Clinical trial NCT05399212: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spermatogenesis and Semen Disorders
Keywords: Spermatogenesis
Male infertility
Orchitis
Mumps virus
Hypogonadism
Lead sponsor: Trieu, Nguyen Thi, M.D.
Sponsor class: INDIV
Collaborators: name: TRAN MINH DUC, MD
First posted: 2022-06-01
Enrollment: 60
Sex: MALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The number of infertile people after recruitment was divided into 2 groups.

* Spermatogenesis.
* Male infertility group due to lack of sperm.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Use FPT-20 drugs to increase sperm count in semen.
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Saigon Biopharma LLC
state: Delaware
city: Hồ Chí Minh
country: Vietnam
facility: Saigon Biopharma Company Limited
state: Ho Chi Minh City
Study officials:
affiliation: Trieu, Nguyen Thi, M.D.
name: Nguyen Thi Trieu, Dr.
role: STUDY_CHAIR
References: