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

NCT06324071 | Recruiting

• 1 other identifier: 2022_TSOD_125
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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® (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

Keywords

TetraSOD®; Idiopathic Male Infertility; Oxidative stress

Outcome Measures

Primary Outcomes (3)

• Sperm motility

  Sperm motility will be assessed according to the method described in the World Health Organization (WHO) 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

• Sperm oxidative stress

  Sperm ROS intracellular will be measured by flow cytometry evaluating the sperm intracellular ROS (superoxide anion, hydroxyl radical, hydrogen peroxide)

  90 days

Secondary Outcomes (3)

• DNA integrity

  90 days

• sORP by MiOXSYS

  90 days

• Adverse effects

  90 days

Study Arms (2)

Control group

EXPERIMENTAL

Group supplemented with a daily dose of placebo

Dietary Supplement: Sham

Experimental group

EXPERIMENTAL

Group supplemented with 125 mg/day 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.

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 125 mg of TetraSOD® in a capsule during 90 days.

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 x 10\^6 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/m2
• 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 (1)

Hospital Clinic

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Infertility, Male

Interventions

salicylhydroxamic acid; Superoxide Dismutase; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Juan M Corral

  Hospital Clinic Barcelona, Spain

  PRINCIPAL INVESTIGATOR

• Meritxell Jodar

  Hospital Clinic Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Infante

CONTACT

+34 956561079; carlos.infante@easyalgae.com

Carlos Unamunzaga

CONTACT

+34 956561079; cue@easyalgae.com

Study Design

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

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: January 8, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)