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

Phase 2

• Conditions: In Vitro Fertilization; Male Factor Infertility
• Interventions: Drug: Ca Ionophore A23187; Other: Placebo

• Registration Number: NCT02992665
• Lead Sponsor: Assiut University

Brief 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.

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-11
• Study First Submitted QC: 2016-12-13
• Last Update Submitted: 2016-12-13
• Study First Posted: 2016-12-14
• Last Update Posted: 2016-12-14
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Severe male factor infertility, Average response to COH,

Exclusion Criteria

• Poor responders,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ca ionophore	Ca Ionophore A23187	Artificial activation of the oocytes using Calcium ionophore in the cases of severe male factor infertility.
Placebo	Placebo	Placebo was used to control the group of Calcium ionophore

Primary Outcome Measures

Name	Time	Method
Fertilization rate	18 hours after injecting the sperms in the oocytes

Trial Locations

Locations (1)

Osama Abdalmageed; 🇪🇬 Assiut, Egypt