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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name ESPART

NCTNCT02047227 (opens ClinicalTrials.gov in a new tab)Other idEMR200061-005Other id2013-003817-16
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
939 participants (actual)
Sponsor
Merck KGaA, Darmstadt, Germany · Industry
Design
Randomized · Single masking
Countries
1 country

Germany

Start
31 Jan 2014
Primary completion
31 Aug 2015
Completion
31 Aug 2015
First posted
28 Jan 2014 (estimated)
Last update posted
24 Aug 2017
Conditions
Infertility

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 3

    ESPART

    NCT02047227

    31 Jan 2014 to 31 Aug 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone \[r-hFSH\]/recombinant human luteinising hormone \[r-hLH\]) and GONAL-f® for multifollicular development as part of an assisted reproductive technology (ART) treatment cycle in poor ovarian responders, as aligned with the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) criteria.

Interventions

  • Pergoveris®Drug
  • GONAL-f®Drug
  • Recombinant human chorionic gonadotrophin (r-hCG)Drug

Arms2

  • Experimental

    Pergoveris®

  • Active comparator

    GONAL-f®

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Oocytes Retrieved

    Time frame · At approximately 34 to 38 hours after r-hCG administration (Day 113)

    Registry description

    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 outcomes(5)

  1. Ongoing Pregnancy Rate

    Time frame · 70 days after embryo transfer (Day 185)

    Registry description

    Ongoing pregnancy rate was defined as the percentage of subjects with a ultrasound confirmation of at least one viable fetus (positive fetal heart beat).

  2. Live Birth Rate

    Time frame · Approximately 180 days following ongoing pregnancy determination (Day 365)

    Registry description

    Live birth rate was defined as the percentage of subjects with at least one live-born neonate.

  3. Embryo Implantation Rate

    Time frame · 35-42 days post r-hCG administration (Day 154)

    Registry description

    Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.

  4. Clinical Pregnancy Rate

    Time frame · 35-42 days post r-hCG administration (Day 154)

    Registry description

    Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity.

  5. Biochemical Pregnancy Rate

    Time frame · 15 to 20 days post r-hCG administration (Day 132)

    Registry description

    Biochemical pregnancy rate was defined as the percentage of subjects with a positive beta-hCG result from the serum pregnancy test.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· At approximately 34 to 38 hours after r-hCG administration (Day 113)

Number of Oocytes Retrieved

GroupValue (oocytes)Spread
Pergoveris3.32.71
GONAL-f3.62.82
Secondary and other outcome results(5)
Secondary outcomeNumber· 70 days after embryo transfer (Day 185)

Ongoing Pregnancy Rate

GroupValue (percentage of subjects)
Pergoveris11.0
GONAL-f12.4
Secondary outcomeNumber· Approximately 180 days following ongoing pregnancy determination (Day 365)

Live Birth Rate

GroupValue (percentage of subjects)
Pergoveris10.6
GONAL-f11.7
Secondary outcomeNumber· 35-42 days post r-hCG administration (Day 154)

Embryo Implantation Rate

GroupValue (percent sacs per embryo)
Pergoveris14.7
GONAL-f15.6
Secondary outcomeNumber· 35-42 days post r-hCG administration (Day 154)

Clinical Pregnancy Rate

GroupValue (percentage of subjects)
Pergoveris14.1
GONAL-f16.8
Secondary outcomeNumber· 15 to 20 days post r-hCG administration (Day 132)

Biochemical Pregnancy Rate

GroupValue (percentage of subjects)
Pergoveris17.3
GONAL-f23.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PergoverisPergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice.–8 / 462111 / 462
GONAL-fGONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice.–17 / 477151 / 477

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultHumaidan P, Chin W, Rogoff D, D'Hooghe T, Longobardi S, Hubbard J, Schertz J; ESPART Study Investigatorsdouble dagger. Efficacy and safety of follitropin alfa/lutropin alfa in ART: a randomized controlled trial in poor ovarian responders. Hum Reprod. 2017 Mar 1;32(3):544-555. doi: 10.1093/humrep/dew360. PMID 28137754
  • DerivedHumaidan P, Schertz J, Fischer R. Efficacy and Safety of Pergoveris in Assisted Reproductive Technology--ESPART: rationale and design of a randomised controlled trial in poor ovarian responders undergoing IVF/ICSI treatment. BMJ Open. 2015 Jul 3;5(7):e008297. doi: 10.1136/bmjopen-2015-008297. PMID 26141305

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 41 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Poor ovarian responders according to specific criteria that are aligned with poor ovarian response (POR) criteria defined by the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) as mentioned in the protocol * Female subjects, less than (\<) 41 years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including intracytoplasmic sperm injection (ICSI) * Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy * Absence of any medical condition in which pregnancy is contraindicated * Body mass index 18 to 30 kilogram per square meter (kg/m\^2), inclusive * Motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). Intracytoplasmic sperm injection will be allowed during this trial * Minimum of 1 month without treatment with either clomiphene citrate or gonadotrophins prior to screening * Signed and dated informed consent indicating that the subject has been informed of all the pertinent aspects of the trial prior to enrollment Exclusion Criteria: * Two episodes of POR after maximal stimulation * History or presence of tumors of the hypothalamus or pituitary gland * History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 mm on the day of randomization * Presence of endometriosis Grade III - IV, confirmed or suspected * Presence of uni- or bilateral hydrosalpinx * Abnormal gynecological bleeding of undetermined origin * Contraindication to being pregnant and/or carrying a pregnancy to term * History or presence of ovarian, uterine or mammary cancer * Use of testicular or epididymal sperm * Other protocol defined exclusion criteria could apply

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