The Effects of Intrauterine Infusion of Human Chorionic Gonadotropin at the Time of Embryo Transfer on IVF/ICSI Outcomes: Randomized, Double-blind Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The purpose of this study is to determine whether intrauterine hCG can improve the implantation rate and clinical pregnancy rate after embryo transfer in IVF/ICSI cycle.
详细描述
Patients at infertility clinic, siriraj hospital who come to start IVF/ICSI treatment cycle or endometrial preparation for embryo transfer are consiferes as eligible subjects.
On the day of embryo transfer (both fresh and frozen-thaw cycle), the subjects will be randomized to 2 groups.
- control group: embryo transfer after intrauterine infusion with standard embryo culture media 4-7 minutes
- study group: embryo transfer after intrauterine infusion with hCG (Pregnyl) 4-7 minutes
The patients will come back for serum beta-hCG measurement 2 weeks later after embryo transfer and other 2 weeks later for transvaginal ultrasound if beta-hCG is positive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •infertile women aged 18-43 years
- •indicated or willing for IVF/ICSI treatment or endometrial preparation for embryo transfer
排除标准
- •Azoospermic male partner
- •Failure to retrieve oocyte after controlled ovarian hyperstimulation
- •No embryo retrieved for transfer
- •Endometrial preparation failure
结局指标
主要结局
Clinical pregnancy rate
时间窗: 2 weeks after positive serum beta-hCG
Transvaginal ultrasound to confirm number of intrauterine gestational sac and fetal heart beats
次要结局
- Chemical pregnancy rate(2 weeks after embryo transfer)
- Implantation rate(2 weeks after positive serum beta-hCG)