Fertile-IBD: Fertility and Pregnancy After Surgery IBD Audit

• Sponsor: University of Campania "Luigi Vanvitelli" (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04663971
• Collaborator: University of Bologna (Other), University of Rome Tor Vergata (Other), Italian Group for the study of Inflammatory Bowel Disease (IG-IBD) (Other)
• Enrollment: 500
• Locations: 4
• Anticipated Duration (Months): 14
• Patients Per Site: 125
• Patients Per Site Per Month: 9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Fertility Disorders; Pregnancy Complications; Delivery Problem	Procedure: Any surgery; Procedure: Any medical treatment

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 Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: IBD Audit on Fertility, Pregnancy and Delivery in Patients With Inflammatory Bowel Disease: a International Study
• Anticipated Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: May 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Crohn's disease Patients with Crohn's disease.	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
Ulcerative colitis Patients with Ulcerative colitis	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

Outcome Measures

Primary Outcome Measures

1. Fertility [through study completion, an average of 1 year]

   Rate of infertility and number of pregnancies. Number of attempts to achieve pregnancy.

2. Pregnancy [through study completion, an average of 1 year]

   Rate of successful pregnancies. Number of miscarriages.

Secondary Outcome Measures

1. In-vitro fertilization [through study completion, an average of 1 year]

   Number of in-vitro fertilization attempts

2. Abortion/s [through study completion, an average of 1 year]

   Number of abortions and reasons.

3. Complications, surgical [through study completion, an average of 1 year]

   Incidence of early and late surgical complications and effects on fertility

4. Complications, medical [through study completion, an average of 1 year]

   Incidence of medical complications and effects on fertility

5. Surgical approach [through study completion, an average of 1 year]

   Rate of minimally invasive surgery use and effect on fertility and pregnancy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Policlinico S.Orsola-Malpighi	Bologna		Italy	40138
2	Rho Memorial Hospital	Milano		Italy	20017
3	Universitá degli Studi della Campania Luigi Vanvitelli	Napoli		Italy	81038
4	Policlinico Tor Vergata	Roma		Italy	00133

Sponsors and Collaborators

• University of Campania "Luigi Vanvitelli"
• University of Bologna
• University of Rome Tor Vergata
• Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)

Investigators

• Study Chair: Giuseppe Sica, MD, PhD, University Tor Vergata Roma
• Study Chair: Matteo Rottoli, MD, PhD, University Alma Mater Bologna
• Study Chair: Francesco Selvaggi, MD, PhD, University of Campania Luigi Vanvitelli Napoli

Study Documents (Full-Text)

None provided.

More Information

Publications

• M Rottoli, P Pezzuto, G Fallani, G Pellino, F Rizzello, P Gionchetti, G Poggioli. P199 Ileal pouch-anal anastomosis in women of childbearing age affected by ulcerative colitis: a single-centre study on the risk factors for infertility and outcomes of pregnancy over 17 years. Journal of Crohn's and Colitis, Volume 16, Issue Supplement_1, January 2022, Pages i259-i261, https://doi.org/10.1093/ecco-jcc/jjab232.326

• Responsible Party: Gianluca Pellino, Lecturer, University of Campania "Luigi Vanvitelli"
• ClinicalTrials.gov Identifier: NCT04663971
• Other Study ID Numbers: Fertile-IBD
• First Posted: Dec 11, 2020
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gianluca Pellino, Lecturer, University of Campania "Luigi Vanvitelli": Crohn's disease; ulcerative colitis; surgery
• Additional relevant MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Pregnancy Complications; Dystocia; Ulcer

Study Results

No Results Posted as of Apr 1, 2022