT00696800 (23) [back to overview]Number of Cumulus-oocyte-complexes
NCT00696800 (23) [back to overview]Percentage of Fertilized Oocytes (Fertilization Rate)
NCT00696800 (23) [back to overview]Percentage of Gestational Sacs (Implantation Rate)
NCT00696800 (23) [back to overview]Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Attempt
NCT00696800 (23) [back to overview]Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Embryo Transfer
NCT00702273 (7) [back to overview]Percentage of Participants in Follow up Trial With a Vital Pregnancy
NCT00702273 (7) [back to overview]Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)
NCT00702273 (7) [back to overview]Percentage of Participants in Follow up Trial With an Ongoing Pregnancy
NCT00702273 (7) [back to overview]Percentage of Participants in Follow up Trial With an Ectopic Pregnancy
NCT00702273 (7) [back to overview]Percentage of Participants in Follow up Trial With a Clinical Pregnancy
NCT00702273 (7) [back to overview]Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy
NCT00702273 (7) [back to overview]Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy
NCT00702546 (7) [back to overview]Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy
NCT00702546 (7) [back to overview]Percentage of Participants in Follow up Study With a Clinical Pregnancy
NCT00702546 (7) [back to overview]Percentage of Participants in Follow up Study With an Ecotopic Pregnancy
NCT00702546 (7) [back to overview]Percentage of Participants in Follow up Study With a Vital Pregnancy
NCT00702546 (7) [back to overview]Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy
NCT00702546 (7) [back to overview]Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)
NCT00702546 (7) [back to overview]Percentage of Participants With an Ongoing Pregnancy
NCT00702624 (5) [back to overview]Number of Expectant Mothers Experiencing Adverse Events (AEs)
NCT00702624 (5) [back to overview]Number of Expectant Mothers Experiencing Serious AEs (SAEs)
NCT00702624 (5) [back to overview]Number of Infants Experiencing AEs
NCT00702624 (5) [back to overview]Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)
NCT00702624 (5) [back to overview]Number of Infants Experiencing SAEs
NCT00702845 (17) [back to overview]Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)
NCT00702845 (17) [back to overview]Number of Participants With Pregnancies
NCT00702845 (17) [back to overview]Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)
NCT00702845 (17) [back to overview]Fertilization Rate
NCT00702845 (17) [back to overview]Implantation Rate for Participants With ET
NCT00702845 (17) [back to overview]Number of Cumulus-oocyte-complexes Retrieved, Per Attempt
NCT00702845 (17) [back to overview]Number of Days Treated With recFSH
NCT00702845 (17) [back to overview]Total Dose of recFSH Administered
NCT00702845 (17) [back to overview]Number of Participants With Miscarriages
NCT00702845 (17) [back to overview]Total Dose of recFSH Administered From Day 8 Onwards
NCT00702845 (17) [back to overview]Total Duration of Stimulation (Days)
NCT00702845 (17) [back to overview]Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)
NCT00702845 (17) [back to overview]Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only)
NCT00702845 (17) [back to overview]Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration
NCT00702845 (17) [back to overview]Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)
NCT00702845 (17) [back to overview]Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)
NCT00702845 (17) [back to overview]Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)
NCT00703014 (6) [back to overview]Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.
NCT00703014 (6) [back to overview]Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.
NCT00703014 (6) [back to overview]Number of Infants in Current Follow Up Trial Experiencing SAEs
NCT00703014 (6) [back to overview]Number of Infants Born in Current Follow Up Trial Experiencing AEs
NCT00703014 (6) [back to overview]Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)
NCT00703014 (6) [back to overview]Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)
NCT00725491 (1) [back to overview]The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met.
NCT00802360 (10) [back to overview]Participants With Biochemical Pregnancy at Day 38
NCT00802360 (10) [back to overview]Participants With Clinical Pregnancy at Week 7
NCT00802360 (10) [back to overview]Number of Embryos Frozen at Day 24
NCT00802360 (10) [back to overview]Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
NCT00802360 (10) [back to overview]Number of Embryos Transferred at Three Stages of Development
NCT00802360 (10) [back to overview]Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved
NCT00802360 (10) [back to overview]Percentage of Participants With Ongoing Pregnancy at Week 8
NCT00802360 (10) [back to overview]Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle
NCT00802360 (10) [back to overview]Number of Follicles Observed at Day 15
NCT00802360 (10) [back to overview]Number of Oocytes Retrieved at Day 18
NCT00823472 (2) [back to overview]Proportion of Top Embryos Per OPU.
NCT00823472 (2) [back to overview]Number of Cumulus Oocyte Complexes Obtained
NCT01153581 (3) [back to overview]Skin Microvascular Responses
NCT01153581 (3) [back to overview]Orthostatic Tolerance
NCT01153581 (3) [back to overview]Baroreceptor Function

Total Antioxidant Status (TAS)

"This other outcome measure was originally specified as Secondary in error and has been updated to Other, Pre-specified to be consistent with the protocol. TAS is an antioxidant and is a biomarker of oxidative stress." (NCT00608062)
Timeframe: Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back

,,,,,
Interventionnmol/L (Mean)
BaselineGnRHant aloneGnRhant+Add-back
Peri11.31.31.3
Peri21.31.31.3
Post11.31.31.3
Post21.31.41.3
Pre11.41.41.4
Pre21.41.51.4

