Actively Recruiting
Study to Verify the Efficacy of a Product Containing 125 mg of TetraSOD® for the Treatment of Male Infertility
Led by Fitoplancton Marino, S.L. · Updated on 2025-03-10
50
Participants Needed
1
Research Sites
99 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
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.
CONDITIONS
Official 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...
- Age between 18 and 45 years
- Male patients with idiopathic infertility diagnosed with asthenozoospermia, oligozoospermia, or oligoasthenozoospermia
- No pregnancy achieved after at least one year of unprotected intercourse with the same partner
You will not qualify if you...
- Absence of spermatozoa (azoospermia) or very low sperm count (< 5 million sperm/ml)
- History of testicular torsion or prostatitis
- Urinary retention or infections
- Current drug consumption
- Undergoing hormone treatments
- Recent surgeries
- Diabetes
- Kidney or liver disease
- Presence of leukocytosis
- Use of antioxidant supplements in the last 3 months
- Body mass index (BMI) over 30 kg/m2
- Endocrine disorders including hypo- or hyperthyroidism
- Chromosomal anomalies such as XX, XYY, or XXY
- Treatment with anticoagulants
- Previous radiotherapy or chemotherapy
- Participation in another clinical study that may affect this study's objectives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Clinic
Barcelona, Spain, 08036
Actively Recruiting
Research Team
C
Carlos Infante
CONTACT
C
Carlos Unamunzaga
CONTACT
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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