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

In Vitro Fertilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02992665
• Other study ID #: CaII
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 11, 2016
• Last updated: December 13, 2016
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Assiut University
• Contact: Osama Abdalmageed
• Email: drosamast1981[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Severe male factor infertility, Average response to COH,

Exclusion Criteria:

• Poor responders,

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• In Vitro Fertilization
• Infertility
• Male Factor Infertility

Intervention

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

Locations

Country	Name	City	State
Egypt	Osama Abdalmageed	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertilization rate		18 hours after injecting the sperms in the oocytes	Yes