Personalized Signature of Chronic Inflammation and Early Aging Predictive of the Comorbidities in Infertile Men
Definition of a Personalized Signature of Chronic Inflammation and Early Aging Predictive of the Development of Comorbidities in Infertile Men
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Andrea Salonia, MD
- Phone Number: 02 2643 5661
- Email: salonia.andrea@hsr.it
Study Contact Backup
- Name: Alessia d'Arma, MSc
- Phone Number: 02 2643 5506
- Email: darma.alessia@hsr.it
Study Locations
-
-
Lombardy
-
Milan, Lombardy, Italy, 20132
- Recruiting
- IRCCS Ospedale San Raffaele
-
Contact:
- Alessia d'Arma, MSc
- Phone Number: 02 2643 5506
- Email: darma.alessia@hsr.it
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 and < 50 years;
- White race
- Men with OAT o iNOA infertility diagnosis
- ability to sign the consent information
Exclusion Criteria:
- inability to sign the consent information
- secondary infertility diagnosis
- history of hematological diseases
- people treated with antibiotics in the six months prior the enrollment
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Infertile men
Men with infertility
|
Collection of clinical and biological material (e.g., samples of semen, stool, urine, blood, buccal swab)
|
|
Fertile men
|
Collection of clinical and biological material (e.g., samples of semen, stool, urine, blood, buccal swab)
|
|
Oncologic patients
Patients with kidney, bladder, chest, or pancreas tumors
|
Collection of clinical and biological material (e.g., samples of semen, stool, urine, blood, buccal swab)
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endocrine-metabolomic parameters
Time Frame: Baseline
|
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
Time Frame: Baseline
|
We will assess:
|
Baseline
|
|
Clinical data
Time Frame: Baseline
|
We will collect:
|
Baseline
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immunological outcomes
Time Frame: Baseline
|
We will assess:
We will assess:
|
Baseline
|
|
Senescence biomarkers
Time Frame: Baseline
|
We will assess:
|
Baseline
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Andrea Salonia, MD, IRCCS Ospedale San Raffaele
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- PNRR-MAD-2022-12375994
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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