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

December 4, 2025 updated by: Enrico Papaleo, IRCCS San Raffaele

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • Milan, Milan, Italy, 20132
        • IRCCS San Raffaele Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

  1. 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

  2. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Affected participants
Subjects diagnosed with gynecological disorders, male or female infertility, or pregnancy-associated conditions.
Other: Blood sampling
Blood sampling
Healthy participants
Subjects without a diagnosis of gynecological disorders, male or female infertility, or pregnancy-associated conditions.
Other: Blood sampling
Blood sampling

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: ENRICO PAPALEO, MD, IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2024

Primary Completion (Estimated)

December 31, 2043

Study Completion (Estimated)

December 31, 2043

Study Registration Dates

First Submitted

September 17, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REPRO-Biobank

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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