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

Launched by FITOPLANCTON MARINO, S.L. · Mar 15, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of a product called TetraSOD®, which is made from a specific type of marine phytoplankton. The goal of the study is to see if a lower dose of TetraSOD® (125 mg per day) can help improve semen quality in men experiencing infertility, especially those who have not been able to conceive after trying for at least a year. Previous studies with a higher dose showed positive results, and this trial aims to explore if the lower dose can also be beneficial.

To participate in this study, men between the ages of 18 and 45 who have been diagnosed with certain types of infertility (like having low sperm count or poor sperm movement) may be eligible. However, men with specific health issues, such as very low sperm counts or certain medical conditions, will not be able to join. Participants can expect to take the TetraSOD® supplement daily and will be monitored over the course of the trial to assess any changes in their semen quality. This research is an important step in understanding how this product may assist men facing challenges with infertility.

Gender

MALE

Eligibility 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