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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02683031
Recruitment Status : Recruiting
First Posted : February 17, 2016
Last Update Posted : August 18, 2016
Benha University
Information provided by (Responsible Party):
Yasmin Magdi, Dar AlMaraa Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fertilization Arrest Other: Ca2+ ionophore Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial Investigating Embryonic Development and Clinical Outcome After Using Ca2+ Ionophore in Cases With Previous Fertilization Arrest
Study Start Date : May 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
No Intervention: Without Ca2+ ionophore
Patients with previous incomplete ICSI cycle due to fertilization arrest were counseled to underwent a subsequent conventional ICSI cycle.
Experimental: 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.
Other: 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.
Other Name: A23187 Ca2+ ionophore

Primary Outcome Measures :
  1. Blastocyst formation rate [ Time Frame: 5 to 7days post oocyte retrival ]
    Defined as the total number of blastocyst / total number of cleaved Embryos

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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02683031

Contact: Yasmin Magdi, M.Sc +201282313979
Contact: Ahmed El-Damen, M.Sc +201002414342

Ahmed el-Damen Recruiting
Cairo, Egypt
Contact: Ahmed El-Damen         
Sponsors and Collaborators
TopLab Company for ART Laboratories Consultation and Training
Benha University
Principal Investigator: Yasmin Magdi, M.Sc Dar Almaraa fertility and gynacology center
Study Chair: Mona M. Awady, MD Department of Community Medicine, Faculty of Medicine, Benha University, Benha, Egypt

Publications of Results:
Other Publications:
Responsible Party: Yasmin Magdi, Senior clinical embryologist, Dar AlMaraa Center Identifier: NCT02683031     History of Changes
Other Study ID Numbers: #0010010
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yasmin Magdi, Dar AlMaraa Center:
fertilization arrest
Cleavage failure
Embryonic development
Calcium ionophore

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action