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

Infertility Clinical Trial

Official title:

New "System Medicine" Approach for the Development of Primary Prevention Strategies for Comorbidities in Infertile Men

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183255
• Other study ID #: RF-201912368847
• Status: Recruiting
• Start date: January 18, 2021
• Est. completion date: July 2025

Study information

• Verified date: December 2023
• Source: IRCCS San Raffaele
• Contact: Andrea Salonia, MD
• Phone: 02 2643 5661
• Email: salonia.andrea[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

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