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Assessment of TetraSOD® Efficacy to Improve Semen Parameters in Men With Idiopathic Infertility

NCT04864314 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-27

Study results available
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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® 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 the present clinical trial, such positive effects will be tested again in a higher number of patients, and additional parameters will be included in order to gain insights into the sperm physiological changes that underpin the improvement in semen quality

Conditions

  • Infertility, Male

Interventions

DIETARY_SUPPLEMENT

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

Participants in the Experimental group will receive a daily dose of 250 mg of TetraSOD® in a capsule during 90 days. After treatment, the group will stop consumption of TetraSOD® and a wash-out period of three months will start

DIETARY_SUPPLEMENT

Sham

Participants in the Control group will receive a daily dose of placebo in a capsule during 90 days. After treatment, the group will stop consumption of placebo and a wash-out period of three months will start

Sponsors & Collaborators

  • Fundacio Clinic Barcelona

    collaborator OTHER

  • Fertypharm

    collaborator INDUSTRY

  • Fitoplancton Marino, S.L.

    lead INDUSTRY

Principal Investigators

  • Juan M Corral, Doctor · Hospital Clinic (Barcelona, Spain)

  • Meritxell Jodar, Doctor · Hospital Clinic (Barcelona, Spain)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-05-12
Primary Completion
2024-06-30
Completion
2024-10-31

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 NCT04864314 on ClinicalTrials.gov