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])
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Number of Cumulus-Oocyte-Complexes Retrieved During Oocyte Pick-up
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Single-Dose MK-8962 + recFSH
干预措施: MK-8962 (Drug)
Single-Dose MK-8962 + recFSH
干预措施: recFSH (Drug)
Single-Dose MK-8962 + recFSH
干预措施: Ganirelix (Drug)
Single-Dose MK-8962 + recFSH
干预措施: human Chorionic Gonadotropin (hCG) (Drug)
Single-Dose MK-8962 + recFSH
干预措施: Progesterone (Drug)
Reference Group recFSH only
干预措施: recFSH (Drug)
Reference Group recFSH only
干预措施: Ganirelix (Drug)
Reference Group recFSH only
干预措施: human Chorionic Gonadotropin (hCG) (Drug)
Reference Group recFSH only
干预措施: Progesterone (Drug)
结局指标
主要结局
Number of Cumulus-Oocyte-Complexes Retrieved During Oocyte Pick-up
时间窗: 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.
次要结局
- Confirmation of Vital Pregnancy(Post treatment; at 35 days from Day of Embryo Transfer)
- Percentage of Participants with Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS)(From Baseline up to 10 weeks after Day of Embryo Transfer)
- Number of Participants with an Ongoing Pregnancy(Post treatment; at approximately 10 weeks from Day of Embryo Transfer)