Evaluation of the Effects of Semen Incubation With ANDROSITOL®DGN on Sperm Motility and Mitochondrial Membrane Potential
Condition: Asthenozoospermia; Mitochondrial Damage
MeSH terms: Asthenozoospermia
Study type: Interventional

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.
    

Detailed description: 
      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, both pathological and normal, treated in
      vitro with ANDROSITOL®DGN - a concentrate solution (66X) containing 133 mg/ml of myo-inositol
      - 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. High
      responders have worst mitochondrial function and lower fertilizing capacity, and could
      represent the category of patients most benefiting from supplementary oral therapy with
      antioxidants and myo-inositol.

      The aim of our 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. To do this, the investigators will enroll at
      least 13 patients for each category (low, medium, and high responder at ANDROSITOL®TEST) and
      they will re-evaluate conventional seminal parameters, mitochondrial function, and response
      to ANDROSITOL®TEST after three months of oral supplementation with ANDROSITOL® (dietary
      supplement of myo-inositol, vitamin E, L-carnitine, L-arginine, folic acid and selenium). The
      investigators hypothesize that, following supplementation, high-responder patients will
      exhibit the best improvement in seminal parameters, in particular in sperm motility.
      Furthermore, if the mitochondrial function is fully restored, they should respond less to the
      ANDROSITOL®TEST and could be reclassified as low responders.
    

Intervention name(s): ANDROSITOL®TEST
Intervention type(s): Diagnostic Test
Intervention description(s): Sperm incubation with ANDROSITOL®DGN and evaluation of sperm motility and mithocondrial membrane potential
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Male infertility; Sperm parameters; Mitochondrial membrane potential