Incubator Temperature for Culturing Human Embryos
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Fetal heart beat rate
研究概览
简要总结
Incubator temperature is one of the most precious variables in IVF labs. When the IVF started, almost all incubator temperatures were set at 37 degrees which mimic in vivo conditions. Some authors speculated that gametes and early embryos might need low temperatures that provide quieter metabolism. We decide to compare Embryo culture at 37 degree or slightly lower 36.5 degree and extensively investigate to find which is better to crucially introduce a solid evidence through this RCT.
详细描述
Since the first IVF birth in 1978, the field of assisted reproductive technology has evolved dramatically. The evolution includes both the ovarian stimulation protocols and the laboratory techniques. Optimization of the laboratory procedures is of great interest to the scientists in the field of IVF.
Incubator temperature is one of the most precious variables in IVF labs. When the IVF started, almost all incubator temperatures were set at 37 degrees which mimic in vivo conditions.
Some authors speculated that gametes and early embryos might need low temperatures that provide quieter metabolism. another group found increase in pregnancy rate for embryos cultured below 37 degree compared to those cultured at 37 degree. Nevertheless; the majority of embryologists still consider culture at 37 degrees is the back bone for the incubators.
The paucity of well designed studies makes it difficult to achieve a satisfactory answer whether lower temperature will improve the pregnancy rate. This encourage us to study the effect of lower temperature (36.5 degrees) on the pregnancy rate compared to conventional temperature (37 degrees).
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
- •Women aged ≤ 33 years
- •Normal responder ( ≥ 8 MII )
- •Fresh cycle
- •First attempt (or with previous successful attempt)
- •Normal or mild oligoasthenoteratozoospermia
排除标准
- •Testicular sperm
- •< 8 MIII collected
- •Difficult transfer cycle
- •endometriotic patients
- •Poor Endometrium < 8mm diameter at OPU
结局指标
主要结局
Fetal heart beat rate
时间窗: 3 months
Compare the fetal heart beat rate between the 2 study arms in the first 3 months following Embryo Transfer.
次要结局
- blastocyst formation rate(one week)
- Top quality embryos Day3(one week)
- Top quality blastocyst(one week)
- Implantation rate(one month)
- Pregnancy rate(one month)
研究者
Muhammad Fawzy
IVF Laboratory Director
Ibn Sina Hospital