Back to resultsCan Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility?
Primary Purpose
In Vitro Fertilization, Male Factor Infertility
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Ca Ionophore A23187
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for In Vitro Fertilization focused on measuring Calcium ionophore, Fertilization, Sperm, Oocyte, ICSI
Eligibility Criteria
Inclusion Criteria:
- Severe male factor infertility, Average response to COH,
Exclusion Criteria:
- Poor responders,
Sites / Locations
- Osama AbdalmageedRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ca ionophore
Placebo
Arm Description
Artificial activation of the oocytes using Calcium ionophore in the cases of severe male factor infertility.
Placebo was used to control the group of Calcium ionophore
Outcomes
Primary Outcome Measures
Fertilization rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02992665
Brief Title
Can Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility?
Official Title
Can Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
In Vitro Fertilization, Male Factor Infertility
Keywords
Calcium ionophore, Fertilization, Sperm, Oocyte, ICSI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ca ionophore
Arm Type
Experimental
Arm Description
Artificial activation of the oocytes using Calcium ionophore in the cases of severe male factor infertility.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo was used to control the group of Calcium ionophore
Intervention Type
Drug
Intervention Name(s)
Ca Ionophore A23187
Other Intervention Name(s)
Ca ionophore
Intervention Description
Sibling oocytes are to be randomized to artificially activated using Calcium ionophore in cases with severely compromized semen parameters
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo is used to control Ca ionophore group
Primary Outcome Measure Information:
Title
Fertilization rate
Time Frame
18 hours after injecting the sperms in the oocytes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe male factor infertility, Average response to COH,
Exclusion Criteria:
Poor responders,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Osama Abdalmageed
Email
drosamast1981@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama Abdalmageed
Organizational Affiliation
Women health center, Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osama Abdalmageed
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama Abdalmageed
Phone
1007972027
Email
drosamast@yahoo.com.au
First Name & Middle Initial & Last Name & Degree
Osama Abdalmageed
Phone
1007972027
Ext
Abdalmageed
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
According to the patient agreement.
Learn more about this trial
Can Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility?
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