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Composition for Treating Spermatogenesis and Semen Disorders / FPT-20

Primary Purpose

Spermatogenesis and Semen Disorders

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
FPT-20
Sponsored by
Trieu, Nguyen Thi, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spermatogenesis and Semen Disorders focused on measuring Spermatogenesis, Male infertility, Orchitis, Mumps virus, Hypogonadism

Eligibility Criteria

25 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Saigon Biopharma Company Limited

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FPT-20

Arm Description

FPT-20 should be used regularly (>6 to 12 months) until the therapeutic purpose is achieved.

Outcomes

Primary Outcome Measures

Use FPT-20 drugs to increase sperm count in semen.
Count the number of sperm in the semen.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2022
Last Updated
May 26, 2022
Sponsor
Trieu, Nguyen Thi, M.D.
Collaborators
Tran Minh Duc
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1. Study Identification

Unique Protocol Identification Number
NCT05399212
Brief Title
Composition for Treating Spermatogenesis and Semen Disorders / FPT-20
Official Title
A New Natural Origin Product, Achieving More Than 80% Efficiency in Spermatogenesis in the Seminiferous Tubules. This Method Opens up Hope for Cases of Infertility Caused by the Inability of Spermatogonia to Develop Into Mature Sperm.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 29, 2020 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trieu, Nguyen Thi, M.D.
Collaborators
Tran Minh Duc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Research to develop a new, natural-derived formulation that eliminates inflammatory tissue and regenerates new tissue of the lobules, epithelium of the tubules, and connective tissue surrounding the seminiferous tubules in the testes. It restores Leydig cells and Sertoli cells' function (because the inflamed testicles were unable to perform spermatogenesis).
Detailed Description
FPT-20 has stabilized cortisol levels, maintained stable B-lymphocytes in the body, verified by quantitative tests of blood B-lymphocytes and blood cortisol, cut off the chronic inflammation chain, promoted the regeneration of the epithelium of the coiled ducts, and repairs the connective tissue surrounding the coils. Select a type of flavonoid that has the ability to protect human body cells by destroying toxic proteins. Targeted flavonoids are selected for multiple simultaneous effects, acting as a chemotactic or physiological modifier. Many studies have shown that flavonoids can also act as cell cycle inhibitors, which can also cause cancer cell death at an early stage (at the stage of a few cells). There have been many documents demonstrating that some flavonoids have the ability to kill cancer cells, stabilize stages of cell differentiation, and improve immunity. Flavonoids present in FPT-20 protect and regenerate cells, clean up inflammatory and fibrotic cells, and facilitate the growth of germ cells. The selected flavonoids in the preparation are also used to regenerate the epithelium in the lumen of the seminiferous tubules, ensure the perfusion of the lobules, and stabilize the spermatogenesis process. FPT-20 is easily distributed in high concentrations in immune cells. It has natural antibacterial activity, promotes lymphocyte proliferation, and is rapidly consumed during inflammation. The effects show a prominent role in the regulation of the immune system, and there is a high degree of interaction, which requires more research to understand its mechanism, FPT-20 will not be effective in the absence of one of the components selected to participate in the test. FPT-20 will reach its therapeutic effect after 6-12 months. After 6-12 months, an amount of progressively motile sperm was found in the semen. According to research, FPT-20 created a homeostasis, protecting cell membranes, cutting off the cell's inflammatory chain, and preventing transcription and translation errors. The mediators regulated the protective responses in the body. Cytokines that have a beneficial effect through specific receptors, and many other unexplained processes, have altered the spermatogenesis status of the testes. The body will absorb the components in FPT-20 through the small intestine wall, this metabolism has created a significant amount of B lymphocytes to provide for the process of restoring the function of the testicles. An appropriately calculated dose of FPT-20 is provided during the treatment, using precursors, enzymes, and flavonoids available in nature to supplement and interfere with biochemical processes taking place in the body. The extracts in the preparation should be used regularly (>6 months) until the therapeutic purpose is achieved. The product has offered hope to patients who are unable to produce sperm from spermatogonia (because the process has been disrupted). Stabilize the semen pH within good limits, to produce high-quality sperm as well as to achieve efficiency into egg penetration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spermatogenesis and Semen Disorders
Keywords
Spermatogenesis, Male infertility, Orchitis, Mumps virus, Hypogonadism

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The number of infertile people after recruitment was divided into 2 groups. Spermatogenesis. Male infertility group due to lack of sperm.
Masking
None (Open Label)
Masking Description
The number of infertile people after recruitment was divided into 2 groups. Spermatogenesis. Male infertility group due to lack of sperm.
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FPT-20
Arm Type
Experimental
Arm Description
FPT-20 should be used regularly (>6 to 12 months) until the therapeutic purpose is achieved.
Intervention Type
Drug
Intervention Name(s)
FPT-20
Intervention Description
FPT-20 should be used regularly, the daily maintenance dose is 1 tablet once a day(>6 to 12 months) until the therapeutic purpose is achieved.
Primary Outcome Measure Information:
Title
Use FPT-20 drugs to increase sperm count in semen.
Description
Count the number of sperm in the semen.
Time Frame
180 days

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Carries the sex chromosome gene XY
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nguyen Thi Trieu, Dr.
Organizational Affiliation
Trieu, Nguyen Thi, M.D.
Official's Role
Study Chair
Facility Information:
Facility Name
Saigon Biopharma Company Limited
City
Hồ Chí Minh
State/Province
Ho Chi Minh City
ZIP/Postal Code
700000
Country
Vietnam

12. IPD Sharing Statement

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Composition for Treating Spermatogenesis and Semen Disorders / FPT-20

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