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

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: recombinant FSH; Drug: menotropin

• Registration Number: NCT02554279
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-31
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Primary Completion: 2017-01-26
• Study Completion: 2017-02-02
• Results First Submitted: 2018-01-25
• Results First Submitted QC: 2018-03-01
• Results First Posted: 2018-03-02
• Status Verified: 2019-03
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 620

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
recombinant FSH	recombinant FSH	-
menotropin	menotropin	menotropins for injection

Primary Outcome Measures

Name	Time	Method
Ongoing Pregnancy Rate	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 Outcome Measures

Name	Time	Method
Positive β-human Chorionic Gonadotropin (hCG) Rate	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.
Clinical Pregnancy Rate	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.
Follicular Development as Assessed by TVUS	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.
Quality of Embryos	3 days after oocyte retrieval	Assessed by cleavage stage.
Early Pregnancy Loss	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.
Number of Oocytes Retrieved	At oocyte retrieval visit (approximately 36 hours after hCG administration)
Number of Metaphase II Oocytes	At oocyte retrieval visit (approximately 36 hours after hCG administration)
Quality of Blastocysts	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).
Fertilization Rate	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.

Trial Locations

Locations (35)

Bloom Reproductive Institute; 🇺🇸 Scottsdale, Arizona, United States

Fertility Treatment Center; 🇺🇸 Tempe, Arizona, United States

HRC Fertility; 🇺🇸 Encino, California, United States

California Fertility Partners; 🇺🇸 Los Angeles, California, United States

Colorado Center for Reproductive Medicine (CCRM); 🇺🇸 Lone Tree, Colorado, United States

Reproductive Associates of Delaware; 🇺🇸 Newark, Delaware, United States

Women's Medical Research Group; 🇺🇸 Clearwater, Florida, United States

Fertility and IVF Center of Miami; 🇺🇸 Miami, Florida, United States

Center for Reproductive Medicine; 🇺🇸 Orlando, Florida, United States

The Reproductive Medicine Group; 🇺🇸 Tampa, Florida, United States

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