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RecruitingNCT04663971Fertile-IBDUpdated Apr 26, 2024

Fertility and Pregnancy After Surgery IBD Audit

An observational study in Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis, sponsored by University of Campania Luigi Vanvitelli. Recruiting at 4 sites in Italy. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-04-26.

Sponsored by University of Campania Luigi Vanvitelli · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
500
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Crohn's disease
  • ulcerative colitis
  • surgery
03

In context

Inflammatory Bowel Diseases

1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.

This study's planned enrollment of 500 is above the median of 140 across 626 observational studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

University of Campania Luigi Vanvitelli is the lead sponsor of 174 studies on the registry; 28 are open to participants now.

Browse University of Campania Luigi Vanvitelli studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureAny surgery

    Any surgical procedures performed for inflammatory bowel diseases

  • ProcedureAny medical treatment

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

06

What researchers measure

Primary outcomes

  1. Fertility

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

    Time frame: through study completion, an average of 1 year

  2. Pregnancy

    Rate of successful pregnancies. Number of miscarriages.

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. In-vitro fertilization

    Number of in-vitro fertilization attempts

    Time frame: through study completion, an average of 1 year

  2. Abortion/s

    Number of abortions and reasons.

    Time frame: through study completion, an average of 1 year

  3. Complications, surgical

    Incidence of early and late surgical complications and effects on fertility

    Time frame: through study completion, an average of 1 year

  4. Complications, medical

    Incidence of medical complications and effects on fertility

    Time frame: through study completion, an average of 1 year

  5. Surgical approach

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

    Time frame: through study completion, an average of 1 year

07

Study locations

2 of 4 sites recruiting
  • Policlinico S.Orsola-Malpighi
    Bologna, 40138, Italy
    Recruiting
    • Matteo Rottoli, MD, PhD · Contact
    • Matteo Rottoli, MD, PhD · Principal investigator
  • Rho Memorial Hospital
    Milano, 20017, Italy
    Not yet recruiting
    • Gianluca M Sampietro · Contact
    • Gianluca M Sampietro · Principal investigator
  • Universitá degli Studi della Campania Luigi Vanvitelli
    Napoli, 81038, Italy
    Not yet recruiting
  • Policlinico Tor Vergata
    Roma, 00133, Italy
    Recruiting
08

References and documents

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
  • 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. PubMed 11122187 ↗
  • 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. PubMed 22253619 ↗
  • 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. PubMed 7827890 ↗
  • 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. Erratum In: Tech Coloproctol. 2020 Aug;24(8):905. doi: 10.1007/s10151-020-02258-x. PubMed 32124113 ↗
  • 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. PubMed 24295646 ↗
  • 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. PubMed 21766164 ↗
  • 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. PubMed 16772310 ↗
  • 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. PubMed 23360923 ↗
  • 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. PubMed 31420214 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2024 (actual). Primary completion is estimated for Oct 2024, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2020
First posted
Dec 11, 2020
StartActual
Feb 1, 2024
Primary completionEst.
Oct 1, 2024
CompletionEst.
Oct 1, 2024
Last update
Apr 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04663971
Lead 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)
Responsible party
Gianluca Pellino (Lecturer, University of Campania Luigi Vanvitelli) — Principal investigator
First posted
Dec 11, 2020
Start date
Feb 1, 2024
Primary completion
Oct 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Apr 26, 2024

Study contacts

Gianluca Pellino, MD, PhD
Contact
gianluca.pellino@unicampania.it
0815667919
Giuseppe Sica, MD, PhD
study chair · University Tor Vergata Roma
Matteo Rottoli, MD, PhD
study chair · University Alma Mater Bologna
Francesco Selvaggi, MD, PhD
study chair · University of Campania Luigi Vanvitelli Napoli

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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