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临床试验/NCT01695096
NCT01695096已完成不适用

High Versus Free Humidity Incubators; A Randomized Clinical Trial

Ibn Sina Hospital4 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
284
试验地点
4
主要终点
Ongoing pregnancy rate

研究概览

简要总结

To compare Top quality embryos either day3 or day 5, Pregnancy rate and most importantly ongoing pregnancy rate between high humidity incubators and humidity free incubators

详细描述

When the IVF started the majority of incubators designed to support high humidity because the designers and IVF specialists believed that the humidity will maintain stable ph and Temp.

Recent reports suggest that humidity is recommended and the others suggest no difference So we decide to go for this RCT. Nevertheless; high humidity is maintained in vivo (uterus and fallopian tubes) due to the fluid content and stable body temperatures at 37°C. David McCulloch reported 15% reduction of the miscarriage rate after changing the humidity from 76% to 100% (Textbook of Assisted Reproductive Techniques: Laboratory Perspectives, Fourth Edition). Some embryologists claim that the humidity free incubators may increase the chance of chemical pregnancy and early fetal loss (Private center IbnSina IVF, Sohag, Egypt. unpublished data). This observations are never tested in a well designed randomized clinical trial (RCT) to eliminate the probability of chance and to reach a solid evidence.

The question that should be asked : is high humidity culture should be applied or there is no difference between dry and high humidity culture conditions?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 33 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • < 33 years, BMI<30,
  • Normo Responder(>8 MII)
  • Fresh Cycle
  • Ist attempt
  • Normal or mild oligoasthenoteratozoospermia.

排除标准

  • Testicular sperm
  • < 8 MII collected
  • difficult transfer cycle
  • Endometriotic patients
  • Poor Endometrium < 8mm diameter at Ovum Pickup
  • any other medical diseases

结局指标

主要结局

Ongoing pregnancy rate

时间窗: 18 months

assessing the ongoing pregnancy rate and its difference between the 2 study arms.

次要结局

未报告次要终点

研究者

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

Muhammad Fawzy

IVF Laboratory Director

Ibn Sina Hospital

研究点 (4)

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