About this trial
This study aims to investigate the effectiveness and safety of assisted oocyte activation (AOA) using Ca²⁺ ionophores in cases of total fertilization failure (TFF) due to oocyte activation deficiency (OAD). The study will be conducted in two phases: Phase I will compare the fertilization rates of oocytes exposed to two types of Ca²⁺ ionophore treatments- Ionomycin solution and commercially available CultActive-against a control group without calcium ionophore treatment. Phase II will assess whether an additional injection of CaCl2, prior to exposure to the chosen ionophore from Phase I, further improves fertilization outcomes. The goal is to identify the optimal AOA protocol for improving fertilization rates and to evaluate the safety and efficacy of this approach in relation to ploidy, with a focus on ensuring normal pre-implantation embryo development.
Eligibility criteria
Qualifiers
Patients undergoing assisted reproductive technology cycles when ICSI is indicated.
Patients with a minimum of 3 MII oocytes after denudation.
Maternal age 18-43 years old.
PGT-A cycles with only trophectoderm biopsies on day 5/6/7.
Disqualifiers
PGT-M/SR cycles.
Fresh and frozen motile ejaculated / FNA sperm.
IVF inseminated oocytes.
Trial design
Treatments tested in this trial
- Group 1: Oocyte Activation (OA) CultActive
- Group 2: Oocyte Activation (OA) Ionomycin
- Group 3: Control