Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06106412
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-10-23
Brief Title:
Efficacy of Oocyte Activation With Two Types of Ca2 Ionophore
Sponsor:
Instituto Valenciano de Infertilidad IVI VALENCIA
Organization:
Instituto Valenciano de Infertilidad IVI VALENCIA
Study Overview
Official Title:
Efficacy of Oocyte Activation With Two Types of Ca2 Ionophore a Prospective Randomized Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Calcifer
Brief Summary:
This study is a prospective ranzomized analysis including 372 human oocytes from 44 women Half of the oocytes from the same patient will be randomly allocated to induce oocyte activation using two protocols in protocol nº 1 we will use ionomycin prepared solution protocol nª2 A23187 GM508 CultActive Gynemed will be applied Non treated oocytes will serve as control Oocyte fertilization rates embryo development and embryo quality will be analyzed Obstetrics variables of offspring will be also followed and compared
Detailed Description:
Background Oocyte non-activation OAD is the main cause of fertilization failure in intracytoplasmic sperm injection ICSI cycles Oocyte activation involves a series of consecutive events that take place in the oocyte during fertilization triggered by the action of sperm-specific phospholipase C zeta PLCz that causes an increase in the amount of free Ca2 This increase as well as its transient elevations in space and time is species-specific Defects in this pattern of Ca2 release and oscillation are attributed to most cases of OAD Several strategies have been described and applied to achieve artificial oocyte activation AOA which use mechanical electrical or chemical stimuli among which the use of calcium ionophores such as ionomycin and A23187 calcimycin predominates Documented fertilization and pregnancy rates appear to be improved in patients with previous low fertilization rates or total fertilization failures after using ICSI-AOA compared to conventional ICSI However the lack of well-designed studies the heterogeneity of the population undergoing AOA and the scarcity of results comparing different AOA protocols make it difficult to assess the clinical efficacy and safety of the technique
Study question In patients with prior fertilization failure or low fertilization rates 30 or less does AOA improve reproductive outcomes compared to conventional ICSI in patients with prior fertilization failure and if it does which protocol is more efficient
Study question In patients with prior fertilization failure or low fertilization rates 30 or less does AOA improve reproductive outcomes compared to conventional ICSI in patients with prior fertilization failure and if it does which protocol is more efficient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None