Saigon Biopharma Company Limited
Hồ Chí Minh, Ho Chi Minh City, 700000, Vietnam
NCT Number: NCT05399212
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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Notify Me25 year–40 year
Male
Interventional
Not applicable
Hồ Chí Minh, Ho Chi Minh City, 700000, Vietnam
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 180 days
Count the number of sperm in the semen.
Trieu, Nguyen Thi, M.D.
Indiv
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.
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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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