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

NCT07265908 | Enrolling By Invitation

• 1 other identifier: REPRO-Biobank
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecological Disorders; Male Infertility; Female Infertility; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Developing a biobank/repository

  Through study completion, an average of 1 year.

Study Arms (2)

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

Blood sampling OTHER

Blood sampling

Affected participants; Healthy participants

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients unable or unwilling to sign the informed consent
• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Irccs San Raffaele Hospital

Milan, Milan, 20132, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

The study involves the collection of surplus material in accordance with procedures within routine clinical practice, as well as the performance of additional procedures (blood sampling).

MeSH Terms

Conditions

Genital Diseases, Female; Infertility, Male; Infertility, Female

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Enrico Papaleo, MD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: December 5, 2025
• Study Start: April 9, 2024
• Primary Completion (Estimated): December 31, 2043
• Study Completion (Estimated): December 31, 2043
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)