Trials / Recruiting
RecruitingNCT04663971
Fertility and Pregnancy After Surgery IBD Audit
IBD Audit on Fertility, Pregnancy and Delivery in Patients With Inflammatory Bowel Disease: a International Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- University of Campania Luigi Vanvitelli · Academic / Other
- Sex
- Female
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Inflammatory Bowel Diseases
- Crohn Disease
- Ulcerative Colitis
- Fertility Disorders
- Pregnancy Complications
- Delivery Problem
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Any surgery | Any surgical procedures performed for inflammatory bowel diseases |
| PROCEDURE | Any medical treatment | Any treatment (including non-surgical) performed for inflammatory bowel diseases |
Timeline
- Start date
- 2024-02-01
- Primary completion
- 2024-10-01
- Completion
- 2024-10-01
- First posted
- 2020-12-11
- Last updated
- 2024-04-26
Locations
4 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT04663971. Inclusion in this directory is not an endorsement.