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Search / Trial NCT06974175

Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · May 8, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a natural supplement called Graminex, found in Deprox HP, on male infertility caused by inflammation in the male reproductive system. Inflammation in areas like the prostate and seminal vesicles can lead to problems with fertility, as it affects the quality and flow of semen. The trial will involve 40 male participants—20 will take Deprox HP with Graminex, and 20 will receive a different treatment. Researchers will look at how this supplement impacts various measurements related to semen quality and inflammation over three months.

To be eligible for this trial, men must have a diagnosis of Male Accessory Glands Inflammation (MAGI) based on medical tests or imaging studies. However, those with certain conditions, like testicular issues, hormonal imbalances, or specific genetic disorders, will not be able to participate. If you join the study, you'll be monitored closely to see how the treatment affects your health and fertility, but it's important to note that this trial is not yet recruiting participants.

Gender

MALE

Eligibility criteria

  • 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.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Roma, , Italy

Patients applied

0 patients applied

Trial Officials

Domenico Milardi

Principal Investigator

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported