Clinical trial Recruiting at 1 site Interventional Ages 18 to 45 Men only

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 typeInterventional
Ages18 Years to 45 Years
SexMen only
Enrollment50 (estimated)
SponsorFitoplancton Marino, S.L.
Industry-sponsored
Drugs / interventionsChemotherapy, radiation
Locations1 site (Barcelona)
StatusRecruiting
StartedJanuary 8, 2024
Main results expectedJune 2025
Study endsDecember 2025
Registry record updatedMarch 10, 2025
Trial IDNCT06324071 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.