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Supine Brachial Blood Pressures

(NCT00608062)
Timeframe: Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment

,,,,,
InterventionmmHg (Mean)
BaselineDay 4 of GnRHant aloneDay 7 of GnRHant plus treatment
Peri1111112108
Peri2109108109
Post1117116112
Post2123115111
Pre1102107103
Pre2108111110

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Progesterone

"This other outcome measure was originally specified as Secondary in error and has been updated to Other, Pre-specified to be consistent with the protocol. Serum progesterone was measured for clinical characteristics and to determine changes in sex hormones." (NCT00608062)
Timeframe: Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back

,,,,,
Interventionnmol/L (Median)
BaselineGnRHant aloneGnRhant+Add-back
Peri11.11.00.8
Peri21.31.01.6
Post11.11.01.0
Post20.90.60.6
Pre11.81.31.0
Pre22.11.71.0

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Plasma Norepinephrine

"This other outcome measure was originally specified as Secondary in error and has been updated to Other, Pre-specified to be consistent with the protocol." (NCT00608062)
Timeframe: Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back

,,,,,
Interventionpg/mL (Median)
BaselineGnRHant aloneGnRhant+Add-back
Peri1227235231
Peri2247233217
Post1231280204
Post2242217221
Pre1161144146
Pre2184156217

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Estradiol

"This other outcome measure was originally specified as Secondary in error and has been updated to Other, Pre-specified to be consistent with the protocol. Serum estradiol for clinical characteristics and to detect changes in estradiol levels with the interventions." (NCT00608062)
Timeframe: Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment

,,,,,
Interventionpmol/L (Median)
BaselineGnRHant aloneGnRhant+Add-back
Peri136092187
Peri214799106
Post13937165
Post2373737
Pre1229147202
Pre2270127134

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Endothelin-1 (ET-1)

"This other outcome measure was originally specified as Secondary in error and has been updated to Other, Pre-specified to be consistent with the protocol." (NCT00608062)
Timeframe: Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back

,,,,,
Interventionpg/mL (Mean)
BaselineGnRHant aloneGnRhant+Add-back
Peri15.96.05.9
Peri26.25.95.7
Post16.26.56.0
Post26.46.56.4
Pre15.25.56.0
Pre25.25.55.0

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Endothelial Function

"Brachial artery flow-mediated dilation (FMD) assessed by ultrasound. This other outcome measure was originally specified as Secondary in error and has been updated to Primary to be consistent with the protocol." (NCT00608062)
Timeframe: Baseline, day 4 of GnRHant and Day 7 of GnRHant and estradiol or placebo treatment

,,,,,
Intervention% Diameter Change (Mean)
BaselineDay 4 of GnRHant aloneDay 7 of GnRHant plus treatmentAcute Vitamin C Infusion Day 7
Peri17.75.89.69.3
Peri26.16.66.111.2
Post15.44.98.47.8
Post25.34.94.26.7
Pre19.87.110.68.4
Pre211.38.97.811.2

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Arterial Stiffness (Carotid Artery Compliance) During Saline

Carotid artery compliance measured by carotid artery ultrasound and brachial artery blood pressure (NCT00608062)
Timeframe: Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment

,,,,,
Interventionmm2/mm Hg×10-1 (Mean)
BaselineGnRHant aloneGnRHant + Add-Back
Peri10.900.890.98
Peri21.020.940.94
Post10.890.850.92
Post20.740.790.80
Pre11.311.271.29
Pre21.341.191.14

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Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Clinical Pregnancy

The miscarriage rate is 100 times the number of miscarriages, divided by the number of clinical pregnancies assessed by USS. A clinical pregnancy is the presence of at least one gestational sac or confirmed by live birth. (NCT00696800)
Timeframe: Up to day of miscarriage (up to 1 year)

InterventionPercentage of participants (Number)
150 µg Corifollitropin Alfa8.4
200 IU recFSH6.8

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Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Vital Pregnancy

The miscarriage rate is 100 times the number of miscarriages, divided by the number of vital pregnancies assessed by USS. A vital pregnancy is the presence of at least one fetus with heart activity. (NCT00696800)
Timeframe: Up to day of miscarriage (up to 1 year)

InterventionPercentage of participants (Number)
150 µg Corifollitropin Alfa2.3
200 IU recFSH2.0

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Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)

An ongoing pregnancy is a fetus with heart activity at least 10 weeks after embryo transfer as assessed by Ultrasound Scan (USS) or Doppler or is confirmed by live birth. The ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy after embryo transfer, divided by the total number of participants who started treatment. Calculations were made per attempt, meaning that participants who did not have embryo transfers were considered not pregnant. (NCT00696800)
Timeframe: Assessed at least 10 weeks after embryo transfer (up to 1 year)

InterventionPercentage of participants (Number)
150 µg Corifollitropin Alfa39.0
200 IU recFSH38.1

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Number of Embryos Obtained on Day 3 Categorized by Quality

