Effect of a Dietary Supplement Containing EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid in Supporting Male Genital Balance in Subjects Exposed to HPV Risk

Pilot interventional study aimed at evaluating the effect of a dietary supplement containing EGCG, vitamin B12, hyaluronic acid, and folic acid on the maintenance of physiological balance of the genital mucosa and natural defenses of the male genital tract, as well as on the maintenance of HPV-DNA test negativity, in subjects undergoing natural procreation pathways. The study will also assess the potential support of sperm parameters, reproductive well-being of the couple, and the reduction of risk factors associated with HPV transmission to the female partner. A total of 34 HPV-positive couples attending the Istituto Scientifico Internazionale "Paolo VI" of the Policlinico A. Gemelli will be enrolled and randomized into two groups: 17 couples in the intervention group, in which the male partner will receive the supplement (EGCG 200 mg, vitamin B12 1 mg, hyaluronic acid 50 mg, folic acid 400 μg, one tablet daily for 6 months), and 17 couples in the control group with no supplementation.

NCT Number	NCT07320183
Lead Sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS Collaborators: Lo.Li.Pharma s.r.l
Conditions	HPV - Anogenital Human Papilloma Virus Infection, Infertilities
Enrollment	96 participants
Start Date	2026-03-01
Primary Completion	2027-09 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2026-01-08