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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02992665
Enrollment
100
Registered
2016-12-14
Start date
2016-12-31
Completion date
2017-12-31
Last updated
2016-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In Vitro Fertilization, Male Factor Infertility

Keywords

Calcium ionophore, Fertilization, Sperm, Oocyte, ICSI

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.

Interventions

DRUGCa Ionophore A23187

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

OTHERPlacebo

Placebo is used to control Ca ionophore group

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

* Severe male factor infertility, Average response to COH,

Exclusion criteria

* Poor responders,

Design outcomes

Primary

MeasureTime frame
Fertilization rate18 hours after injecting the sperms in the oocytes

Countries

Egypt

Contacts

Primary ContactOsama Abdalmageed
drosamast1981@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026