Assessment of TetraSOD® Efficacy to Improve Semen Parameters in Men With Idiopathic Infertility (NCT04864314) | Clinical Trial Compass
CompletedNot Applicable
Assessment of TetraSOD® Efficacy to Improve Semen Parameters in Men With Idiopathic Infertility
Spain80 participantsStarted 2021-05-12
Plain-language summary
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® 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 the present clinical trial, such positive effects will be tested again in a higher number of patients, and additional parameters will be included in order to gain insights into the sperm physiological changes that underpin the improvement in semen quality
Who can participate
Age range18 Years – 45 Years
SexMALE
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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 million 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/m\^2
* 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