Analgesia for Endometrial Scratching in Subfertile Women: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Maximum pain during procedure
研究概览
简要总结
The aim of this study is to evaluate whether Ibuprofen alone or combined with lorazepam reduce the pain associated with endometrial scratching/injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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 undergoing assisted reproduction (IUI, IVF/ICSI, frozen embryo transfer)
- •Being submitted to endometrial scratching/injury with a Pipelle on the first four days of the menstrual cycle.
- •Not have performed endometrial scratching in the last 90 days.
排除标准
- 未提供
研究组 & 干预措施
Ibuprofen+Lorazepam
Oral ibuprofen (600 mg) + lorazepam (1 mg); one hour before endometrial scratching.
干预措施: Ibuprofen 600 mg (Drug)
Ibuprofen+Lorazepam
Oral ibuprofen (600 mg) + lorazepam (1 mg); one hour before endometrial scratching.
干预措施: Lorazepam 1 mg (Drug)
Ibuprofen
Oral ibuprofen (600 mg) + Placebo; one hour before endometrial scratching.
干预措施: Ibuprofen 600 mg (Drug)
Ibuprofen
Oral ibuprofen (600 mg) + Placebo; one hour before endometrial scratching.
干预措施: Placebo (Drug)
Placebo
Placebo + Placebo; one hour before endometrial scratching.
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum pain during procedure
时间窗: 5 minutes
Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10).
次要结局
- Rejection to a new procedure(5 minutes)
- Pain after the procedure(5 minutes)
研究者
Wellington P Martins, MD
Associate Professor
University of Sao Paulo