Fertility and Pregnancy After Surgery IBD Audit (Fertile-IBD)

October 24, 2022 updated by: Gianluca Pellino, University of Campania "Luigi Vanvitelli"

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Policlinico S.Orsola-Malpighi
        • Contact:
          • Matteo Rottoli, MD, PhD
        • Principal Investigator:
          • Matteo Rottoli, MD, PhD
      • Milano, Italy, 20017
        • Rho Memorial Hospital
        • Contact:
          • Gianluca M Sampietro
        • Principal Investigator:
          • Gianluca M Sampietro
      • Napoli, Italy, 81038
        • Università degli Studi della Campania Luigi Vanvitelli
        • Contact:
        • Sub-Investigator:
          • Francesco Selvaggi, MD
      • Roma, Italy, 00133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female patients diagnosed with Crohn's disease or ulcerative colitis, treated when 35-year-old or younger.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 15, 2022

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

November 27, 2020

First Submitted That Met QC Criteria

December 5, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fertile-IBD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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