Clinical trial NCT06974175: Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation
Official title: Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation. Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Male Infertility
Prostatitis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 50
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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,
* ultrasound testicular volume \<12 mL,
* FSH \>8 mUI/L,
* fever or drug use within 3 months prior to the enrollment in this study
* azoospermia.

Primary outcomes:
measure: Modifications of number of spermatozoa
timeFrame: 6 months
measure: Modification of sperm motility
timeFrame: 6 months
measure: Modifications of number of typical forms
timeFrame: 6 months
Secondary outcomes:
measure: Modifications of seminal inflammatory parameters
timeFrame: 6 months
measure: Modifications of seminal oxidative parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Domenico Milardi
role: PRINCIPAL_INVESTIGATOR
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