Fertility and Pregnancy After Surgery IBD Audit

Last updated: April 25, 2024
Sponsor: University of Campania "Luigi Vanvitelli"
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Inflammatory Bowel Disease

Ulcers

Treatment

Any surgery

Any medical treatment

Clinical Study ID

NCT04663971
Fertile-IBD
  • Ages 18-35
  • Female

Study Summary

Crohn's disease and Ulcerative colitis are chronic disease that are usually diagnosed at young age. The diseases and the associated treatment can impact on patient's sexual function, fertility, pregnancy, and delivery. This study aims to assess the impact of inflammatory bowel diseases on these aspects in female patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Crohn's disease diagnosis
  • ulcerative disease diagnosis
  • operated on before 36 years of age

Exclusion

Exclusion Criteria:

  • younger than 18 years old at follow-up
  • no definitive diagnosis
  • no surgical procedures performed A subgroup of patients who did not undergo surgery will be used, at least one for eachcountry.

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Any surgery
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
October 01, 2024

Study Description

This is a cross-sectional, international, multicentre study. Female patients diagnosed with inflammatory bowel diseases (Crohn's disease and ulcerative colitis) treated at several Italian centres will be retrospectively assessed for inclusion.

Those who underwent surgery below the age of 35 years between 2000 and 2020 will be included. The study aims to obtain information on female fertility, pregnancy and delivery, and to identify factors associated with infertility and problems to conclude the pregnancy.

For each nation, at least one centre will collect data on patients who were not treated with surgery.

Patients who meet inclusion criteria will be asked to prospectively fill a questionnaire on fertility and pregnancy.

Data on treatments and demographic will be retrospectively collected by the local investigators and uploaded on a secure online database.

Connect with a study center

  • Policlinico S.Orsola-Malpighi

    Bologna, 40138
    Italy

    Active - Recruiting

  • Rho Memorial Hospital

    Milano, 20017
    Italy

    Site Not Available

  • Universitá degli Studi della Campania Luigi Vanvitelli

    Napoli, 81038
    Italy

    Site Not Available

  • Policlinico Tor Vergata

    Roma, 00133
    Italy

    Active - Recruiting

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