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

Ferring

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: menotropin; Drug: recombinant FSH

Study type: Interventional

Funder types: Industry

Identifiers

NCT02554279

000205

Details and patient eligibility

About

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.

Enrollment: 620 patients

Sex: Female

Ages: 21 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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620 participants in 2 patient groups

menotropin

Experimental group

Description:

menotropins for injection

Treatment:

Drug: menotropin

recombinant FSH

Active Comparator group

Treatment:

Drug: recombinant FSH