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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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In Vitro Fertilization, Male Factor Infertility

Intervention / Treatment
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* Drug: Ca Ionophore A23187
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe male factor infertility, Average response to COH, Exclusion Criteria: Poor responders,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ca ionophore<br>Artificial activation of the oocytes using Calcium ionophore in the cases of severe male factor infertility. | Drug: Ca Ionophore A23187<br>* Sibling oocytes are to be randomized to artificially activated using Calcium ionophore in cases with severely compromized semen parameters<br>* Other names: Ca ionophore;|
| Experimental: Placebo<br>Placebo was used to control the group of Calcium ionophore | Other: Placebo<br>* Placebo is used to control Ca ionophore group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate |  | 18 hours after injecting the sperms in the oocytes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcium ionophore, Fertilization, Sperm, Oocyte, ICSI