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

NCT ID: NCT02992665

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-12-31

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.

Conditions

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In Vitro Fertilization Male Factor Infertility

Keywords

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Calcium ionophore Fertilization Sperm Oocyte ICSI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ca ionophore

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

Group Type EXPERIMENTAL

Ca Ionophore A23187

Intervention Type DRUG

Sibling oocytes are to be randomized to artificially activated using Calcium ionophore in cases with severely compromized semen parameters

Placebo

Placebo was used to control the group of Calcium ionophore

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Placebo is used to control Ca ionophore group

Interventions

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Ca Ionophore A23187

Sibling oocytes are to be randomized to artificially activated using Calcium ionophore in cases with severely compromized semen parameters

Intervention Type DRUG

Placebo

Placebo is used to control Ca ionophore group

Intervention Type OTHER

Other Intervention Names

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Ca ionophore

Eligibility Criteria

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Inclusion Criteria

* Severe male factor infertility, Average response to COH,

Exclusion Criteria

* Poor responders,
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Osama Saber Thabet Abdalmageed

Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osama Abdalmageed

Role: PRINCIPAL_INVESTIGATOR

Women health center, Assiut University

Locations

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Osama Abdalmageed

Asyut, Asyut Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Osama Abdalmageed

Role: CONTACT

Email: [email protected]

Facility Contacts

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Osama Abdalmageed

Role: primary

Osama Abdalmageed

Role: backup

Other Identifiers

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CaII

Identifier Type: -

Identifier Source: org_study_id