跳至主要内容
临床试验/NCT02992665
NCT02992665Unknown2 期

Can Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility?

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
100
试验地点
1
主要终点
Fertilization rate

研究概览

简要总结

The purpose of this study is to determine the impact of the use of calcium ionophore on the ICSI outcomes in couples with severe male factor infertility. Investigators conduct a randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in these cases.

详细描述

Elevation of calcium levels inside the oocyte is one of the most initial steps which takes place during normal fertilization (1). The interaction between the sperm and oocytes surface protein receptors may be the triggering event for oocyte activation during the process of fertilization (2). It is suggested that the process of intracellular Calcium elevation is triggered by binding of the sperm to the oocyte oolemma and hence the fertilization starts (3). Severe male factor couples might have compromised fertilization and pregnancy outcomes (4).

A prospective multicenter non-randomized study indicated that calcium ionophore could improve the fertilization as well as the clinical pregnancy rates in these patients (5). On the other hand, a randomized controlled trial did not find any significance for the use of calcium ionophore in the couples with poor ovarian reserve with regards the fertilization and clinical pregnancy rates (6). The purpose of this study is to determine the impact of the use of calcium ionophore on the ICSI outcomes in couples with severe male factor infertility. Investigators conduct a randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in these cases.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Severe male factor infertility, Average response to COH,

排除标准

  • Poor responders,

研究组 & 干预措施

Ca ionophore

Experimental

Artificial activation of the oocytes using Calcium ionophore in the cases of severe male factor infertility.

干预措施: Ca Ionophore A23187 (Drug)

Placebo

Experimental

Placebo was used to control the group of Calcium ionophore

干预措施: Placebo (Other)

结局指标

主要结局

Fertilization rate

时间窗: 18 hours after injecting the sperms in the oocytes

次要结局

未报告次要终点

研究者

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

Osama Saber Thabet Abdalmageed

Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity

Assiut University

研究点 (1)

Loading locations...

相似试验