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By applying a "system medicine" approach, the project aims to identify new biomarkers and/or prognostic tools aimed at developing personalized strategies to prevent the onset of comorbidities in infertile men.
By applying a "system medicine" approach, the project aims to identify new biomarkers and/or prognostic tools aimed at developing personalized strategies to prevent the onset of comorbidities in infertile men.
The findings will provide new insights into the relationship between male infertility and somatic health, and shed light on the role of the microbiome in modulating the activity of the immune system. A "signature" of lack of immunological tolerance and biomarkers could be useful to predict future oncologic and non-oncological comorbidities in infertile men. This will let the development of a more clinically reliable and cost-effective personalized primary/secondary prevention strategy in a population at high risk of clinically relevant diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infertile men | Men with a diagnosis of pure Male Factor Infertility, as for WHO criteria |
| |
| Fertile men | Fathers with at least one child, spontaneously conceived, with a time-to-pregnancy within 12 months, as for WHO criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation and evaluation of clinical parameters in the two cohorts | Other | During medical history evaluation, all factors that could negatively affect male fertility, like prevalent comorbidities, previous testis surgery, and any disorder affecting testicular function will be investigated in fertile and infertile men. Moreover, family history will be deeply investigated, including fertility status and prevalence of malignant Non Communicables Diseases. A comprehensive physical examination will be performed on each infertile and fertile man. |
| Measure | Description | Time Frame |
|---|---|---|
| Medical anamnesis | Data collection on Charlson Comorbidity Index (CCI), partner's age, partner's health status; | Baseline |
| Objective examination | presence of varicocele; testicular size and number | Baseline |
| Testosterone | data on testosterone (ng/dL) | Baseline |
| Genetic profile | Data on karyotype and microdeletions of the Y chromosome | Baseline |
| Semen volume | Semen volume (ml) | Baseline |
| Body mass index | Dataon Body mass index | Baseline |
| Follicle-stimulating hormone | Data on follicle-stimulating hormone (mIU/ml) | Baseline |
| Luteinizing hormone | Data on luteinizing hormone (mIU/dl) | Baseline |
| Anti-Müllerian hormone | Data on Anti-Müllerian hormone (ng/ml) |
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Inclusion Criteria:
Exclusion Criteria:
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Fertile and infertile men according to WHO criteria (2010)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Salonia, MD | Contact | 02 2643 5661 | salonia.andrea@hsr.it | |
| Alessia d'Arma, PhD | Contact | 02 2643 5506 | darma.alessia@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Salonia, MD | IRCCS Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Recruiting | Milan | Lombardy | 20132 | Italy |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| Baseline |
| Inhibin B | Data on Inhibin B (UI/mL) | Baseline |
| Prolactin | Data on Prolactin (µg/l) | Baseline |
| Thyroid-stimulating hormone | Data on thyroid-stimulating hormone (mU/L) | Baseline |
| Osteocalcin levels | Data on osteocalcin levels (ng/ml) | Baseline |
| Semen concentration | number of spermatozoa (million/ml) | Baseline |
| Spermatozoa motility and morphology | motility and morphology of spermatozoa (%) | Baseline |