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 | Not Yet Recruiting

• 1 other identifier: 8298
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief 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

HPV Infection; Infertilities

Keywords

HPV; INFERTILITY

Outcome Measures

Primary Outcomes (1)

• The aim of the study is to evaluate the effect of a combination of EGCG, vitamin B12, hyaluronic acid, and folic acid on the maintenance of physiological balance and natural defense mechanisms of the male genital tract in subjects who, due to infertility

  The aim is to ensure continued HPV test negativity in the male partner throughout the six-month course of Pervistop therapy. The presence of the viral genotype will be determined by urethral swab sampling, followed by gene amplification using polymerase chain reaction (PCR) methodology.

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Patients taking Pervistop

EXPERIMENTAL

24 couples in which both partners will be treated with a combination of EGCG (200 mg), vitamin B12 (1 mg), hyaluronic acid (50 mg), and folic acid (400 µg), administered orally as one tablet once daily for 6 months.

Dietary Supplement: Pervistop

Patients NO taking Pervistop

NO INTERVENTION

24 couples who will not receive any supplementation

Interventions

Pervistop DIETARY_SUPPLEMENT

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

Patients taking Pervistop

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Lo.Li.Pharma s.r.l: collaborator

Related Publications (41)

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MeSH Terms

Conditions

Papillomavirus Infections; Infertility

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Domenico Milardi

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Domenico Milardi

CONTACT

3394826008; domenico.milardi@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 15, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share