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临床试验/NCT00816387
NCT00816387已完成不适用

Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle: a Prospective Randomized Study

IRCCS Burlo Garofolo2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2007年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
2
主要终点
clinical pregnancy rate

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of fallopian sperm perfusion (FSP) in comparison with standard intrauterine insemination (IUI) in natural cycle for couples with unexplained infertility or mild male factor.

详细描述

A number of randomised controlled trials have been published comparing the efficacy of FSP with standard IUI. A recent meta-analysis has suggested that in couples with unexplained infertility Fallopian tube sperm perfusion together with controlled ovarian hyperstimulation (COH) leads to increased pregnancy rates than IUI and COH. No study has been published comparing the two insemination techniques in natural cycle.

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
24 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • infertility for at least 2 years
  • age <40 years
  • unexplained infertility or mild male factor

排除标准

  • previous assisted reproduction treatment

结局指标

主要结局

clinical pregnancy rate

时间窗: 2 years

次要结局

  • Abortion rate(2 years)
  • Ectopic pregnancy rate(2 years)

研究者

发起方
IRCCS Burlo Garofolo
申办方类型
Other

研究点 (2)

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