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 (PERVI-M)

January 7, 2026 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Dietary supplement: pervistop
combination of EGCG, vitamin B12, hyaluronic acid, and folic acid
No Intervention: Patients no taking Pervistop
24 couples with no supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative HPV-DNA test
Time Frame: 6 months
Proportion of participants with a negative HPV DNA test at the end of the study
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Lo.Li.Pharma s.r.l

Investigators

  • Principal Investigator: Domenico Milardi, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Estimated)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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