Does Local Endometrial Injury Improve Implantation Rates in Women Undergoing Their First ICSI Cycle.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- implantation rate
研究概览
简要总结
Midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix, the step that will be beneficial to embryo transfer procedure.
Controller ovarian hyperstimulation; will be done using the long luteal phase agonist protocol and the short protocol(as judged by patient,s age ovarian reserve judged by day 3 FSH and antral follicular count and previous history of ovarian response).
Ovarian response will be monitored by vaginal ultrasound and HCG will be given when when there is >=1 follicle >=18 mm. and >=3 follicles >=16 mm. Ultasound guided oocyte retrieval will be carried out 35 hours later. Embryo transfer will be performed on day 2 or day 3 after oocyt retrieval according to number and quality of embryos.
Embryo transfer will be carried out under trans-abdominal ultrasound guidance pregnancy test will be done using qualitative blood HCG detection 2 weeks after the embryo transfer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •subfertile women indicated for ICSI.
- •normal uterine cavity demonstrated by transvaginal ultrasound and hystrogram.
- •FSH<10mIU/mL on day 3 of her cycle.
排除标准
- •presence of endometrial polyp or fibroid distorting the uterine cavity.
- •hydrosalpinx.
- •ICSI carried out for preimplantation genetic diagnosis.
- •FSH>10mIU\mL.
结局指标
主要结局
implantation rate
时间窗: 14 days after embryo transfer
number of sacs identifiable through ultrasonography divided by the number of embryos transferred
clinical pregnancy rate
时间窗: 4 weeks after embryo transfer
the detection of fetal cardiac activity within a gestational sac on ultrasonography examination
次要结局
- multiple pregnancy rate(4 weeks after embryo transfer)
- abortion rate(12 weeks of gestational age)
研究者
Ahmed M Maged, MD
Assistant professor
Cairo University