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临床试验/NCT03778866
NCT03778866已完成不适用

Whether the Use of HEPES-buffered Medium Would Affect Live Birth Rate After ICSI

Muhammad Fawzy4 个研究点 分布在 1 个国家目标入组 1,057 人开始时间: 2019年1月15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
发起方
入组人数
1,057
试验地点
4
主要终点
live birth rate

研究概览

简要总结

The pH stability during human gamete handling for intracytoplasmic sperm injection (ICSI) is physiologically sound. As the pH change for bicarbonate-buffered medium, scientists assumed whether the use of HEPES or MOPS buffered medium would provide more stable pH, thereby better outcomes. However, the oil use and time frame outside the incubators have not been accounted for. This study is to evaluate the use of HEPES buffered medium compared with the bicarbonate-buffered medium on ICSI outcomes.

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, Investigator, 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 indicated cycles

排除标准

  • severe medical illness

研究组 & 干预措施

Bicarbonate-buffered Medium

Experimental

干预措施: Bicarbonate-buffered handling medium (Other)

HEPES-MOPS-buffered Medium

No Intervention

结局指标

主要结局

live birth rate

时间窗: 40 weeks

viable neonate after 30 weeks of Gestation

次要结局

  • embryo developmental rates(6 days of culture)
  • Ongoing pregnancy rate(16 weeks)
  • Clinical pregnancy rate(12 weeks)
  • biochemical pregnancy rate(two weeks)

研究者

发起方
Muhammad Fawzy
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Muhammad Fawzy

IVF Lab Director

Ibn Sina Hospital

研究点 (4)

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