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.
Study Type
OBSERVATIONAL
Enrollment
200
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.
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy
RECRUITINGMedical anamnesis
Data collection on Charlson Comorbidity Index (CCI), partner's age, partner's health status;
Time frame: Baseline
Objective examination
presence of varicocele; testicular size and number
Time frame: Baseline
Testosterone
data on testosterone (ng/dL)
Time frame: Baseline
Genetic profile
Data on karyotype and microdeletions of the Y chromosome
Time frame: Baseline
Semen volume
Semen volume (ml)
Time frame: Baseline
Body mass index
Dataon Body mass index
Time frame: Baseline
Follicle-stimulating hormone
Data on follicle-stimulating hormone (mIU/ml)
Time frame: Baseline
Luteinizing hormone
Data on luteinizing hormone (mIU/dl)
Time frame: Baseline
Anti-Müllerian hormone
Data on Anti-Müllerian hormone (ng/ml)
Time frame: Baseline
Inhibin B
Data on Inhibin B (UI/mL)
Time frame: Baseline
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Prolactin
Data on Prolactin (µg/l)
Time frame: Baseline
Thyroid-stimulating hormone
Data on thyroid-stimulating hormone (mU/L)
Time frame: Baseline
Osteocalcin levels
Data on osteocalcin levels (ng/ml)
Time frame: Baseline
Semen concentration
number of spermatozoa (million/ml)
Time frame: Baseline
Spermatozoa motility and morphology
motility and morphology of spermatozoa (%)
Time frame: Baseline