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临床试验/NCT05399212
NCT05399212已完成不适用

An Open-Label Study on the Efficacy of a New Natural Origin Product (FPT-20) in Improving Spermatogenesis and Semen Parameters in Men With Spermatogenic Failure.

Trieu, Nguyen Thi, M.D.3 个研究点 分布在 2 个国家目标入组 16 人开始时间: 2020年10月29日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
3
主要终点
Use FPT-20 drugs to increase sperm count in semen.

研究概览

简要总结

This clinical study aims to evaluate the efficacy and safety of a novel, natural-derived formulation (FPT-20) in supporting spermatogenesis. The investigation focuses on the formulation's potential to reduce inflammatory processes and support tissue regeneration within the testicular lobules, seminiferous tubule epithelium, and surrounding connective tissues. Additionally, the study assesses its ability to restore Leydig and Sertoli cell functions in patients with spermatogenic failure secondary to testicular inflammation.

详细描述

This study investigates the mechanisms and therapeutic potential of FPT-20, a natural-derived formulation rich in targeted flavonoids, for the treatment of spermatogenic failure and semen disorders secondary to chronic testicular inflammation.

The formulation is hypothesized to modulate immune responses and mitigate chronic inflammatory pathways, as monitored through blood cortisol levels and B-lymphocyte quantification. By downregulating inflammatory mediators, FPT-20 aims to support the regeneration of the seminiferous tubule epithelium and the surrounding connective tissue, thereby improving microcirculation and perfusion within the testicular lobules.

The specific flavonoids selected in FPT-20 are intended to provide cytoprotective effects, stabilize cell membranes, and promote a favorable microenvironment for the differentiation and maturation of germ cells (spermatogonia). Furthermore, the intervention is designed to optimize semen parameters, including pH stabilization, to support sperm quality and function.

Patients receive a standardized, calculated daily dose of FPT-20 over a continuous period of 6 to 12 months. The study evaluates the long-term efficacy of this nutritional and biochemical intervention in restoring Leydig and Sertoli cell functions, with the primary clinical endpoint focused on the reappearance and improvement of progressively motile sperm in the ejaculate of men previously diagnosed with maturation arrest.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

The number of infertile people after recruitment was divided into 2 groups.

  • Spermatogenesis.
  • Male infertility group due to lack of sperm.

入排标准

年龄范围
25 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • The selected person has evidence of spermatogenesis disorder, no sperm, and weak sperm that do not meet the standards in terms of quantity and quality.
  • There are signs of orchitis.
  • Accepting patients with other comorbidities such as metabolic diseases, congenital or acquired immunodeficiency, HIV/AIDS, HBV, HCV, and Tuberculosis.

排除标准

  • Do not select patients with advanced cancer.

结局指标

主要结局

Use FPT-20 drugs to increase sperm count in semen.

时间窗: 180 days

Count the number of sperm in the semen.

次要结局

未报告次要终点

研究者

发起方
Trieu, Nguyen Thi, M.D.
申办方类型
Indiv
责任方
Sponsor

研究点 (3)

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