Comparison of Two Types of Calcium (Ca²⁺) Ionophore Treatments for Oocyte Activation in Cases of Suboptimal Fertilization Potential

Starting soon · Not applicable

Conditions studied: ICSI, Testicular Sperm Extraction in Azoospermic Patients, Male Infertility, PGT-A

In brief

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.

Key facts

Study ID

NCT07570342

Run by

ART Fertility Clinics LLC

People needed

20

Starts

2026-04-30

Expected to finish

2026-12-31

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older, up to 43. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.
• BMI<35.
• Fresh and frozen immotile ejaculated sperm.
• Fresh and frozen TESE sperm (motile and immotile).
• Globozoospermia.
• Couples undergoing ICSI due to poor fertilization history (≤30%), or previous fertilization failure.

You may not qualify if…

• PGT-M/SR cycles.
• Fresh and frozen motile ejaculated / FNA sperm.
• IVF inseminated oocytes.

Full record on ClinicalTrials.gov

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