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

Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation. Pilot Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Male Infertility; Prostatitis
• Intervention / Treatment: Other: Deprox_HP; Other: Peacist

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Domenico Milardi; Phone Number: +390630155297; Email: domenico.milardi@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Contact: DOMENICO MILARDI; Phone Number: +0630155297; Email: domenico.milardi@policlinicogemelli.it
    • Principal Investigator: DOMENICO MILARDI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Deprox HP; Patients with MAGI that will be given Deprox HP therapy	Other: Deprox_HP; Use of nutraceutic based on a compound of pollen extracts from pollen, mais and timothy
Active Comparator: Group 2: PEA+bromelin+horse chestnut extract; Patients with MAGI that will be given PEA+bromelin+horse chestnut extract	Other: Peacist; Use of a nutraceutic based on palmitoilethanolamide + Bromelin + Horse Chestunt extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modifications of number of spermatozoa	Modifications of the number of spermatozoa in Millions	6 months
Modification of sperm motility	Modification of sperm progressive motility in %	6 months
Modifications of number of typical forms	Modifications of number of typical forms in %	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modifications of seminal inflammatory parameters	Modifications of seminal inflammatory parameters ST2 and SuPAR, both expressed in ng/mL	6 months
Modifications of seminal oxidative parameters	Modifications of reactive oxygen species expressed in mEq	6 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Domenico Milardi, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

General Publications

• La Vignera S, Condorelli RA, Vicari E, D'Aagata R, Salemi M, Calogero AE. Hyperviscosity of semen in patients with male accessory gland infection:direct measurement with quantitative viscosimeter. Andrologia. 2012 May;44 Suppl 1:556-9. doi: 10.1111/j.1439-0272.2011.01226.x. Epub 2011 Sep 15.
• Gopalkrishnan K, Padwal V, Balaiah D. Does seminal fluid viscosity influence sperm chromatin integrity? Arch Androl. 2000 Sep-Oct;45(2):99-103. doi: 10.1080/014850100418783.
• Comhaire FH, Mahmoud AM, Depuydt CE, Zalata AA, Christophe AB. Mechanisms and effects of male genital tract infection on sperm quality and fertilizing potential: the andrologist's viewpoint. Hum Reprod Update. 1999 Sep-Oct;5(5):393-8. doi: 10.1093/humupd/5.5.393.
• Alvarez JG, Touchstone JC, Blasco L, Storey BT. Spontaneous lipid peroxidation and production of hydrogen peroxide and superoxide in human spermatozoa. Superoxide dismutase as major enzyme protectant against oxygen toxicity. J Androl. 1987 Sep-Oct;8(5):338-48. doi: 10.1002/j.1939-4640.1987.tb00973.x.
• Jones R, Mann T, Sherins R. Peroxidative breakdown of phospholipids in human spermatozoa, spermicidal properties of fatty acid peroxides, and protective action of seminal plasma. Fertil Steril. 1979 May;31(5):531-7. doi: 10.1016/s0015-0282(16)43999-3.
• Jones R, Mann T. Damage to ram spermatozoa by peroxidation of endogenous phospholipids. J Reprod Fertil. 1977 Jul;50(2):261-8. doi: 10.1530/jrf.0.0500261.
• Autilio C, Morelli R, Milardi D, Grande G, Marana R, Pontecorvi A, Zuppi C, Baroni S. Soluble urokinase-type plasminogen activator receptor as a putative marker of male accessory gland inflammation. Andrology. 2015 Nov;3(6):1054-61. doi: 10.1111/andr.12084. Epub 2015 Sep 18.
• Milardi D, Grande G, Autilio C, Mancini F, De Marinis L, Marana R, Zuppi C, Urbani A, Pontecorvi A, Baroni S. Seminal suPAR Levels as Marker of Abacterial Male Accessory Gland Inflammation in Hypogonadism. Protein Pept Lett. 2018;25(5):478-482. doi: 10.2174/0929866525666180418121421.
• Schroder K, Tschopp J. The inflammasomes. Cell. 2010 Mar 19;140(6):821-32. doi: 10.1016/j.cell.2010.01.040.
• Inan, S. The Potential Role of Nutraceuticals in Inflammation and Oxidative Stress. IntechOpen. 2020.
• Zhang X, Ibrahim E, de Rivero Vaccari JP, Lotocki G, Aballa TC, Dietrich WD, Keane RW, Lynne CM, Brackett NL. Involvement of the inflammasome in abnormal semen quality of men with spinal cord injury. Fertil Steril. 2013 Jan;99(1):118-124.e2. doi: 10.1016/j.fertnstert.2012.09.004. Epub 2012 Oct 3.
• Cui ZW, Xie ZX, Wang BF, Zhong ZH, Chen XY, Sun YH, Sun QF, Yang GY, Bian LG. Carvacrol protects neuroblastoma SH-SY5Y cells against Fe(2+)-induced apoptosis by suppressing activation of MAPK/JNK-NF-kappaB signaling pathway. Acta Pharmacol Sin. 2015 Dec;36(12):1426-36. doi: 10.1038/aps.2015.90. Epub 2015 Nov 23.
• Di Nicuolo F, Specchia M, Trentavizi L, Pontecorvi A, Scambia G, Di Simone N. An Emerging Role of Endometrial Inflammasome in Reproduction: New Therapeutic Approaches. Protein Pept Lett. 2018;25(5):455-462. doi: 10.2174/0929866525666180412160045.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: May 8, 2025
• First Posted (Actual): May 15, 2025

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Inflammation; Infertility; Infertility, Male; Prostatitis
• Other Study ID Numbers: 5878 (CTEP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No