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Completed

NCT Number: NCT02554279

MENOPUR® in a Gonadotropin-Releasing Hormone (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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

21 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Bloom Reproductive Institute, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

menotropin

Drug

Other names: Menopur®

recombinant FSH

Drug

Other names: Gonal-f®

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Number of Oocytes Retrieved

    Time frame: At oocyte retrieval visit (approximately 36 hours after hCG administration)

  7. Number of Metaphase II Oocytes

    Time frame: At oocyte retrieval visit (approximately 36 hours after hCG administration)

  8. 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.

  9. 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.

  10. Quality of Embryos

    Time frame: 3 days after oocyte retrieval

    Assessed by cleavage stage.

  11. 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).

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: MEGASET HR

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 18, 2015
Registry last updated
Sep 21, 2023

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.

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