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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

Qualifiers

Signed informed consent

Couple seeking pregnancy

Male partner aged 25-65 years

HPV DNA test indicating active HPV infection in the male partner

Disqualifiers

Concomitant diseases causing immunosuppression

Treatment with immunomodulatory therapies

Use of EGCG or other green tea extracts

Trial design

Treatments tested in this trial

  • pervistop

Treatment groups

96 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators