NCT06082362

Brief Summary

The aim of the project is identify new biomarkers and/or prognostic factors in order to develop personalized strategies to prevent the onset of tumor and/or non tumor comorbidity in infertile men.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

June 21, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

June 13, 2023

Last Update Submit

October 9, 2023

Conditions

Male Infertility

Keywords

InfertilityMale InfertilityComorbidityAndrologyImmuno-epidemiologyEnvironmental factorsGenetic factors

Outcome Measures

Primary Outcomes (3)

  • Endocrine-metabolomic parameters

    Endocrine-metabolomic parameters from blood samples: Sex Hormone Binding Globulin (SHBG), 17 beta estradiol (E2), Follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin, thyroid-stimulating hormone (TSH), inhibin B, Anti-Muller Hormone (AMH), Glucose 6-phosphate Dehydrogenase (G6PD), parathyroid hormone (PTH), Vitamine D, blood glucose test, osteocalcin, Prostate Specific Antigen (PSA), albumin.

    Baseline

  • Functional characterization of immune cells

    We will assess: * presence and frequency of different myeloid and lymphoid populations through a multi-color flow cytometry * the ability of Cluster of Differentiation CD4+ cells and of Cluster of Differentiation CD8+ T cells to proliferate and secrete cytokines in response to anti-Cluster of Differentiation CD3 monoclonal antibodies * the presence and concentration of cytokines and chemokines in the other leucocyte populations * Depth T cell compartments through a single cell RiboNucleic Acid-sequencing analysis

    Baseline

  • Clinical data

    We will collect: * Clinical andrological and medical data through the physician's assessment * Body Mass Index (BMI) * waist circumference * a spermiogram analysis: the presence, the number, the motility, and the shape of spermatozoa

    Baseline

Secondary Outcomes (2)

  • Immunological outcomes

    Baseline

  • Senescence biomarkers

    Baseline

Study Arms (3)

Infertile men

Men with infertility

Other: Collection of clinical and biological material

Fertile men

Fertile men

Other: Collection of clinical and biological material

Oncologic patients

Patients with kidney, bladder, chest, or pancreas tumors

Other: Collection of clinical and biological material

Interventions

Collection of clinical and biological materialOTHER

Collection of clinical and biological material (e.g., samples of semen, stool, urine, blood, buccal swab)

Fertile menInfertile menOncologic patients

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Infertile men compared to fertile men and men with uro-oncologic tumors.

You may qualify if:

  • Age \> 18 and \< 50 years;
  • White race
  • Men with OAT o iNOA infertility diagnosis
  • ability to sign the consent information

You may not qualify if:

  • inability to sign the consent information
  • secondary infertility diagnosis
  • history of hematological diseases
  • people treated with antibiotics in the six months prior the enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Infertility, MaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Andrea Salonia, MD

    IRCCS Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Salonia, MD

CONTACT

02 2643 5661salonia.andrea@hsr.it

Alessia d'Arma, MSc

CONTACT

02 2643 5506darma.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

June 13, 2023

First Posted

October 13, 2023

Study Start

June 21, 2023

Primary Completion

June 20, 2024

Study Completion

June 20, 2025

Last Updated

October 13, 2023

Record last verified: 2023-10

Locations

IT(1)