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Male InfertilityNCT06082362

Personalized Signature of Chronic Inflammation and Early Aging Predictive of the Comorbidities in Infertile Men

An observational study of Male Infertility, run by IRCCS San Raffaele at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Male Infertility
What is being tested?
Collection of clinical and biological material
How many people
350 participants
Where
1 siteItaly
Study dates
21 Jun 2023to 20 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Andrea Salonia, MD contact

02 2643 5661

salonia.andrea@hsr.it

Alessia d'Arma, MSc contact

02 2643 5506

darma.alessia@hsr.it

Italy1 site, 1 recruiting
  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132

    Alessia d'Arma, MSc, 02 2643 5506, darma.alessia@hsr.it

    Recruiting

Other trials in Italy

About this study

Official title: Definition of a Personalized Signature of Chronic Inflammation and Early Aging Predictive of the Development of Comorbidities in Infertile Men

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.

Read the detailed description

Infertility is a disease of nearly endemic proportions, affecting up to 15% of couples of reproductive ages. Overall, a pure male factor infertility underlies the problem in at least 30% of cases. General health status in infertile men is gaining increasing clinical attention throughout the last decades. Indeed, infertile men were shown to be at increased risk of nononcologic and oncologic morbidity and mortality compared to age-comparable fertile ones. Despite emerging and solid epidemiological studies, the common ground fostering overall health status and male infertility is still far from being understood. Notwithstanding the numerous hypotheses that have been considered to explain the potential link overall men's health status and male infertility - e.g., including genetic, endocrinological, and metabolic abnormalities - the exact nature of these associations remains unclear. Recent clinical findings showed evidence of onset of age-related comorbidities 10-15 years earlier in infertile compared to fertile men. Single-cell transcriptome profiling of testes of men with idiopathic germ cell aplasia revealed an immature testis with a somatic environment stuck at puberty with immaturity of Leydig cells associated with chronic tissue inflammation, fibrosis, and senescence phenotype of the somatic cells, as well markers of chronic inflammation in the blood. Compelling evidence indicate that defects in the regulatory arms of the immune system and metabolic status can be associated with the risk of developing numerous oncological and non-oncological diseases. Thus far, limited reliable data on the immunological status of infertile men are available. Preliminary data from the coordinating group of the project revealed increased pro-inflammatory cells and reduced T cells in peripheral blood of infertile men. Moreover, the few T cells observed in infertile men displayed an exhausted phenotype. The investigators proposed an innovative multidisciplinary approach to identify causal links between infertility as a disease and chronic inflammation and comorbidities. Moreover, the investigators aim at identifying novel prognostic biomarkers/tools toward the development of tailored prevention strategies of severe comorbidities in infertile men. They will combine extensive clinical data of a unique and homogenous cohort of infertile men and controls with state-of-the art transcriptomic approaches, a comprehensive monitoring and functional characterization of adaptive and innate immune cells, and the endocrine-metabolomic signature of men with primary infertility. The success of our strategy will be instrumental for defining novel molecular causes of male infertility, along with the pathophysiological mechanism behind the higher burden of comorbid conditions. Results will provide information on cell compartments, and the senescent and endocrine status, mostly in men with primary idiopathic infertility, and new insights into the etiology responsible for the early onset of comorbidities in infertile men. This will represent a breakthrough in the infertility field and a major advancement towards better caring of male patients and healthy ageing in the real-life setting and will set the stage for the development of more tailored clinical approaches to prevent malignant and nonmalignant comorbidities in infertile men. Thereof, the findings of the research project will have a significant rebound in terms of cost-effectiveness on the national health system.

Being tested
Collection of clinical and biological material
Keywords
Infertility, Male Infertility, Comorbidity, Andrology, Immuno-epidemiology, Environmental factors, Genetic factors
Medical subject headings
Infertility, Male, Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collection of clinical and biological materialOther

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

Study groups in NCT06082362
Study groupRoleWhat they receive
Infertile menMen with infertility
Receives: Other: Collection of clinical and biological material
Fertile menFertile men
Receives: Other: Collection of clinical and biological material
Oncologic patientsPatients with kidney, bladder, chest, or pancreas tumors
Receives: Other: Collection of clinical and biological material

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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

    Measured: Baseline

  3. 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

    Measured: Baseline

Secondary outcomes (2)
  1. Immunological outcomes

    We will assess:

    • the activation of the inflammasome
    • IL-1ß/IL-18 release in response to Toll-like receptors stimulation through Enzyme-Linked Immunosorbent Assay
    • the expression of CASP1, NLRP3, AIM2, NLRC4, ASC, and IL1B genes through real-time PCR (polymerase chain reaction)

    We will assess:

    • the activation of the inflammasome
    • IL-1ß/IL-18 release in response to Toll-like receptors stimulation through Enzyme-Linked Immunosorbent Assay
    • the expression of CASP1, NLRP3, AIM2, NLRC4, ASC, and IL1B genes through real-time polymerase chain reaction (PCR)

    Measured: Baseline

  2. Senescence biomarkers

    We will assess:

    • senescence markers
    • mutations in a well-defined set of genes associated with normal ageing

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2023
  2. Study start21 Jun 2023
  3. Primary completion20 Jun 2024 (estimated)
  4. Study completion20 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06082362
Sponsor's protocol ID
PNRR-MAD-2022-12375994
Status last verified
Oct 2023
First submitted
13 Jun 2023
Last updated
13 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Male Infertility, run by IRCCS San Raffaele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andrea Salonia, MD (02 2643 5661, salonia.andrea@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endocrine-metabolomic parameters (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.

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