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

New "System Medicine" Approach for the Development of Primary Prevention Strategies for 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.

Study Overview

• Status: Recruiting
• Conditions: Infertility; Male Infertility
• Intervention / Treatment: Other: Observation and evaluation of clinical parameters in the two cohorts

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Andrea Salonia, MD; Phone Number: 02 2643 5661; Email: salonia.andrea@hsr.it
• Study Contact Backup: Name: Alessia d'Arma, PhD; Phone Number: 02 2643 5506; Email: darma.alessia@hsr.it

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • IRCCS Ospedale San Raffaele
      • Contact: Alessia d'Arma, PhD; Phone Number: 02 2643 5506; Email: darma.alessia@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Fertile and infertile men according to WHO criteria (2010)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Principal Investigator: Andrea Salonia, MD, IRCCS Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Estimated): December 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Infertility; Comorbidity; Male Infertility
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Infertility; Infertility, Male
• Other Study ID Numbers: RF-201912368847

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No