Levomefolic acid Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

A Phase 3 clinical trial sponsored by an academic medical institution, the University Hospital of Lille, is currently recruiting participants to evaluate the therapeutic utility of levomefolic acid in reproductive medicine. The study investigates the impact of nutritional supplementation during clomiphene citrate-induced ovulation in women diagnosed with polycystic ovary syndrome. Ultimately, researchers aim to determine whether optimizing folate-dependent metabolic pathways improves fertility outcomes in this patient population.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03059173	RECRUITING	Polycystic Ovary Syndrome; Reproductive Medicine	University Hospital, Lille	2023-09-12	PHASE3

(data from https://clinicaltrials.gov, updated on 2026-04-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Levomefolic acid functions as an essential coenzyme and methyl donor in one-carbon metabolism, enabling the remethylation of homocysteine to methionine and supporting purine and pyrimidine nucleotide biosynthesis. By facilitating cellular methylation capacity and reducing metabolic accumulation, it maintains DNA synthesis and cellular integrity, which plays a critical role in optimizing reproductive medicine outcomes and managing metabolic imbalances in polycystic ovary syndrome.

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>).