MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 620
- 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.
- 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)
California Fertility Partners
🇺🇸Los Angeles, California, United States
Houston Fertility Institute
🇺🇸Houston, Texas, United States
Georgia Reproductive Specialists
🇺🇸Sandy Springs, Georgia, United States
Colorado Center for Reproductive Medicine (CCRM)
🇺🇸Lone Tree, Colorado, United States
Idaho Center for Reproductive Medicine
🇺🇸Boise, Idaho, United States
IVF New England
🇺🇸Lexington, Massachusetts, United States
Boston IVF
🇺🇸Waltham, Massachusetts, United States
Fertility Treatment Center
🇺🇸Tempe, Arizona, United States
Fertility and IVF Center of Miami
🇺🇸Miami, Florida, United States
Fertility Center of Las Vegas
🇺🇸Las Vegas, Nevada, United States
Bloom Reproductive Institute
🇺🇸Scottsdale, Arizona, United States
Women's Medical Research Group
🇺🇸Clearwater, Florida, United States
Shady Grove Fertility
🇺🇸Towson, Maryland, United States
Reproductive Medicine Associates of New Jersey
🇺🇸Basking Ridge, New Jersey, United States
Reproductive Associates of Delaware
🇺🇸Newark, Delaware, United States
Center for Reproductive Medicine
🇺🇸Orlando, Florida, United States
Shady Grove Fertility Centers
🇺🇸Rockville, Maryland, United States
The Reproductive Medicine Group
🇺🇸Tampa, Florida, United States
Fertility Centers of Illinois
🇺🇸Chicago, Illinois, United States
HRC Fertility
🇺🇸Encino, California, United States
The Advanced IVF Institute
🇺🇸Naperville, Illinois, United States
Fertility Institute of Hawaii
🇺🇸Honolulu, Hawaii, United States
InVia Fertility Specialists, SC
🇺🇸Hoffman Estates, Illinois, United States
Reach
🇺🇸Charlotte, North Carolina, United States
Carolina Conceptions
🇺🇸Raleigh, North Carolina, United States
Main Line Fertility Center
🇺🇸Bryn Mawr, Pennsylvania, United States
Center for Assisted Reproduction
🇺🇸Bedford, Texas, United States
Coastal Fertility Specialists
🇺🇸Mount Pleasant, South Carolina, United States
Abington Hospital, Jefferson Health
🇺🇸Abington, Pennsylvania, United States
Center of Reproductive Medicine
🇺🇸Webster, Texas, United States
Reproductive Care Center
🇺🇸Sandy, Utah, United States
Virginia Center for Reproductive Medicine
🇺🇸Reston, Virginia, United States
Utah Fertility Center
🇺🇸Pleasant Grove, Utah, United States
The Jones Institute for Reproductive Medicine
🇺🇸Norfolk, Virginia, United States
Seattle Reproductive Medicine
🇺🇸Seattle, Washington, United States