ClinicalTrials.gg
Not yet recruitingNCT06974175DEPR_1Updated Aug 14, 2025

Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation

An interventional study of Deprox_HP and Peacist in Male Infertility and Prostatitis, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to male participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
20 Years to 55 Years
Sex
Male
01

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.

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Conditions studied

  • Male Infertility
  • Prostatitis
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In context

Infertility, Male

282 studies on the registry are indexed under Infertility, Male; 65 are open to participants now.

This study's planned enrollment of 50 is below the median of 80 across 187 interventional studies indexed under Infertility, Male.

Browse Infertility, Male studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Group 1: Deprox HP

    Patients with MAGI that will be given Deprox HP therapy

    Other: Deprox_HP

  • Active comparator
    Group 2: PEA+bromelin+horse chestnut extract

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

    Other: Peacist

Interventions

  • OtherDeprox_HP

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

  • OtherPeacist

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

06

What researchers measure

Primary outcomes

  1. Modifications of number of spermatozoa

    Modifications of the number of spermatozoa in Millions

    Time frame: 6 months

  2. Modification of sperm motility

    Modification of sperm progressive motility in %

    Time frame: 6 months

  3. Modifications of number of typical forms

    Modifications of number of typical forms in %

    Time frame: 6 months

Secondary outcomes

  1. Modifications of seminal inflammatory parameters

    Modifications of seminal inflammatory parameters ST2 and SuPAR, both expressed in ng/mL

    Time frame: 6 months

  2. Modifications of seminal oxidative parameters

    Modifications of reactive oxygen species expressed in mEq

    Time frame: 6 months

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Study locations

1 site
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References and documents

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. PubMed 21919943 ↗
  • 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. PubMed 11028927 ↗
  • 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. PubMed 10582779 ↗
  • 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. PubMed 2822642 ↗
  • 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. PubMed 446777 ↗
  • 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. PubMed 881664 ↗
  • 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. PubMed 26384478 ↗
  • 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. PubMed 29667546 ↗
  • Schroder K, Tschopp J. The inflammasomes. Cell. 2010 Mar 19;140(6):821-32. doi: 10.1016/j.cell.2010.01.040. PubMed 20303873 ↗
  • 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. PubMed 29651937 ↗
  • 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. PubMed 23040525 ↗
  • 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. PubMed 26592517 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06974175
Responsible party
Sponsor
First posted
May 15, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Mar 30, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
Aug 14, 2025

Study contacts

Domenico Milardi
Contact
domenico.milardi@policlinicogemelli.it
+390630155297
Domenico Milardi
principal investigator · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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