Embryos obtained on Day 3 were categorized by their qualiity as follows: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: < 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 3: fair: 20-50% fragmentation and/or less than 6 cells and/or multinucleation (if observed). Other Grade: Embryos that do not qualify as Grades 1, 2 or 3. Grades 1 and 2 are considered good quality. (NCT00696800)
Timeframe: Post fertilization Day 3 (up to 1 year)

,
InterventionNumber of embryos (Mean)
TotalGood QualityGrade 1Grade 2Grade 3Other Grade
150 µg Corifollitropin Alfa8.44.72.62.12.41.4
200 IU recFSH7.54.52.52.02.01.1

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Number of Embryos Transferred on Day 3

After fertilization, the mean number of embryos transferred on Day 3 were assessed. Total and good quality embryos are presented, with good quality embryos, Grades 1 and 2, defined as the following: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: < 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. (NCT00696800)
Timeframe: Post fertilization Day 3 (up to 1 year)

,
InterventionNumber of embryos (Mean)
TotalGood Quality
150 µg Corifollitropin Alfa1.71.4
200 IU recFSH1.71.4

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Number of Follicles Categorized by Size on Stimulation Day 1

Ovaries were assessed during stimulation by ultrasonographic investigation (USS), and the mean number of follicles are categorized by their size. (NCT00696800)
Timeframe: On Day 1 of treatment (up to 1 year)

,
InterventionNumber of follicles (Mean)
>=11 mm>=15 mm>=17 mm
150 µg Corifollitropin Alfa0.10.00.0
200 IU recFSH0.10.00.0

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Number of Follicles Categorized by Size on Stimulation Day 5

Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size. (NCT00696800)
Timeframe: On Day 5 of treatment (up to 1 year)

,
InterventionNumber of follicles (Mean)
>=11 mm>=15 mm>=17 mm
150 µg Corifollitropin Alfa4.40.30.1
200 IU recFSH4.70.40.1

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Number of Follicles Categorized by Size on Stimulation Day 8

Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size. (NCT00696800)
Timeframe: On Day 8 of treatment (up to 1 year)

,
InterventionNumber of follicles (Mean)
>=11 mm>=15 mm>=17 mm
150 µg Corifollitropin Alfa12.85.02.1
200 IU recFSH11.65.22.5

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Number of Follicles Categorized by Size on the Day of hCG

Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size. (NCT00696800)
Timeframe: Day of HCG treatment (up to 1 year)

,
InterventionNumber of follicles (Mean)
>=11 mm>=15 mm>=17 mm
150 µg Corifollitropin Alfa16.09.65.7
200 IU recFSH13.98.75.6

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Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI)

The number of oocytes used for ICSI was assessed, and categorized based on their quality (NCT00696800)
Timeframe: Up to 36 hours after administration of hCG (up to 1 year)

,
InterventionNumber of oocytes (Mean)
TotalMetaphase IMetaphase IIGerminal vesicles
150 µg Corifollitropin Alfa13.81.110.81.4
200 IU recFSH12.20.99.21.7

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Serum Estradiol (E2) Levels During Stimulation

Mean serum E2 levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment. (NCT00696800)
Timeframe: Up to day of hCG treatment (up to 1 year)

,
Interventionpmol/L (Mean)
Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724)Day 5 (Cori. Alfa N=725; recFSH N=722)Day 8 (Cori. Alfa N=708; recFSH N=678)Day of hCG (Cori. Alfa N=698; recFSH N=708)
150 µg Corifollitropin Alfa126.131859.393700.925486.67
200 IU recFSH124.791392.973750.965154.88

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Serum FSH Levels During Stimulation

Mean serum FSH are presented over one Controlled Ovarian Stimulation (COS) cycle: from Day 1 (Pre-dose) up to the day of hCG treatment. (NCT00696800)
Timeframe: Up to day of hCG treatment (up to 1 year)

,
InterventionIU/L (Mean)
Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724)Day 5 (Cori. Alfa N=725; recFSH N=722)Day 8 (Cori. Alfa N=708; recFSH N=678)Day of hCG (Cori. Alfa N=698; recFSH N=708)
150 µg Corifollitropin Alfa6.7023.4911.7612.54
200 IU recFSH6.6011.6111.5911.59

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Serum Inhibin-B Levels During Stimulation

Mean serum Inhibin-B levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment (NCT00696800)
Timeframe: Up to day of hCG treatment (up to 1 year)

,
Interventionpg/mL (Mean)
Day 1 (Pre-dose) (Cori. Alfa N=736; recFSH N=724)Day 5 (Cori. Alfa N=731; recFSH N=724)Day 8 (Cori. Alfa N=713; recFSH N=679)Day of hCG (Cori. Alfa N=704; recFSH N=710)
150 µg Corifollitropin Alfa52.78488.54578.21608.35
200 IU recFSH52.95493.86642.27612.19

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Serum Luteinizing Hormone (LH) Levels During Stimulation

Mean serum LH levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment. (NCT00696800)
Timeframe: Up to day of hCG treatment (up to 1 year)

,
InterventionIU/L (Mean)
Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724)Day 5 (Cori. Alfa N=725; recFSH N=722)Day 8 (Cori. Alfa N=708; recFSH N=678)Day of hCG (Cori. Alfa N=698; recFSH N=708)
150 µg Corifollitropin Alfa4.803.621.291.38
200 IU recFSH4.672.232.051.86

