NCT02992665

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• In Vitro Fertilization
• Male Factor Infertility

Interventions

Type	Name	Description
DRUG	Ca Ionophore A23187	Sibling oocytes are to be randomized to artificially activated using Calcium ionophore in cases with severely compromized semen parameters
OTHER	Placebo	Placebo is used to control Ca ionophore group

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-12-14
• Last updated: 2016-12-14

Locations

1 site across 1 country: Egypt