NCT02309671已完成2 期
A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Japanese Women Undergoing an Assisted Reproductive Technology 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
- 159
- 试验地点
- 1
- 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 Japanese women undergoing IVF/ICSI 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
- 20 Years 至 39 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 and/or ICSI treatment
- •Women aged 20-39 years
- •Women with body mass index (BMI) of 17.5-32.0 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
FOLLISTIM 150 IU
Active Comparator
follitropin beta
干预措施: follitropin beta (Drug)
FE 999049 6 µg
Experimental
干预措施: FE 999049 (Drug)
FE 999049 12 µg
Experimental
干预措施: FE 999049 (Drug)
FE 999049 9 µg
Experimental
干预措施: FE 999049 (Drug)
结局指标
主要结局
Number of oocytes retrieved
时间窗: End of stimulation (max 16 days after investigational medicinal product (IMP) start)
次要结局
- Size of follicles during stimulation(Up to 16 days)
- Successful pregnancy rate(5-6 weeks after transfer)
- Number of follicles during stimulation(Up to 16 days)
- Intensity of adverse events(From signing informed consent form until end of trial visit = 8-9 weeks)
- Endocrine profile measured by circulating levels of hormones(Up to 16 days)
- Total IMP dose administered measured from first until last dose (end of stimulation)(Up to 16 days)
- Embryo quality measured by fertilised oocytes and number and quality of embryos and blastocysts during culturing(5 days (from oocyte retrieval to embryo transfer))
- Frequency of adverse events(From signing informed consent form until end of trial visit = 8-9 weeks)
研究者
研究点 (1)
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