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Study to Verify the Efficacy of a Product Containing 125 mg of TetraSOD® for the Treatment of Male Infertility
Sponsor: Fitoplancton Marino, S.L.
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
Conditions
Interventions
Sham
Participants in the Control group will receive a daily dose of placebo in a capsule during 90 days.
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