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

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ClinicalTrials.gov Identifier: NCT02992665
Recruitment Status : Unknown
Verified December 2016 by Osama Saber Thabet Abdalmageed, Assiut University.
Recruitment status was:  Recruiting
First Posted : December 14, 2016
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Osama Saber Thabet Abdalmageed, Assiut University

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
In Vitro Fertilization Male Factor Infertility 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 Type : Interventional  (Clinical Trial)
Estimated 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 : December 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Infertility

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 Name: Ca ionophore

Experimental: Placebo
Placebo was used to control the group of Calcium ionophore
Other: Placebo
Placebo is used to control Ca ionophore group




Primary Outcome Measures :
  1. Fertilization rate [ Time Frame: 18 hours after injecting the sperms in the oocytes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe male factor infertility, Average response to COH,

Exclusion Criteria:

  • Poor responders,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992665


Contacts
Contact: Osama Abdalmageed drosamast1981@gmail.com

Locations
Egypt
Osama Abdalmageed Recruiting
Assiut, Egypt, 71515
Contact: Osama Abdalmageed    1007972027    drosamast@yahoo.com.au   
Contact: Osama Abdalmageed    1007972027 ext Abdalmageed      
Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: Osama Abdalmageed Women health center, Assiut University

Responsible Party: Osama Saber Thabet Abdalmageed, Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity, Assiut University
ClinicalTrials.gov Identifier: NCT02992665     History of Changes
Other Study ID Numbers: CaII
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: According to the patient agreement.

Keywords provided by Osama Saber Thabet Abdalmageed, Assiut University:
Calcium ionophore
Fertilization
Sperm
Oocyte
ICSI

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Calcium, Dietary
Ionophores
Calcium Ionophores
Bone Density Conservation Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action