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Search / Trial NCT04864314

Assessment of TetraSOD® Efficacy to Improve Semen Parameters in Men With Idiopathic Infertility

Launched by FITOPLANCTON MARINO, S.L. · Apr 27, 2021

Trial Information

Current as of May 02, 2025

Completed

Keywords

Tetra Sod® Infertility

ClinConnect Summary

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 approximately 50% of the infertile couples, a large number of them of unknown or idiopathic origin.

Spermatogenesis is a complex biological process that requires a highly regulated genetic and hormonal program in a singular environment created by the interaction with different cell types to orchestrate a successful differentiation process. This process occurs periodically every 72 days during...

Gender

MALE

Eligibility 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 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

About Fitoplancton Marino, S.L.

Fitoplancton Marino, S.L. is a pioneering biotechnology company specializing in the cultivation and research of marine microalgae for various applications, including nutraceuticals, pharmaceuticals, and environmental sustainability. With a strong emphasis on innovation and scientific rigor, the company focuses on harnessing the unique properties of marine organisms to develop high-quality products that contribute to health and wellness. Fitoplancton Marino is committed to advancing marine biotechnology through rigorous clinical trials and collaborations, ensuring the efficacy and safety of its offerings while promoting sustainable practices in marine resource utilization.

Locations

Barcelona, , Spain

Patients applied

0 patients applied

Trial Officials

Juan M Corral, Doctor

Principal Investigator

Hospital Clinic (Barcelona, Spain)

Meritxell Jodar, Doctor

Principal Investigator

Hospital Clinic (Barcelona, Spain)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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