Impact of Inflammatory Bowel Diseases on Fertility and Pregnancy
IBD Audit on Fertility, Pregnancy and Delivery in Patients With Inflammatory Bowel Disease: a International Study
This study is trying to see how inflammatory bowel diseases like Crohn's and ulcerative colitis affect fertility and pregnancy outcomes in women who had surgery before turning 36.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | University of Campania Luigi Vanvitelli Academic / other |
| Locations | 4 sites (Bologna and 3 other locations) |
| Trial ID | NCT04663971 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the effects of inflammatory bowel diseases, specifically Crohn's disease and ulcerative colitis, on fertility and pregnancy outcomes in female patients. It involves a cross-sectional, international, multicenter approach, where data will be collected from female patients who underwent surgery before the age of 36 between 2000 and 2020. Participants will complete a questionnaire regarding their fertility and pregnancy experiences, while demographic and treatment data will be retrospectively gathered by local investigators. The study aims to identify factors associated with infertility and complications during pregnancy and delivery.
Who should consider this trial
Good fit: Ideal candidates are female patients diagnosed with Crohn's disease or ulcerative colitis who underwent surgery before the age of 36.
Not a fit: Patients younger than 18 years old at follow-up or those without a definitive diagnosis or surgical procedures performed may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the reproductive health of women with inflammatory bowel diseases, leading to improved care and support.
How similar studies have performed: While similar studies have explored the impact of inflammatory bowel diseases on fertility, this specific approach focusing on surgical patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bologna and 3 other locations
- Policlinico S.Orsola-Malpighi — Bologna, Italy (Recruiting)
- Rho Memorial Hospital — Milano, Italy (Not_yet_recruiting)
- Universitá degli Studi della Campania Luigi Vanvitelli — Napoli, Italy (Not_yet_recruiting)
- Policlinico Tor Vergata — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Gianluca Pellino, MD, PhD
- Email: gianluca.pellino@unicampania.it
- Phone: 0815667919
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.