Fertility and Pregnancy After Surgery IBD Audit

Ulcerative Colitis Clinical Trial

— Fertile-IBD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04663971
• Other study ID #: Fertile-IBD
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2024
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Gianluca Pellino, MD, PhD
• Phone: 0815667919
• Email: gianluca.pellino[@]unicampania.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Delivery Problem
• Dystocia
• Fertility Disorders
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Pregnancy Complications
• Ulcerative Colitis

Intervention

Procedure:
• Any surgery
Any surgical procedures performed for inflammatory bowel diseases
• Any medical treatment
Any treatment (including non-surgical) performed for inflammatory bowel diseases

Locations

Country	Name	City	State
Italy	Policlinico S.Orsola-Malpighi	Bologna
Italy	Rho Memorial Hospital	Milano
Italy	Universitá degli Studi della Campania Luigi Vanvitelli	Napoli
Italy	Policlinico Tor Vergata	Roma

Sponsors (4)

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

Country where clinical trial is conducted

Italy, 

References & Publications (10)

Bernell O, Lapidus A, Hellers G. Risk factors for surgery and recurrence in 907 patients with primary ileocaecal Crohn's disease. Br J Surg. 2000 Dec;87(12):1697-701. doi: 10.1046/j.1365-2168.2000.01589.x. — View 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. — View 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-Sa — View Citation

Cosnes J, de Parades V, Carbonnel F, Beaugerie L, Ngo Y, Gendre JP, Sezeur A, Gallot D, Malafosse M, le Quintrec Y. Classification of the sequelae of bowel resection for Crohn's disease. Br J Surg. 1994 Nov;81(11):1627-31. doi: 10.1002/bjs.1800811122. — View 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 — View 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

Pellino G, Keller DS, Sampietro GM, Carvello M, Celentano V, Coco C, Colombo F, Geccherle A, Luglio G, Rottoli M, Scarpa M, Sciaudone G, Sica G, Sofo L, Zinicola R, Leone S, Danese S, Spinelli A, Delaini G, Selvaggi F; Italian Society of Colorectal Surger — View 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. — View Citation

Spinelli A, Sacchi M, Bazzi P, Leone N, Danese S, Montorsi M. Laparoscopic surgery for recurrent Crohn's disease. Gastroenterol Res Pract. 2012;2012:381017. doi: 10.1155/2012/381017. Epub 2012 Jan 2. — View 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. — View Citation

Outcome

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