InfertilityNCT06183255
"System Medicine" Approach for Prevention Strategies for Comorbidities in Infertile Men
An observational study of Infertility and Male Infertility, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Infertility, Male Infertility
- What is being tested?
- Observation and evaluation of clinical parameters in the two cohorts
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jan 2021to Jul 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 years and older
- Men only
- Adult, Older adult
Study population: Fertile and infertile men according to WHO criteria (2010)
Who may be able to join
- Signature of the informed consent;
- Be adults aged > 18;
- Caucasian race;
- Documented diagnosis of primary male infertility with pure male factor;
Who cannot join
- Failure to obtain informed consent;
- Patients with a known history of haematological disease;
- Patients undergoing antibiotic treatments in the last 6 months
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
Alessia d'Arma, PhD, 02 2643 5506, darma.alessia@hsr.it
About this study
Official title: New "System Medicine" Approach for the Development of Primary Prevention Strategies for Comorbidities in Infertile Men
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.
Read the detailed description
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.
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
- Infertility, Male Infertility
- Being tested
- Observation and evaluation of clinical parameters in the two cohorts
- Keywords
- Infertility, Male Infertility, Comorbidity
- Medical subject headings
- Infertility, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation and evaluation of clinical parameters in the two cohortsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Infertile men | Men with a diagnosis of pure Male Factor Infertility, as for WHO criteria Receives: 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 Receives: Other: Observation and evaluation of clinical parameters in the two cohorts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical anamnesis
Data collection on Charlson Comorbidity Index (CCI), partner's age, partner's health status;
Measured: Baseline
Objective examination
presence of varicocele; testicular size and number
Measured: Baseline
Testosterone
data on testosterone (ng/dL)
Measured: Baseline
Genetic profile
Data on karyotype and microdeletions of the Y chromosome
Measured: Baseline
Semen volume
Semen volume (ml)
Measured: Baseline
Body mass index
Dataon Body mass index
Measured: Baseline
Follicle-stimulating hormone
Data on follicle-stimulating hormone (mIU/ml)
Measured: Baseline
Luteinizing hormone
Data on luteinizing hormone (mIU/dl)
Measured: Baseline
Anti-Müllerian hormone
Data on Anti-Müllerian hormone (ng/ml)
Measured: Baseline
Inhibin B
Data on Inhibin B (UI/mL)
Measured: Baseline
Prolactin
Data on Prolactin (µg/l)
Measured: Baseline
Thyroid-stimulating hormone
Data on thyroid-stimulating hormone (mU/L)
Measured: Baseline
Osteocalcin levels
Data on osteocalcin levels (ng/ml)
Measured: Baseline
Semen concentration
number of spermatozoa (million/ml)
Measured: Baseline
Spermatozoa motility and morphology
motility and morphology of spermatozoa (%)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start18 Jan 2021
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Salonia, IRCCS San Raffaele
- Investigators
- Andrea Salonia, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183255
- Sponsor's protocol ID
- RF-201912368847
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New "System Medicine" Approach for the Development of Primary Prevention Strategies for Comorbidities in Infertile Men
- ClinicalTrials.gov ID
- NCT06183255
- Acronym / sponsor ID
- RF-201912368847
- Conditions
- Infertility, Male Infertility
- Keywords
- Infertility, Male Infertility, Comorbidity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infertile men | – | Other: Observation and evaluation of clinical parameters in the two cohortsMen with a diagnosis of pure Male Factor Infertility, as for WHO criteria |
| Fertile men | – | Other: Observation and evaluation of clinical parameters in the two cohortsFathers with at least one child, spontaneously conceived, with a time-to-pregnancy within 12 months, as for WHO criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Fertile and infertile men according to WHO criteria (2010)
Key inclusion criteria (4 listed)
- Signature of the informed consent;
- Be adults aged > 18;
- Caucasian race;
- Documented diagnosis of primary male infertility with pure male factor;
Key exclusion criteria (3 listed)
- Failure to obtain informed consent;
- Patients with a known history of haematological disease;
- Patients undergoing antibiotic treatments in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation and evaluation of clinical parameters in the two cohortsDuring 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. | Other | Fertile men, Infertile men |
Primary outcome
Medical anamnesis
Time frame: Baseline
Data collection on Charlson Comorbidity Index (CCI), partner's age, partner's health status;
Objective examination
Time frame: Baseline
presence of varicocele; testicular size and number
Testosterone
Time frame: Baseline
data on testosterone (ng/dL)
Genetic profile
Time frame: Baseline
Data on karyotype and microdeletions of the Y chromosome
Semen volume
Time frame: Baseline
Semen volume (ml)
Body mass index
Time frame: Baseline
Dataon Body mass index
Follicle-stimulating hormone
Time frame: Baseline
Data on follicle-stimulating hormone (mIU/ml)
Luteinizing hormone
Time frame: Baseline
Data on luteinizing hormone (mIU/dl)
Anti-Müllerian hormone
Time frame: Baseline
Data on Anti-Müllerian hormone (ng/ml)
Inhibin B
Time frame: Baseline
Data on Inhibin B (UI/mL)
Prolactin
Time frame: Baseline
Data on Prolactin (µg/l)
Thyroid-stimulating hormone
Time frame: Baseline
Data on thyroid-stimulating hormone (mU/L)
Osteocalcin levels
Time frame: Baseline
Data on osteocalcin levels (ng/ml)
Semen concentration
Time frame: Baseline
number of spermatozoa (million/ml)
Spermatozoa motility and morphology
Time frame: Baseline
motility and morphology of spermatozoa (%)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Salonia, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and 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 3 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 27 Dec 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?
Medical anamnesis (time frame: Baseline). The study lists 15 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 27 Dec 2023.