Fertility and Pregnancy After Surgery IBD Audit

Recruiting

• Conditions: Fertility Disorders; Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease; Pregnancy Complications; Delivery Problem
• Interventions: Procedure: Any surgery; Procedure: Any medical treatment

• Registration Number: NCT04663971
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-12-05
• Study First Posted: 2020-12-11
• Study Start: 2024-02-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ulcerative colitis	Any surgery	Patients with Ulcerative colitis
Crohn's disease	Any medical treatment	Patients with Crohn's disease.
Crohn's disease	Any surgery	Patients with Crohn's disease.
Ulcerative colitis	Any medical treatment	Patients with Ulcerative colitis

Primary Outcome Measures

Name	Time	Method
Fertility	through study completion, an average of 1 year	Rate of infertility and number of pregnancies. Number of attempts to achieve pregnancy.
Pregnancy	through study completion, an average of 1 year	Rate of successful pregnancies. Number of miscarriages.

Secondary Outcome Measures

Name	Time	Method
Complications, medical	through study completion, an average of 1 year	Incidence of medical complications and effects on fertility
Surgical approach	through study completion, an average of 1 year	Rate of minimally invasive surgery use and effect on fertility and pregnancy
Abortion/s	through study completion, an average of 1 year	Number of abortions and reasons.
In-vitro fertilization	through study completion, an average of 1 year	Number of in-vitro fertilization attempts
Complications, surgical	through study completion, an average of 1 year	Incidence of early and late surgical complications and effects on fertility

Trial Locations

Locations (4)

Policlinico S.Orsola-Malpighi; 🇮🇹 Bologna, Italy

Rho Memorial Hospital; 🇮🇹 Milano, Italy

Universitá degli Studi della Campania Luigi Vanvitelli; 🇮🇹 Napoli, Italy

Policlinico Tor Vergata; 🇮🇹 Roma, Italy