Overview

This trial is active, not recruiting.

Condition infertility
Treatments menotropin, recombinant fsh
Phase phase 4
Sponsor Ferring Pharmaceuticals
Start date August 2015
End date December 2016
Trial size 600 participants
Trial identifier NCT02554279, 000205

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
menotropins for injection
menotropin Menopur®
(Active Comparator)
recombinant fsh Gonal-f®

Primary Outcomes

Measure
Ongoing pregnancy rate
time frame: 8-9 weeks after blastocyst transfer in the fresh cycle

Secondary Outcomes

Measure
Positive β-human Chorionic Gonadotropin (hCG) rate
time frame: Approximately 10-14 days after blastocyst transfer in the fresh cycle and approximately 2 days later
Clinical pregnancy rate
time frame: 3-4 weeks after blastocyst transfer in the fresh cycle
Early pregnancy loss
time frame: At 10-11 weeks 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)
Follicular development as assessed by TVUS
time frame: 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)
Number of metaphase II oocytes
time frame: At oocyte retrieval visit (approximately 36 hours after hCG administration)
Fertilization rate
time frame: On day 1 post-insemination
Quality of embryos
time frame: 3 days after oocyte retrieval
Quality of blastocysts
time frame: 5 days after oocyte retrieval

Eligibility Criteria

Female participants from 21 years up to 35 years old.

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.

Additional Information

Official 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Ferring Pharmaceuticals.