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Serum Progesterone (P) Levels During Stimulation

Mean serum P levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment (NCT00696800)
Timeframe: Up to day of hCG treatment (up to 1 year)

,
Interventionnmol/mL (Mean)
Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724)Day 5 (Cori. Alfa N=725; recFSH N=722)Day 8 (Cori. Alfa N=708; recFSH N=678)Day of hCG (Cori. Alfa N=698; recFSH N=708)
150 µg Corifollitropin Alfa1.802.131.953.20
200 IU recFSH1.851.612.643.16

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Mean Number of Oocytes Retrieved

Up to 36 hours after receiving hCG, cumulus-oocyte-complexes were retrieved. Mean numbers retrieved were calculated per attempt, meaning that if a participant did not reach this stage in In Vitro Fertilization (IVF) treatment, zero values were imputed. (NCT00696800)
Timeframe: Up to 36 hours after administration of hCG (up to 1 year)

InterventionNumber of oocytes (Mean)
150 µg Corifollitropin Alfa13.8
200 IU recFSH12.6

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Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1

The amount of recFSH administered for a participant to reach 3 follicles >= 17 mm, starting from treatment Day 1 onwards. (NCT00696800)
Timeframe: From Day 1 to day of hCG treatment (up to 1 year)

InterventionIU (Median)
150 µg Corifollitropin Alfa400
200 IU recFSH1800

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Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8

The amount of recFSH administered for a participant to reach 3 follicles >= 17 mm, starting from treatment Day 8 onwards. (NCT00696800)
Timeframe: From Day 8 to Day of hCG treatment (up to 1 year)

InterventionIU (Median)
150 µg Corifollitropin Alfa400
200 IU recFSH400

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Number of Cumulus-oocyte-complexes

Prior to IVF the mean number of cumulus-oocyte-complexes used for IVF was assessed (NCT00696800)
Timeframe: Up to 36 hours after administration of hCG (up to 1 year)

InterventionNumber of cumulus-oocyte complexes (Mean)
150 µg Corifollitropin Alfa13.6
200 IU recFSH12.8

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Percentage of Fertilized Oocytes (Fertilization Rate)

The fertilization rate is 100 times the number of fertilized 2 pro-nuclei (2PN) oocytes obtained, divided by the number of oocytes fertilized by IVF or ICSI (NCT00696800)
Timeframe: Up to 18 hours after start of fertilization (up to 1 year)

InterventionPercentage of fertilized oocytes (Mean)
150 µg Corifollitropin Alfa66.0
200 IU recFSH67.6

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Percentage of Gestational Sacs (Implantation Rate)

The implantation rate is 100 times the number of gestational sacs assessed by USS after embryo transfer, divided by the number of embryos transferred. (NCT00696800)
Timeframe: Up to 6 weeks after embryo transfer (up to 1 year)

InterventionPercentage of gestational sacs (Mean)
150 µg Corifollitropin Alfa36.2
200 IU recFSH32.2

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Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Attempt

Biochemical pregnancy was assessed by measuring serum or urinary hCG. Per attempt means that if a participant did not reach the stage of pregnancy assessment zero values were imputed. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed. (NCT00696800)
Timeframe: Two weeks after embryo transfer (up to 1 year)

InterventionPercentage of participants (Number)
150 µg Corifollitropin Alfa48.1
200 IU recFSH46.9

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Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Embryo Transfer

Biochemical pregnancy was assessed for participants who had embryo transfer by measuring serum or urinary hCG. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed. (NCT00696800)
Timeframe: Two weeks after embryo transfer (up to 1 year)

InterventionPercentage of participants (Number)
150 µg Corifollitropin Alfa54.2
200 IU recFSH50.0

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Percentage of Participants in Follow up Trial With a Vital Pregnancy

A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed. (NCT00702273)
Timeframe: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

InterventionPercentage of participants (Number)
150 µg Corifollitropin Alfa39.9
200 IU RecFSH31.8

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Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)

An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed by live birth.The cumulative ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base Trial P05787 (NCT00696800), or after one or more FTET cycles in follow-up Trial P05716 following cryopreservation, divided by the total number of participants that started treatment in base Trial P05787 (NCT00696800). Participants who did not have cryopreserved embryos, or embryo transfers in the FTET cycle(s), were considered 'not pregnant'. (NCT00702273)
Timeframe: Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial

InterventionPercentage of participants (Number)
150 µg Corifollitropin Alfa47.2
200 IU RecFSH44.9

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Percentage of Participants in Follow up Trial With an Ongoing Pregnancy

An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed. (NCT00702273)
Timeframe: After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)

InterventionPercentage of participants (Number)
150 µg Corifollitropin Alfa38.7
200 IU RecFSH30.7

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Percentage of Participants in Follow up Trial With an Ectopic Pregnancy

An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET. (NCT00702273)
Timeframe: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

InterventionPercentage of participants (Number)
150 µg Corifollitropin Alfa1.2
200 IU RecFSH0.6

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Percentage of Participants in Follow up Trial With a Clinical Pregnancy

A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed. (NCT00702273)
Timeframe: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

