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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05222841 on ClinicalTrials.gov