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临床试验/NCT02488434
NCT02488434已完成3 期

The Effectiveness of Using Fertile Chip on Intracytoplasmic Sperm Injection Undergoing Ivf Programme in Unexplained Infertile Couples

Baskent University1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
122
试验地点
1
主要终点
increase fertilisation rate

研究概览

简要总结

The aim of the current study is to evaluate to effectiveness of sperm selection by using fertile chip in unexplained infertile couples on intracytoplasmic sperm injection (ICSI) cycles.

详细描述

The aim of the current study is to evaluate to effectiveness of sperm selection by using fertile chip in unexplained infertile couples on intracytoplasmic sperm injection (ICSI) cycles. On study arm sperm selection will be performed by using special microchannel system which is called fertile chip (FC) without using sperm wash procedure. This FC system leads to select lineer motile progressive sperm selection. In control group, sperm selection will be performed by classical way which sperm will be undertaken to sperm wash by gradient method.

After selection of sperm in both arms, ICSI will be performed. The outcomes of ICSI schedule will be assesed by fertilization and clinical pregnancy rates.

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, Investigator)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • between 20-37 year-old women
  • normal tubal patency, normal uterine cavity, normal ovulation,
  • between 20-40 year-old men
  • normal semen analyse by WHO criterias
  • unexplained infertile couples

排除标准

  • poor ovarian reserve which is diagnosed by Bologna criterias
  • abnormal semen analyse by WHO sperm criterias
  • abnormal ovulation problems,tubal patency or uterine cavity

结局指标

主要结局

increase fertilisation rate

时间窗: 2 days

次要结局

  • Clinical pregnancy rates(10 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Selçuk Yetkinel

Clinical Doctor

Baskent University

研究点 (1)

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