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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Pervistop
  combination of EGCG, vitamin B12, hyaluronic acid, and folic acid.

Первичные конечные точки

• 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 [Срок оценки: From enrollment to the end of treatment at 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Ono A, Koshiyama M, Nakagawa M, Watanabe Y, Ikuta E, Seki K, Oowaki M. The Preventive Effect of Dietary Antioxidants on Cervical Cancer Development. Medicina (Kaunas). 2020 Nov 10;56(11):604. doi: 10.3390/medicina56110604. PMID 33182663
• Zhang D, Wen X, Wu W, Guo Y, Cui W. Elevated homocysteine level and folate deficiency associated with increased overall risk of carcinogenesis: meta-analysis of 83 case-control studies involving 35,758 individuals. PLoS One. 2015 May 18;10(5):e0123423. doi: 10.1371/journal.pone.0123423. eCollection 2015. PMID 25985325
• Ahn WS, Yoo J, Huh SW, Kim CK, Lee JM, Namkoong SE, Bae SM, Lee IP. Protective effects of green tea extracts (polyphenon E and EGCG) on human cervical lesions. Eur J Cancer Prev. 2003 Oct;12(5):383-90. doi: 10.1097/00008469-200310000-00007. PMID 14512803
• Weinberg M, Sar-Shalom Nahshon C, Feferkorn I, Bornstein J. Evaluation of human papilloma virus in semen as a risk factor for low sperm quality and poor in vitro fertilization outcomes: a systematic review and meta-analysis. Fertil Steril. 2020 May;113(5):955-969.e4. doi: 10.1016/j.fertnstert.2020.01.010. PMID 32386620
• 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. PMID 40508059
• Tinelli A, Gustapane S, Licchelli M, Coluccia AC, Panese G, Proietti S, Gambioli R. Treatment with Epigallocatechin Gallate, Folic Acid, Vitamin B12, and Hyaluronic Acid Decreases HPV Positivity in Women Attending Regional Screening in Puglia. Microorganisms. 2024 Sep 14;12(9):1897. doi: 10.3390/microorganisms12091897. PMID 39338571
• Aragona C, Bezerra Espinola MS, Bilotta G, Porcaro G, Calcagno M. Evaluating the Efficacy of Pervistop(R), a New Combination Based on EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid on Patients with Human Papilloma Virus (HPV) Persistent Infections and Cervical Lesions: A Pilot Study. J Clin Med. 2023 Mar 10;12(6):2171. doi: 10.3390/jcm12062171. PMID 36983172
• Kwanbunjan K., Saengkar P., Cheeramakara C., Thanomsak W., Benjachai W.,Laisupasin P., Buchachart K., Songmuaeng K., Boontaveeyuwat N. Low folate status as a risk factor for cervical dysplasia in Thai women. Nutr. Res. 2005;25:641-654. doi: 10.1016/j.nutres.2005.05.004.

Идентификаторы

NCT: NCT07344337 · 8298

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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