High Versus Free Humidity Incubators; A Randomized Clinical Trial
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 unpublished data).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
- 是
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
Muhammad Fawzy
IVF Laboratory Director
Ibn Sina Hospital
