CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
ANDROSITOL®TESTother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04291495
NCT04291495N/ACompleted

Evaluation of the Effects of Semen Incubation With ANDROSITOL®DGN on Sperm Motility and Mitochondrial Membrane Potential Before and After Oral Supplementation With Antioxidants and Myo-inositol

University of Catania·interventional·Posted Mar 2, 2020·Updated May 13, 2021

In Brief

A clinical study evaluating ANDROSITOL®TEST for Asthenozoospermia and Mitochondrial Damage. Completed, enrolled 25 participants across 1 site.

Detailed Summary

Mitochondria is the cellular organelle responsible for the production of the energy necessary to fuel sperm motility. It has been demonstrated that mitochondrial efficiency is correlated to the fertilizing capacity of the spermatozoon and to the production of high quality embryos. Mitochondria efficiency is measured in the laboratory setting by evaluating the mitochondrial membrane potential. Myo-inositol is the most represented stereoisomer of the family of inositols and is the only one physiologically concentrated within the seminal plasma. It is essential for sperm maturation and motility and its deficiency is also associated to a reduced sperm count. Myo-inositol promotes motility and allows recovering a higher number of sperm cells after swim-up, both in normospermic patients and in patients with altered seminal parameters. Scientific studies have shown that semen samples treated in vitro with ANDROSITOL®DGN, show an improvement in mitochondrial efficiency that results in an increase in spermatozoa progressive motility. Based on the percentage increase in the progressive motility showed by the spermatozoa after incubation with ANDROSITOL®DGN (ANDROSITOL®TEST), it is possible to subdivide the semen samples into three categories: low, medium, and high responders. The aim of the study is to evaluate whether the in vitro response of spermatozoa to ANDROSITOL®TEST correlates with the in vivo improvement of seminal parameters after oral treatment with antioxidants and myo-inositol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 2, 2020
Enrollment StartOct 23, 2018
Primary CompletionOct 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.3 years ago

Interventions

ANDROSITOL®TESTother

Sperm incubation with ANDROSITOL®DGN and evaluation of sperm motility and mithocondrial membrane potential