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NCT Number: NCT06974175

Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation

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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Key information

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location contact

DOMENICO MILARDI

CONTACT

[email protected]

+0630155297

DOMENICO MILARDI

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deprox_HP

Other

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

Peacist

Other

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

Primary outcomes

  1. Modifications of number of spermatozoa

    Time frame: 6 months

    Modifications of the number of spermatozoa in Millions

  2. Modification of sperm motility

    Time frame: 6 months

    Modification of sperm progressive motility in %

  3. Modifications of number of typical forms

    Time frame: 6 months

    Modifications of number of typical forms in %

Secondary outcomes

  1. Modifications of seminal inflammatory parameters

    Time frame: 6 months

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

  2. Modifications of seminal oxidative parameters

    Time frame: 6 months

    Modifications of reactive oxygen species expressed in mEq

Study contacts

Contact information is provided by the study sponsor or research team.

Domenico Milardi

CONTACT

[email protected]

+390630155297

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: DEPR_1

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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