Infertility, Male, Spermatogenesis and Semen Disorders
Conditions
Keywords
Spermatogenesis, Male infertility, Orchitis, Mumps virus, Hypogonadism
Brief summary
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.
Detailed description
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.
Interventions
DRUGFPT-20
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.
Sponsors
Trieu, Nguyen Thi, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use FPT-20 drugs to increase sperm count in semen. | 180 days | Count the number of sperm in the semen. |
Countries
Vietnam
Contacts
STUDY_CHAIRNguyen Thi Trieu, Dr.
Trieu, Nguyen Thi, M.D.
Outcome results
None listed