Hysteroscopic Tubal Occlusion Using Iso-amyl- 2-cyanoacrylate With or Without Ethiodized Oil (Lipidol) in Patients With Hydrosalpinx Prior to IVF
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Fallopian tube occlusion
研究概览
简要总结
Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate with or without Ethiodized oil (Lipidol) in patients with hydrosalpinx prior to IVF
详细描述
hysteroscopic injection of iso-amyl- 2-cyanoacrylate with or without Ethiodized oil (Lipidol) in patients with hydrosalpinx requiring IVF. after one months and two months of the primary injection hysterosalpingography will be done to test for tubal occlusion.
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
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Infertile women due to tubal factor with hydrosalpinx (unilateral or bilateral) prepared for IVF
排除标准
- •• Any patient with acute pelvic inflammatory disease, endometritis, lower genital tract infection.
- •The presence of intrauterine synechiae that might hinder the proper hysteroscopic examination and tubal cannulation diagnosed by diagnostic hysteroscopy.
- •The presence of uterine anomalies that might hinder the proper hysteroscopic examination and tubal cannulation diagnosed by diagnostic hysteroscopy.
- •Undiagnosed genital bleeding.
研究组 & 干预措施
Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil
Group 2 including 20 patients with hydrosalpinx refaired for hysteroscopic tubal occlusion prior to IVF using iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil.
干预措施: iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil (Drug)
Hysteroscopic tubal occlusion using only iso-amyl- 2-cyanoacrylate
Group 1 including 25 patients with hydrosalpinx refaired for hysteroscopic tubal occlusion prior to IVF using iso-amyl- 2-cyanoacrylate .
干预措施: iso-amyl- 2-cyanoacrylate. (Drug)
结局指标
主要结局
Fallopian tube occlusion
时间窗: one to three months
hysteosaplingographic diagnosis of tubal occlusion
次要结局
未报告次要终点
研究者
Mohamed I Amer
professor
Ain Shams University