Preventing comorbidities in infertile men using a system medicine approach
New "System Medicine" Approach for the Development of Primary Prevention Strategies for Comorbidities in Infertile Men
This study is trying to find new ways to help men with infertility stay healthier by looking at their overall health and the role of their gut bacteria.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT06183255 on ClinicalTrials.gov |
What this trial studies
This project utilizes a system medicine approach to identify new biomarkers and prognostic tools aimed at developing personalized strategies for preventing comorbidities in men with infertility. The study will evaluate clinical parameters in cohorts of infertile men to understand the relationship between male infertility and overall health. It will also explore the role of the microbiome in immune system activity, potentially leading to more effective prevention strategies for related health issues.
Who should consider this trial
Good fit: Ideal candidates are adult Caucasian men over 18 with a documented diagnosis of primary male infertility.
Not a fit: Patients with a known history of hematological disease or those undergoing antibiotic treatments in the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized prevention strategies that reduce the risk of comorbidities in infertile men.
How similar studies have performed: While the approach is innovative, similar studies have shown promise in understanding the links between infertility and overall health, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signature of the informed consent; * Be adults aged \> 18; * Caucasian race; * Documented diagnosis of primary male infertility with pure male factor; Exclusion Criteria: * Failure to obtain informed consent; * Patients with a known history of haematological disease; * Patients undergoing antibiotic treatments in the last 6 months
Where this trial is running
Milan, Lombardy
- IRCCS Ospedale San Raffaele — Milan, Lombardy, Italy (Recruiting)
Study contacts
- Principal investigator: Andrea Salonia, MD — IRCCS Ospedale San Raffaele
- 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.