Evaluation of FPT-20 for the Treatment of Spermatogenesis and Semen Disorders
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ho Chi Minh City
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Hồ Chí Minh, Ho Chi Minh City, Vietnam, 700000
- Saigon Biopharma Company Limited
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: FPT-20 Intervention Group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Use FPT-20 drugs to increase sperm count in semen.
Time Frame: 180 days
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Count the number of sperm in the semen.
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180 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Nguyen Thi Trieu, Dr., Trieu, Nguyen Thi, M.D.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPT-20-2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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