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® (dose: 250 mg/day) 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 a further clinical trial close to finish (ClinicalTrials.gov Identifier: NCT04864314) using the same dose, such positive results have been tested again in a higher number of patients, and additional parameters have been included in order to gain insights into the sperm physiological changes that underpin the improvement in semen quality. In this new clinical trial, an intermediate dose (125 mg/day) is going to be tested in an attempt to determine a range of TetraSOD® dosage being clinically active for the treatment of male infertility.
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
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
Parallel
Sham
Dietary supplementParticipants in the Control group will receive a daily dose of placebo in a capsule during 90 days.
Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity
Dietary supplementParticipants in the Experimental group will receive a daily dose of 125 mg of TetraSOD® in a capsule during 90 days.
Sperm motility
Sperm motility will be assessed according to the method described in the World Health Organization (WHO) laboratory manual for the examination and processing of human semen, 5th ed. Geneva: World Health Organization (2010)
Sperm concentration
Sperm concentration will be determined according to the method described in the WHO laboratory manual for the examination and processing of human semen, 5th ed. Geneva: World Health Organization (2010)
Sperm oxidative stress
Sperm ROS intracellular will be measured by flow cytometry evaluating the sperm intracellular ROS (superoxide anion, hydroxyl radical, hydrogen peroxide)
DNA integrity
DNA integrity/fragmentation will be evaluated using the COMET assay
sORP by MiOXSYS
sORP will be also assessed using the MiOXSYS system
Adverse effects
Any kind of adverse event attributable to TetraSOD® will be recorded during the duration of the trial
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