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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
pervistop
Dietary supplementcombination of EGCG, vitamin B12, hyaluronic acid, and folic acid
Treatment groups
Trial outcomes
Primary outcomes
Negative HPV-DNA test
Proportion of participants with a negative HPV DNA test at the end of the study
Locations
Sponsors and contacts
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead sponsor
Lo.Li.Pharma s.r.l
Collaborator
This trial is not recruiting at the moment. You can still explore other options: