Does Intralipid Infusion Improve the Implantation Rate in Repeated Implantation Failure: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm injection ( ICSI) failure due to elevated TH1 cytokine response.
详细描述
Infertile patients undergoing Intracytoplasmic Sperm Injection (ICSI) cycle with history of repeated implantation failure, intralipid will be given to the intervention group.
The primary outcome measure is the clinical pregnancy rate, secondary outcome measures implantation rate, ongoing pregnancy rate, abortion rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Infertile patients undergoing ICSI cycle with history of repeated implantation failure
排除标准
- •Disturbances of normal fat metabolism such as pathologic hyperlipemia
- •Allergic to it; or to eggs, soybean oil, or safflower oil.
- •Severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.
- •Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.
研究组 & 干预措施
control
Saline 0.9% IV infusion between day 4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test
干预措施: Saline (Drug)
intralipid
IV infusion of intralipid 20% between day4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test
干预措施: intralipid (Drug)
结局指标
主要结局
clinical pregnancy rate
时间窗: 10 month
pregancy sac with fetal heart activity
次要结局
- implantation rate(10 month)
- ongoing pregnancy rate(14 month)
研究者
Waleed El-khayat
Assisstant professor
Cairo University