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

Recruiting

• Conditions: Infertility; Male Infertility
• Interventions: Other: Observation and evaluation of clinical parameters in the two cohorts

• Registration Number: NCT06183255
• Lead Sponsor: IRCCS San Raffaele

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 Timeline

• Study Start: 2021-01-18
• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-13
• Last Update Submitted: 2023-12-13
• Study First Posted: 2023-12-27
• Last Update Posted: 2023-12-27
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infertile men	Observation and evaluation of clinical parameters in the two cohorts	Men with a diagnosis of pure Male Factor Infertility, as for WHO criteria
Fertile men	Observation and evaluation of clinical parameters in the two cohorts	Fathers with at least one child, spontaneously conceived, with a time-to-pregnancy within 12 months, as for WHO criteria

Primary Outcome Measures

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

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Lombardy, Italy