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

Assiut University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: In Vitro Fertilization; Male Factor Infertility

Treatments: Other: Placebo; Drug: Ca Ionophore A23187

Study type: Interventional

Funder types: Other

Identifiers

NCT02992665

CaII

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe male factor infertility, Average response to COH,

Exclusion criteria

• Poor responders,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Ca ionophore

Experimental group

Description:

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

Treatment:

Drug: Ca Ionophore A23187

Placebo

Experimental group

Description:

Placebo was used to control the group of Calcium ionophore

Treatment:

Other: Placebo