Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation

NCT06974175 | Not Yet Recruiting

• 1 other identifier: 5878
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Infertility; Prostatitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Modifications of seminal inflammatory parameters

  6 months

• Modifications of seminal oxidative parameters

  6 months

Study Arms (2)

Group 1: Deprox HP

EXPERIMENTAL

Patients with MAGI that will be given Deprox HP therapy

Other: Deprox_HP

Group 2: PEA+bromelin+horse chestnut extract

ACTIVE COMPARATOR

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

Other: Peacist

Interventions

Deprox_HP OTHER

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

Group 1: Deprox HP

Peacist OTHER

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

Group 2: PEA+bromelin+horse chestnut extract

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male patients with a diagnosis of MAGI based on clinical and/or ultrasonographic criteria.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

Related Publications (13)

• 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.

  PMID: 21919943 RESULT

• 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.

  PMID: 11028927 RESULT

• 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.

  PMID: 10582779 RESULT

• 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.

  PMID: 2822642 RESULT

• 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.

  PMID: 446777 RESULT

• 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.

  PMID: 881664 RESULT

• 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.

  PMID: 26384478 RESULT

• 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.

  PMID: 29667546 RESULT

• Schroder K, Tschopp J. The inflammasomes. Cell. 2010 Mar 19;140(6):821-32. doi: 10.1016/j.cell.2010.01.040.

  PMID: 20303873 RESULT

• 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.

  PMID: 29651937 RESULT

• Inan, S. The Potential Role of Nutraceuticals in Inflammation and Oxidative Stress. IntechOpen. 2020.

  RESULT

• 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.

  PMID: 23040525 RESULT

• 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.

  PMID: 26592517 RESULT

MeSH Terms

Conditions

Infertility, Male; Prostatitis

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Prostatic Diseases

Study Officials

• Domenico Milardi

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Domenico Milardi

CONTACT

+390630155297; domenico.milardi@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: May 15, 2025
• Study Start: September 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: May 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-07

Locations

IT (1)