An Efficacy and Safety Study of Corifollitropin Alfa (MK-8962) in Contrast to Recombinant FSH for Use in Controlled Ovarian Stimulation of Indian Women (P07056, Also Known as MK-8962-029)

February 1, 2022 updated by: Organon and Co

A Multi-center, Open-label, Randomized Trial in India to Investigate the Efficacy and Safety of a Single Injection of MK-8962 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation Using Daily Recombinant FSH as a Reference (Phase III, Protocol No. MK-8962-029-00 [Also Known as SCH900962, P07056])

This study, conducted in India, will be recruiting women participants who are between the ages of 18 and 42, and who have an indication for controlled ovarian stimulation (COS), but have not yet undergone in-vitro fertilization and/or intracytoplasmic sperm injection (IVF/ICSI). The study is designed to compare the difference in oocyte (immature egg cell) production after administration of the investigative drug, MK-8962 (corifollitropin alfa) + recombinant follicle stimulating hormone (recFSH), in contrast to use of only the reference drug, recFSH.

Study Overview

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Please Note: In this trial an Indian female participant is defined as a woman 1) with native Indian parents, and 2) who is also in possession of an Indian identification card.

  • Indian woman with an indication for COS and IVF/ICSI, but has not yet undergone IVF/ICSI.
  • Body mass index (BMI) of 18.0 to 32.0 kg/m2
  • Regular spontaneous menstrual cycle (ie, a menstrual schedule that consistently occurs within a range of 24 to 35 days)
  • Access to available ejaculatory sperm. Use of donated and/or cryopreserved sperm is allowed, however sperm obtained via surgical sperm retrieval is not allowed.
  • Results documented as 'within normal limits' from clinical laboratory tests (ie, complete blood count [CBC], blood chemistries, and urinalysis).
  • Normal cervical smear result obtained within 12 months prior to study enrollment, otherwise test will be performed during screening.
  • Able to adhere to dose and study visit schedules

Exclusion Criteria:

- Has a recent (ie, within 3 years prior to enrollment in study) history of/or

any active endocrine abnormality, treated or untreated.

  • Contraindicated use of gonadotropins
  • History of ovarian hyper-responsiveness
  • History of/or current polycystic ovary syndrome (PCOS)
  • Has less than 2 ovaries or has any other ovarian abnormality, including endometrioma (greater than 10 mm in size), and/or has unilateral or bilateral hydrosalpinx and/or intrauterine fibroids (5 cm in size or greater), confirmed by an ultrasound scan.
  • Has any clinically relevant pathology that may impair embryo implantation or continuation of pregnancy.
  • Experienced more than three unsuccessful COS cycles for IVF/ICSI since

the last established ongoing pregnancy, if applicable.

  • History of non- or low ovarian response to FSH and/or Menopausal Gonadotropin (hMG) treatment.
  • History of recurrent miscarriage (ie, 3 or more)
  • Positive test results for Human Immunodeficiency Virus (HIV) or

Hepatitis B

  • Recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease, any of which required or requires treatment.
  • Smokes or recently stopped smoking (ie, within 3 months of study enrollment)
  • History of/or active alcohol and/or drug abuse (ie, within 12 months prior to study enrollment).
  • Previous use of corifollitropin alfa
  • Use of hormonal agents known to affect ovulation or any drug/agent considered to be teratogenic
  • Use of any experimental drug within 3 months prior to study enrollment or participation in another clinical study, other than one that is survey-questionnaire based.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Single-Dose MK-8962 + recFSH

MK-8962 is supplied in a ready-to-use prefilled syringe containing

100 microgram (μg) or 150 μg corifollitropin alfa per 0.5 mL. Participants are randomized to receive a single subcutaneous (SC) injection of MK-8962 in the abdominal wall on Cycle Day 2 or Cycle Day 3. Dose of administered MK-8962 is weight-based. Participants who weigh 60 kilograms (kg) or less will be given 100 μg MK-8962 and those who weigh more than 60 kg will be given 150 μg MK-8962.

