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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
menotropin
recombinant FSH
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

21 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Bloom Reproductive Institute
  • Fertility Treatment Center
  • HRC Fertility
  • California Fertility Partners
  • Colorado Center for Reproductive Medicine (CCRM)
  • Reproductive Associates of Delaware
  • Women's Medical Research Group
  • Fertility and IVF Center of Miami
  • Center for Reproductive Medicine
  • The Reproductive Medicine Group
  • Georgia Reproductive Specialists
  • Fertility Institute of Hawaii
  • Idaho Center for Reproductive Medicine
  • Fertility Centers of Illinois
  • InVia Fertility Specialists, SC
  • The Advanced IVF Institute
  • Shady Grove Fertility Centers
  • Shady Grove Fertility
  • IVF New England
  • Boston IVF
  • Fertility Center of Las Vegas
  • Reproductive Medicine Associates of New Jersey
  • Reach
  • Carolina Conceptions
  • Abington Hospital, Jefferson Health
  • Main Line Fertility Center
  • Coastal Fertility Specialists
  • Center for Assisted Reproduction
  • Houston Fertility Institute
  • Center of Reproductive Medicine
  • Utah Fertility Center
  • Reproductive Care Center
  • The Jones Institute for Reproductive Medicine
  • Virginia Center for Reproductive Medicine
  • Seattle Reproductive Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

menotropin

recombinant FSH

Arm Description

menotropins for injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Positive β-human Chorionic Gonadotropin (hCG) Rate
Defined as the percentage of participants with 2 positive β-hCG tests within 2 days in serum.
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.
Early Pregnancy Loss
Defined as participants with 2 positive β-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.
Follicular Development as Assessed by TVUS
Defined as average follicle size and average size of 3 largest follicles.
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.
Number of Oocytes Retrieved
Number of Metaphase II Oocytes
Fertilization Rate
Defined as 100 times the ratio of number of fertilized 2 pronuclei oocytes to the number of oocytes retrieved, for each participant.
Quality of Embryos
Assessed by blastomere uniformity, cell size, the degree of fragmentation, and visual signs of multinucleation.
Quality of Embryos
Assessed by cleavage stage.
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).

Full Information

First Posted
September 9, 2015
Last Updated
September 8, 2023
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02554279
Brief Title
MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 31, 2015 (Actual)
Primary Completion Date
January 26, 2017 (Actual)
Study Completion Date
February 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
620 (Actual)

8. Arms, Groups, and Interventions

Arm Title
menotropin
Arm Type
Experimental
Arm Description
menotropins for injection
Arm Title
recombinant FSH
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
menotropin
Other Intervention Name(s)
Menopur®
Intervention Type
Drug
Intervention Name(s)
recombinant FSH
Other Intervention Name(s)
Gonal-f®
Primary Outcome Measure Information:
Title
Ongoing Pregnancy Rate
Description
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.
Time Frame
8-9 weeks after blastocyst transfer in the fresh cycle
Secondary Outcome Measure Information:
Title
Positive β-human Chorionic Gonadotropin (hCG) Rate
Description
Defined as the percentage of participants with 2 positive β-hCG tests within 2 days in serum.
Time Frame
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
Title
Clinical Pregnancy Rate
Description
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.
Time Frame
4-5 weeks after blastocyst transfer in the fresh cycle
Title
Early Pregnancy Loss
Description
Defined as participants with 2 positive β-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.
Time Frame
At 10-11 weeks of gestation in the fresh cycle
Title
Follicular Development as Assessed by TVUS
Description
Defined as average follicle size and average size of 3 largest follicles.
Time Frame
On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)
Title
Follicular Development as Assessed by TVUS
Description
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.
Time Frame
On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)
Title
Number of Oocytes Retrieved
Time Frame
At oocyte retrieval visit (approximately 36 hours after hCG administration)
Title
Number of Metaphase II Oocytes
Time Frame
At oocyte retrieval visit (approximately 36 hours after hCG administration)
Title
Fertilization Rate
Description
Defined as 100 times the ratio of number of fertilized 2 pronuclei oocytes to the number of oocytes retrieved, for each participant.
Time Frame
On day 1 post-insemination
Title
Quality of Embryos
Description
Assessed by blastomere uniformity, cell size, the degree of fragmentation, and visual signs of multinucleation.
Time Frame
3 days after oocyte retrieval
Title
Quality of Embryos
Description
Assessed by cleavage stage.
Time Frame
3 days after oocyte retrieval
Title
Quality of Blastocysts
Description
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).
Time Frame
5 days after oocyte retrieval

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Compliance
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Bloom Reproductive Institute
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Fertility Treatment Center
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
HRC Fertility
City
Encino
State/Province
California
Country
United States
Facility Name
California Fertility Partners
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Colorado Center for Reproductive Medicine (CCRM)
City
Lone Tree
State/Province
Colorado
Country
United States
Facility Name
Reproductive Associates of Delaware
City
Newark
State/Province
Delaware
Country
United States
Facility Name
Women's Medical Research Group
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Fertility and IVF Center of Miami
City
Miami
State/Province
Florida
Country
United States
Facility Name
Center for Reproductive Medicine
City
Orlando
State/Province
Florida
Country
United States
Facility Name
The Reproductive Medicine Group
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Georgia Reproductive Specialists
City
Sandy Springs
State/Province
Georgia
Country
United States
Facility Name
Fertility Institute of Hawaii
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Idaho Center for Reproductive Medicine
City
Boise
State/Province
Idaho
Country
United States
Facility Name
Fertility Centers of Illinois
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
InVia Fertility Specialists, SC
City
Hoffman Estates
State/Province
Illinois
Country
United States
Facility Name
The Advanced IVF Institute
City
Naperville
State/Province
Illinois
Country
United States
Facility Name
Shady Grove Fertility Centers
City
Rockville
State/Province
Maryland
Country
United States
Facility Name
Shady Grove Fertility
City
Towson
State/Province
Maryland
Country
United States
Facility Name
IVF New England
City
Lexington
State/Province
Massachusetts
Country
United States
Facility Name
Boston IVF
City
Waltham
State/Province
Massachusetts
Country
United States
Facility Name
Fertility Center of Las Vegas
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Reproductive Medicine Associates of New Jersey
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Reach
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Carolina Conceptions
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Abington Hospital, Jefferson Health
City
Abington
State/Province
Pennsylvania
Country
United States
Facility Name
Main Line Fertility Center
City
Bryn Mawr
State/Province
Pennsylvania
Country
United States
Facility Name
Coastal Fertility Specialists
City
Mount Pleasant
State/Province
South Carolina
Country
United States
Facility Name
Center for Assisted Reproduction
City
Bedford
State/Province
Texas
Country
United States
Facility Name
Houston Fertility Institute
City
Houston
State/Province
Texas
Country
United States
Facility Name
Center of Reproductive Medicine
City
Webster
State/Province
Texas
Country
United States
Facility Name
Utah Fertility Center
City
Pleasant Grove
State/Province
Utah
Country
United States
Facility Name
Reproductive Care Center
City
Sandy
State/Province
Utah
Country
United States
Facility Name
The Jones Institute for Reproductive Medicine
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Virginia Center for Reproductive Medicine
City
Reston
State/Province
Virginia
Country
United States
Facility Name
Seattle Reproductive Medicine
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
37480456
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.
Results Reference
result
PubMed Identifier
34223253
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.
Results Reference
derived
PubMed Identifier
32416978
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.
Results Reference
derived

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

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