Testing a marine product for treating 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
Run by Fitoplancton Marino, S.L. · NCT06324071 · Data updated 2026-11-12
This study is testing a marine product to see if it can improve semen quality in men aged 18 to 45 who have been struggling with infertility.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Men only |
| Enrollment | 50 (estimated) |
| Sponsor | Fitoplancton Marino, S.L. Industry-sponsored |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (Barcelona) |
| Status | Recruiting |
| Started | January 8, 2024 |
| Main results expected | June 2025 |
| Study ends | December 2025 |
| Registry record updated | March 10, 2025 |
| Trial ID | NCT06324071 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men aged 18 to 45 with idiopathic infertility characterized by asthenozoospermia, oligozoospermia, or oligoasthenozoospermia.
✕Probably not a fit
Patients with azoospermia, severe oligozoospermia, or other significant health issues such as diabetes or recent surgeries may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the efficacy of TetraSOD®, a marine phytoplankton extract, in improving semen quality in men with idiopathic infertility. The study will administer a lower dose of 125 mg/day to assess its effectiveness compared to previous trials that used a higher dose. Participants will be male patients aged 18 to 45 who have been diagnosed with specific forms of infertility after a year of unsuccessful attempts to conceive. The trial aims to explore the relationship between oxidative stress and male fertility, potentially offering new insights into treatment options.
Why it matters
Potential benefit: If successful, this treatment could improve fertility outcomes for men suffering from idiopathic infertility.
How similar studies have gone: Previous studies using similar marine phytoplankton products have shown promising results in improving semen quality, suggesting a potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hospital Clinic
Barcelona, Spain Recruiting
Study contacts
- Principal investigator: Juan M Corral — Hospital Clinic Barcelona, Spain
- Study coordinator: Carlos Infante
- Email: carlos.infante@easyalgae.com
- Phone: +34 956561079
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.