Clinical Trials

Multiple clinical trials evaluate ionomycin calcium in reproductive medicine, focusing on female and male infertility, intracytoplasmic sperm injection, preimplantation genetic testing for aneuploidies, and testicular sperm extraction in azoospermic patients. Sponsored by hospital networks and clinical centers, these predominantly non-applicable phase trials assess the compound's utility as an oocyte activation agent or handling medium to improve fertilization outcomes. The current research landscape spans completed, upcoming, and active or unverified recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07570342 NOT_YET_RECRUITING
ICSI; Testicular Sperm Extraction in Azoospermic Patients; Male Infertility; PGT-A
ART Fertility Clinics LLC
 2026-04-30
NCT06106412 UNKNOWN
Infertility, Female
Instituto Valenciano de Infertilidad, IVI VALENCIA
 2024-01-01
NCT03678610 COMPLETED
Infertility
Ibn Sina Hospital
 2018-09-25

(data from https://clinicaltrials.gov, updated on 2026-05-11)

Check the Ionomycin calcium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ionomycin calcium acts as a selective divalent cation ionophore that binds calcium ions and transports them across biological cell membranes, thereby inducing intracellular calcium influx, phosphoinositide hydrolysis, and protein kinase C activation. This elevation of cytosolic calcium triggers downstream cellular responses including T-cell proliferation and artificial oocyte activation, supporting its clinical utility in improving fertilization success during intracytoplasmic sperm injection for male and female infertility.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.