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

NCT02554279 | Completed Phase 4 Results

• 1 other identifier: 000205
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 35

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Positive β-human Chorionic Gonadotropin (hCG) Rate

  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

• Clinical Pregnancy Rate

  4-5 weeks after blastocyst transfer in the fresh cycle

• Early Pregnancy Loss

  At 10-11 weeks of gestation in the fresh cycle

• Follicular Development as Assessed by TVUS

  On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)

• Follicular Development as Assessed by TVUS

  On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)

Study Arms (2)

menotropin

EXPERIMENTAL

menotropins for injection

Drug: menotropin

recombinant FSH

ACTIVE COMPARATOR

Drug: recombinant FSH

Interventions

menotropin DRUG

Also known as: Menopur®

menotropin

recombinant FSH DRUG

Also known as: Gonal-f®

recombinant FSH

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (35)

Bloom Reproductive Institute

Scottsdale, Arizona, United States

Location

Fertility Treatment Center

Tempe, Arizona, United States

Location

HRC Fertility

Encino, California, United States

Location

California Fertility Partners

Los Angeles, California, United States

Location

Colorado Center for Reproductive Medicine (CCRM)

Lone Tree, Colorado, United States

Location

Reproductive Associates of Delaware

Newark, Delaware, United States

Location

Women's Medical Research Group

Clearwater, Florida, United States

Location

Fertility and IVF Center of Miami

Miami, Florida, United States

Location

Center for Reproductive Medicine

Orlando, Florida, United States

Location

The Reproductive Medicine Group

Tampa, Florida, United States

Location

Georgia Reproductive Specialists

Sandy Springs, Georgia, United States

Location

Fertility Institute of Hawaii

Honolulu, Hawaii, United States

Location

Idaho Center for Reproductive Medicine

Boise, Idaho, United States

Location

Fertility Centers of Illinois

Chicago, Illinois, United States

Location

InVia Fertility Specialists, SC

Hoffman Estates, Illinois, United States

Location

The Advanced IVF Institute

Naperville, Illinois, United States

Location

Shady Grove Fertility Centers

Rockville, Maryland, United States

Location

Shady Grove Fertility

Towson, Maryland, United States

Location

IVF New England

Lexington, Massachusetts, United States

Location

Boston IVF

Waltham, Massachusetts, United States

Location

Fertility Center of Las Vegas

Las Vegas, Nevada, United States

Location

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, United States

Location

Reach

Charlotte, North Carolina, United States

Location

Carolina Conceptions

Raleigh, North Carolina, United States

Location

Abington Hospital, Jefferson Health

Abington, Pennsylvania, United States

Location

Main Line Fertility Center

Bryn Mawr, Pennsylvania, United States

Location

Coastal Fertility Specialists

Mt. Pleasant, South Carolina, United States

Location

Center for Assisted Reproduction

Bedford, Texas, United States

Location

Houston Fertility Institute

Houston, Texas, United States

Location

Center of Reproductive Medicine

Webster, Texas, United States

Location

Utah Fertility Center

Pleasant Grove, Utah, United States

Location

Reproductive Care Center

Sandy City, Utah, United States

Location

The Jones Institute for Reproductive Medicine

Norfolk, Virginia, United States

Location

Virginia Center for Reproductive Medicine

Reston, Virginia, United States

Location

Seattle Reproductive Medicine

Seattle, Washington, United States

Location

Related Publications (3)

• 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.

  PMID: 37480456 RESULT

• 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.

  PMID: 34223253 DERIVED

• 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.

  PMID: 32416978 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Menotropins; follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 18, 2015
• Study Start: August 31, 2015
• Primary Completion: January 26, 2017
• Study Completion: February 2, 2017
• Last Updated: September 21, 2023
• Results First Posted: March 2, 2018

Record last verified: 2019-03

Locations

US (35)