Fertility and Pregnancy After Surgery IBD Audit (Fertile-IBD)

University of Campania "Luigi Vanvitelli"

Status: Enrolling

Conditions: Fertility Disorders; Pregnancy Complications; Delivery Problem; Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Procedure: Any surgery; Procedure: Any medical treatment

Study type: Observational

Funder types: Other

Identifiers

NCT04663971

Fertile-IBD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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 each country.

Trial design

500 participants in 2 patient groups

Crohn's disease

Description:

Patients with Crohn's disease.

Treatment:

Procedure: Any medical treatment

Procedure: Any surgery

Ulcerative colitis

Description:

Patients with Ulcerative colitis

Treatment:

Procedure: Any medical treatment

Procedure: Any surgery