Other Names:
  • Corifollitropin alfa
Recombinant Follicle Stimulating Hormone (recFSH) will be supplied as a ready-to-use solution in a 600 IU cartridge for SC injection via the recFSH Pen. Starting on Day 2 or 3 of the menstrual cycle (Stimulation Day 1), recFSH will be administered daily, each morning, via injections in the abdominal wall. A starting dose of between 150 - 300 IU will be administered and is fixed for the first week of stimulation. After 6 days, and based on each participant's individual response, the Investigator may decide to reduce the fixed dose for the remainder of the study. The maximum duration of stimulation is 19 days; recFSH will not be administered on the Day of hCG Administration.
Other Names:
  • follitropin beta
0.25 mg/day SC injection in the upper leg, administered on Stimulation Day 5 up to and including Day of hCG Administration
Other Names:
  • Ganirelix acetate or Ganirelix diacetate
Single dose of 10,000 or 5,000 IU hCG, administered via SC injection on Day of hCG Administration.
Other Names:
  • human Chorionic Gonadotrophin
Crinone 8% (90 mg) gel administered intravaginally via a single-use, one piece polyethylene vaginal applicator once-daily on Day of Oocyte Pick-up or 1 day later and continued for at least 6 weeks or either up to menses or up to a negative pregnancy test performed at least 18 days after Day of Oocyte Pick-up.
Other Names:
  • Crinone®
ACTIVE_COMPARATOR: Reference Group recFSH only
Recombinant Follicle Stimulating Hormone (recFSH) will be supplied as a ready-to-use solution in a 600 IU cartridge for SC injection via the recFSH Pen. Starting on Day 2 or 3 of the menstrual cycle (Stimulation Day 1), recFSH will be administered daily, each morning, via injections in the abdominal wall. A starting dose of between 150 - 300 IU will be administered and is fixed for the first week of stimulation. After 6 days, and based on each participant's individual response, the Investigator may decide to reduce the fixed dose for the remainder of the study. The maximum duration of stimulation is 19 days; recFSH will not be administered on the Day of hCG Administration.
Other Names:
  • follitropin beta
0.25 mg/day SC injection in the upper leg, administered on Stimulation Day 5 up to and including Day of hCG Administration
Other Names:
  • Ganirelix acetate or Ganirelix diacetate
Single dose of 10,000 or 5,000 IU hCG, administered via SC injection on Day of hCG Administration.
Other Names:
  • human Chorionic Gonadotrophin
Crinone 8% (90 mg) gel administered intravaginally via a single-use, one piece polyethylene vaginal applicator once-daily on Day of Oocyte Pick-up or 1 day later and continued for at least 6 weeks or either up to menses or up to a negative pregnancy test performed at least 18 days after Day of Oocyte Pick-up.
Other Names:
  • Crinone®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Cumulus-Oocyte-Complexes Retrieved During Oocyte Pick-up
Time Frame: 34 to 36 hours after Day of Administration of Human Chorionic Gonadotropin (hCG)
The criterion of hCG administration is defined as three or more follicles ≥17 mm, confirmed by ultrasound. Oocyte pick up occurs 34-36 hours after the Day of hCG Administration, based on confirmed ultrasound findings.
34 to 36 hours after Day of Administration of Human Chorionic Gonadotropin (hCG)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmation of Vital Pregnancy
Time Frame: Post treatment; at 35 days from Day of Embryo Transfer
Per study protocol, vital pregnancy is defined as the presence of at least one fetus with heart activity at approximately 5 weeks (ie, ~ 35 days) after Day of Embryo Transfer in the COS treatment cycle.
Post treatment; at 35 days from Day of Embryo Transfer
Percentage of Participants with Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS)
Time Frame: From Baseline up to 10 weeks after Day of Embryo Transfer
Per study protocol, OHSS is defined as more than 30 follicles ≥11 mm in size demonstrated by ultrasound.
From Baseline up to 10 weeks after Day of Embryo Transfer
Number of Participants with an Ongoing Pregnancy
Time Frame: Post treatment; at approximately 10 weeks from Day of Embryo Transfer
Per study protocol, ongoing pregnancy is defined as confirmed pregnancy at 10 or more weeks ( ~ 70 days) after Day of Embryo Transfer, documented by a positive pregnancy test and ultrasound scan demonstrating at least one gestational sac with heart activity.
Post treatment; at approximately 10 weeks from Day of Embryo Transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ANTICIPATED)

May 1, 2015

Study Completion (ANTICIPATED)

June 1, 2015

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 14, 2012

First Posted (ESTIMATE)

May 16, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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