N/A N=80 Randomized Triple-blind Treatment

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

Infertility, Male

Bottom Line

View on ClinicalTrials.gov: NCT04864314 ↗

Enrolled (actual)

Serious AEs

3.2%

Results posted

Mar 2026

Primary outcome: Primary: Sperm Progressive Motility — 19.62; 25.11 percentage

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity (Dietary_supplement); Sham (Dietary_supplement)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: Fitoplancton Marino, S.L.
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Sperm Progressive Motility	19.62; 25.11	—
PRIMARY Sperm Concentration	38.70; 37.79	—
SECONDARY DNA Integrity	31.29; 30.31; 31.41; 26.60	—
SECONDARY Adverse Effects	2; 0	—

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

Eligibility Criteria

Inclusion Criteria

Age: 18 to 45
Male patients with idiopathic infertility classified with asthenozoospermia, oligozoospermia or oligoasthenozoospermia after seminal assessment.
Not achieving pregnancy after at least one year of intercourse with the same partner without protective measures

Exclusion Criteria

Azoospermia (absence of spermatozoa) or severe oligozoospermia ( 30 Kg/m^2
Endocrinopathies, hypo and hyperthyroidism
Chromosomal anomalies (XX, XYY, XXY)
Treatments with anticoagulants
Radiotherapy/Chemotherapy
Participation in another clinical study prior to inclusion in this study that could affect the objectives of the current study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04864314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.