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Study to Verify the Efficacy of a Product Containing 125 mg of TetraSOD® for the Treatment of Male Infertility

NCT06324071 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-03-10

No results posted yet for this study

Summary

TetraSOD® is a unique marine phytoplankton (Tetraselmis chuii) SOD-rich ingredient that is grown under patent-protected technology exclusively designed by the company Fitoplancton Marino, S.L. (Spain). In a previous pilot trial, the ability of TetraSOD® (dose: 250 mg/day) to improve semen characteristics in idiopathic infertile men after three months of treatment was assessed, revealing significant improvements in almost all of the analyzed parameters. In a further clinical trial close to finish (ClinicalTrials.gov Identifier: NCT04864314) using the same dose, such positive results have been tested again in a higher number of patients, and additional parameters have been included in order to gain insights into the sperm physiological changes that underpin the improvement in semen quality. In this new clinical trial, an intermediate dose (125 mg/day) is going to be tested in an attempt to determine a range of TetraSOD® dosage being clinically active for the treatment of male infertility.

Conditions

  • Male Infertility

Interventions

DIETARY_SUPPLEMENT

Sham

Participants in the Control group will receive a daily dose of placebo in a capsule during 90 days.

DIETARY_SUPPLEMENT

Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity

Participants in the Experimental group will receive a daily dose of 125 mg of TetraSOD® in a capsule during 90 days.

Sponsors & Collaborators

  • Fundacio Clinic Barcelona

    collaborator OTHER

  • Fertypharm

    collaborator INDUSTRY

  • Fitoplancton Marino, S.L.

    lead INDUSTRY

Principal Investigators

  • Juan M Corral · Hospital Clinic Barcelona, Spain

  • Meritxell Jodar · Hospital Clinic Barcelona, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • Spain

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 NCT06324071 on ClinicalTrials.gov