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临床试验/NCT03641014
NCT03641014已完成不适用

Sequential pH Effect on Blastocyst Formation Rate

Ibn Sina Hospital3 个研究点 分布在 1 个国家目标入组 1,312 人开始时间: 2018年8月28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
1,312
试验地点
3
主要终点
Ongoing Pregnancy rate

研究概览

简要总结

Any drift in extracellular pH (pHe) from the intercellular pH (pHi) could alter the mechanism regulating transporters and exchangers through the plasma membrane. This could lead to difficulty in restoring the physiological level of pHi. The critical stages that lack robust mechanism of regulating the pHi are the denuded oocyte, early stage of fertilization or a thawed embryo. This, in turn, could lead to a significant effect of the perturbations on embryo development. Convincing evidence regarding the optimal pHe for culturing human embryo is, so far, scanty and mostly anecdotal. The embryo has been reported to have a compensatory mechanism to grow at pHe between 7.0-7.4. Others have recommended that embryo need a sequential pH to viably grow suggesting that the post-genomic activation stage needs a slightly alkaline range of pH. However, whether this holds true remains to be examined.

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
Triple (Participant, Care Provider, 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
否

入选标准

  • •ICSI cycles

排除标准

  • •No exclusion

研究组 & 干预措施

Sequential pH culture (7.23 then 7.35)

Experimental

A split embryo at day 3 to continue culture at a pHe of 7.23±0.02 or to be cultured at a pH of 7.35±0.02 and monitor the effect on blastocyst development.

干预措施: pH Effect on blastocyst formation (Other)

Continuously pH culture at 7.23

No Intervention

Embryo culture from day 0 to 5 or 6 at 7.23

结局指标

主要结局

Ongoing Pregnancy rate

时间窗: 12 weeks

women with continued pregnancy at week 12 of gestation

次要结局

  • rate of usable blastocysts(6 days of culture)
  • Blastocyst formation rate(6 days of culture)
  • Clinical pregnancy rate(3 months)
  • Implantation rate(7 weeks)

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 (3)

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