Skip to main content
OpenTrials
Completed

NCT Number: NCT02047227

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility Behavior Genital Diseases Helping Behavior Social Behavior Urogenital Diseases

Age range

18 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Please contact the Merck KGaA Communication Center

Darmstadt, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pergoveris®

Drug

Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of r-hCG (Ovidrel) 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.

Other names: r-hFSH/r-hLH, Follitropin alfa/Lutropin alfa

Gonal-F®

Drug

GONAL-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.

Other names: r-hFSH, Follitropin alfa

Recombinant human chorionic gonadotrophin (r-hCG)

Drug

On r-hCG day, 250 mcg of r-hCG was administered once subcutaneously

Other names: Ovidrel®, Ovitrelle®, choriogonadotropin alfa

Primary outcomes

  1. Number of Oocytes Retrieved

    Time frame: 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 outcomes

  1. Ongoing Pregnancy Rate

    Time frame: 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).

  2. Live Birth Rate

    Time frame: 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.

  3. Embryo Implantation Rate

    Time frame: 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.

  4. Clinical Pregnancy Rate

    Time frame: 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.

  5. Biochemical Pregnancy Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

A Phase III, Randomized, Controlled, Single-blind, Multicentre, Parallel Arm Trial to Assess the Efficacy and Safety of Pergoveris® (Follitropin Alfa and Lutropin Alfa) and GONAL-f® (Follitropin Alfa) for Multifollicular Development as Part of an Assisted Reproductive Technology Treatment Cycle in Poor Ovarian Responders, as Defined by the European Society of Human Reproduction and Embryology Criteria

Acronym: ESPART

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 28, 2014
Registry last updated
Aug 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.