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临床试验/NCT02418416
NCT02418416已完成不适用

Calcium Ionophore Together With Strontium Chloride Would Likely Have a Positive But Non-traumatic Impact on Human Embryo Development

Ibn Sina Hospital4 个研究点 分布在 2 个国家目标入组 400 人开始时间: 2015年5月6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
400
试验地点
4
主要终点
Clinical Pregnancy rate ( % )

研究概览

简要总结

Novel approach for Oocyte fertilization failure for difficult cases not respond to traditional methods of assisted reproduction as intracytoplasmic sperm injection.

详细描述

In some cases undergoes assisted reproduction technique specially Intracytoplasmic sperm injection, in subgroup of patient they fail to fertilize or poorly fertilized, some authors recommend chemical activation for those group of patient with Ca ionophore but still with Ca ionophore there are some cases with total fertilization failure or low fertilization specially in those patient with 2 separate factors like teratozoospermia with poor quality Oocytes so the investigators decided to test the effect of double activation methods by using tow agents proven with life birth rate Ca ionophore and strontium chloride.

We Do intracytoplasmic sperm injection and immediately activate oocyte with Ca Ionophore followed by strontium chloride activation and monitoring the embryogenesis until the blastocyst formation and pregnancy outcome in multicenter assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • poor sperm
  • poor quality Oocytes
  • previous failed fertilization
  • previous poor embryogenesis

排除标准

  • normal patient
  • previous successful outcome

研究组 & 干预措施

Double activation

Experimental

The Oocytes in this arm will undergo double activation with Ca ionophore 5 micro mol for 20 min them Strontium chloride 10 micro mol for 60 min.

干预措施: Oocyte double chemical activation (Other)

Control arm

No Intervention

The Oocytes will undergo Intracytoplasmic sperm injection only

结局指标

主要结局

Clinical Pregnancy rate ( % )

时间窗: 3 months

To predict percentage of pregnant women from those will undergo Embryo transfer

次要结局

  • Blastocyst rate ( % )(3 months)

研究者

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

Muhammad Fawzy

IVF Laboratory Director

Ibn Sina Hospital

研究点 (4)

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