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.
NCT ID: NCT07344337
Last Updated: 2026-01-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
96 participants
Study Classification
INTERVENTIONAL
Study Start Date
2026-03-31
Study Completion Date
2028-03-31
Brief Summary
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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.
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Detailed Description
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This randomized, pilot interventional study is designed to investigate the potential role of a dietary supplementation combining epigallocatechin gallate (EGCG), vitamin B12, hyaluronic acid, and folic acid in supporting the physiological balance and natural defense mechanisms of the male genital tract in subjects exposed to human papillomavirus (HPV) infection who are undergoing evaluation or treatment for infertility at natural procreation centers.
A total of 48 couples (96 participants) attending the outpatient clinics of the International Scientific Institute (ISI) "Paolo VI" at Policlinico A. Gemelli will be enrolled. All couples will include a male partner with documented HPV positivity. Participants will be randomly assigned, using a computer-generated randomization list, to one of two study arms. In the intervention group, 24 couples will receive an oral dietary supplement containing EGCG 200 mg, vitamin B12 1 mg, hyaluronic acid 50 mg, and folic acid 400 µg, administered as one tablet daily for a duration of six months to both partners. The control group will consist of 24 couples who will not receive any supplementation.
The primary objective of the study is to assess whether the combined supplementation contributes to the maintenance of physiological homeostasis and natural defense functions of the male genital system in individuals exposed to HPV. Secondary objectives include evaluating the potential effect of the supplementation on sperm quality parameters, the overall reproductive well-being of the couples, and the maintenance of genital mucosal physiological balance, with particular attention to factors that may influence the risk of HPV transmission to the female partner. Additionally, the study explores whether the supplementation supports physiological balance in the presence of possible co-infections or alterations of the genital microbiota.
As a pilot study, the results will provide preliminary data on feasibility, safety, and potential biological effects, contributing to the design of future larger-scale clinical investigations in this population.
A total of 48 couples (96 participants) attending the outpatient clinics of the International Scientific Institute (ISI) "Paolo VI" at Policlinico A. Gemelli will be enrolled. All couples will include a male partner with documented HPV positivity. Participants will be randomly assigned, using a computer-generated randomization list, to one of two study arms. In the intervention group, 24 couples will receive an oral dietary supplement containing EGCG 200 mg, vitamin B12 1 mg, hyaluronic acid 50 mg, and folic acid 400 µg, administered as one tablet daily for a duration of six months to both partners. The control group will consist of 24 couples who will not receive any supplementation.
The primary objective of the study is to assess whether the combined supplementation contributes to the maintenance of physiological homeostasis and natural defense functions of the male genital system in individuals exposed to HPV. Secondary objectives include evaluating the potential effect of the supplementation on sperm quality parameters, the overall reproductive well-being of the couples, and the maintenance of genital mucosal physiological balance, with particular attention to factors that may influence the risk of HPV transmission to the female partner. Additionally, the study explores whether the supplementation supports physiological balance in the presence of possible co-infections or alterations of the genital microbiota.
As a pilot study, the results will provide preliminary data on feasibility, safety, and potential biological effects, contributing to the design of future larger-scale clinical investigations in this population.
Conditions
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HPV Infection
Infertilities
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Patients taking Pervistop
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.
Group Type
EXPERIMENTAL
Pervistop
Intervention Type
DIETARY_SUPPLEMENT
combination of EGCG, vitamin B12, hyaluronic acid, and folic acid.
Patients NO taking Pervistop
24 couples who will not receive any supplementation
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Pervistop
combination of EGCG, vitamin B12, hyaluronic acid, and folic acid.
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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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
* 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
* 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
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Lo.Li.Pharma s.r.l
INDUSTRY
Sponsor Role
collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Domenico Milardi
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Central Contacts
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References
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BACKGROUND
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Reference Type
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Perez-Andino J, Buck CB, Ribbeck K. Adsorption of human papillomavirus 16 to live human sperm. PLoS One. 2009 Jun 9;4(6):e5847. doi: 10.1371/journal.pone.0005847.
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RESULT
Porcaro G, Pavone-Cossut MR, Moretti S, Bilotta G, Aragona C, Unfer V. Oral Treatment with EGCG, Folic Acid, Vitamin B12, and Hyaluronic Acid Improves HPV Clearance and Counteracts Its Persistence: A Clinical Study. Int J Mol Sci. 2025 May 29;26(11):5251. doi: 10.3390/ijms26115251.
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RESULT
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RESULT
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Bosch FX, Broker TR, Forman D, Moscicki AB, Gillison ML, Doorbar J, Stern PL, Stanley M, Arbyn M, Poljak M, Cuzick J, Castle PE, Schiller JT, Markowitz LE, Fisher WA, Canfell K, Denny LA, Franco EL, Steben M, Kane MA, Schiffman M, Meijer CJ, Sankaranarayanan R, Castellsague X, Kim JJ, Brotons M, Alemany L, Albero G, Diaz M, de Sanjose S; ICO Monograph 'Comprehensive Control of HPV Infections and Related Diseases' Vaccine Volume 30, Supplement 5, 2012. Comprehensive control of human papillomavirus infections and related diseases. Vaccine. 2013 Dec 30;31 Suppl 6:G1-31. doi: 10.1016/j.vaccine.2013.10.002.
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Reference Type
RESULT
Other Identifiers
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8298
Identifier Type: -
Identifier Source: org_study_id
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