MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population
NCT ID: NCT02554279
Last Updated: 2023-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
620 participants
INTERVENTIONAL
2015-08-31
2017-02-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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menotropin
menotropins for injection
menotropin
recombinant FSH
recombinant FSH
Interventions
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menotropin
recombinant FSH
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
35 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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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
Main Line Fertility Center
Bryn Mawr, Pennsylvania, United States
Coastal Fertility Specialists
Mt. Pleasant, South Carolina, United States
Center for Assisted Reproduction
Bedford, Texas, United States
Houston Fertility Institute
Houston, Texas, United States
Center of Reproductive Medicine
Webster, Texas, United States
Utah Fertility Center
Pleasant Grove, Utah, United States
Reproductive Care Center
Sandy City, Utah, United States
The Jones Institute for Reproductive Medicine
Norfolk, Virginia, United States
Virginia Center for Reproductive Medicine
Reston, Virginia, United States
Seattle Reproductive Medicine
Seattle, Washington, United States
Countries
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References
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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-Comparison Analysis. Pharmacoecon Open. 2023 Sep;7(5):851-860. doi: 10.1007/s41669-023-00429-8. Epub 2023 Jul 22.
Robins JC, Khair AF, Widra EA, Alper MM, Nelson WW, Foster ED, Sinha A, Ando M, Heiser PW, Daftary GS. Economic evaluation of highly purified human menotropin or recombinant follicle-stimulating hormone for controlled ovarian stimulation in high-responder patients: analysis of the Menopur in Gonadotropin-releasing Hormone Antagonist Single Embryo Transfer-High Responder (MEGASET-HR) trial. F S Rep. 2020 Nov 10;1(3):257-263. doi: 10.1016/j.xfre.2020.09.010. eCollection 2020 Dec.
Witz CA, Daftary GS, Doody KJ, Park JK, Seifu Y, Yankov VI, Heiser PW; Menopur in GnRH Antagonist Cycles with Single Embryo Transfer - High Responder (MEGASET-HR) Trial Group. Randomized, assessor-blinded trial comparing highly purified human menotropin and recombinant follicle-stimulating hormone in high responders undergoing intracytoplasmic sperm injection. Fertil Steril. 2020 Aug;114(2):321-330. doi: 10.1016/j.fertnstert.2020.03.029. Epub 2020 May 13.
Provided Documents
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Document Type: Study Protocol: Clinical Trial Protocol (including amendments 1-4)
Document Type: Statistical Analysis Plan
Other Identifiers
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000205
Identifier Type: -
Identifier Source: org_study_id
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