Trial · NCT02047227

Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)

NCT02047227, Phase 3, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2017-01-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART). Trials, record NCT02047227. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02047227

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Trial

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

Title: Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)
NCT number: NCT02047227
Status: Completed
Phases: Phase 3
Enrollment: 939 participants, actual
Lead sponsor: Merck KGaA, Darmstadt, Germany
Conditions: Infertility
Interventions: Pergoveris®, GONAL-f®, Recombinant human chorionic gonadotrophin (r-hCG)
First posted: 2014-01-28
Last updated: 2017-08-24
Other registries' IDs: eudract:2013-003817-16
Results first posted: 2017-01-24

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Number of Oocytes Retrieved	At approximately 34 to 38 hours after r-hCG administration (Day 113)	Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
Secondary	Ongoing Pregnancy Rate	70 days after embryo transfer (Day 185)	Ongoing pregnancy rate was defined as the percentage of subjects with a ultrasound confirmation of at least one viable fetus (positive fetal heart beat).
Secondary	Live Birth Rate	Approximately 180 days following ongoing pregnancy determination (Day 365)	Live birth rate was defined as the percentage of subjects with at least one live-born neonate.
Secondary	Embryo Implantation Rate	35-42 days post r-hCG administration (Day 154)	Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.
Secondary	Clinical Pregnancy Rate	35-42 days post r-hCG administration (Day 154)	Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity.
Secondary	Biochemical Pregnancy Rate	15 to 20 days post r-hCG administration (Day 132)	Biochemical pregnancy rate was defined as the percentage of subjects with a positive beta-hCG result from the serum pregnancy test.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Oocytes Retrieved	At approximately 34 to 38 hours after r-hCG administration (Day 113)	Intent-to-treat (ITT) analysis set included all subjects randomized who received at least 1 dose of GONAL-f or Pergoveris.	oocytes	MEAN
SECONDARY	Ongoing Pregnancy Rate	70 days after embryo transfer (Day 185)	Modified intent-to-treat (MITT) analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.	percentage of subjects	NUMBER
SECONDARY	Live Birth Rate	Approximately 180 days following ongoing pregnancy determination (Day 365)	MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.	percentage of subjects	NUMBER
SECONDARY	Embryo Implantation Rate	35-42 days post r-hCG administration (Day 154)	MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure.	percent sacs per embryo	NUMBER
SECONDARY	Clinical Pregnancy Rate	35-42 days post r-hCG administration (Day 154)	MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.	percentage of subjects	NUMBER
SECONDARY	Biochemical Pregnancy Rate	15 to 20 days post r-hCG administration (Day 132)	MITT Analysis Set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.	percentage of subjects	NUMBER

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
Number of Oocytes Retrieved	Pergoveris	3.3	Standard Deviation 2.71	oocytes
Number of Oocytes Retrieved	GONAL-f	3.6	Standard Deviation 2.82	oocytes
Ongoing Pregnancy Rate	Pergoveris	11.0		percentage of subjects
Ongoing Pregnancy Rate	GONAL-f	12.4		percentage of subjects
Live Birth Rate	Pergoveris	10.6		percentage of subjects
Live Birth Rate	GONAL-f	11.7		percentage of subjects
Embryo Implantation Rate	Pergoveris	14.7		percent sacs per embryo
Embryo Implantation Rate	GONAL-f	15.6		percent sacs per embryo
Clinical Pregnancy Rate	Pergoveris	14.1		percentage of subjects
Clinical Pregnancy Rate	GONAL-f	16.8		percentage of subjects

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Pergoveris	462
Overall Study	STARTED	GONAL-f	477
Overall Study	Completed Ovarian Stimulation Phase	Pergoveris	424
Overall Study	Completed Ovarian Stimulation Phase	GONAL-f	440
Overall Study	COMPLETED	Pergoveris	318
Overall Study	COMPLETED	GONAL-f	347
Overall Study	NOT COMPLETED	Pergoveris	144
Overall Study	NOT COMPLETED	GONAL-f	130

Source ClinicalTrials.gov

Adverse events372

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
other	Anaemia of pregnancy	Blood and lymphatic system disorders	Pergoveris	0	462
other	Anaemia of pregnancy	Blood and lymphatic system disorders	GONAL-f	1	477
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Pergoveris	0	462
other	Iron deficiency anaemia	Blood and lymphatic system disorders	GONAL-f	1	477
other	Lymph node pain	Blood and lymphatic system disorders	Pergoveris	1	462
other	Lymph node pain	Blood and lymphatic system disorders	GONAL-f	0	477
other	Lymphadenopathy	Blood and lymphatic system disorders	Pergoveris	0	462
other	Lymphadenopathy	Blood and lymphatic system disorders	GONAL-f	1	477
other	Palpitations	Cardiac disorders	Pergoveris	2	462
other	Palpitations	Cardiac disorders	GONAL-f	0	477

1 to 10 of 372Source ClinicalTrials.gov

See all 372 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pergoveris
Total, all-cause mortality	GONAL-f
Total, other adverse events	Pergoveris	111	462
Total, other adverse events	GONAL-f	151	477
Total, serious adverse events	Pergoveris	8	462
Total, serious adverse events	GONAL-f	17	477

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26141305	DERIVED	PubMed
28137754	RESULT	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
Pergoveris vs GONAL-f: 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/NCT02047227

GET https://conductscience.org/api/trials/v1/NCT02047227/events?page=2

API reference For AI assistants