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
Sham
+ Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity
Urogenital Diseases+3
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
Study start date: January 8, 2024
Actual date on which the first participant was enrolled.This clinical trial focuses on exploring whether a dietary supplement called TetraSOD® can improve sperm quality in men with unexplained infertility. Infertility is a growing issue affecting many people worldwide, and male-related factors contribute to about half of these cases. Often, the cause of male infertility is unknown, but oxidative stress is believed to play a significant role. Oxidative stress can lead to damage in sperm DNA, which affects sperm quality. This study aims to determine if a lower dose of TetraSOD®, an antioxidant derived from marine microalgae, can enhance sperm quality by reducing oxidative stress and improving sperm DNA integrity. Participants in the study will take a daily dose of 125 mg of TetraSOD® for three months, which aligns with a full cycle of sperm production. Researchers will measure various semen parameters, such as sperm concentration, motility, and DNA fragmentation, to assess changes in sperm quality. The study will also evaluate the correlation between sperm DNA fragmentation and oxidative stress levels using a system called MiOXSYS. By comparing these results with those from a previous trial using a higher dose, the study aims to identify an effective dosage range for TetraSOD® as a treatment for male infertility. This research could offer new hope for improving fertility outcomes in men with idiopathic infertility.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 18 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location