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Clinical Trials in Italy / NCT06974175
Starting soon Not applicable

Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation

NCT06974175 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Not applicable
Started
2025-09-01
Last updated
2025-08-14

Condition(s) studied

Male InfertilityProstatitis

Investigational drug(s) / intervention(s)

Deprox_HPPeacist

Deprox_HP: Use of nutraceutic based on a compound of pollen extracts from pollen, mais and timothy

Peacist: Use of a nutraceutic based on palmitoilethanolamide + Bromelin + Horse Chestunt extract

Study 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

Sex
MALE
Min age
20 Years
Max age
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.

Primary outcome measure(s)

  • 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 %

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS Roma Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06974175 on ClinicalTrials.gov ↗ ← All trials in Italy