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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, , Italy
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