New "System Medicine" Approach for the Development of Primary Prevention Strategies for Comorbidities in Infertile Men
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Genetic profile
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Genetic profile
Time Frame: Baseline
Data on karyotype and microdeletions of the Y chromosome
Semen volume
Time Frame: Baseline
Semen volume (ml)
Body mass index
Time Frame: Baseline
Dataon Body mass index
Thyroid-stimulating hormone
Time Frame: Baseline
Data on thyroid-stimulating hormone (mU/L)
Semen concentration
Time Frame: Baseline
number of spermatozoa (million/ml)
Testosterone
Time Frame: Baseline
data on testosterone (ng/dL)
Medical anamnesis
Time Frame: Baseline
Data collection on Charlson Comorbidity Index (CCI), partner's age, partner's health status;
Objective examination
Time Frame: Baseline
presence of varicocele; testicular size and number
Follicle-stimulating hormone
Time Frame: Baseline
Data on follicle-stimulating hormone (mIU/ml)
Luteinizing hormone
Time Frame: Baseline
Data on luteinizing hormone (mIU/dl)
Anti-Müllerian hormone
Time Frame: Baseline
Data on Anti-Müllerian hormone (ng/ml)
Inhibin B
Time Frame: Baseline
Data on Inhibin B (UI/mL)
Prolactin
Time Frame: Baseline
Data on Prolactin (µg/l)
Osteocalcin levels
Time Frame: Baseline
Data on osteocalcin levels (ng/ml)
Spermatozoa motility and morphology
Time Frame: Baseline
motility and morphology of spermatozoa (%)
Secondary Outcomes
No secondary outcomes reported
Investigators
Andrea Salonia
Professor
IRCCS San Raffaele