跳至主要内容
临床试验/NCT03630900
NCT03630900已完成不适用

5% O2 or Lower is the Ideal Tension for Culturing Human Embryo Development From Day 3 Onward

Ibn Sina Hospital4 个研究点 分布在 1 个国家目标入组 487 人开始时间: 2018年8月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
487
试验地点
4
主要终点
Ongoing Implantation rate

研究概览

简要总结

Myriads of elements affect human embryo culture in vitro. These include, but not limited to, air quality, culture media, culture temperature, incubator humidity, pH, and O2 levels. O2 tension has been thoroughly investigated and, to date, 5% O2 level is superior to 20%. Reports showed that lowering the O2 from Day 3 of embryo culture seems to be physiological.

研究设计

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

入排标准

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

入选标准

  • ICSI cycles undergoing their first ICSI attempt

排除标准

  • ICSI cycles with a previous failure

研究组 & 干预措施

Sequential O2 culture (5% then 2.5%)

Experimental

Embryo culture from day 0 to 3 in 5% O2 then split to either 5% or 2.5% O2 until Day 5 or 6.

干预措施: Sequential O2 Culture (Other)

5% O2 culture

No Intervention

结局指标

主要结局

Ongoing Implantation rate

时间窗: three months

number of sacs with a heartbeat after week twelve of gestation

次要结局

  • human embryo development in vitro(three months)
  • clinical and ongoing pregnancies(three months)

研究者

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

Muhammad Fawzy

IVF Lab Director

Ibn Sina Hospital

研究点 (4)

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