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

NCT06183255 | Unknown DMC

• 1 other identifier: RF-201912368847
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Male Infertility

Keywords

Infertility; Male Infertility; Comorbidity

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (2)

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

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

Interventions

Observation and evaluation of clinical parameters in the two cohorts OTHER

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; Infertile men

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fertile and infertile men according to WHO criteria (2010)

You may qualify if:

• Signature of the informed consent;
• Be adults aged \> 18;
• Caucasian race;
• Documented diagnosis of primary male infertility with pure male factor;

You may not qualify if:

• Failure to obtain informed consent;
• Patients with a known history of haematological disease;
• Patients undergoing antibiotic treatments in the last 6 months

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Infertility; Infertility, Male

Interventions

Observation

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Andrea Salonia, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Salonia, MD

CONTACT

02 2643 5661; salonia.andrea@hsr.it

Alessia d'Arma, PhD

CONTACT

02 2643 5506; darma.alessia@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 27, 2023
• Study Start: January 18, 2021
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)