FertilityNCT06189677
Creation of a Biobank of Fertile Men
An observational study of Fertility, run by IRCCS San Raffaele at 2 sites in Italy.
Trial summary
Collection and conservation of human biological material from fertile subjects, i.e. men with previous parenthood (normospermic men, natural fathers). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Fertility
- What is being tested?
- Observation of biological characteristics of fertile men
- How many people
- 2,000 participants
- Where
- 2 sitesItaly
- Study dates
- 16 Jun 2016to 15 Jun 2026
- 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 60 years
- Men only
- Adult
Study population: Normospermic male individuals, naturally fertile men recruited on an outpatient and day-hospital basis.
Who may be able to join
- Normospermic male individuals
- Naturally fertile male individuals
- Male individuals > 18 years
Who cannot join
- Non-normospermic male individuals
- Male individuals who are not naturally fertile
- Male individuals < 18 years
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
Andrea Salonia, MD, 02 2643 5661, salonia.andrea@hsr.it
- Recruiting
IRCCS San Raffaele Hospital
Milan, 20132
Andrea Salonia, MD, +390226435661
About this study
Official title: Creation of a Biobank of Biological Samples From Fertile Men
Collection and conservation of human biological material from fertile subjects, i.e. men with previous parenthood (normospermic men, natural fathers).
Read the detailed description
The project aims to collect biological material derived both from surgical resections of the most common urological tumors and from peripheral blood or other biological fluids such as urine or seminal fluid when available. The objective of the study is to establish a biobank of human biological material, which will allow access to samples of extreme value for the pathophysiological study of the tumor, its origin, mechanisms and markers of progression, as well as the creation of this collection it will represent an extremely valuable tool for the study of individual response to therapies.
- Conditions
- Fertility
- Being tested
- Observation of biological characteristics of fertile men
- Keywords
- Fertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of biological characteristics of fertile menOther
Sampling in outpatient settings, after biopsy or after surgery and collection of biological samples in fertile subjects
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic role of the biological material
Biological signature in fertile men predicting potential therapeutic, prognostic and diagnostic biomarkers
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start16 Jun 2016
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189677
- Sponsor's protocol ID
- Urimales-2016
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Biobank of Biological Samples From Fertile Men
- ClinicalTrials.gov ID
- NCT06189677
- Acronym / sponsor ID
- Urimales-2016
- Conditions
- Fertility
- Keywords
- Fertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 3 Jan 2024 (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.
Collection and conservation of human biological material from fertile subjects, i.e. men with previous parenthood (normospermic men, natural fathers).
Detailed description
The project aims to collect biological material derived both from surgical resections of the most common urological tumors and from peripheral blood or other biological fluids such as urine or seminal fluid when available. The objective of the study is to establish a biobank of human biological material, which will allow access to samples of extreme value for the pathophysiological study of the tumor, its origin, mechanisms and markers of progression, as well as the creation of this collection it will represent an extremely valuable tool for the study of individual response to therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Normospermic male individuals, naturally fertile men recruited on an outpatient and day-hospital basis.
Key inclusion criteria (3 listed)
- Normospermic male individuals
- Naturally fertile male individuals
- Male individuals > 18 years
Key exclusion criteria (3 listed)
- Non-normospermic male individuals
- Male individuals who are not naturally fertile
- Male individuals < 18 years
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 of biological characteristics of fertile menSampling in outpatient settings, after biopsy or after surgery and collection of biological samples in fertile subjects | Other | – |
Primary outcome
Prognostic role of the biological material
Time frame: Baseline
Biological signature in fertile men predicting potential therapeutic, prognostic and diagnostic biomarkers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility, run by IRCCS San Raffaele at 2 sites 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 3 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic role of the biological material (time frame: Baseline). 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 3 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.