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

Primary Purpose

Fertilization Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ca2+ ionophore
Sponsored by
TopLab Company for ART Laboratories Consultation and Training
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fertilization Arrest focused on measuring fertilization arrest, Cleavage failure, Embryonic development, Calcium ionophore

Eligibility Criteria

20 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ahmed el-DamenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Without Ca2+ ionophore

With Ca2+ ionophore

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Blastocyst formation rate
Defined as the total number of blastocyst / total number of cleaved Embryos

Secondary Outcome Measures

Full Information

First Posted
February 11, 2016
Last Updated
August 17, 2016
Sponsor
TopLab Company for ART Laboratories Consultation and Training
Collaborators
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT02683031
Brief Title
Effect of Ca2+ Ionophore on Embryonic Development and Clinical Outcome in Cases With Previous Fertilization Arrest
Official Title
A Prospective Randomized Controlled Trial Investigating Embryonic Development and Clinical Outcome After Using Ca2+ Ionophore in Cases With Previous Fertilization Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TopLab Company for ART Laboratories Consultation and Training
Collaborators
Benha University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertilization Arrest
Keywords
fertilization arrest, Cleavage failure, Embryonic development, Calcium ionophore

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Without Ca2+ ionophore
Arm Type
No Intervention
Arm Description
Patients with previous incomplete ICSI cycle due to fertilization arrest were counseled to underwent a subsequent conventional ICSI cycle.
Arm Title
With Ca2+ ionophore
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Ca2+ ionophore
Other Intervention Name(s)
A23187 Ca2+ ionophore
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blastocyst formation rate
Description
Defined as the total number of blastocyst / total number of cleaved Embryos
Time Frame
5 to 7days post oocyte retrival

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasmin Magdi, M.Sc
Phone
+201282313979
Email
Yas.magdi@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed El-Damen, M.Sc
Phone
+201002414342
Email
Ahmed_eldamen@Yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasmin Magdi, M.Sc
Organizational Affiliation
Dar Almaraa fertility and gynacology center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mona M. Awady, MD
Organizational Affiliation
Department of Community Medicine, Faculty of Medicine, Benha University, Benha, Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Ahmed el-Damen
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed El-Damen

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22921909
Citation
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.
Results Reference
background
PubMed Identifier
25596904
Citation
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.
Results Reference
background
PubMed Identifier
26507280
Citation
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.
Results Reference
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Effect of Ca2+ Ionophore on Embryonic Development and Clinical Outcome in Cases With Previous Fertilization Arrest

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