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Scottsdale, Arizona

  • Infertility

Purpose:

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.


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.


Study is Available At:


Original ID:

000205


NCT ID:

NCT02554279


Secondary ID:


Study Acronym:

MEGASET HR


Brief Title:

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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Female


Minimum Age:

21 Years


Maximum Age:

35 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ferring Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

620


Enrollment Type:

Actual


Overall Contact Information

Official Name:Global Clinical Compliance
Study Director
Ferring Pharmaceuticals

Study Dates

Start Date:August 31, 2015
Completion Date:February 2, 2017
Completion Type:Actual
Primary Completion Date:January 26, 2017
Primary Completion Type:Actual
Verification Date:March 2019
Last Changed Date:March 5, 2019
First Received Date:September 9, 2015
First Results Date:January 25, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Quality of Blastocysts
Time Frame:5 days after oocyte retrieval
Safety Issues:False
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 (degenerativ
Outcome Type:Secondary Outcome
Measure:Quality of Embryos
Time Frame:3 days after oocyte retrieval
Safety Issues:False
Description:Assessed by cleavage stage.
Outcome Type:Secondary Outcome
Measure:Quality of Embryos
Time Frame:3 days after oocyte retrieval
Safety Issues:False
Description:Assessed by blastomere uniformity, cell size, the degree of fragmentation, and visual signs of multinucleation.
Outcome Type:Secondary Outcome
Measure:Fertilization Rate
Time Frame:On day 1 post-insemination
Safety Issues:False
Description:Defined as 100 times the ratio of number of fertilized 2 pronuclei oocytes to the number of oocytes retrieved, for each participant.
Outcome Type:Secondary Outcome
Measure:Number of Metaphase II Oocytes
Time Frame:At oocyte retrieval visit (approximately 36 hours after hCG administration)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of Oocytes Retrieved
Time Frame:At oocyte retrieval visit (approximately 36 hours after hCG administration)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Follicular Development as Assessed by TVUS
Time Frame:On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Follicular Development as Assessed by TVUS
Time Frame:On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)
Safety Issues:False
Description:Defined as average follicle size and average size of 3 largest follicles.
Outcome Type:Secondary Outcome
Measure:Early Pregnancy Loss
Time Frame:At 10-11 weeks of gestation in the fresh cycle
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Clinical Pregnancy Rate
Time Frame:4-5 weeks after blastocyst transfer in the fresh cycle
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Positive β-human Chorionic Gonadotropin (hCG) Rate
Time Frame:First test approximately 10-14 days after blastocyst transfer in the fresh cycle, with a second test
Safety Issues:False
Description:Defined as the percentage of participants with 2 positive β-hCG tests within 2 days in serum.
Outcome Type:Primary Outcome
Measure:Ongoing Pregnancy Rate
Time Frame:8-9 weeks after blastocyst transfer in the fresh cycle
Safety Issues:False
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.

Study Interventions

Intervention Type:Drug
Name:menotropin
Arm Name:menotropin
Other Name:Menopur®
Intervention Type:Drug
Name:recombinant FSH
Arm Name:recombinant FSH
Other Name:Gonal-f®

Study Arms

Study Arm Type:Experimental
Arm Name:menotropin
Description:menotropins for injection
Study Arm Type:Active Comparator
Arm Name:recombinant FSH

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Ferring Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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