Can Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility?
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|ClinicalTrials.gov Identifier: NCT02992665|
Recruitment Status : Recruiting
First Posted : December 14, 2016
Last Update Posted : December 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|In Vitro Fertilization Male Factor Infertility||Drug: Ca Ionophore A23187 Other: Placebo||Phase 2 Phase 3|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
Placebo was used to control the group of Calcium ionophore
Placebo is used to control Ca ionophore group
- Fertilization rate [ Time Frame: 18 hours after injecting the sperms in the oocytes ]
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
|Contact: Osama Abdalmageedemail@example.com|
|Assiut, Egypt, 71515|
|Contact: Osama Abdalmageed 1007972027 firstname.lastname@example.org|
|Contact: Osama Abdalmageed 1007972027 ext Abdalmageed|
|Principal Investigator:||Osama Abdalmageed||Women health center, Assiut University|