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Evaluation of the Effect of a Dietary Supplement Based on EGCG, Vitamin B12, Hyaluronic Acid, and Folic Acid on the Maintenance of Physiological Balance and the Natural Defenses of the Male Genital System in Subjects Exposed to HPV Infection.

NCT07344337 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-01-15

No results posted yet for this study

Summary

This is a randomized 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 and natural defenses of the male genital tract in subjects exposed to HPV infection and seeking care for infertility at natural procreation centers. The study includes 48 couples (96 participants) recruited at the International Scientific Institute "Paolo VI" of the A. Gemelli Policlinico, randomly assigned to two groups: 24 couples in which both partners receive one oral tablet per day of the supplement for 6 months, and 24 control couples receiving no supplementation. In addition to the primary objective, secondary outcomes assess potential support of sperm parameters, reproductive well-being of the couples, maintenance of genital mucosal physiological balance with possible reduction of HPV transmission risk to female partners, and support of physiological balance in the presence of co-infections or alterations of the genital microbiota.

Conditions

Interventions

DIETARY_SUPPLEMENT

Pervistop

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

Sponsors & Collaborators

  • Lo.Li.Pharma s.r.l

    collaborator INDUSTRY

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Domenico Milardi · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-09-30
Completion
2028-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07344337 on ClinicalTrials.gov