Early Embryo Cleavage And Multiple Pregnancies After ICSI
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 193
- 主要终点
- clinical pregnancy
研究概览
简要总结
To observe whether Number of early cleavage embryos can be a predictor for multiple pregnancies after ICSI.
详细描述
A total of 193 infertile couples, attending the ART unit, International Islamic Center for Population Studies and Research (IICPSR), -Al- Azhar University in the period from December 2010 to September 2012, were included in this study.
The controlled ovarian hyperstimulation protocol was performed according to a long GnRH agonist protocol starting in the midluteal phase (day 21) of the preceding cycle. Embryos were assessed at 25 - 27 hr after ICSI for early cleavage. Embryos which reached the two cell stage at this interval were classified as Early Cleavage (EC) embryos, and the remaining as Non Early Cleavage (NEC) embryos. Embryos were assessed again at 64 - 68 hours post-ICSI for day-three embryo morphology. Day 3 embryo transfer was done. The best two or three embryos, according to day 3 embryo morphology were transferred. The patients were subdivided into two subgroups; one will transfer early cleavage embryos (EC) and the other will transfer non early cleavage embryo (NEC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI >25 - 30 kg/m2
- •Have two ovaries
- •Regular cycles
- •first ICSI cycle
- •Long midluteal GnRH protocol.
排除标准
- •uterine factor as a cause of female factor infertility
- •pelvic masses or diseases (e.g: endometriosis, fibroids, hydrosalpnix, ...)
- •history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver diseases, renal diseases,...)
- •azoospermia as a cause of male factor infertility
研究组 & 干预措施
transfer early cleavage embryos (EC)
transfer early cleavage embryos
干预措施: transfer early cleavage embryos (Procedure)
transfer non early cleavage embryo (NEC)
transfer non early cleavage embryos
干预措施: transfer non early cleavage embryo (Procedure)
结局指标
主要结局
clinical pregnancy
时间窗: 6 weeks
次要结局
- multiple pregnancy(8 weeks)
研究者
Edessy Mahmoud
Obstetrics and Gynecology Department, faculty of medicine (Assiut)
Al-Azhar University