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

Fertilization Arrest Clinical Trial

Official title:

A Prospective Randomized Controlled Trial Investigating Embryonic Development and Clinical Outcome After Using Ca2+ Ionophore in Cases With Previous Fertilization Arrest

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02683031
• Other study ID #: #0010010
• Status: Recruiting
• Phase: N/A
• First received: February 11, 2016
• Last updated: August 17, 2016
• Start date: May 2014
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: TopLab Company for ART Laboratories Consultation and Training
• Contact: Yasmin Magdi, M.Sc
• Phone: +201282313979
• Email: Yas.magdi[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fertilization Arrest
• Heart Arrest

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ahmed el-Damen	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
TopLab Company for ART Laboratories Consultation and Training	Benha University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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 — View Citation

Ebner T, Köster 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. — View 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, Krüssel J, Maxrath B, Gnoth C, Friol K, Tigges J, Wünsch 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blastocyst formation rate	Defined as the total number of blastocyst / total number of cleaved Embryos	5 to 7days post oocyte retrival	No