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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FPT-20 Intervention Group | Experimental | A single-arm group consisting of 16 infertile men with spermatogenic failure secondary to testicular inflammation. All participants receive a standardized therapeutic dose of the natural-derived formulation FPT-20 daily for a duration of 6 to 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Use FPT-20 drugs to increase sperm count in semen. | Count the number of sperm in the semen. | 180 days |
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Inclusion Criteria:
Exclusion Criteria:
Carries the sex chromosome gene XY
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| Name | Affiliation | Role |
|---|---|---|
| Nguyen Thi Trieu, Dr. | Trieu, Nguyen Thi, M.D. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saigon Biopharma Company Limited | Hồ Chí Minh | Ho Chi Minh City | 700000 | Vietnam |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 6, 2026 | Jun 5, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2026 | Jun 5, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D009920 | Orchitis |
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| D052801 |
| Male Urogenital Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |