Testing a marine product for treating 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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Male |
| Sponsor | Fitoplancton Marino, S.L. Industry-sponsored |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06324071 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 to 45 with idiopathic infertility characterized by asthenozoospermia, oligozoospermia, or oligoasthenozoospermia.
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.
Why it matters
Potential benefit: If successful, this treatment could improve fertility outcomes for men suffering from idiopathic infertility.
How similar studies have performed: Previous studies using similar marine phytoplankton products have shown promising results in improving semen quality, suggesting a potential for success in this trial.
Eligibility criteria
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 this trial is running
Barcelona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.