Fertility and Pregnancy After Surgery IBD Audit

NCT04663971 | Recruiting

• 1 other identifier: Fertile-IBD
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 4

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Fertility Disorders; Pregnancy Complications; Delivery Problem

Keywords

Crohn's disease; ulcerative colitis; surgery

Outcome Measures

Primary Outcomes (2)

• Fertility

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

  through study completion, an average of 1 year

• Pregnancy

  Rate of successful pregnancies. Number of miscarriages.

  through study completion, an average of 1 year

Secondary Outcomes (5)

• In-vitro fertilization

  through study completion, an average of 1 year

• Abortion/s

  through study completion, an average of 1 year

• Complications, surgical

  through study completion, an average of 1 year

• Complications, medical

  through study completion, an average of 1 year

• Surgical approach

  through study completion, an average of 1 year

Study Arms (2)

Crohn's disease

Patients with Crohn's disease.

Procedure: Any surgery; Procedure: Any medical treatment

Ulcerative colitis

Patients with Ulcerative colitis

Procedure: Any surgery; Procedure: Any medical treatment

Interventions

Any surgery PROCEDURE

Any surgical procedures performed for inflammatory bowel diseases

Crohn's disease; Ulcerative colitis

Any medical treatment PROCEDURE

Any treatment (including non-surgical) performed for inflammatory bowel diseases

Crohn's disease; Ulcerative colitis

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: All female patients will be included
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Crohn's disease diagnosis
• ulcerative disease diagnosis
• operated on before 36 years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Policlinico S.Orsola-Malpighi

Bologna, 40138, Italy

RECRUITING

Rho Memorial Hospital

Milan, 20017, Italy

NOT YET RECRUITING

Universitá degli Studi della Campania Luigi Vanvitelli

Napoli, 81038, Italy

NOT YET RECRUITING

Policlinico Tor Vergata

Roma, 00133, Italy

RECRUITING

Related Publications (10)

• 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

  BACKGROUND

• 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.

  PMID: 11122187 RESULT

• 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.

  PMID: 22253619 RESULT

• 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.

  PMID: 7827890 RESULT

• 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 Surgery SICCR. Inflammatory bowel disease position statement of the Italian Society of Colorectal Surgery (SICCR): ulcerative colitis. Tech Coloproctol. 2020 May;24(5):397-419. doi: 10.1007/s10151-020-02175-z. Epub 2020 Mar 2.

  PMID: 32124113 RESULT

• 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.

  PMID: 24295646 RESULT

• 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.

  PMID: 21766164 RESULT

• 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.

  PMID: 16772310 RESULT

• 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.

  PMID: 23360923 RESULT

• 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.

  PMID: 31420214 RESULT

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Pregnancy Complications; Dystocia

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications

Study Officials

• 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 CHAIR

Central Study Contacts

Gianluca Pellino, MD, PhD

CONTACT

0815667919; gianluca.pellino@unicampania.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 11, 2020
• Study Start: February 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)