InterventionPercentage of participants (Number)
150 µg Corifollitropin Alfa43.5
200 IU RecFSH38.6

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Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy

Miscarriages were calculated per clinical pregnancy, meaning the presence of at least one gestational sac or confirmed by live birth. (NCT00702273)
Timeframe: After one or more FTET cycles, up to day of miscarriage (up to 1 year)

InterventionPercentage of participants (Number)
150 µg Corifollitropin Alfa8.2
200 IU RecFSH17.6

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Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy

Miscarriages were calculated per vital pregnancy, meaning the presence of at least one fetus with heart activity. (NCT00702273)
Timeframe: After one or more FTET cycles, up to day of miscarriage (up to 1 year)

InterventionPercentage of participants (Number)
150 µg Corifollitropin Alfa0
200 IU RecFSH0

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Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy

Miscarriages were calculated per clinical pregnancy, defined as the presence of at least one gestational sac as assessed by USS or Doppler, or confirmed by live birth. (NCT00702546)
Timeframe: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

InterventionPercentage of participants (Number)
Corifollitropin Alfa 100 μg13.6
recFSH 150 IU10.0

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Percentage of Participants in Follow up Study With a Clinical Pregnancy

A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed. (NCT00702546)
Timeframe: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

InterventionPercentage of participants (Number)
Corifollitropin Alfa 100 μg28.6
recFSH 150 IU40.0

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Percentage of Participants in Follow up Study With an Ecotopic Pregnancy

An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET. (NCT00702546)
Timeframe: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

InterventionPercentage of participants (Number)
Corifollitropin Alfa 100 μg1.3
recFSH 150 IU0.0

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Percentage of Participants in Follow up Study With a Vital Pregnancy

A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed. (NCT00702546)
Timeframe: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

InterventionPercentage of participants (Number)
Corifollitropin Alfa 100 μg24.7
recFSH 150 IU36.0

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Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy

Miscarriages were calculated per vital pregnancy, defined as the presence of at least one fetus with heart activity as assessed by USS or Doppler, or confirmed by live birth. (NCT00702546)
Timeframe: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

InterventionPercentage of participants (Number)
Corifollitropin Alfa 100 μg0.0
recFSH 150 IU0.0

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Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)

Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690. (NCT00702546)
Timeframe: Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711

InterventionPercentage of participants (Number)
Corifollitropin Alfa 100 μg32.1
recFSH 150 IU41.4

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Percentage of Participants With an Ongoing Pregnancy

An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed. (NCT00702546)
Timeframe: After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)

InterventionPercentage of participants (Number)
Corifollitropin Alfa 100 μg23.4
recFSH 150 IU36.0

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Number of Expectant Mothers Experiencing Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. (NCT00702624)
Timeframe: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

InterventionParticipants (Number)
Corifollitropin Alfa 100 μg Expectant Mothers48
recFSH 150 IU Expectant Mothers35

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Number of Expectant Mothers Experiencing Serious AEs (SAEs)

An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. (NCT00702624)
Timeframe: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

InterventionParticipants (Number)
Corifollitropin Alfa 100 μg Expectant Mothers38
recFSH 150 IU Expectant Mothers21

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Number of Infants Experiencing AEs

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. (NCT00702624)
Timeframe: Up to 12 weeks after birth

InterventionLive born infants (Number)
Corifollitropin Alfa 100 μg Follow-Up Infants37
recFSH 150 IU Follow-Up Infants27

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Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)

The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study. (NCT00702624)
Timeframe: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

InterventionPercentage of participants (Number)
Corifollitropin Alfa 100 μg Women23.5
recFSH 150 IU Women34.4

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Number of Infants Experiencing SAEs

An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. (NCT00702624)
Timeframe: Up to 12 weeks after birth

InterventionLive born infants (Number)
Corifollitropin Alfa 100 μg Follow-Up Infants30
recFSH 150 IU Follow-Up Infants16

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Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)

Blood samples for assessment of serum E2 were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET. (NCT00702845)
Timeframe: Predose up to 2 weeks after ET (up to maximum of 6 weeks)

,
Interventionpmol/L (Median)
Stimulation Day 1 (pre-dose) (n=265,122)Stimulation Day 3 (n=265,127)Stimulation Day 5 (n=265,127)Stimulation Day 8 (n=255,121)Day of hCG injection (n=262,126)Day of ET (n=242,121)2 weeks after ET (n=245,121)
100 μg Corifollitropin Alfa118.17803.731901.062899.304440.703475.49168.45
150 IU recFSH120.38506.461295.513167.214440.703670.00392.69

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Number of Participants With Pregnancies

A Biochemical Pregnancy was defined as a pregnancy proven by a biochemical pregnancy test. (Participants not having a positive biochemical pregnancy test result, but with an ultrasound showing at least one gestational sac were counted as having a biochemical pregnancy.) A Clinical Pregnancy was defined as the presence of at least one gestational sac as assessed by an USS scan. A Vital Pregnancy was considered the presence of at least one fetus with heart activity as assessed by USS. An Ongoing Pregnancy was defined as the presence of at least one fetus with heart activity at least 10 weeks after ET as assessed by USS or Doppler, or confirmed by live birth. (NCT00702845)
Timeframe: Up to 10 weeks after ET (up to a maximum of 14 weeks)

