Post-Marketing Surveillance Orgalutran (Ganirelix)®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 711
- 主要终点
- Number of retrieved oocytes by COH based on Per stage approach
研究概览
简要总结
The purpose of this post-marketing surveillance is to identify problems and questions regarding the safety and efficacy of Orgalutran (Ganirelix)® when used for the prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must be undergoing COH for ART
排除标准
- •Hypersensitivity to the active substance or to any of the excipients
- •Hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue
- •Moderate or severe impairment of renal or hepatic function
- •Pregnancy or lactation
研究组 & 干预措施
Participants Treated
Women undergoing controlled ovarian COH for ART
干预措施: Orgalutran (Drug)
结局指标
主要结局
Number of retrieved oocytes by COH based on Per stage approach
时间窗: Baseline to End of Study
Number of Serious Adverse Events
时间窗: Baseline to End of Study
Number of Unlabeled (Unexpected) Adverse Drug Reactions
时间窗: Baseline to End of Study
Number of Labeled Adverse Drug Reactions
时间窗: Baseline to End of Study
Number of Non-serious Adverse Events
时间窗: Baseline to End of Study
Number of Adverse events by drug misuse/abuse or drug-drug interaction
时间窗: Baseline to End of Study
次要结局
未报告次要终点