AzTrials
AzTrials

Male InfertilityDEPR_1NCT06974175

Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation

A study testing Deprox_HP and Peacist in people with Male Infertility and Prostatitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 20 to 55 years, men only
Conditions the study is for
Male Infertility, Prostatitis
What is being tested?
Deprox_HP and Peacist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteItaly
Study dates
1 Sep 2025to 1 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 55 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Domenico Milardi contact

+390630155297

domenico.milardi@policlinicogemelli.it

Italy1 site

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168

    DOMENICO MILARDI, +0630155297, domenico.milardi@policlinicogemelli.it

    DOMENICO MILARDI

Other trials in Italy

About this study

Official title: 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.

Being tested
Deprox_HP, Peacist
Medical subject headings
Infertility, Male, Prostatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deprox_HPOther

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

  • PeacistOther

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

Study groups in NCT06974175
Study groupRoleWhat they receive
Group 1: Deprox HPExperimentalPatients with MAGI that will be given Deprox HP therapy
Receives: Other: Deprox_HP
Group 2: PEA+bromelin+horse chestnut extractActive comparatorPatients with MAGI that will be given PEA+bromelin+horse chestnut extract
Receives: Other: Peacist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modifications of number of spermatozoa

    Modifications of the number of spermatozoa in Millions

    Measured: 6 months

  2. Modification of sperm motility

    Modification of sperm progressive motility in %

    Measured: 6 months

  3. Modifications of number of typical forms

    Modifications of number of typical forms in %

    Measured: 6 months

Secondary outcomes (2)

  1. Modifications of seminal inflammatory parameters

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

    Measured: 6 months

  2. Modifications of seminal oxidative parameters

    Modifications of reactive oxygen species expressed in mEq

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion30 Mar 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06974175
Sponsor's protocol ID
5878
Acronym
DEPR_1
Status last verified
Jul 2025
First submitted
21 Nov 2024
Last updated
14 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Deprox_HP and Peacist in people with Male Infertility and Prostatitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Domenico Milardi (+390630155297, domenico.milardi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modifications of number of spermatozoa (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06974175, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

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