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

NCT ID: NCT07320183

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2028-03-31

Brief Summary

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.

Detailed Description

This pilot, randomized interventional study aims to assess the effect of a dietary supplement containing epigallocatechin gallate (EGCG), vitamin B12, hyaluronic acid, and folic acid on the maintenance of physiological balance and natural defenses of the male genital tract in men with HPV infection attending natural procreation centers. The study also seeks to evaluate whether supplementation may support sperm quality, improve reproductive well-being of participating couples, and reduce risk factors associated with HPV transmission to the female partner.

A total of 48 couples (96 participants) will be enrolled at the Istituto Scientifico Internazionale "Paolo VI" of the Policlinico A. Gemelli. Eligible couples, characterized by an HPV-positive male partner and an HPV-negative female partner, will be randomized into two groups: a supplement group, in which both partners will receive oral supplementation with EGCG (200 mg), vitamin B12 (1 mg), hyaluronic acid (50 mg), and folic acid (400 μg) once daily for 6 months, and a control group receiving no supplementation. Randomization will be performed using a computer-generated list.

The primary endpoint is the proportion of male participants achieving a negative HPV DNA test at the end of the 6-month intervention period. Secondary endpoints include changes in sperm quality parameters assessed by semen analysis according to WHO 2021 guidelines, measures of reproductive outcomes such as fertility potential and achievement of pregnancy, and maintenance of genital mucosal health, including absence of infections or recurrences and reduced risk of HPV transmission. HPV genotyping will be assessed by PCR on urethral swab samples. The overall study duration is expected to be 18 months following ethics committee approval.

Conditions

HPV - Anogenital Human Papilloma Virus Infection; Infertilities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patients taking Pervistop

24 couples in which both partners will receive a supplement containing EGCG (200 mg), vitamin B12 (1 mg), hyaluronic acid (50 mg), and folic acid (400 μg), one tablet daily orally for 6 month

Group Type: EXPERIMENTAL

pervistop

Intervention Type: DIETARY_SUPPLEMENT

combination of EGCG, vitamin B12, hyaluronic acid, and folic acid

Patients no taking Pervistop

24 couples with no supplementation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

pervistop

combination of EGCG, vitamin B12, hyaluronic acid, and folic acid

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Signed informed consent
• Couple seeking pregnancy
• Male partner aged 25-65 years
• HPV DNA test indicating active HPV infection in the male partner
• HPV DNA test indicating negativity for HPV infection in the female partner

Exclusion Criteria

• Concomitant diseases causing immunosuppression
• Treatment with immunomodulatory therapies
• Use of EGCG or other green tea extracts

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lo.Li.Pharma s.r.l

INDUSTRY

Sponsor Role: collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Domenico Milardi

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Central Contacts

Domenico Milardi

Role: CONTACT

domenico.milardi@policlinicogemelli.it

3394826008

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Other Identifiers

8299

Identifier Type: -

Identifier Source: org_study_id