Fertility and Pregnancy After Surgery IBD Audit

Study Overview
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Brief Summary
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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
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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.

Official Title
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IBD Audit on Fertility, Pregnancy and Delivery in Patients With Inflammatory Bowel Disease: a International Study

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

Intervention / Treatment
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* Procedure: Any surgery
* Procedure: Any medical treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crohn's disease<br>Patients with Crohn's disease. | Procedure: Any surgery<br>* Any surgical procedures performed for inflammatory bowel diseases<br>Procedure: Any medical treatment<br>* Any treatment (including non-surgical) performed for inflammatory bowel diseases<br>|
| Ulcerative colitis<br>Patients with Ulcerative colitis | Procedure: Any surgery<br>* Any surgical procedures performed for inflammatory bowel diseases<br>Procedure: Any medical treatment<br>* Any treatment (including non-surgical) performed for inflammatory bowel diseases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertility | Rate of infertility and number of pregnancies. Number of attempts to achieve pregnancy. | through study completion, an average of 1 year | 
| Pregnancy | Rate of successful pregnancies. Number of miscarriages. | through study completion, an average of 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, ulcerative colitis, surgery