,
InterventionParticipants (Number)
Biochemical pregnancy, per attempt (n=268,128)Biochemical pregnancy, per ET (n=246,121)Clinical pregnancy, per attempt (n=268,128)Clinical pregnancy, per ET (n=246,121)Vital pregnancy, per attempt (n=268,128)Vital pregnancy, per ET (n=246,121)Ongoing pregnancy, per attempt (n=268,128)Ongoing pregnancy, per ET (n=246,121)
100 μg Corifollitropin Alfa101101787869696868
150 IU recFSH5858484845454444

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Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)

Blood samples for assessment of serum FSH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET. (NCT00702845)
Timeframe: Predose up to 2 weeks after ET (up to maximum of 6 weeks)

,
InterventionIU/L (Median)
Stimulation Day 1 (pre-dose) (n=265,122)Stimulation Day 3 (n=265,127)Stimulation Day 5 (n=265,127)Stimulation Day 8 (n=255,121)Day of hCG injection (n=262,126)Day of ET (n=242,121)2 weeks after ET (n=245,121)
100 μg Corifollitropin Alfa6.4626.3019.5010.1011.502.524.46
150 IU recFSH6.519.1810.2010.3010.651.321.90

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Fertilization Rate

Fertilization rate, defined as 100 times the ratio of the number of fertilized 2 pronuclei (PN) oocytes obtained and the number of oocytes incubated, was tabulated for each treatment group. (NCT00702845)
Timeframe: Up to 10 weeks after ET

InterventionPercentage (Mean)
100 μg Corifollitropin Alfa67.6
150 IU recFSH67.7

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Implantation Rate for Participants With ET

The implantation rate was defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan (USS) after ET divided by the number of embryos transferred (per participant), maximized to 100%. (NCT00702845)
Timeframe: Up to 6 weeks after ET within a treatment cycle (up to a maximum 10 weeks)

InterventionPercentage (Mean)
100 μg Corifollitropin Alfa23.6
150 IU recFSH28.5

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Number of Cumulus-oocyte-complexes Retrieved, Per Attempt

The primary efficacy parameter was defined as the number of cumulus-oocyte-complexes retrieved from participants in a controlled ovarian stimulation (COS) cycle for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). For participants who did not have cumulus-oocyte-complex retrieval, the number retrieved was set to zero. (NCT00702845)
Timeframe: One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days)

InterventionNumber of cumulus-oocyte-complexes (Mean)
100 μg Corifollitropin Alfa13.3
150 IU recFSH10.6

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Number of Days Treated With recFSH

Numbers of days treated with recFSH was defined as the total number of days participants received recFSH (excluding coasting days) until they reached the criterion for administration of hCG (at least 3 follicles >=17mm). (NCT00702845)
Timeframe: One COS cycle (up to a maximum total duration of 19 stimulation days)

InterventionDays (Median)
100 μg Corifollitropin Alfa2.0
150 IU recFSH9.0

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Total Dose of recFSH Administered

Total dose of recFSH (IU) administered was defined as the total amount of recFSH needed by participants to reach the criterion for administration of hCG (at least 3 follicles >=17mm). (NCT00702845)
Timeframe: One COS cycle (up to a maximum total duration of 19 stimulation days)

InterventionInternational Unit (IU) (Median)
100 μg Corifollitropin Alfa300.0
150 IU recFSH1350.0

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Number of Participants With Miscarriages

"A miscarriage, also known as a spontaneous abortion, was defined as the loss of a fetus without induction or instrumentation." (NCT00702845)
Timeframe: Up to 10 weeks after ET (up to a maximum of 14 weeks)

,
InterventionParticipants (Number)
Per clinical pregnancy (n=78,48)Per vital pregnancy (n=69,45)
100 μg Corifollitropin Alfa101
150 IU recFSH41

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Total Dose of recFSH Administered From Day 8 Onwards

Total dose of recFSH (IU) needed from Stimulation Day 8 onwards to reach the criterion for administration of hCG (at least 3 follicles >=17mm). (NCT00702845)
Timeframe: Stimulation Day 8 of COS cycle up to day of hCG administration (up to a maximum total duration of 19 stimulation days)

InterventionInternational Unit (IU) (Median)
100 μg Corifollitropin Alfa300.0
150 IU recFSH275.0

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Total Duration of Stimulation (Days)

Total duration of stimulation was defined as the number of days from first drug administration up to and including the Day of hCG administration. (NCT00702845)
Timeframe: One COS cycle (up to a maximum total duration of 19 stimulation days)

InterventionDays (Median)
100 μg Corifollitropin Alfa9.0
150 IU recFSH9.0

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Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)

"Embryo quality was rated Grade 1, 2, 3, or other. Grade 1 represented excellent quality; Grade 2 good quality; Grade 3 fair quality. Other grade embryos were those that did not qualify as Grade 1, 2, or 3." (NCT00702845)
Timeframe: Post fertilization Day 3 (up to a maximum of 2 days after hCG administration)

,
InterventionNumber of embryos (Mean)
Total (n=259,123)Good qualityGrade 1Grade 2Grade 3Other
100 μg Corifollitropin Alfa7.23.41.71.82.81.0
150 IU recFSH6.23.01.41.62.40.7

