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

Last updated: December 13, 2016
Sponsor: Assiut University
Overall Status: Trial Status Unknown

Phase

2/3

Condition

Infertility

In Vitro Fertilization

Treatment

N/A

Clinical Study ID

NCT02992665
CaII
  • Ages 18-35
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Severe male factor infertility, Average response to COH,

Exclusion

Exclusion Criteria:

  • Poor responders,

Study Design

Total Participants: 100
Study Start date:
December 01, 2016
Estimated Completion Date:
December 31, 2017

Study 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.

Connect with a study center

  • Osama Abdalmageed

    Assiut, 71515
    Egypt

    Active - Recruiting

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