Clinical trial NCT02554279: MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 620
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ongoing Pregnancy Rate
timeFrame: 8-9 weeks after blastocyst transfer in the fresh cycle
Secondary outcomes:
measure: Positive β-human Chorionic Gonadotropin (hCG) Rate
timeFrame: 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
measure: Clinical Pregnancy Rate
timeFrame: 4-5 weeks after blastocyst transfer in the fresh cycle
measure: Early Pregnancy Loss
timeFrame: At 10-11 weeks of gestation in the fresh cycle
measure: Follicular Development as Assessed by TVUS
timeFrame: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)
measure: Follicular Development as Assessed by TVUS
timeFrame: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)
measure: Number of Oocytes Retrieved
timeFrame: At oocyte retrieval visit (approximately 36 hours after hCG administration)
measure: Number of Metaphase II Oocytes
timeFrame: At oocyte retrieval visit (approximately 36 hours after hCG administration)
measure: Fertilization Rate
timeFrame: On day 1 post-insemination
measure: Quality of Embryos
timeFrame: 3 days after oocyte retrieval
measure: Quality of Embryos
timeFrame: 3 days after oocyte retrieval
measure: Quality of Blastocysts
timeFrame: 5 days after oocyte retrieval
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Bloom Reproductive Institute
state: Arizona
city: Tempe
country: United States
facility: Fertility Treatment Center
state: Arizona
city: Encino
country: United States
facility: HRC Fertility
state: California
city: Los Angeles
country: United States
facility: California Fertility Partners
state: California
city: Lone Tree
country: United States
facility: Colorado Center for Reproductive Medicine (CCRM)
state: Colorado
city: Newark
country: United States
facility: Reproductive Associates of Delaware
state: Delaware
city: Clearwater
country: United States
facility: Women's Medical Research Group
state: Florida
city: Miami
country: United States
facility: Fertility and IVF Center of Miami
state: Florida
city: Orlando
country: United States
facility: Center for Reproductive Medicine
state: Florida
city: Tampa
country: United States
facility: The Reproductive Medicine Group
state: Florida
city: Sandy Springs
country: United States
facility: Georgia Reproductive Specialists
state: Georgia
city: Honolulu
country: United States
facility: Fertility Institute of Hawaii
state: Hawaii
city: Boise
country: United States
facility: Idaho Center for Reproductive Medicine
state: Idaho
city: Chicago
country: United States
facility: Fertility Centers of Illinois
state: Illinois
city: Hoffman Estates
country: United States
facility: InVia Fertility Specialists, SC
state: Illinois
city: Naperville
country: United States
facility: The Advanced IVF Institute
state: Illinois
city: Rockville
country: United States
facility: Shady Grove Fertility Centers
state: Maryland
city: Towson
country: United States
facility: Shady Grove Fertility
state: Maryland
city: Lexington
country: United States
facility: IVF New England
state: Massachusetts
city: Waltham
country: United States
facility: Boston IVF
state: Massachusetts
city: Las Vegas
country: United States
facility: Fertility Center of Las Vegas
state: Nevada
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
city: Charlotte
country: United States
facility: Reach
state: North Carolina
city: Raleigh
country: United States
facility: Carolina Conceptions
state: North Carolina
city: Abington
country: United States
facility: Abington Hospital, Jefferson Health
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Main Line Fertility Center
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Fertility Specialists
state: South Carolina
city: Bedford
country: United States
facility: Center for Assisted Reproduction
state: Texas
city: Houston
country: United States
facility: Houston Fertility Institute
state: Texas
city: Webster
country: United States
facility: Center of Reproductive Medicine
state: Texas
city: Pleasant Grove
country: United States
facility: Utah Fertility Center
state: Utah
city: Sandy
country: United States
facility: Reproductive Care Center
state: Utah
city: Norfolk
country: United States
facility: The Jones Institute for Reproductive Medicine
state: Virginia
city: Reston
country: United States
facility: Virginia Center for Reproductive Medicine
state: Virginia
city: Seattle
country: United States
facility: Seattle Reproductive Medicine
state: Washington
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.