NCT02941341已完成不适用
Ambispective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Techniques in Spain.
Finox AG1 个研究点 分布在 1 个国家目标入组 1,222 人开始时间: 2016年10月最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,222
- 试验地点
- 1
- 主要终点
- Total number of oocytes retrieved
研究概览
简要总结
Non-comparative, observational, ambispective post-authorisation study (EPA-SP).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 years
- •Currently undergoing an IVF or ICSI cycle or are oocyte-donors
- •Have completed controlled ovarian stimulation
- •Have received at least 5 doses of Bemfola®
- •Are pituitary suppressed with a GnRH antagonist
- •Have undergone oocyte retrieval
- •Have signed the Informed Consent Form
排除标准
- •Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients listed
- •Presence of tumours of the hypothalamus or pituitary gland
结局指标
主要结局
Total number of oocytes retrieved
时间窗: 34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment
次要结局
- Quality of oocytes(At Day 4-5)
- Number of fertilised oocytes(1 day after ovum pick-up)
- Number and quality of transferred embryos(Day of embryo transfer, either 2,3 or 5 days after oocyte retrieval)
- Fertilization and implantation rate(5 to 6 weeks after oocyte retrieval)
- Incidence of serious adverse events, including moderate-to-severe OHSS(From Day 1 of stimulation)
研究者
研究点 (1)
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