Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen(Follitropin Delta)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 728
- 试验地点
- 15
- 主要终点
- Proportion of subjects with ovarian hyperstimulation syndrome (OHSS)
研究概览
简要总结
This post-marketing surveillance study was conducted in accordance with the regulations for re-examination of domestic new drugs (Standard for Re-Examination of New Drugs: Ministry of Food and Drug Safety [MFDS]: Notification No. 2017-95, 21 Nov, 2017).
It was important to monitor the pattern of drug use in general practice for a long term after marketing authorization, and to investigate and identify potential new adverse events (AEs) and their onset status that were not observed during the drug development phases and any potential factors that affect safety and effectiveness of the new drug.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants who were prescribed with REKOVELLE (follitropin delta) for the first time according to the approved administration method and dose
- •Participants who have consented to personal information use
排除标准
- •Participants who are prohibited from use according to the special warnings and precautions for use of REKOVELLE (follitropin delta)
结局指标
主要结局
Proportion of subjects with ovarian hyperstimulation syndrome (OHSS)
时间窗: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
Proportion of subjects with serious AEs and adverse drug reactions (ADRs)
时间窗: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
Proportion of subjects with unexpected AEs/ADRs not reflected in 'Precautions for Use'
时间窗: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
Proportion of subjects with expected ADRs
时间窗: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
Technical malfunction of REKOVELLE pre-filled pen
时间窗: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
Proportion of subjects with non-serious ADRs
时间窗: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
次要结局
- Number of the oocytes retrieved(At the oocyte retrieval visit, after completion of controlled ovarian stimulation and approximately 36 hours after human chorionic gonadotropin (hCG) administration.)
- Ongoing pregnancy rate in women undergoing controlled ovarian stimulation(Between 10-11 weeks after embryo transfer)