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

NCT04864314 | Completed Results

• 1 other identifier: 2020_TSOD_01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

TetraSOD®; Infertility

Outcome Measures

Primary Outcomes (2)

• Sperm Progressive Motility

  Sperm progressive motility (in percentage) will be assessed according to the method described in the WHO (World Health Organization) laboratory manual for the examination and processing of human semen, 5th ed. Geneva: World Health Organization (2010)

  90 days

• Sperm Concentration

  Sperm concentration will be determined according to the method described in the WHO laboratory manual for the examination and processing of human semen, 5th ed. Geneva: World Health Organization (2010)

  90 days

Secondary Outcomes (2)

• DNA Integrity

  90 days

• Adverse Effects

  90 days

Other Outcomes (1)

• MiOXSYS System as a Diagnostic Test of Abnormal Seminal Parameters and DNA Fragmentation

  90 days

Study Arms (2)

Control group

PLACEBO COMPARATOR

Group supplemented with a daily dose of placebo

Dietary Supplement: Sham

Experimental group

EXPERIMENTAL

Group supplemented with a daily dose of TetraSOD®

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

Interventions

Sham DIETARY_SUPPLEMENT

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

Control group

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

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

Also known as: TetraSOD®

Experimental group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Azoospermia (absence of spermatozoa) or severe oligozoospermia (\< 5 million spermatozoa/ml of ejaculate)
• Testicular torsion or prostatitis
• Urinary retention and infections
• Drug consumption
• Hormone treatments
• Recent surgical interventions
• Diabetes
• Kidney or liver disease
• Leukocytosis
• Antioxidant supplement consumption in the last 3 months
• BMI \>30 Kg/m\^2
• Endocrinopathies, hypo and hyperthyroidism
• Chromosomal anomalies (XX, XYY, XXY)
• Treatments with anticoagulants
• Radiotherapy/Chemotherapy

Sponsors & Collaborators

• Fitoplancton Marino, S.L.: lead
• Fundacio Clinic Barcelona: collaborator
• Fertypharm: collaborator

Study Sites (2)

Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital Clinic

Barcelona, Spain

Location

MeSH Terms

Conditions

Infertility, Male; Infertility

Interventions

Superoxide Dismutase; Exercise; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Oxidoreductases; Enzymes; Enzymes and Coenzymes; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr Meritxell Jodar
• Organization: Molecular Biology of Reproduction and Development Research Group, Fundació Recerca Clínic Barcelona - IDIBAPS. Genetics Unit, Department of Biomedicine, Universitat de Barcelona (UB), Barcelona, Spain

mjodar@clinic.cat

+34 93 227 55 10

Study Officials

• Juan M Corral, Doctor

  Hospital Clinic (Barcelona, Spain)

  PRINCIPAL INVESTIGATOR

• Meritxell Jodar, Doctor

  Hospital Clinic (Barcelona, Spain)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: April 28, 2021
• Study Start: May 12, 2021
• Primary Completion: June 30, 2024
• Study Completion: October 31, 2024
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)