Double Blind Randomized Controlled Trial on the Effect of Pre-washing the Insemination Catheter on Pregnancy Outcome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Pregnancy Rate
研究概览
简要总结
The investigators hypothesize that washing the insemination catheter prior to performing the IUI (intrauterine insemination) will improve the pregnancy outcome in IUI cycles when compared to controls (without pre-washing the catheter).
Catheter washing is performed routinely before embryo transfer, however it is not done for IUI catheters. Therefore no data is available on applying the technique to IUI catheters prior to insemination.
详细描述
OBJECTIVES:
Primary objective:
To determine if pre-washing the catheter before insemination improves the pregnancy outcome in women undergoing IUI.
Secondary objectives:
- To evaluate the impact of pre-washing the catheter before insemination on the ectopic pregnancy rate in women undergoing IUI.
- To evaluate the impact of pre-washing the catheter before insemination on the miscarriage rate in women undergoing IUI.
- To evaluate the impact of pre-washing the catheter before insemination on the multiple pregnancy rates in women undergoing IUI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Infertile women age ranges from 18 to 40 years at the time of treatment at the MUHC reproductive centre.
- •Patients undergoing IUI.
- •Fresh and frozen sperm treatment cycles
- •Hormone induced and natural cycle (no hormonal stimulation).
- •Patients speaking English or/and French.
- •Patients able to consent.
排除标准
- •Patients younger than 18 years or older than 40 years of age.
- •Patients undergoing ovarian stimulation without IUI.
- •Patients who have been recruited in our study in a previous IUI cycle.
- •Patients who don't speak English or French.
- •Patients who are not able or refuse to consent.
- •Patient who are recruited in a different IUI research study.
研究组 & 干预措施
Catheter prewashing
Intervention: prewashing the catheter before IUI.
450 patients randomly included in this group will have their insemination catheter prewashed with the same media used to wash the sperm, prior to performing the insemination using the washed catheter.
干预措施: washing the insemination catheter with sperm washing media (Other)
Control group
450 patients randomly assigned in this group will have their insemination performed routinely, without washing the insemination catheter..
结局指标
主要结局
Pregnancy Rate
时间窗: 19months
To determine if pre-washing the catheter before insemination improves the pregnancy outcome in women undergoing IUI.
次要结局
- Clinical pregnancy rate(19 months)
- miscarriage Rate(19 months)
- Live birth rate(19 months)
- Ectopic Pregnancy Rate(19 months)
研究者
Patricia Monnier
Associate Professor at MUHC reproductive health center
McGill University Health Centre/Research Institute of the McGill University Health Centre