NCT02554279已完成4 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 620
- 试验地点
- 35
- 主要终点
- Ongoing Pregnancy Rate
研究概览
简要总结
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.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
menotropin
Experimental
menotropins for injection
干预措施: menotropin (Drug)
recombinant FSH
Active Comparator
干预措施: recombinant FSH (Drug)
结局指标
主要结局
Ongoing Pregnancy Rate
时间窗: 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.
次要结局
- Positive β-human Chorionic Gonadotropin (hCG) Rate(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)
- Clinical Pregnancy Rate(4-5 weeks after blastocyst transfer in the fresh cycle)
- Follicular Development as Assessed by TVUS(On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days))
- Quality of Embryos(3 days after oocyte retrieval)
- Early Pregnancy Loss(At 10-11 weeks of gestation in the fresh cycle)
- Number of Oocytes Retrieved(At oocyte retrieval visit (approximately 36 hours after hCG administration))
- Number of Metaphase II Oocytes(At oocyte retrieval visit (approximately 36 hours after hCG administration))
- Quality of Blastocysts(5 days after oocyte retrieval)
- Fertilization Rate(On day 1 post-insemination)
研究者
研究点 (35)
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