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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital Clinic
RECRUITING
Barcelona
Contact Information
Primary
Carlos Infante
carlos.infante@easyalgae.com
+34 956561079
Backup
Carlos Unamunzaga
cue@easyalgae.com
+34 956561079
Time Frame
Start Date: 2024-01-08
Estimated Completion Date: 2025-12
Participants
Target number of participants: 50
Treatments
Experimental: Control group
Group supplemented with a daily dose of placebo
Experimental: Experimental group
Group supplemented with 125 mg/day of TetraSOD®
Related Therapeutic Areas
Sponsors
Leads: Fitoplancton Marino, S.L.
Collaborators: Fertypharm, Fundacio Clinic Barcelona

This content was sourced from clinicaltrials.gov