Clinical trial NCT04663971: Fertility and Pregnancy After Surgery IBD Audit
Official title: IBD Audit on Fertility, Pregnancy and Delivery in Patients With Inflammatory Bowel Disease: a International Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Fertility Disorders
Pregnancy Complications
Delivery Problem
Keywords: Crohn's disease
ulcerative colitis
surgery
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
Collaborators: name: University of Bologna
name: University of Rome Tor Vergata
name: Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
First posted: 2020-12-11
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients diagnosed with Crohn's disease or ulcerative colitis, treated when 35-year-old or younger.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Fertility
timeFrame: through study completion, an average of 1 year
measure: Pregnancy
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: In-vitro fertilization
timeFrame: through study completion, an average of 1 year
measure: Abortion/s
timeFrame: through study completion, an average of 1 year
measure: Complications, surgical
timeFrame: through study completion, an average of 1 year
measure: Complications, medical
timeFrame: through study completion, an average of 1 year
measure: Surgical approach
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
city: Milano
country: Italy
facility: Rho Memorial Hospital
city: Napoli
country: Italy
facility: Universitá degli Studi della Campania Luigi Vanvitelli
city: Roma
country: Italy
facility: Policlinico Tor Vergata
Study officials:
affiliation: University Tor Vergata Roma
name: Giuseppe Sica, MD, PhD
role: STUDY_CHAIR
affiliation: University Alma Mater Bologna
name: Matteo Rottoli, MD, PhD
role: STUDY_CHAIR
affiliation: University of Campania Luigi Vanvitelli Napoli
name: Francesco Selvaggi, MD, PhD
role: STUDY_CHAIR
References:
citation: 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
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citation: Calvet X, Panes J, Alfaro N, Hinojosa J, Sicilia B, Gallego M, Perez I, Lazaro y de Mercado P, Gomollon F; Members of Consensus Group; Aldeguera X, Alos R, Andreu M, Barreiro M, Bermejo F, Casis B, Domenech E, Espin E, Esteve M, Garcia-Sanchez V, Lopez-Sanroman A, Martinez-Montiel P, Luis Mendoza J, Gisbert JP, Vera M, Dosal A, Sanchez E, Marin L, Sanroman L, Pinilla P, Murciano F, Torrejon A, Ramon Garcia J, Ortega M, Roldan J. Delphi consensus statement: Quality Indicators for Inflammatory Bowel Disease Comprehensive Care Units. J Crohns Colitis. 2014 Mar;8(3):240-51. doi: 10.1016/j.crohns.2013.10.010. Epub 2013 Dec 2.
citation: Rajaratnam SG, Eglinton TW, Hider P, Fearnhead NS. Impact of ileal pouch-anal anastomosis on female fertility: meta-analysis and systematic review. Int J Colorectal Dis. 2011 Nov;26(11):1365-74. doi: 10.1007/s00384-011-1274-9. Epub 2011 Jul 16.
citation: Waljee A, Waljee J, Morris AM, Higgins PD. Threefold increased risk of infertility: a meta-analysis of infertility after ileal pouch anal anastomosis in ulcerative colitis. Gut. 2006 Nov;55(11):1575-80. doi: 10.1136/gut.2005.090316. Epub 2006 Jun 13.
citation: Beyer-Berjot L, Maggiori L, Birnbaum D, Lefevre JH, Berdah S, Panis Y. A total laparoscopic approach reduces the infertility rate after ileal pouch-anal anastomosis: a 2-center study. Ann Surg. 2013 Aug;258(2):275-82. doi: 10.1097/SLA.0b013e3182813741.
citation: Gorgun E, Cengiz TB, Aytac E, Aiello A, da Silva G, Goldberg JM, Holubar SD, Stocchi L, Wexner SD, Steele SR, Hull TL. Does laparoscopic ileal pouch-anal anastomosis reduce infertility compared with open approach? Surgery. 2019 Oct;166(4):670-677. doi: 10.1016/j.surg.2019.04.045. Epub 2019 Aug 14.