Actively Recruiting
A Double-blind Randomized Placebo-controlled Clinical Study to Verify the Efficacy of TetraSOD in the Improvement of Semen Quality in Patients With Idiopathic Infertility
Led by Fitoplancton Marino, S.L. · Updated on 2025-03-10
50
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
F
Fitoplancton Marino, S.L.
Lead Sponsor
F
Fundacio Clinic Barcelona
Collaborating Sponsor
AI-Summary
What this Trial Is About
Male infertility, particularly idiopathic infertility where the cause is unknown, affects many men worldwide and is linked to various lifestyle and environmental factors. This research investigates the effects of TetraSOD , a marine microalgae product rich in the antioxidant enzyme superoxide dismutase (SOD), on improving semen quality. Previous studies with higher doses showed promising improvements in sperm characteristics, and this trial aims to assess the impact of a lower dose (125 mg/day) on sperm quality and oxidative stress markers. Participants will be randomly assigned to receive either a daily capsule containing 125 mg of TetraSOD or a placebo for 90 days. This double-blind, placebo-controlled study compares the effects of these interventions on semen parameters. The trial includes measuring classical semen parameters and oxidative stress using the Male Infertility Oxidative System (MiOXSYS) to explore sperm DNA fragmentation and other physiological changes. During the 90-day study period, participants will undergo semen analysis to evaluate sperm motility, concentration, and oxidative stress. Researchers will also assess DNA integrity and monitor for any adverse effects. These evaluations will provide insights into the potential clinical activity of TetraSOD at this lower dose for treating male infertility. The total participation duration is 90 days with careful monitoring throughout the trial.
CONDITIONS
Brief Title
Study to Verify the Efficacy of a Product Containing 125 mg of TetraSOD® for the Treatment of Male Infertility
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 to 45 years
- Diagnosed with idiopathic infertility with asthenozoospermia, oligozoospermia, or oligoasthenozoospermia
- Has not achieved pregnancy after at least one year of intercourse with the same partner without protective measures
You will not qualify if you...
- Azoospermia or severe oligozoospermia (less than 5 million sperm/ml)
- History of testicular torsion or prostatitis
- Urinary retention or infections
- Current drug consumption
- Use of hormone treatments
- Recent surgical interventions
- Diabetes
- Kidney or liver disease
- Leukocytosis
- Antioxidant supplement use in the last 3 months
- Body mass index over 30 kg/m2
- Endocrinopathies, hypo- or hyperthyroidism
- Chromosomal anomalies (XX, XYY, XXY)
- Treatment with anticoagulants
- Previous radiotherapy or chemotherapy
- Participation in another clinical study that could affect this study's objectives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 90 days
Participants receive a daily capsule of either 125 mg of TetraSOD® or placebo for 90 days to assess improvement in semen quality.
Baseline visit and follow-up visits during treatment
Trial Site Locations
Total: 1 location
1
Hospital Clinic
Barcelona, Spain, 08036
Actively Recruiting
Research Team
C
Carlos Infante
C
Carlos Unamunzaga
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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