Infertility Clinical Trial
— MEGASET HROfficial 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
Verified date | March 2019 |
Source | Ferring Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 620 |
Est. completion date | February 2, 2017 |
Est. primary completion date | January 26, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 35 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Abington Hospital, Jefferson Health | Abington | Pennsylvania |
United States | Reproductive Medicine Associates of New Jersey | Basking Ridge | New Jersey |
United States | Center for Assisted Reproduction | Bedford | Texas |
United States | Idaho Center for Reproductive Medicine | Boise | Idaho |
United States | Main Line Fertility Center | Bryn Mawr | Pennsylvania |
United States | Reach | Charlotte | North Carolina |
United States | Fertility Centers of Illinois | Chicago | Illinois |
United States | Women's Medical Research Group | Clearwater | Florida |
United States | HRC Fertility | Encino | California |
United States | InVia Fertility Specialists, SC | Hoffman Estates | Illinois |
United States | Fertility Institute of Hawaii | Honolulu | Hawaii |
United States | Houston Fertility Institute | Houston | Texas |
United States | Fertility Center of Las Vegas | Las Vegas | Nevada |
United States | IVF New England | Lexington | Massachusetts |
United States | Colorado Center for Reproductive Medicine (CCRM) | Lone Tree | Colorado |
United States | California Fertility Partners | Los Angeles | California |
United States | Fertility and IVF Center of Miami | Miami | Florida |
United States | Coastal Fertility Specialists | Mount Pleasant | South Carolina |
United States | The Advanced IVF Institute | Naperville | Illinois |
United States | Reproductive Associates of Delaware | Newark | Delaware |
United States | The Jones Institute for Reproductive Medicine | Norfolk | Virginia |
United States | Center for Reproductive Medicine | Orlando | Florida |
United States | Utah Fertility Center | Pleasant Grove | Utah |
United States | Carolina Conceptions | Raleigh | North Carolina |
United States | Virginia Center for Reproductive Medicine | Reston | Virginia |
United States | Shady Grove Fertility Centers | Rockville | Maryland |
United States | Reproductive Care Center | Sandy | Utah |
United States | Georgia Reproductive Specialists | Sandy Springs | Georgia |
United States | Bloom Reproductive Institute | Scottsdale | Arizona |
United States | Seattle Reproductive Medicine | Seattle | Washington |
United States | The Reproductive Medicine Group | Tampa | Florida |
United States | Fertility Treatment Center | Tempe | Arizona |
United States | Shady Grove Fertility | Towson | Maryland |
United States | Boston IVF | Waltham | Massachusetts |
United States | Center of Reproductive Medicine | Webster | Texas |
Lead Sponsor | Collaborator |
---|---|
Ferring Pharmaceuticals |
United States,
Khair A, Brown T, Markert M, Barsoe CR, Daftary GS, Heiser PW. Highly Purified Human Menopausal Gonadotropin (HP-hMG) Versus Recombinant Follicle-Stimulating Hormone (rFSH) for Controlled Ovarian Stimulation in US Predicted High-Responder Patients: A Cost — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 8-9 weeks after blastocyst transfer in the fresh cycle | |
Secondary | Positive ß-human Chorionic Gonadotropin (hCG) Rate | Defined as the percentage of participants with 2 positive ß-hCG tests within 2 days in serum. | 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 | |
Secondary | 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. | 4-5 weeks after blastocyst transfer in the fresh cycle | |
Secondary | Early Pregnancy Loss | Defined as participants with 2 positive ß-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. | At 10-11 weeks of gestation in the fresh cycle | |
Secondary | Follicular Development as Assessed by TVUS | Defined as average follicle size and average size of 3 largest follicles. | On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days) | |
Secondary | 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. | On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days) | |
Secondary | Number of Oocytes Retrieved | At oocyte retrieval visit (approximately 36 hours after hCG administration) | ||
Secondary | Number of Metaphase II Oocytes | At oocyte retrieval visit (approximately 36 hours after hCG administration) | ||
Secondary | Fertilization Rate | Defined as 100 times the ratio of number of fertilized 2 pronuclei oocytes to the number of oocytes retrieved, for each participant. | On day 1 post-insemination | |
Secondary | Quality of Embryos | Assessed by blastomere uniformity, cell size, the degree of fragmentation, and visual signs of multinucleation. | 3 days after oocyte retrieval | |
Secondary | Quality of Embryos | Assessed by cleavage stage. | 3 days after oocyte retrieval | |
Secondary | 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). | 5 days after oocyte retrieval |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03607409 -
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
|
||
Recruiting |
NCT02312076 -
GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles
|
Phase 4 | |
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Completed |
NCT03287479 -
Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)
|
N/A | |
Terminated |
NCT03522350 -
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
|
N/A | |
Completed |
NCT04496284 -
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
|
N/A | |
Completed |
NCT03623659 -
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
|
N/A | |
Completed |
NCT03895099 -
New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors
|
Phase 3 | |
Active, not recruiting |
NCT04142112 -
Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation
|
N/A | |
Completed |
NCT03152643 -
Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer
|
N/A | |
Recruiting |
NCT03683771 -
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
|
||
Recruiting |
NCT03161119 -
Comparing Two Different Embryo Transfer Catheters
|
N/A | |
Completed |
NCT04108039 -
Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.
|
N/A | |
Completed |
NCT03678597 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
|
N/A | |
Completed |
NCT03678818 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)
|
N/A | |
Completed |
NCT03678610 -
Handling Medium for ICSI With Ionomycin and Latrunculin A
|
N/A | |
Completed |
NCT03678584 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
|
N/A | |
Completed |
NCT03678558 -
Oocyte Vitrification Aided With Cytochalasin B
|
N/A | |
Completed |
NCT03677492 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
|
N/A | |
Completed |
NCT03678571 -
Oocyte Vitrification Aided With Latrunculin A
|
N/A |