Laser Assisted ICSI; Has it Role Whatsoever? Does it Affect the ICSI Outcome Positively?1
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
laser-assisted ICSI (LA-ICSI) was described to be a new method combining a less invasive ICSI technique with assisted hatching.This procedure is usually used for MII oocytes possessing oolemma breakage difficulties, but why not using it for even normal Oocytes?!. Especially because data indicated that in addition to an improved oocyte survival, this new approach increases the hatching rate in vitro. But since it is still debatable that such a small opening might impair the hatching process, so modified zona thinning technique was proposed for more embryo safety.
详细描述
This study aims to compare the LA- ICSI by drilling a micro hole (LAD-ICSI) and modified LA-ICSI by zona pellucida thinning (LAT-ICSI) with conventional ICSI in order to effectively assess whether this approach can be applied routinely to improve ICSI outcome.
One arm study divided into three interventions; Conventional ICSI (control group) was compared with LAD-ICSI (Study group 1) and LAT- ICSI (study group 2) in sibling oocytes.
The rates of maturation, fertilization, Devision, Blastulation and good quality blastulation rates were assessed in the three groups
Cases were randomly selected for embryo transfer from the three groups,Then chemical pregnancy and clinical pregnancy rates were compared between the three groups.
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, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients aged from 20 years old to 37 years old
- •good res-ponders
- •gives more than 15 oocytes
- •endometrial thickness more than 9 mm
排除标准
- •poor res-ponders
- •severe oligoasthinozoospermia of male partners
- •testicular samples
- •Poor quality oocytes
结局指标
主要结局
Clinical pregnancy rate
时间窗: three-four weeks after embryo transfer
confirmed by sac observation using ultrasound
次要结局
- Blastulation rate(5 days later after ICSI procedure)
- Hatching rate(5 days later after ICSI procedure)