NCT02992665

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 14, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

December 11, 2016

Last Update Submit

December 13, 2016

Conditions

In Vitro FertilizationMale Factor Infertility

Keywords

Calcium ionophoreFertilizationSpermOocyteICSI

Outcome Measures

Primary Outcomes (1)

  • Fertilization rate

    18 hours after injecting the sperms in the oocytes

Study Arms (2)

Ca ionophore

EXPERIMENTAL

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

Drug: Ca Ionophore A23187

Placebo

EXPERIMENTAL

Placebo was used to control the group of Calcium ionophore

Other: Placebo

Interventions

Ca Ionophore A23187DRUG

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

Also known as: Ca ionophore
Ca ionophore
PlaceboOTHER

Placebo is used to control Ca ionophore group

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Severe male factor infertility, Average response to COH,

You may not qualify if:

  • Poor responders,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osama Abdalmageed

Asyut, Asyut Governorate, 71515, Egypt

RECRUITING

Study Officials

  • Osama Abdalmageed

    Women health center, Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Osama Abdalmageed

CONTACT

drosamast1981@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity

Study Record Dates

First Submitted

December 11, 2016

First Posted

December 14, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 14, 2016

Record last verified: 2016-12

Locations

EG(1)