MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population (MEGASET HR)
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|ClinicalTrials.gov Identifier: NCT02554279|
Recruitment Status : Completed
First Posted : September 18, 2015
Results First Posted : March 2, 2018
Last Update Posted : March 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: menotropin Drug: recombinant FSH||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||620 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Actual Study Start Date :||August 31, 2015|
|Actual Primary Completion Date :||January 26, 2017|
|Actual Study Completion Date :||February 2, 2017|
menotropins for injection
Other Name: Menopur®
|Active Comparator: recombinant FSH||
Drug: recombinant FSH
Other Name: Gonal-f®
- Ongoing Pregnancy Rate [ Time Frame: 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.
- Positive β-human Chorionic Gonadotropin (hCG) Rate [ 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 ]Defined as the percentage of participants with 2 positive β-hCG tests within 2 days in serum.
- Clinical Pregnancy Rate [ Time Frame: 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.
- Early Pregnancy Loss [ Time Frame: 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.
- Follicular Development as Assessed by TVUS [ Time Frame: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days) ]Defined as average follicle size and average size of 3 largest follicles.
- Follicular Development as Assessed by TVUS [ Time Frame: 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.
- 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 ]Defined as 100 times the ratio of number of fertilized 2 pronuclei oocytes to the number of oocytes retrieved, for each participant.
- Quality of Embryos [ Time Frame: 3 days after oocyte retrieval ]Assessed by blastomere uniformity, cell size, the degree of fragmentation, and visual signs of multinucleation.
- Quality of Embryos [ Time Frame: 3 days after oocyte retrieval ]Assessed by cleavage stage.
- Quality of Blastocysts [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554279
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|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|