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Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only)

The number of oocytes used for ICSI was assessed and categorized based on their quality (i.e., metaphase I oocytes, metaphase II oocytes, and germinal vesicles stage oocytes). (NCT00702845)
Timeframe: Up to 36 hours after administration of hCG

,
InterventionNumber of oocytes (Mean)
Oocytes assessed prior to ICSIMetaphase I oocytesMetaphase II oocytesGerminal vesicles stage oocytes
100 μg Corifollitropin Alfa12.70.810.71.1
150 IU recFSH9.90.77.81.3

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Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration

For each participant, the number of follicles ≥11 mm, ≥15 mm, and ≥17 mm, documented by ultrasonography on defined days during the treatment cycle, was calculated. (NCT00702845)
Timeframe: Predose up to day of hCG administration (up to a maximum total duration of 19 stimulation days, including day of hCG administration)

,
InterventionFollicles (Mean)
Stimulation Day 1, >=11mm (n=266,124)Stimulation Day 1, >=15mm (n=266,124)Stimulation Day 1, >=17mm (n=266,124)Stimulation Day 3, >=11mm (n=268,128)Stimulation Day 3, >=15mm (n=268,128)Stimulation Day 3, >=17mm (n=268,128)Stimulation Day 5, >=11mm (n=267,128)Stimulation Day 5, >=15mm (n=267,128)Stimulation Day 5, >=17mm (n=267,128)Stimulation Day 6, >=11mm (n=9,5)Stimulation Day 6, >=15mm (n=9,5)Stimulation Day 6, >=17mm (n=9,5)Stimulation Day 7, >=11mm (n=30,12)Stimulation Day 7, >=15mm (n=30,12)Stimulation Day 7, >=17mm (n=30,12)Stimulation Day 8, >=11mm (n=259,121)Stimulation Day 8, >=15mm (n=259,121)Stimulation Day 8, >=17mm (n=259,121)Stimulation Day 9, >=11mm (n=185,76)Stimulation Day 9, >=15mm (n=185,76)Stimulation Day 9, >=17mm (n=185,76)Stimulation Day 10, >=11mm (n=101,40)Stimulation Day 10, >=15mm (n=101,40)Stimulation Day 10, >=17mm (n=101,40)Stimulation Day 11, >=11mm (n=38,14)Stimulation Day 11, >=15mm (n=38,14)Stimulation Day 11, >=17mm (n=38,14)Stimulation Day 12, >=11mm (n=17,6)Stimulation Day 12, >=15mm (n=17,6)Stimulation Day 12, >=17mm (n=17,6)Stimulation Day 13, >=11mm (n=5,4)Stimulation Day 13, >=15mm (n=5,4)Stimulation Day 13, >=17mm (n=5,4)Stimulation Day 14, >=11mm (n=2,1)Stimulation Day 14, >=15mm (n=2,1)Stimulation Day 14, >=17mm (n=2,1)Stimulation Day 15, >=11mm (n=1,1)Stimulation Day 15, >=15mm (n=1,1)Stimulation Day 15, >=17mm (n=1,1)Day of hCG administration, >=11mm (n=266,127)Day of hCG administration, >=15mm (n=266,127)Day of hCG administration, >=17mm (n=266,127)
100 μg Corifollitropin Alfa0.00.00.00.60.00.04.70.30.07.61.80.711.94.51.811.85.02.013.46.92.613.97.43.613.97.73.912.76.83.517.010.64.413.510.56.07.04.02.014.99.45.3
150 IU recFSH0.00.00.00.50.00.04.10.30.08.64.01.89.23.31.110.65.12.411.16.02.613.07.54.011.67.13.89.35.22.710.36.34.03.00.00.04.04.03.012.98.55.1

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Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)

Blood samples for assessment of serum P were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET. (NCT00702845)
Timeframe: Predose up to 2 weeks after ET (up to maximum of 6 weeks)

,
Interventionnmol/L (Median)
Stimulation Day 1 (pre-dose) (n=264,120)Stimulation Day 3 (n=263,126)Stimulation Day 5 (n=265,127)Stimulation Day 8 (n=255,121)Day of hCG injection (n=262,126)Day of ET (n=242,121)2 weeks after ET (n=244,120)
100 μg Corifollitropin Alfa1.361.231.651.392.10421.3538.64
150 IU recFSH1.40NA1.282.032.39333.9051.99

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Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)

Blood samples for assessment of serum LH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET. (NCT00702845)
Timeframe: Predose up to 2 weeks after ET (up to maximum of 6 weeks)

,
InterventionIU/L (Median)
Stimulation Day 1 (pre-dose) (n=265,122)Stimulation Day 3 (n=265,127)Stimulation Day 5 (n=264,127)Stimulation Day 8 (n=255,121)Day of hCG injection (n=262,126)Day of ET (n=242,121)2 weeks after ET (n=245,121)
100 μg Corifollitropin Alfa4.461.181.910.820.88NA2.38
150 IU recFSH4.121.461.491.601.30NA1.02

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Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)

Blood samples for assessment of serum inhibin-B were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET. (NCT00702845)
Timeframe: Predose up to 2 weeks after ET (up to maximum of 6 weeks)

,
Interventionpg/mL (Median)
Stimulation Day 1 (pre-dose) (n=265,123)Stimulation Day 3 (n=265,127)Stimulation Day 5 (n=264,127)Stimulation Day 8 (n=255,121)Day of hCG injection (n=262,126)Day of ET (n=242,121)2 weeks after ET (n=245,121)
100 μg Corifollitropin Alfa54.20351.00598.00619.00729.5018.2017.50
150 IU recFSH57.80259.00489.00650.00615.5017.00NA

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Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.

The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer. (NCT00703014)
Timeframe: At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)

InterventionPercentage of Participants (Number)
Mothers Corifollitropin Alfa 150 µg40.0
Mothers recFSH 200 IU36.6

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Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.

The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial. (NCT00703014)
Timeframe: At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)

InterventionPercentage of Participants (Number)
Mothers Corifollitropin Alfa 150 µg35.6
Mothers recFSH 200 IU34.4

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Number of Infants in Current Follow Up Trial Experiencing SAEs

A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. (NCT00703014)
Timeframe: Up to 12 weeks following delivery (up to 1 year)

InterventionParticipants (Number)
Infants Corifollitropin Alfa 150 µg106
Infants recFSH 200 IU94

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Number of Infants Born in Current Follow Up Trial Experiencing AEs

An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product. (NCT00703014)
Timeframe: Up to 12 weeks following delivery (up to 1 year)

InterventionParticipants (Number)
Infants Corifollitropin Alfa 150 µg164
Infants recFSH 200 IU161

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Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)

An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product. (NCT00703014)
Timeframe: Up to one day following delivery (up to 1 year)

InterventionParticipants (Number)
Mothers Corifollitropin Alfa 150 µg222
Mothers recFSH 200 IU214

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Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)

A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. (NCT00703014)
Timeframe: Up to one day following delivery (up to 1 year)

InterventionParticipants (Number)
Mothers Corifollitropin Alfa 150 µg129
Mothers recFSH 200 IU117

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The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met.

The hCG criterion is met the first day that 3 follicles >= 17 mm are observed. (NCT00725491)
Timeframe: At completion of ovarian stimulation; maximally after 18 days of recFSH administration.

Interventioninternational units (IU) (Mean)
Ganirelix1272.0
Triptorelin1415.6

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Participants With Biochemical Pregnancy at Day 38

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

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

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Participants With Clinical Pregnancy at Week 7

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

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

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Number of Embryos Frozen at Day 24

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

Interventionembryos (Mean)
Menopur1.9
Follistim1.6

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

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

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

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Number of Embryos Transferred at Three Stages of Development

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

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

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Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved

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

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

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Percentage of Participants With Ongoing Pregnancy at Week 8

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

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

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

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

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

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Number of Follicles Observed at Day 15

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

Interventionfollicles (Mean)
Menopur15.6
Follistim16.2

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Number of Oocytes Retrieved at Day 18

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

Interventionoocytes (Mean)
Menopur11.5
Follistim13.8

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Proportion of Top Embryos Per OPU.

Proportion of top embryos per ovum pick-up (NCT00823472)
Timeframe: 1 year

Interventionpercentage embryos (Number)
Start rFSH Cycle Day 251.1
Start rFSH on Cycle Day 541.8

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Number of Cumulus Oocyte Complexes Obtained

Number of cumulus oocyte complexes obtained after ovum pick-up (NCT00823472)
Timeframe: one year

Interventionoocytes (Mean)
Start rFSH Cycle Day 29.8
Start rFSH on Cycle Day 58.5

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Skin Microvascular Responses

"Changes in blood flow in the small vessel in the skin are measured in response to sequential heat and drug stimulation. It is measured in volts, and then corrected for a maximum level and expressed as % max. This is measured with a Laser Doppler probes, which measures volts." (NCT01153581)
Timeframe: 2 months

InterventionPercent of max volts (Mean)
Women With Orthostatic Intolerance4.02
Women Without Orthostatic Tolerance5.18

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Orthostatic Tolerance

We used a measure called cumulative stress index to determine orthostatic tolerance, which is the amount of time at a level of negative pressure each subject can maintain before feeling as if she is going to pass out. This is calculated by multiplying the pressure in mm Hg by the time in min. (NCT01153581)
Timeframe: 2 months

InterventionmmHg*min (Mean)
Women With and Without Orthostatic Intolerance634

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Baroreceptor Function

"This is a measure of how the body responds to changes in pressure induced by changes in position such as sitting, lying standing. The pressure changes are induced by gravity. The measurement described below to assess baroreceptor function is units of change in forearm vascular resistance for a given change in lower body negative pressure. This allows us to determine how good the body is at sending signals to the periphery to respond to postural changes.~Baroreflex sensitivity is defined as the change in interbeat interval (IBI) in milliseconds per unit change in BP. For example, when the BP rises by 10 mmHg and IBI increases by 100 ms, BRS would be 100/10 = 10 ms/mmHg." (NCT01153581)
Timeframe: 2 months

Interventionms/mm Hg (Mean)
Low Orthostatic Tolerance0.140
High Orthostatic Tolerant0.128

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