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临床试验/NCT01594645
NCT01594645撤回1 期

The Impact of Selecting Acrosome Reacted Spermatozoa for ICSI- a Prospective RCT

Hadassah Medical Organization2 个研究点 分布在 1 个国家开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
1 期
状态
撤回
试验地点
2
主要终点
fertilization rate

研究概览

简要总结

Presently spermatozoa for ICSI are selected based on morphology and motion, without determining if acrosome reaction (AR) had occurred during sperm preparation or not. Although not critical if the sperm is injected into the ooplasm, the occurrence of AR might might be an indicator of better spermatozoon quality and implantation potential, especially in severe OTA cases. It is impossible with conventional plain optic microscopy used in IVF units to determine in vivo (without fixation) if AR has occurred, and as a result spermatozoa are injected randomly. It is readily possible to distinguish AR+ from AR- spermatozoa using polarized light microscopy due to different bifriengance.

In this study the investigators seek to determine, by a prospective RCT, if selecting only acrosome reacted spermatozoa, in severe OTA cases, will improve the outcome of ICSI and the entire IVF process.

详细描述

A prospective RCT to determine the effect of polscope based spermatozoa selection for ICSI.

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
None

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Female: normal uterine cavity and ovarian reserve. Male: TMC < 1000000 cells.

排除标准

  • Female: Abnormal uterine anatomy, low ovarian reserve, contributing egg factor, PGD.

结局指标

主要结局

fertilization rate

时间窗: 24-72 h

Determine the impact of AR+ spermatozoa selection of fertilization and in vitro embryonic development.

次要结局

  • Clinical pregnancy(up to 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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