Gynecological DisordersNCT07265908
Biobank Aimed to Study Gynecological Pathologies, of Male and Female Infertility and Pregnancy Pathologies
An observational study of Gynecological Disorders and Male Infertility, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The REPRO-Biobank has been established at San Raffaele Hospital in Milan for the purpose of collecting and preserving human biological samples and associated data. Its primary objective is to support biomedical research, with a particular focus on advancing scientific knowledge - including in the field of genetics … Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gynecological Disorders, Male Infertility, Female Infertility
- What is being tested?
- Blood sampling
- How many people
- 3,000 participants
- Where
- 1 siteItaly
- Study dates
- 9 Apr 2024to 31 Dec 2043
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: REPRO-Biobank anticipates the enrollment of approximately 300 individuals annually, comprising adult and pediatric patients diagnosed with gynecological disorders, male or female infertility, or pregnancy-related conditions, currently under care at the Gynecology and Obstetrics Unit / Centro Scienze della Natalità of San Raffaele Hospital, as well as healthy volunteers associated with the same Unit.
Who may be able to join
None listed.
Who cannot join
- Patients unable or unwilling to sign the informed consent
- Healthy participants Inclusion Criteria
- Healthy adult subjects (including pregnant and lactating women)
- Able to give informed consent for participation in the study
- Patients unable or unwilling to sign the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Establishment of a Biobank Aimed at Studying Gynecological Pathologies, of Male and Female Infertility and Pregnancy Pathologies
The REPRO-Biobank has been established at San Raffaele Hospital in Milan for the purpose of collecting and preserving human biological samples and associated data. Its primary objective is to support biomedical research, with a particular focus on advancing scientific knowledge - including in the field of genetics - related to gynecological disorders, male and female infertility, and pregnancy-related conditions.
- Being tested
- Blood sampling
- Medical subject headings
- Genital Diseases, Female, Infertility, Male, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Affected participants | Subjects diagnosed with gynecological disorders, male or female infertility, or pregnancy-associated conditions. Receives: Other: Blood sampling | |
| Healthy participants | Subjects without a diagnosis of gynecological disorders, male or female infertility, or pregnancy-associated conditions. Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developing a biobank/repository
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start9 Apr 2024
- Primary completion31 Dec 2043 (estimated)
- Study completion31 Dec 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological DisordersStudies 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Papaleo, IRCCS San Raffaele
- Investigators
- Enrico Papaleo, MD, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265908
- Sponsor's protocol ID
- REPRO-Biobank
- Status last verified
- Dec 2025
- First submitted
- 17 Sep 2025
- Last updated
- 5 Dec 2025
- 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 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Biobank Aimed at Studying Gynecological Pathologies, of Male and Female Infertility and Pregnancy Pathologies
- ClinicalTrials.gov ID
- NCT07265908
- Acronym / sponsor ID
- REPRO-Biobank
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 31 Dec 2043 (estimated)
- Study completion
- 31 Dec 2043 (estimated)
- First posted
- 5 Dec 2025 (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.
The REPRO-Biobank has been established at San Raffaele Hospital in Milan for the purpose of collecting and preserving human biological samples and associated data. Its primary objective is to support biomedical research, with a particular focus on advancing scientific knowledge - including in the field of genetics - related to gynecological disorders, male and female infertility, and pregnancy-related conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affected participants | – | Other: Blood samplingSubjects diagnosed with gynecological disorders, male or female infertility, or pregnancy-associated conditions. |
| Healthy participants | – | Other: Blood samplingSubjects without a diagnosis of gynecological disorders, male or female infertility, or pregnancy-associated conditions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- REPRO-Biobank anticipates the enrollment of approximately 300 individuals annually, comprising adult and pediatric patients diagnosed with gynecological disorders, male or female infertility, or pregnancy-related conditions, currently under care at the Gynecology and Obstetrics Unit / Centro Scienze della Natalità of San Raffaele Hospital, as well as healthy volunteers associated with the same Unit.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Healthy participants Inclusion Criteria
- Patients unable or unwilling to sign the informed consent
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 |
|---|---|---|
| Blood samplingBlood sampling | Other | Affected participants, Healthy participants |
Primary outcome
Developing a biobank/repository
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- 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.
Enrico Papaleo, MD principal investigator
IRCCS 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 Gynecological Disorders 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 0 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 5 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developing a biobank/repository (time frame: Through study completion, an average of 1 year.). 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 5 Dec 2025.