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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 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: menotropin Drug: recombinant FSH Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 31, 2015
Actual Primary Completion Date : January 26, 2017
Actual Study Completion Date : February 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Menotropins

Arm Intervention/treatment
Experimental: menotropin
menotropins for injection
Drug: menotropin
Other Name: Menopur®

Active Comparator: recombinant FSH Drug: recombinant FSH
Other Name: Gonal-f®




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Number of Oocytes Retrieved [ Time Frame: At oocyte retrieval visit (approximately 36 hours after hCG administration) ]
  7. Number of Metaphase II Oocytes [ Time Frame: At oocyte retrieval visit (approximately 36 hours after hCG administration) ]
  8. 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.

  9. 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.

  10. Quality of Embryos [ Time Frame: 3 days after oocyte retrieval ]
    Assessed by cleavage stage.

  11. 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).



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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554279


  Show 35 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Ferring Pharmaceuticals:
Statistical Analysis Plan  [PDF] March 8, 2017


Additional Information:
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02554279     History of Changes
Other Study ID Numbers: 000205
First Posted: September 18, 2015    Key Record Dates
Results First Posted: March 2, 2018
Last Update Posted: March 2, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Follicle Stimulating Hormone
Menotropins
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents