Trial · NCT00884221

MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer

NCT00884221, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2012-04-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer. Trials, record NCT00884221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00884221

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer
NCT number: NCT00884221
Status: Completed
Phases: Phase 3
Enrollment: 749 participants, actual
Lead sponsor: Ferring Pharmaceuticals
Conditions: Infertility
Interventions: Highly purified menotrophin, Recombinant FSH
First posted: 2009-04-20
Last updated: 2012-04-20
Other registries' IDs: eudract:2008-006775-67
Results first posted: 2012-04-18

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set	10-11 weeks after embryo transfer at the blastocyst stage	Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage
Primary	Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set	10-11 weeks after embryo transfer at the blastocyst stage	Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage
Secondary	Endocrine Profile (Estradiol), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	Blood samples for analysis of circulating concentrations of endocrine parameters were drawn
Secondary	Endocrine Profile (FSH), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	Blood samples for analysis of circulating concentrations of endocrine parameters were drawn
Secondary	Endocrine Profile (Free Androgen Index), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	Blood samples for analysis of circulating concentrations of endocrine parameters were drawn. Free androgen index = (testosterone (nmol/L)/ sex hormone binding globulin (nmol/L))\*100
Secondary	Endocrine Profile (Luteinizing Hormone), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	Blood samples for analysis of circulating concentrations of endocrine parameters were drawn
Secondary	Endocrine Profile (Progesterone), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	Blood samples for analysis of circulating concentrations of endocrine parameters were drawn
Secondary	Endocrine Profile (Prolactin), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	Blood samples for analysis of circulating concentrations of endocrine parameters were drawn
Secondary	Endocrine Profile (Sex Hormone Binding Globulin), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	Blood samples for analysis of circulating concentrations of endocrine parameters were drawn
Secondary	Endocrine Profile (Testosterone), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	Blood samples for analysis of circulating concentrations of endocrine parameters were drawn

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set	10-11 weeks after embryo transfer at the blastocyst stage	The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.	Percentage of participants	MEAN
SECONDARY	Endocrine Profile (Estradiol), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.	pmol/L	MEAN
SECONDARY	Endocrine Profile (FSH), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.	IU/L	MEAN
SECONDARY	Endocrine Profile (Free Androgen Index), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.	Percentage of participants	MEAN
SECONDARY	Endocrine Profile (Luteinizing Hormone), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.	IU/L	MEAN
SECONDARY	Endocrine Profile (Progesterone), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.	nmol/L	MEAN
PRIMARY	Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set	10-11 weeks after embryo transfer at the blastocyst stage	The per-protocol (PP) analysis set was defined as all randomized and exposed participants except those excluded as a result of major protocol deviations, such as significant non-compliance or other serious unforeseen deviations deemed to invalidate the data and affect the conclusions of the trial.	Percentage of participants	MEAN
SECONDARY	Endocrine Profile (Prolactin), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.	pmol/L	MEAN
SECONDARY	Endocrine Profile (Sex Hormone Binding Globulin), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.	nmol/L	MEAN
SECONDARY	Endocrine Profile (Testosterone), Intention-to-treat (ITT) Analysis Set	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist	The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.	nmol/L	MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group52

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set	Highly Purified Menotrophin	29	Standard Deviation 2.3	Percentage of participants
Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set	Recombinant FSH	27	Standard Deviation 2.3	Percentage of participants
Endocrine Profile (Estradiol), Intention-to-treat (ITT) Analysis Set	Highly Purified Menotrophin	8797	Standard Deviation 6030	pmol/L
Endocrine Profile (Estradiol), Intention-to-treat (ITT) Analysis Set	Recombinant FSH	7022	Standard Deviation 4945	pmol/L
Endocrine Profile (FSH), Intention-to-treat (ITT) Analysis Set	Highly Purified Menotrophin	15.7	Standard Deviation 4.1	IU/L
Endocrine Profile (FSH), Intention-to-treat (ITT) Analysis Set	Recombinant FSH	12.6	Standard Deviation 3.7	IU/L
Endocrine Profile (Free Androgen Index), Intention-to-treat (ITT) Analysis Set	Highly Purified Menotrophin	2.8	Standard Deviation 2.0	Percentage of participants
Endocrine Profile (Free Androgen Index), Intention-to-treat (ITT) Analysis Set	Recombinant FSH	2.5	Standard Deviation 2.2	Percentage of participants
Endocrine Profile (Luteinizing Hormone), Intention-to-treat (ITT) Analysis Set	Highly Purified Menotrophin	2.8	Standard Deviation 2.8	IU/L
Endocrine Profile (Luteinizing Hormone), Intention-to-treat (ITT) Analysis Set	Recombinant FSH	2.1	Standard Deviation 1.6	IU/L

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Highly Purified Menotrophin	374
Overall Study	STARTED	Recombinant FSH	375
Overall Study	COMPLETED	Highly Purified Menotrophin	340
Overall Study	COMPLETED	Recombinant FSH	343
Overall Study	NOT COMPLETED	Highly Purified Menotrophin	34
Overall Study	NOT COMPLETED	Recombinant FSH	32

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Highly Purified Menotrophin	18	374	19
other	Nausea	Gastrointestinal disorders	Recombinant FSH	15	375	16
other	Headache	Nervous system disorders	Highly Purified Menotrophin	25	374	30
other	Headache	Nervous system disorders	Recombinant FSH	19	375	23
other	Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	Highly Purified Menotrophin	27	374	27
other	Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	Recombinant FSH	19	375	19
other	Pelvic pain	Reproductive system and breast disorders	Highly Purified Menotrophin	18	374	23
other	Pelvic pain	Reproductive system and breast disorders	Recombinant FSH	16	375	20
other	Vaginal haemorrhage	Reproductive system and breast disorders	Highly Purified Menotrophin	21	374	25
other	Vaginal haemorrhage	Reproductive system and breast disorders	Recombinant FSH	10	375	13

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Highly Purified Menotrophin
Total, all-cause mortality	Recombinant FSH
Total, other adverse events	Highly Purified Menotrophin	66	374
Total, other adverse events	Recombinant FSH	47	375
Total, serious adverse events	Highly Purified Menotrophin	5	374
Total, serious adverse events	Recombinant FSH	7	375

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22244781	RESULT	PubMed
23394782	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Highly Purified Menotrophin vs Recombinant FSH: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00884221

GET https://conductscience.org/api/trials/v1/NCT00884221/results?page=2

API reference For AI assistants