NCT01426386已完成2 期
A Randomised, Controlled, Assessor-blind, Parallel Groups, Multi-national, Multi-centre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Women Undergoing an ART Programme
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 8
- 主要终点
- Number of Oocytes Retrieved
研究概览
简要总结
This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) 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
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with tubal infertility, unexplained infertility, infertility related to endometriosis stage I/II or with partners diagnosed with male factor infertility
- •Women eligible for IVF (in-vitro fertilisation) and/or ICSI (intracytoplasmic sperm injection) treatment
- •Women aged 18-37 years
- •Women with body mass index (BMI) of 18.5-32.0 kg/m2
排除标准
- •Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis stage III/IV
- •Women with history of recurrent miscarriage
- •Women with contraindications to controlled ovarian stimulation with gonadotropins
- •Women with three or more controlled ovarian stimulation cycles
研究组 & 干预措施
11 µg FbM (150 IU)
Active Comparator
干预措施: Gonal - F (Drug)
10.3 µg
Experimental
干预措施: FE 999049 (Drug)
12.1 µg
Experimental
干预措施: FE 999049 (Drug)
8.6 µg
Experimental
干预措施: FE 999049 (Drug)
6.9 µg
Experimental
干预措施: FE 999049 (Drug)
5.2 µg
Experimental
干预措施: FE 999049 (Drug)
结局指标
主要结局
Number of Oocytes Retrieved
时间窗: Day of oocyte retrieval (up to Day 18 after start of stimulation)
次要结局
- Clinical Pregnancy With Fetal Heart Beat Rate(5-6 weeks after transfer)
- Frequency and Intensity of Adverse Events(From signing informed consent form until end of trial visit (up to 5 months))
- Number and Size of Follicles During Stimulation(End of stimulation (up to 16 stimulation days))
- Endocrine Profile(End of stimulation (up to 16 stimulation days))
- Total IMP Dose(End of stimulation (up to 16 stimulation days))
- Number of Fertilised Oocytes(Day 1 after insemination)
- Number and Quality of Blastocysts on Day 5(Day 5 after oocyte retrieval)
研究者
研究点 (8)
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