MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population

Infertility Clinical Trial

— MEGASET HR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554279
• Other study ID #: 000205
• Status: Completed
• Phase: Phase 4
• Start date: August 31, 2015
• Est. completion date: February 2, 2017

Study information

• Verified date: March 2019
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• menotropin

• recombinant FSH

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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