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

RecruitingNAAges 18 Years - 45 YearsMaleFitoplancton Marino, S.L.
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Sham
  • Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity
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Where

1 site
Hospital Clinic
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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