"System Medicine" Approach for Prevention Strategies for Comorbidities in Infertile Men

San Donato Group (GSD)

Status: Enrolling

Conditions: Infertility; Male Infertility

Treatments: Other: Observation and evaluation of clinical parameters in the two cohorts

Study type: Observational

Funder types: Other

Identifiers

NCT06183255

RF-201912368847

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Infertile men

Description:

Men with a diagnosis of pure Male Factor Infertility, as for WHO criteria

Treatment:

Other: Observation and evaluation of clinical parameters in the two cohorts

Fertile men

Description:

Fathers with at least one child, spontaneously conceived, with a time-to-pregnancy within 12 months, as for WHO criteria

Treatment:

Other: Observation and evaluation of clinical parameters in the two cohorts