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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Concomitant diseases causing immunosuppression
- •Treatment with immunomodulatory therapies
- •Use of EGCG or other green tea extracts
研究组 & 干预措施
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.
干预措施: Pervistop (Dietary Supplement)
Patients NO taking Pervistop
24 couples who will not receive any supplementation
结局指标
主要结局
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
时间窗: From enrollment to the end of treatment at 6 months
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.
次要结局
未报告次要终点