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Inflammatory Bowel DiseasesFertile-IBDNCT04663971

Fertility and Pregnancy After Surgery IBD Audit

An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by University of Campania Luigi Vanvitelli at 4 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 35 years, women only
What is being tested?
Any surgery and Any medical treatment
Type of treatment
Surgery or procedure
How many people
500 participants
Where
4 sitesItaly
Study dates
1 Feb 2024to 1 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

Gianluca Pellino, MD, PhD contact

0815667919

gianluca.pellino@unicampania.it

Italy4 sites, 4 recruiting

  • Policlinico S.Orsola-Malpighi

    Bologna, 40138

    Matteo Rottoli, MD, PhD

    Matteo Rottoli, MD, PhD

    Recruiting

  • Rho Memorial Hospital

    Milan, 20017

    Gianluca M Sampietro

    Gianluca M Sampietro

    Not yet recruiting

  • Universitá degli Studi della Campania Luigi Vanvitelli

    Naples, 81038

    Gianluca Pellino, MD, PhD, gianluca.pellino@unicampania.it

    Francesco Selvaggi, MD

    Not yet recruiting

  • Policlinico Tor Vergata

    Roma, 00133

    Giuseppe Sica, MD, PhD, antonella.piccioli@uniroma2.it

    Giuseppe Sica, MD, PhD

    Recruiting

Other trials in Italy

About this study

Official title: 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.

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.

Being tested
Any surgery, Any medical treatment
Keywords
Crohn's disease, ulcerative colitis, surgery
Medical subject headings
Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Pregnancy Complications, Dystocia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Any surgeryProcedure or surgery

    Any surgical procedures performed for inflammatory bowel diseases

  • Any medical treatmentProcedure or surgery

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

Study groups in NCT04663971
Study groupRoleWhat they receive
Crohn's diseasePatients with Crohn's disease.
Receives: Procedure: Any surgery; Procedure: Any medical treatment
Ulcerative colitisPatients with Ulcerative colitis
Receives: Procedure: Any surgery; Procedure: Any medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fertility

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

    Measured: through study completion, an average of 1 year

  2. Pregnancy

    Rate of successful pregnancies. Number of miscarriages.

    Measured: through study completion, an average of 1 year

Secondary outcomes (5)

  1. In-vitro fertilization

    Number of in-vitro fertilization attempts

    Measured: through study completion, an average of 1 year

  2. Abortion/s

    Number of abortions and reasons.

    Measured: through study completion, an average of 1 year

  3. Complications, surgical

    Incidence of early and late surgical complications and effects on fertility

    Measured: through study completion, an average of 1 year

  4. Complications, medical

    Incidence of medical complications and effects on fertility

    Measured: through study completion, an average of 1 year

  5. Surgical approach

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

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2020
  2. Study start1 Feb 2024
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion1 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04663971
Sponsor's protocol ID
Fertile-IBD
Acronym
Fertile-IBD
Status last verified
Apr 2024
First submitted
27 Nov 2020
Last updated
26 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    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

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by University of Campania Luigi Vanvitelli at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gianluca Pellino, MD, PhD (0815667919, gianluca.pellino@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fertility (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04663971, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.

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