Study to Verify the Efficacy of a Product Containing 125 mg of TetraSOD® for the Treatment of Male Infertility
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
Fitoplancton Marino, S.L.
50 participants
Jan 8, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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
Exclusion Criteria16
- 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
- Participation in another clinical study prior to inclusion in this study that could affect the objectives of the current study
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Interventions
Participants in the Control group will receive a daily dose of placebo in a capsule during 90 days.
Participants in the Experimental group will receive a daily dose of 125 mg of TetraSOD® in a capsule during 90 days.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06324071