MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population (MEGASET HR)

September 8, 2023 updated by: Ferring Pharmaceuticals

A Randomized, Assessor-blind Trial Comparing MENOPUR® (Menotropins for Injection) and Recombinant FSH (Follicle Stimulating Hormone) in a GnRH Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population

The purpose of this trial is to demonstrate non-inferiority of MENOPUR® versus recombinant Follicle Stimulating Hormone (rFSH) (Gonal-f®) with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation (COS) following GnRH treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

620

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States
        • Bloom Reproductive Institute
      • Tempe, Arizona, United States
        • Fertility Treatment Center
    • California
      • Encino, California, United States
        • HRC Fertility
      • Los Angeles, California, United States
        • California Fertility Partners
    • Colorado
      • Lone Tree, Colorado, United States
        • Colorado Center for Reproductive Medicine (CCRM)
    • Delaware
      • Newark, Delaware, United States
        • Reproductive Associates of Delaware
    • Florida
      • Clearwater, Florida, United States
        • Women's Medical Research Group
      • Miami, Florida, United States
        • Fertility and IVF Center of Miami
      • Orlando, Florida, United States
        • Center for Reproductive Medicine
      • Tampa, Florida, United States
        • The Reproductive Medicine Group
    • Georgia
      • Sandy Springs, Georgia, United States
        • Georgia Reproductive Specialists
    • Hawaii
      • Honolulu, Hawaii, United States
        • Fertility Institute of Hawaii
    • Idaho
      • Boise, Idaho, United States
        • Idaho Center for Reproductive Medicine
    • Illinois
      • Chicago, Illinois, United States
        • Fertility Centers of Illinois
      • Hoffman Estates, Illinois, United States
        • InVia Fertility Specialists, SC
      • Naperville, Illinois, United States
        • The Advanced IVF Institute
    • Maryland
      • Rockville, Maryland, United States
        • Shady Grove Fertility Centers
      • Towson, Maryland, United States
        • Shady Grove Fertility
    • Massachusetts
      • Lexington, Massachusetts, United States
        • IVF New England
      • Waltham, Massachusetts, United States
        • Boston IVF
    • Nevada
      • Las Vegas, Nevada, United States
        • Fertility Center of Las Vegas
    • New Jersey
      • Basking Ridge, New Jersey, United States
        • Reproductive Medicine Associates of new Jersey
    • North Carolina
      • Charlotte, North Carolina, United States
        • Reach
      • Raleigh, North Carolina, United States
        • Carolina Conceptions
    • Pennsylvania
      • Abington, Pennsylvania, United States
        • Abington Hospital, Jefferson Health
      • Bryn Mawr, Pennsylvania, United States
        • Main Line Fertility Center
    • South Carolina
      • Mount Pleasant, South Carolina, United States
        • Coastal Fertility Specialists
    • Texas
      • Bedford, Texas, United States
        • Center for Assisted Reproduction
      • Houston, Texas, United States
        • Houston Fertility Institute
      • Webster, Texas, United States
        • Center of Reproductive Medicine
    • Utah
      • Pleasant Grove, Utah, United States
        • Utah Fertility Center
      • Sandy, Utah, United States
        • Reproductive Care Center
    • Virginia
      • Norfolk, Virginia, United States
        • The Jones Institute for Reproductive Medicine
      • Reston, Virginia, United States
        • Virginia Center for Reproductive Medicine
    • Washington
      • Seattle, Washington, United States
        • Seattle Reproductive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Females aged 21 to 35 years with regular ovulatory menstrual cycles of 21 to 45 days, with a Body Mass Index (BMI) between 18 and 30 kg/m2 who desire pregnancy.
  • Subjects must be high responders, defined as subjects who have a serum anti-Müllerian hormone (AMH) ≥5 ng/mL at screening.
  • Documented history of infertility (e.g., unable to conceive for at least 12 months or for at least 6 months if receiving donor sperm) with a Day 2 or Day 3 serum FSH level between 1 and 12 IU/L (inclusive), the results of which should be obtained within 6 months prior to randomization.

Exclusion Criteria:

  • Known stage III-IV endometriosis (American Society for Reproductive Medicine, 2012).
  • History of recurrent miscarriage not followed by a live birth (recurrent is defined as two (2) or more consecutive miscarriages).
  • Previous in vitro fertilization (IVF) or assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response is defined as development of ≤2 mature follicles or history of 2 previous failed cycle cancellations prior to oocytes retrieval due to poor response.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: menotropin
menotropins for injection
Drug: menotropin
Other Names:
  • Menopur®
Active Comparator: recombinant FSH
Drug: recombinant FSH
Other Names:
  • Gonal-f®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing Pregnancy Rate
Time Frame: 8-9 weeks after blastocyst transfer in the fresh cycle
Defined as the percentage of participants with the presence of at least 1 intrauterine pregnancy with a detectable fetal heartbeat at 10-11 weeks of gestation.
8-9 weeks after blastocyst transfer in the fresh cycle

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive β-human Chorionic Gonadotropin (hCG) Rate
Time Frame: First test approximately 10-14 days after blastocyst transfer in the fresh cycle, with a second test approximately 2 days later if first test was positive
Defined as the percentage of participants with 2 positive β-hCG tests within 2 days in serum.
First test approximately 10-14 days after blastocyst transfer in the fresh cycle, with a second test approximately 2 days later if first test was positive
Clinical Pregnancy Rate
Time Frame: 4-5 weeks after blastocyst transfer in the fresh cycle
Defined as percentage of participants with transvaginal ultrasound (TVUS) showing at least 1 intrauterine gestational sac with fetal heart beat at 6-7 weeks of gestation.
4-5 weeks after blastocyst transfer in the fresh cycle
Early Pregnancy Loss
Time Frame: At 10-11 weeks of gestation in the fresh cycle
Defined as participants with 2 positive β-hCG tests but no ongoing pregnancy at 10-11 weeks of gestation in the fresh cycle. Percentage of participants with early pregnancy loss is presented.
At 10-11 weeks of gestation in the fresh cycle
Follicular Development as Assessed by TVUS
Time Frame: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)
Defined as average follicle size and average size of 3 largest follicles.
On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)
Follicular Development as Assessed by TVUS
Time Frame: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)
Defined as percentage of participants with follicles having a diameter of ≤9 mm, 10-11 mm, 12-14 mm, 15-16 mm, and ≥17 mm.
On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)
Number of Oocytes Retrieved
Time Frame: At oocyte retrieval visit (approximately 36 hours after hCG administration)
At oocyte retrieval visit (approximately 36 hours after hCG administration)
Number of Metaphase II Oocytes
Time Frame: At oocyte retrieval visit (approximately 36 hours after hCG administration)
At oocyte retrieval visit (approximately 36 hours after hCG administration)
Fertilization Rate
Time Frame: On day 1 post-insemination
Defined as 100 times the ratio of number of fertilized 2 pronuclei oocytes to the number of oocytes retrieved, for each participant.
On day 1 post-insemination
Quality of Embryos
Time Frame: 3 days after oocyte retrieval
Assessed by blastomere uniformity, cell size, the degree of fragmentation, and visual signs of multinucleation.
3 days after oocyte retrieval
Quality of Embryos
Time Frame: 3 days after oocyte retrieval
Assessed by cleavage stage.
3 days after oocyte retrieval
Quality of Blastocysts
Time Frame: 5 days after oocyte retrieval
Assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cell).
5 days after oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Investigators

  • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2015

Primary Completion (Actual)

January 26, 2017

Study Completion (Actual)

February 2, 2017

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimated)

September 18, 2015

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000205

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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