Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06324071
NA

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

Sponsor: Fitoplancton Marino, S.L.

View on ClinicalTrials.gov

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.

Official title: A Double-blind Randomized Placebo-controlled Clinical Study to Verify the Efficacy of TetraSOD® in the Improvement of Semen Quality in Patients With iIdiopathic Infertility

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-01-08

Completion Date

2025-12

Last Updated

2025-03-10

Healthy Volunteers

No

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.

Locations (1)

Hospital Clinic

Barcelona, Spain