Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation (DEPR_1)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Prostatitis; Male Infertility

Treatments: Other: Peacist; Other: Deprox_HP

Study type: Interventional

Funder types: Other

Identifiers

NCT06974175

5878 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Group 1: Deprox HP

Experimental group

Description:

Patients with MAGI that will be given Deprox HP therapy

Treatment:

Other: Deprox_HP

Group 2: PEA+bromelin+horse chestnut extract

Active Comparator group

Description:

Patients with MAGI that will be given PEA+bromelin+horse chestnut extract

Treatment:

Other: Peacist