The Effectiveness of Spermotrend Food Supplement in the Treatment of Male Infertility
NCT05222841 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2023-03-28
Summary
Spermotrend is a natural based product manufactured by Catalysis Laboratories. Its composition contains different essential elements for spermatogenesis: selenium, zinc and fructose. In addition, it contains L-arginine, natural precursor of nitric oxide that favors vasodilation, and pygeum africanum extract with antioxidant, antiinflammatory, antiandrogenic and antiproliferative action.
Its main action resides in the control of oxidative damage to the tissues of the male reproductive system, as well as the control of correct spermatogenesis.
Given that sperm quality can be altered by oxidative stress and that male infertility affects more and more people, the prevention and management of this deterioration becomes increasingly important.
Therefore, to evaluate Spermotrend as a new therapy for male infertility, the investigators are going to study the safety and efficacy of this treatment in this clinical trial.
RESEARCH HYPOTHESIS
The treatment with Spermotrend improves the parameters of the spermatogenesis.
GENERAL OBJECTIVES
To evaluate the effectiveness and the safety level of the natural Spermotrend product in the treatment of male infertility.
SPECIFIC OBJECTIVES
* Evaluate the increase in sperm motility and concentration.
* Identify the improvement in the seminal fluid volume.
* Identify the positive changes in the sperm morphology.
* Determine how to maintain the semen analysis in a normal range.
* Describe the adverse effects.
SECONDARY OBJECTIVES
* Identify the improvement in urinary symptoms related with benign prostatic hyperplasia.
* Identify the improvement in varicocele.
Conditions
- Male Infertility
- Benign Prostatic Hyperplasia
- Spermatogenesis and Semen Disorders
Interventions
- DIETARY_SUPPLEMENT
-
Spermotrend
Patients who are treated with Spermotrend (536,62g) are given 3 capsules every day for 3 months, taken orally every 8 hours.
Sponsors & Collaborators
-
Catalysis SL
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-15
- Primary Completion
- 2022-06-20
- Completion
- 2022-12-15
Countries
- Nicaragua
Study Locations
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