Status:
COMPLETED
Assessment of TetraSOD® Efficacy to Improve Semen Parameters in Men With Idiopathic Infertility
Lead Sponsor:
Fitoplancton Marino, S.L.
Collaborating Sponsors:
Fundacio Clinic Barcelona
Fertypharm
Conditions:
Infertility, Male
Eligibility:
MALE
18-45 years
Phase:
NA
Brief 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)...
Detailed Description
IInfertility is an increasing global public health problem present in about 15-20% of the population of reproductive age, affecting as many as 186 million people worldwide. A male factor is present in...
Eligibility Criteria
Inclusion
- 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
- 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/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
Key Trial Info
Start Date :
May 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04864314
Start Date
May 12 2021
End Date
October 31 2024
Last Update
March 10 2025
Active Locations (2)
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1
Hospital Clinic
Barcelona, Spain, 08036
2
Hospital Clinic
Barcelona, Spain