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NCT05677269Recruiting

The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory

Source: ClinicalTrials.gov · Last updated 21 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

To goal of this study is to determine whether laparoscopic resection of colorectal endometriosis results in an increased cumulative live birth rate (CLBR) both spontaneous and after ART (including in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), and better patient reported outcome measures (PROMs) compared to an IVF/ICSI treatment trajectory.

Status (registry)
Recruiting
Study type
Observational
Enrollment
339 (estimated)
First submitted
9 Dec 2022
Start date
17 Feb 2023
Primary completion date
Jul 2028
Lead sponsor
Leiden University Medical Center
NCT number
NCT05677269

What you commit to

  • Study type: Observational
  • Planned participants: 339
  • From 17 Feb 2023 to the primary completion date, Jul 2028
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who conceive spontaneously prior to intervention;
  • Patients requiring surgery on short notice and therefore unable to opt for IVF/ICSI (e.g. in case of unilateral or bilateral hydronephrosis, severe bowel stenosis and suspicion of an impending ileus);

Other illness

  • Patients diagnosed with other diseases causing infertility (e.g. recurrent miscarriages, antiphospholipid syndrome);

Age

  • Patients with a contra-indication for IVF/ICSI (e.g. diminished ovarian reserve (premature ovarian failure) (AMH (when available) \<p10 adjusted for age), untreated congenital uterine abnormalities, maltreated/untreated systemic or malignant disease or severe risk factors for oocyte aspiration);

Other

  • Patients with deep endometriosis without colorectal involvement;
  • Not able to read and understand Dutch or English.

Who the study is looking for

  • Colorectal endometriosis defined as endometriosis involving the (colo)rectum:
    • #Enzian classification score C1,C2,C3 (C=rectum) or FI (F=far locations, I=sigmoid colon) detected with ultrasound or MRI;
  • Women in a heterosexual or in a same-sex relationship;
  • The patient has an active wish to conceive and experiences at least one of the following criteria:
    • At least one year of non-conception (either spontaneous of after intra uterine inseminations)
    • Inability to have timed intercourse because of pain (dyspareunia and/or chronic pelvic pain)
    • Severe complaints (expectant management is not acceptable (anymore)
  • The patients has an indication for IVF/ICSI according to Dutch guidelines (Werkgroep netwerkrichtlijn, december 2010);
    • failed intra uterine insemination
    • male factor subfertility (oligoasthenoteratozoospermia defined as VCM \<1 million)
    • bilateral tubal pathology (e.g. bilateral hydrosalpinx, bilateral tubal occlusion)
    • age \> 38 years and (unexplained) subfertility
    • severe endometriosis in case of subfertility
  • The patient is faces the choice between IVF/ICSI or laparoscopic (colorectal) endometriosis or is on the waiting list for a respective treatment at T=0 (at the beginning of the treatment trajectory), T=1 (after one unsuccessful IVF/ICSI cycle) or T=2 (after 2 unsuccessful IVF/ICSI cycles)

Age in the registry: 21 years to 40 years · Sex: Female

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Catharina Ziekenhuis
Coordinator of this site? Confirm its status
EindhovenNetherlandsRecruiting
Medical Spectrum Twente
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EnschedeNetherlandsRecruiting
University Medical Center Groningen
Coordinator of this site? Confirm its status
GroningenNetherlandsRecruiting
Leiden University Medical Center
Coordinator of this site? Confirm its status
LeidenNetherlandsRecruiting
Maastricht University Medical Center
Coordinator of this site? Confirm its status
MaastrichtNetherlandsRecruiting
Radboud University Medical Center
Coordinator of this site? Confirm its status
NijmegenNetherlandsRecruiting
Erasmus Medical Centre
Coordinator of this site? Confirm its status
RotterdamNetherlandsRecruiting
Haaglanden Medical Center
Coordinator of this site? Confirm its status
The HagueNetherlandsRecruiting
Utrecht Medical Center
Coordinator of this site? Confirm its status
UtrechtNetherlandsRecruiting
Nederlandse Endometriose Kliniek (Reinier de Graaf Gasthuis)
Coordinator of this site? Confirm its status
VoorburgNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.