Effect of Ca2+ Ionophore on Embryonic Development and Clinical Outcome in Cases With Previous Fertilization Arrest

NCT ID: NCT02683031

Last Updated: 2016-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-12-31

Brief Summary

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We aimed to investigate the efficiency of chemical oocyte activation using readymade Ca2+ ionophore on cases with previously cancelled cases due to fertilization arrest at pronuclear stage i.e: cleavage failure to find out if there is any improvement in embryonic developmental stages.

Detailed Description

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Many studies reported that Ca2+ ionophore has a positive effect on embryo development in cases with complete or partial fertilization failure. However, only one preliminary report suggested a beneficial effect of Ca2+ ionophore activation in four cases with fertilization arrest.

Conditions

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Fertilization Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Without Ca2+ ionophore

Patients with previous incomplete ICSI cycle due to fertilization arrest were counseled to underwent a subsequent conventional ICSI cycle.

Group Type NO_INTERVENTION

No interventions assigned to this group

With Ca2+ ionophore

Patients with previous incomplete ICSI cycle due to fertilization arrest were counseled to underwent a subsequent ICSI cycle combined with artificial oocyte activation using Ca2+ ionophore.

Group Type EXPERIMENTAL

Ca2+ ionophore

Intervention Type OTHER

Ca2+ ionophore is a chemical agent used to perform oocyte activation after ICSI. It showed effective treatment to get better fertilization, pregnancy, and healthy livebirth in cases with total or partial fertilization failure.

Interventions

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Ca2+ ionophore

Ca2+ ionophore is a chemical agent used to perform oocyte activation after ICSI. It showed effective treatment to get better fertilization, pregnancy, and healthy livebirth in cases with total or partial fertilization failure.

Intervention Type OTHER

Other Intervention Names

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A23187 Ca2+ ionophore

Eligibility Criteria

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Inclusion Criteria

* Patients with previous history of complete fertilization arrest.
* ovarian stimulation with the GnRH agonist and recombinant FSH in a long protocol.

Exclusion Criteria

* Female age \>40 years
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role collaborator

TopLab Company for ART Laboratories Consultation and Training

OTHER

Sponsor Role lead

Responsible Party

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Yasmin Magdi

Senior clinical embryologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasmin Magdi, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Dar Almaraa fertility and gynacology center

Mona M. Awady, MD

Role: STUDY_CHAIR

Department of Community Medicine, Faculty of Medicine, Benha University, Benha, Egypt

Locations

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Ahmed el-Damen

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Yasmin Magdi, M.Sc

Role: CONTACT

+201282313979

Ahmed El-Damen, M.Sc

Role: CONTACT

+201002414342

Facility Contacts

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Ahmed El-Damen

Role: primary

References

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Ebner T, Koster M, Shebl O, Moser M, Van der Ven H, Tews G, Montag M. Application of a ready-to-use calcium ionophore increases rates of fertilization and pregnancy in severe male factor infertility. Fertil Steril. 2012 Dec;98(6):1432-7. doi: 10.1016/j.fertnstert.2012.07.1134. Epub 2012 Aug 24.

Reference Type BACKGROUND
PMID: 22921909 (View on PubMed)

Ebner T, Montag M; Oocyte Activation Study Group; Montag M, Van der Ven K, Van der Ven H, Ebner T, Shebl O, Oppelt P, Hirchenhain J, Krussel J, Maxrath B, Gnoth C, Friol K, Tigges J, Wunsch E, Luckhaus J, Beerkotte A, Weiss D, Grunwald K, Struller D, Etien C. Live birth after artificial oocyte activation using a ready-to-use ionophore: a prospective multicentre study. Reprod Biomed Online. 2015 Apr;30(4):359-65. doi: 10.1016/j.rbmo.2014.11.012. Epub 2014 Dec 9.

Reference Type BACKGROUND
PMID: 25596904 (View on PubMed)

Darwish E, Magdi Y. A preliminary report of successful cleavage after calcium ionophore activation at ICSI in cases with previous arrest at the pronuclear stage. Reprod Biomed Online. 2015 Dec;31(6):799-804. doi: 10.1016/j.rbmo.2015.08.012. Epub 2015 Aug 28.

Reference Type RESULT
PMID: 26507280 (View on PubMed)

Other Identifiers

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#0010010

Identifier Type: -

Identifier Source: org_study_id

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