Clinical Trial

Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation

Study acronym: DEPR_1
Not Yet Recruiting
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Record status
This record was last updated August 14, 2025 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-08.
Trial Details
NCT Number NCT06974175
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Male Infertility, Prostatitis
Enrollment 50 participants
Start Date 2025-09-01
Primary Completion 2026-03-30 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-14