Male Infertility, Prostatitis
Conditions
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.
Interventions
OTHERDeprox_HP
Use of nutraceutic based on a compound of pollen extracts from pollen, mais and timothy
OTHERPeacist
Use of a nutraceutic based on palmitoilethanolamide + Bromelin + Horse Chestunt extract
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modifications of number of spermatozoa | 6 months | Modifications of the number of spermatozoa in Millions |
| Modification of sperm motility | 6 months | Modification of sperm progressive motility in % |
| Modifications of number of typical forms | 6 months | Modifications of number of typical forms in % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modifications of seminal inflammatory parameters | 6 months | Modifications of seminal inflammatory parameters ST2 and SuPAR, both expressed in ng/mL |
| Modifications of seminal oxidative parameters | 6 months | Modifications of reactive oxygen species expressed in mEq |
Countries
Italy
Contacts
Primary ContactDomenico Milardi
Outcome results
None listed