Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age20-55
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

Male Accessory Glands Inflammations (MAGI) include inflammatory diseases involving seminal vescicles and the prostate. Patients suffering from them present an impaired fertility because of seminal duct obstruction and alterations of the rheologic and functional parameters of semen, induced by direct microbiological action as well as inflammatory and oxidative damage. Inflammation in seminal plasma can be detected and measured by dosing of inflammatory molecules such as SuPAR and ST2. Treatment of MAGIs include specific antibiotic therapy in addition to use of anti-inflammatory nutraceutics. Deprox HP is a nutraceutic containing GraminexTM, a compound made of pollen extracts of rye, mais and timothy. To investigate its efficacy, we evalued seminal parameters, inflammatory and oxidative molecules in seminal plasma and clinical and ultrasonographic features of male accessory glands before and after 3 months of treatment in 20 patients taking Deprox HP and 20 patients undergoing treatment with palmitoilethanolammide, bromelin and horse chestnut extract.

Eligibility criteria

Qualifiers

Male patients with a diagnosis of MAGI based on clinical and/or ultrasonographic criteria.

Disqualifiers

History of cryptorchidism, orchitis, testicular torsion or trauma,

Hypogonadism,

Occupational chemical exposure,

Y chromosome microdeletions, karyotype abnormalities and Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) mutations,

Trial design

Treatments tested in this trial

  • Deprox_HP
  • Peacist

Treatment groups

50 Participants
are divided into 2 treatment groups