Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation

Not Applicable

Not yet recruiting

• Conditions: Male Infertility; Prostatitis

• Registration Number: NCT06974175
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15
• Study Start: 2025-05-20
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, Italy