Clinical trial NCT02683031: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Fertilization Arrest
Keywords: fertilization arrest
Cleavage failure
Embryonic development
Calcium ionophore
Lead sponsor: TopLab Company for ART Laboratories Consultation and Training
Sponsor class: OTHER
Collaborators: name: Benha University
First posted: 2016-02-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Blastocyst formation rate
timeFrame: 5 to 7days post oocyte retrival
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed el-Damen
Study officials:
affiliation: Dar Almaraa fertility and gynacology center
name: Yasmin Magdi, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Community Medicine, Faculty of Medicine, Benha University, Benha, Egypt
name: Mona M. Awady, MD
role: STUDY_CHAIR
References:
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.
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.
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.