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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02992665
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
12
Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ca Ionophore A23187
  • Other: Placebo
 Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Can Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility?
Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ca ionophore

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

Drug: Ca Ionophore A23187
Sibling oocytes are to be randomized to artificially activated using Calcium ionophore in cases with severely compromized semen parameters
Other Names:
  • Ca ionophore

    		•
    Experimental: Placebo

    Placebo was used to control the group of Calcium ionophore

    Other: Placebo
    Placebo is used to control Ca ionophore group

    Outcome Measures

    Primary Outcome Measures

    1. Fertilization rate [18 hours after injecting the sperms in the oocytes]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Severe male factor infertility, Average response to COH,
    Exclusion Criteria:
    • Poor responders,

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Osama Abdalmageed Assiut Egypt 71515

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Osama Abdalmageed, Women health center, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Osama Saber Thabet Abdalmageed, Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity, Assiut University
    ClinicalTrials.gov Identifier:
    NCT02992665
    Other Study ID Numbers:
    • CaII
    First Posted:
    Dec 14, 2016
    Last Update Posted:
    Dec 14, 2016
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Osama Saber Thabet Abdalmageed, Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity, Assiut University
    Calcium ionophore
    Fertilization
    Sperm
    Oocyte
    ICSI
    Additional relevant MeSH terms:
    Infertility
    Ionophores

    Study Results

    No Results Posted as of Dec 14, 2016