Clinical trial NCT01599494: 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)
Official title: 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])
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Infertility
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2012-05-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Cumulus-Oocyte-Complexes Retrieved During Oocyte Pick-up
timeFrame: 34 to 36 hours after Day of Administration of Human Chorionic Gonadotropin (hCG)
Secondary outcomes:
measure: Confirmation of Vital Pregnancy
timeFrame: Post treatment; at 35 days from Day of Embryo Transfer
measure: Percentage of Participants with Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS)
timeFrame: From Baseline up to 10 weeks after Day of Embryo Transfer
measure: Number of Participants with an Ongoing Pregnancy
timeFrame: Post treatment; at approximately 10 weeks from Day of Embryo Transfer
Other outcomes:
Locations:
Study officials:
References: