Analyzing microbiome and metabolites in men with non-obstructive azoospermia
Microbiome and Metabolomics Analysis in a Population of Infertile Patients Suffering From Non-obstructive Azospermia and Examination of Their Impact on the Reproductive Potential and Global Health of the Individual
This study looks at the gut bacteria and metabolites in men who can’t produce sperm to see if there are any clues that could help them have children.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT06181851 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the microbiome and metabolomic profiles of patients with non-obstructive azoospermia to identify prognostic factors that may predict the presence of spermatozoa after testicular pulp extraction. It compares these profiles with those of fertile men and older men to explore potential etiopathogenic pathways and assess similarities that may indicate premature aging in infertile patients. The study aims to provide insights into the biological mechanisms underlying this condition.
Who should consider this trial
Good fit: Ideal candidates include men diagnosed with idiopathic non-obstructive azoospermia and fertile men aged 65 to 75.
Not a fit: Patients with varicocele, endocrine alterations, chromosomal alterations, or known genetic alterations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and potential new treatment strategies for men suffering from non-obstructive azoospermia.
How similar studies have performed: While the specific approach of combining microbiome and metabolomics in this context is novel, similar studies have shown promise in understanding infertility.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of idiopathic non-obstructive azoospermia * fertile men (pregnancy within 12 months from the start of the couple's search) * men known to have been fertile aged between 65 and 75 (pregnancy within 12 months of the couple starting searching) Exclusion Criteria: * diagnosis of varicocele * endocrine alterations * chromosomal alterations * known genetic alterations
Where this trial is running
Milan, Lombardy
- IRCCS Ospedale San Raffaele — Milan, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Andrea Salonia, MD
- Email: salonia.andrea@hsr.it
- Phone: 02 2643 5661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.