Laparoscopic Tubal Patency Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pregnancy rate
研究概览
简要总结
- Methylene blue in laparoscopy use for tubal patency assessment
- Methylene blue could have negative effect on sperm motility, oocyte granulosa cell and fertility.
- tubal washing after Methylene blue administration could be effective in pregnancy rate after operation.
详细描述
women with unexplained infertility and without any problem during laparoscopy and hysteroscopy entered in the study.After randomization in one group after dye test,washing with normal saline was done until all of visible Methylene blue removed.In second group washing with normal saline did not done. pregnancy rate until three months after operation was followed without any intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with unexplained infertility
排除标准
- •any intervention during operation like ovarian drilling or septum resection
研究组 & 干预措施
Dye& normal saline/ 20ml methylene blue +50 ml normal saline
first arm:20 ml methylene blue washing with50 ml normal saline
干预措施: methylen blue &normal saline (Drug)
Dye& normal saline/ 20ml methylene blue +50 ml normal saline
first arm:20 ml methylene blue washing with50 ml normal saline
干预措施: methylene blue (Drug)
Dye& normal saline/ 20ml methylene blue +50 ml normal saline
first arm:20 ml methylene blue washing with50 ml normal saline
干预措施: metheylne blue with normal saline (Drug)
injection of 20ml metheylen blue
20 ml methylene blue injected without washing
干预措施: methylene blue (Drug)
结局指标
主要结局
Pregnancy rate
时间窗: up to 12 weeks
次要结局
- complications rate in two group(Up to 12 weeks)