Biobank Aimed to Study Gynecological Pathologies, of Male... | NCT07265908

Studies
Biobank Aimed to Study Gynecological Pathologies, of Male and Female Infertility and Pregnancy Pathologies

NCT07265908

Sponsor

IRCCS San Raffaele

Status

Enrolling by invitation

Last Update Posted

Dec 5, 2025Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Gynecological Disorders
Male Infertility
Female Infertility
Pregnancy

Interventions

Blood sampling

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 9, 2024Actual

Primary Completion Date

Dec 31, 2043Estimated

Completion Date

Dec 31, 2043Estimated

First Submitted Date

Sep 17, 2025

First Submission Date that Met QC Criteria

Dec 4, 2025

First Posted Date

Dec 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2025

Last Update Posted Date

Dec 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 - related to gynecological disorders, male and female infertility, and pregnancy-related conditions.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Affected participants		Subjects diagnosed with gynecological disorders, male or female infertility, or pregnancy-associated conditions.	Other: Blood sampling
Healthy participants		Subjects without a diagnosis of gynecological disorders, male or female infertility, or pregnancy-associated conditions.	Other: Blood sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sampling	Other	Blood sampling	Affected participants Healthy participants

Measure	Description	Time Frame
Developing a biobank/repository		Through study completion, an average of 1 year.

Eligibility Module

Eligibility Criteria

Affected participants

Inclusion Criteria for adult patients (including pregnant and breastfeeding women) and pediatric patients affected by:
- Male infertility
- Female infertility
- Gynecological disorders
- Pregnancy-related conditions
- Conditions requiring fertility preservation treatment (oocyte cryopreservation, ovarian tissue preservation)
- Informed consent signed by the adult patient or by the parents/legal guardians of pediatric patients
Exclusion Criteria
- 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

Exclusion Criteria

Patients unable or unwilling to sign the informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Enrico Papaleo, MD	IRCCS San Raffaele	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Irccs San Raffaele Hospital		Milan	Milan	20132	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005831	Genital Diseases, Female
D007248	Infertility, Male
D007247	Infertility, Female

Ancestor Terms

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided