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

Completed · Phase 4

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT02554279

Run by

Ferring Pharmaceuticals

People needed

620

Starts

2015-08-31

Expected to finish

2017-02-02

Last updated by the study team

2023-09-21

Who can join

Age: 21 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Georgia Reproductive Specialists — Sandy Springs, Georgia, United States
• Fertility Institute of Hawaii — Honolulu, Hawaii, United States
• Idaho Center for Reproductive Medicine — Boise, Idaho, United States
• Fertility Centers of Illinois — Chicago, Illinois, United States
• InVia Fertility Specialists, SC — Hoffman Estates, Illinois, United States
• The Advanced IVF Institute — Naperville, Illinois, United States
• Shady Grove Fertility Centers — Rockville, Maryland, United States
• Shady Grove Fertility — Towson, Maryland, United States
• IVF New England — Lexington, Massachusetts, United States
• Boston IVF — Waltham, Massachusetts, United States
• Fertility Center of Las Vegas — Las Vegas, Nevada, United States
• Reproductive Medicine Associates of New Jersey — Basking Ridge, New Jersey, United States
• Reach — Charlotte, North Carolina, United States
• Carolina Conceptions — Raleigh, North Carolina, United States
• Abington Hospital, Jefferson Health — Abington, Pennsylvania, United States

Full record on ClinicalTrials.gov

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