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)
- Conditions
- Infertility
- Interventions
- Registration Number
- NCT01599494
- Lead Sponsor
- Organon and Co
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single-Dose MK-8962 + recFSH MK-8962 - Single-Dose MK-8962 + recFSH recFSH - Single-Dose MK-8962 + recFSH human Chorionic Gonadotropin (hCG) - Reference Group recFSH only recFSH - Reference Group recFSH only human Chorionic Gonadotropin (hCG) - Single-Dose MK-8962 + recFSH Ganirelix - Single-Dose MK-8962 + recFSH Progesterone - Reference Group recFSH only Ganirelix - Reference Group recFSH only Progesterone -
- Primary Outcome Measures
Name Time Method Number of Cumulus-Oocyte-Complexes Retrieved During Oocyte Pick-up 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.
- Secondary Outcome Measures
Name Time Method Confirmation of Vital Pregnancy 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.
Percentage of Participants with Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS) 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.
Number of Participants with an Ongoing Pregnancy 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.