Can Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility?
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
- 否
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
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
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
Osama Saber Thabet Abdalmageed
Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity
Assiut University
