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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
620
Ongoing Pregnancy Rate
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.
Time frame: 8-9 weeks after blastocyst transfer in the fresh cycle
Positive β-human Chorionic Gonadotropin (hCG) Rate
Defined as the percentage of participants with 2 positive β-hCG tests within 2 days in serum.
Time frame: 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
Clinical Pregnancy Rate
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.
Time frame: 4-5 weeks after blastocyst transfer in the fresh cycle
Early Pregnancy Loss
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.
Time frame: At 10-11 weeks of gestation in the fresh cycle
Follicular Development as Assessed by TVUS
Defined as average follicle size and average size of 3 largest follicles.
Time frame: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)
Follicular Development as Assessed by TVUS
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.
Time frame: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)
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Bloom Reproductive Institute
Scottsdale, Arizona, United States
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Tempe, Arizona, United States
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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
...and 25 more locations
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
Defined as 100 times the ratio of number of fertilized 2 pronuclei oocytes to the number of oocytes retrieved, for each participant.
Time frame: On day 1 post-insemination
Quality of Embryos
Assessed by blastomere uniformity, cell size, the degree of fragmentation, and visual signs of multinucleation.
Time frame: 3 days after oocyte retrieval
Quality of Embryos
Assessed by cleavage stage.
Time frame: 3 days after oocyte retrieval
Quality of Blastocysts
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).
Time frame: 5 days after oocyte retrieval