"System Medicine" Approach for Prevention Strategies for Comorbidities in Infertile Men
NCT ID: NCT06183255
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2021-01-18
2025-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Infertile men
Men with a diagnosis of pure Male Factor Infertility, as for WHO criteria
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.
Fertile men
Fathers with at least one child, spontaneously conceived, with a time-to-pregnancy within 12 months, as for WHO criteria
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Be adults aged \> 18;
* Caucasian race;
* Documented diagnosis of primary male infertility with pure male factor;
Exclusion Criteria
* Patients with a known history of haematological disease;
* Patients undergoing antibiotic treatments in the last 6 months
18 Years
MALE
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Andrea Salonia
Professor
Principal Investigators
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Andrea Salonia, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Ospedale San Raffaele
Locations
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IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy
Countries
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Central Contacts
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Facility Contacts
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Alessia d'Arma, PhD
Role: primary
Other Identifiers
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RF-201912368847
Identifier Type: -
Identifier Source: org_study_id