An interventional study of Ionomycin SIGMA and A23187 in Infertility, Female, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Recruiting at 1 site in Spain. Open to female participants. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Not applicable, Interventional, and Treatment
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.
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?
552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.
This study's planned enrollment of 44 is below the median of 100 across 378 interventional studies indexed under Infertility, Female.
Browse Infertility, Female studies →Instituto Valenciano de Infertilidad, IVI VALENCIA is the lead sponsor of 72 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
The oocytes obtained from the patients allocated to this group will be subdivided again in two groups Group 1a: Oocytes treated with SIGMA ionomycin (treatment). Group 1b: Oocytes that will not be treated with any activator (Control).
Drug: Ionomycin SIGMA
The oocytes obtained from the patients allocated to this group will be subdivided again in two groups Group 2a: Oocytes treated with A23187 (treatment). Group 2b: Oocytes that will not be treated with any activator (Control).
Drug: A23187
Oocytes will be activated with Ionomycin SIGMA
Oocytes will be activated with A23187
Improvement in the percetage of usable blastocyst per injeected oocyte
To evaluate which AOA protocol with the use of two calcium (Ca2+) ionophores, ionomycin and A23187 (calcimycin), is better (improvement from 15% to 25%)
Time frame: 1 YEAR
Sequencing unfertilized oocytes and arrested embryos using RNAseq
To quantify sequenced oocytes and arrested embryos after using RNAseq
Time frame: 1 year
Quantification of PLCZ in sperm cells by flow
To quantify PLCZ in sperm
Time frame: 1 year
Started Jan 2024 (actual). Primary completion is estimated for Dec 2024, 11 months after the start.
Of 141 non-industry interventional studies with no phase under Infertility, Female, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 11 months is below that.
Counting every sponsor, half of 155 studies reached it within 23 months; a quarter within 9 and three quarters within 41.
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Instituto Valenciano de Infertilidad, IVI VALENCIA