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Trial record 2 of 2 for:    MEGASET

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

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ClinicalTrials.gov Identifier: NCT02554279
Recruitment Status : Completed
First Posted : September 18, 2015
Results First Posted : March 2, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE September 9, 2015
First Posted Date  ICMJE September 18, 2015
Results First Submitted Date  ICMJE January 25, 2018
Results First Posted Date  ICMJE March 2, 2018
Last Update Posted Date March 20, 2019
Actual Study Start Date  ICMJE August 31, 2015
Actual Primary Completion Date January 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2018)
Ongoing Pregnancy Rate [ Time Frame: 8-9 weeks after blastocyst transfer in the fresh cycle ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 17, 2015)
Ongoing Pregnancy Rate [ Time Frame: 8-9 weeks after blastocyst transfer in the fresh cycle ]
Defined as the presence of at least 1 intrauterine pregnancy with a detectable fetal heartbeat at 10-11 weeks gestation
Change History Complete list of historical versions of study NCT02554279 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2018)
  • 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 approximately 2 days later if first test was positive ]
    Defined as the percentage of participants with 2 positive β-hCG tests within 2 days in serum.
  • Clinical Pregnancy Rate [ Time Frame: 4-5 weeks after blastocyst transfer in the fresh cycle ]
    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 [ Time Frame: At 10-11 weeks of gestation in the fresh cycle ]
    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 [ Time Frame: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days) ]
    Defined as average follicle size and average size of 3 largest follicles.
  • Follicular Development as Assessed by TVUS [ Time Frame: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days) ]
    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 [ Time Frame: At oocyte retrieval visit (approximately 36 hours after hCG administration) ]
  • Number of Metaphase II Oocytes [ Time Frame: At oocyte retrieval visit (approximately 36 hours after hCG administration) ]
  • Fertilization Rate [ Time Frame: On day 1 post-insemination ]
    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 [ Time Frame: 3 days after oocyte retrieval ]
    Assessed by blastomere uniformity, cell size, the degree of fragmentation, and visual signs of multinucleation.
  • Quality of Embryos [ Time Frame: 3 days after oocyte retrieval ]
    Assessed by cleavage stage.
  • Quality of Blastocysts [ Time Frame: 5 days after oocyte retrieval ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2015)
  • Positive β-human Chorionic Gonadotropin (hCG) Rate [ Time Frame: Approximately 10-14 days after blastocyst transfer in the fresh cycle and approximately 2 days later ]
    2 positive β-hCG tests
  • Clinical Pregnancy Rate [ Time Frame: 3-4 weeks after blastocyst transfer in the fresh cycle ]
    Transvaginal ultrasound (TVUS) showing at least 1 intrauterine gestational sac with fetal heart beat at 5-6 weeks gestation
  • Early Pregnancy Loss [ Time Frame: At 10-11 weeks gestation in the fresh cycle ]
    Defined as 2 positive β-hCG tests but no ongoing pregnancy at 10-11 weeks gestation in the fresh cycle
  • Follicular Development as Assessed by TVUS [ Time Frame: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days) ]
    Total number of follicles
  • Follicular Development as Assessed by TVUS [ Time Frame: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days) ]
    Number of follicles with a diameter of ≤9mm, 10-11 mm, 12-14 mm, 15-16 mm, and ≥17 mm
  • Number of Oocytes Retrieved [ Time Frame: At oocyte retrieval visit (approximately 36 hours after hCG administration) ]
  • Number of Metaphase II Oocytes [ Time Frame: At oocyte retrieval visit (approximately 36 hours after hCG administration) ]
  • Fertilization Rate [ Time Frame: On day 1 post-insemination ]
    Number of 2 pronuclei (PN) oocytes divided by the number of oocytes retrieved
  • Quality of Embryos [ Time Frame: 3 days after oocyte retrieval ]
    Assessed by cleavage stage, blastomere uniformity, cell size, the degree of fragmentation, and visual signs of multinucleation
  • Quality of blastocysts [ Time Frame: 5 days after oocyte retrieval ]
    Assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: menotropin
    Other Name: Menopur®
  • Drug: recombinant FSH
    Other Name: Gonal-f®
Study Arms  ICMJE
  • Experimental: menotropin
    menotropins for injection
    Intervention: Drug: menotropin
  • Active Comparator: recombinant FSH
    Intervention: Drug: recombinant FSH
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2017)
620
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2015)
600
Actual Study Completion Date  ICMJE February 2, 2017
Actual Primary Completion Date January 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02554279
Other Study ID Numbers  ICMJE 000205
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Compliance Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP