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Completed

NCT Number: NCT05399212

Evaluation of FPT-20 for the Treatment of Spermatogenesis and Semen Disorders

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.

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Key information

Age range

25 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Saigon Biopharma Company Limited

Hồ Chí Minh, Ho Chi Minh City, 700000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Do not select patients with advanced cancer.

Treatment and study plan

FPT-20

Drug

Participants receive FPT-20 orally at a standardized dosage of 1 tablet once daily. The intervention is administered continuously for a duration of 6 to 12 months to ensure sufficient exposure for the evaluation of therapeutic efficacy on spermatogenesis.

Primary outcomes

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

    Time frame: 180 days

    Count the number of sperm in the semen.

Sponsors and collaborators

Lead sponsor

Trieu, Nguyen Thi, M.D.

Indiv

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2022
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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