The Effectiveness of Spermotrend Food Supplement in the Treatment of Male Infertility

March 27, 2023 updated by: Catalysis SL

The Effectiveness of the Spermotrend Food Supplement in the Treatment of Male Infertility and Benign Prostatic Hyperplasia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Every day, all over the world, increasingly more couples have to go to specialised centres in the hope of solving their infertility problems. In the past, female infertility was thought to be the main cause of this problem, but in the course of time, those of us who work in the field of Gynaecology, which is such a delicate issue, are convinced that the initial statistics concerning the prevalence of infertility in women is now just pure myth. The male factor is the main cause of infertility in numerous couples that go to the doctor every day, the percentage of which surpasses that of female infertility in many places. Not everyone have access to the high-tech assisted reproduction techniques which compensate for any spermatogenesis. Many studies have been carried out in the hope of improving the sperm quality in men. Antioxidants play an important role in the spermiogenesis, but so far no product has been found that really meets the expectations of improving the spermatogenesis in the short term. A product that naturally or through low- tech assisted reproduction techniques improves the pregnancy rates among couples that suffer from this type of disorder.

Catalysis Laboratories is specialized in natural antioxidant products as adjuvants and alternative treatments for prevention, management and recovery from different diseases.

The aim of this clinical trial is to study the efficacy and safety of Spermotrnend, a natural product manufactured by Catalysis Laboratories, in the improvement of sperm's quality and quantity in male infertility as well as in urinary symptoms and varicocele in those patients who suffer it in association or not with infertility.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nicaragua
      • Managua, Nicaragua, 13035
        • Clinica Seniors Managua

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males over 18.
  • Patient who shows alterations of the spermatogenesis and/or benign prostatic hyperplasia.
  • Patients without testicular pathology.
  • Serology and HIV negative.
  • Signed informed consent.

Exclusion Criteria:

  • Patients with associated pathologies: epididymo-orchitis, radiation or chemotherapy.
  • Patients with a testicular pathology that has been resolved.
  • Patients with non-transmissible chronic pathologies.
  • Patients who have not agreed to take part in the study.
  • Patients that are undergoing antioxidant treatment or who have completed this treatment in the last six months.
  • Patients who are being treated with vitamins or who have completed this treatment in the last six months.
  • Patients that are being treated with anti-inflammatory medications or who have completed this treatment in the last six months.
  • Patients who are undergoing hormone treatment prescribed for andrology or who have completed this treatment in the last six months.
  • Patients with serology or who are HIV positive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Spermotrend
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sperm motility
Time Frame: 3 months
Evaluate the change in sperm motility by spermiogram.
3 months
Sperm concentration
Time Frame: 3 months
Evaluate the changes in sperm concentration by spermiogram.
3 months
Seminal fluid volume.
Time Frame: 3 months
To identify the changes in the seminal fluid volume by spermiogram.
3 months
Sperm morphology.
Time Frame: 3 months
Identify the changes in the sperm morphology by spermiogram.
3 months
Incidence of adverse events during the treatment with Spermotrend
Time Frame: 3 months
To study and asses any adverse event related with the product assay in patients with male infertility, measured by means of a bimonthly personal questionnaire: nausea, vomiting, digestive pain, stomach ache... (mild, moderate, severe, yes or no).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance of semen quality in a normal range.
Time Frame: 6 months
Time of maintenance of the semen quality spermiogram analysis compared to the base line (weeks/months).
6 months
Evaluation of the function of the urinary bladder and urethra
Time Frame: 3 months
Residual urine will be determined by urodynamic evaluation (Volume in mL).
3 months
Evaluation of the function of the urinary bladder and urethra
Time Frame: 3 months
Urine flow rates (Qmax) will be determined by urodynamic evaluation (milliliters).
3 months
Clinical evoluation of Benign prostatic hyperplasia
Time Frame: 3 months
To evaluate the urinary symptoms related with benign prostatic hyperplasia by blood analysis: AUA guideline prostate-specific antigen (PSA) and serum creatinine measurements will be measured to evaluate the benign prostatic hyperplasia . Serum PSA level should be determined in men in the BPH age group, preferably before the rectal examination. A careful history taking and physical examination will usually identify patients at risk for bleeding tendencies.
3 months
Evaluation of urinary symptoms related with benign prostatic hyperplasia
Time Frame: 3 months

To evaluate the urinary symptoms related with benign prostatic hyperplasia by the specific questionnaire International Prostate Symptom Score (IPSS). Answers will be scored from 0=Not at all; 1= Less than 1 time in 5; 2=Less than half of time; 3= About Half of time; 4=More than half of time; to 5= Almost always.

(For example: - How often have you haf the sensation of not emptying your bladder completely after you finished urinating? From 0 to 5).

The summatory of symptom scores will be evaluated as 1-7 mild symptoms; 8-19 moderate symptoms; and 20-35 severe symptoms.
3 months
Prostate size in patients with benign prostatic hyperplasia
Time Frame: 3 months
To evaluate the benign prostatic hyperplasia volume by image analysis with ultrasound. Residual urine and urine flow rates will be determined by urodynamic evaluation.
3 months
Varicocele Degree
Time Frame: 3 months
To evaluate varicocele degree (1, 2 or 3) in term of size and its evolution in male infertility from the base line to the end of the treatment with Spermotrend.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Actual)

June 20, 2022

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPT-NICA-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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