NCT02835469已完成不适用
Non-Interventional Clinical Study on Efficacy and Safety of Highly Purified Human Menopausal Gonadotrophin (HP-hMG) Menopur® Multidose in Korean Female Patients With Infertility
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 412
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after embryo transfer in patients treated with Menopur® Multidose
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Decision made to prescribe Menopur® multidose according to Summary of product characteristics
- •The study cycle will be either
- •1st controlled ovarian stimulation cycle ever, or
- •2nd controlled ovarian stimulation cycle ever, or
- •1st or 2nd controlled ovarian stimulation cycle after having achieved ongoing pregnancy in a previous controlled ovarian stimulation cycle (note: the subject cannot be included if she has had made more than one failed cycle before the cycle resulting in ongoing pregnancy)
排除标准
- •Known ovarian disease (e.g. ovarian cysts, polycystic ovarian disease etc.)
- •Diagnosed as "poor responder", defined as either
- •>20 days of gonadotrophin stimulation in a previous controlled ovarian stimulation cycle, or
- •any previous cancellation of a controlled ovarian stimulation cycle due to limited follicular response, or
- •development of less than 4 follicles ≥15 mm in a previous controlled ovarian stimulation cycle
- •Ovarian hyperstimulation syndrome (OHSS)
研究组 & 干预措施
Menopur® Multidose
Treatment according to routine clinical practice.
干预措施: Menotrophin (Drug)
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 10-11 weeks after embryo transfer
Defined as presence of at least 1 intrauterine pregnancy with a viable fetus
次要结局
- Mean Luteinizing Hormone (LH) level(At baseline and last stimulation day (max 20 days after start of stimulation))
- Mean Estradiol 2 (E2) level(At baseline and last stimulation day (max 20 days after start of stimulation))
- Mean Follicle Stimulating Hormone (FSH) level(At baseline and last stimulation day (max 20 days after start of stimulation))
- Mean endometrial thickness(On last stimulation day (max 20 days after start of stimulation))
- Fertilization rate(1 day after oocyte retrieval)
- Number of oocytes retrieved(36 hours (±2h) after human Chorionic Gonadotrophin (hCG) administration)
- Follicular development(On last stimulation day (max 20 days after start of stimulation))
研究者
研究点 (1)
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