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

Last updated: November 19, 2024
Sponsor: Leiden University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometriosis

Infertility

Treatment

Laparoscopic excision of endometriosis, including colorectal endometriosis

In vitro fertilisation or intracytoplasmic sperm injection

In vitro fertilisation

Clinical Study ID

NCT05677269
N22.085
  • Ages 21-40
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Colorectal endometriosis defined as endometriosis involving the (colo)rectum:

#Enzian classification score C1,C2,C3 (C=rectum) or FI (F=far locations, I=sigmoidcolon) 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 thefollowing criteria:

  • At least one year of non-conception (either spontaneous of after intra uterineinseminations)

  • Inability to have timed intercourse because of pain (dyspareunia and/or chronicpelvic pain)

  • Severe complaints (expectant management is not acceptable (anymore)

  • The patients has an indication for IVF/ICSI according to Dutch guidelines (Werkgroepnetwerkrichtlijn, december 2010);

  • failed intra uterine insemination

  • male factor subfertility (oligoasthenoteratozoospermia defined as VCM <1million)

  • bilateral tubal pathology (e.g. bilateral hydrosalpinx, bilateral tubalocclusion)

  • 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 thebeginning of the treatment trajectory), T=1 (after one unsuccessful IVF/ICSI cycle)or T=2 (after 2 unsuccessful IVF/ICSI cycles)

Exclusion

Exclusion Criteria:

  • Patients with deep endometriosis without colorectal involvement;

  • 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 andsuspicion of an impending ileus);

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

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

  • Not able to read and understand Dutch or English.

Study Design

Total Participants: 339
Treatment Group(s): 3
Primary Treatment: Laparoscopic excision of endometriosis, including colorectal endometriosis
Phase:
Study Start date:
February 17, 2023
Estimated Completion Date:
January 01, 2029

Study Description

Endometriosis is characterized by extra-uterine endometrium like tissue and affects 10-15% of the women in their reproductive years and in 5-12% of these women colorectal endometriosis is present. The quality of life is lowered due to severe pain symptoms (dysmenorrhea, dyschezia, dysuria, chronic pelvic pain) and subfertility.The management of colorectal endometriosis-related subfertility is challenging. While the impact of colorectal endometriosis per se remains inconclusive as other intraperitoneal endometriosis lesions are frequently present, fertility is most likely affected by multiple mechanisms including inflammatory alterations in peritoneal fluid, alterations in estrogen and progesterone hormone levels, lowered endometrium receptivity, associated adenomyosis, a lower ovarian reserve (in case endometriomas are present) and adhesion formation that disrupts adnexal anatomy and function. Usually, surgery is preferred in case of dominant pain complaints, while IVF/ICSI is started when the wish to conceive is dominant. Recent evidence suggests a CLBR of 44.9% in patients with rectosigmoid endometriosis treated by surgery compared to 55.9% after 4 cycles of IVF/ICSI treatment without surgery. In the Netherlands, the number of reimbursed IV/ICSI attempts in limited to three. In addition, a combined strategy may result in even higher cumulative live birth rates. However, the place and optimal timing of surgery in patients with colorectal endometriosis and a desire to have children is unknown.

To provide robust evidence that can be extrapolated to the Dutch healthcare system, this study aims to determine whether surgical excision of colorectal endometriosis results in increased CLBR both spontaneous and after IVF/ICSI, and better PROMs compared to an IVF/ICSI treatment trajectory.

Connect with a study center

  • Endometriosis in Balance expertise center (HMC)

    Den Haag,
    Netherlands

    Site Not Available

  • Haaglanden Medical Center

    Den Haag,
    Netherlands

    Active - Recruiting

  • Catharina Ziekenhuis

    Eindhoven,
    Netherlands

    Active - Recruiting

  • Medical Spectrum Twente

    Enschede,
    Netherlands

    Active - Recruiting

  • University Medical Center Groningen

    Groningen,
    Netherlands

    Active - Recruiting

  • Leiden University Medical Center

    Leiden,
    Netherlands

    Active - Recruiting

  • Maastricht University Medical Center

    Maastricht,
    Netherlands

    Active - Recruiting

  • Radboud university medical center

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Erasmus Medical Centre

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Utrecht Medical Center

    Utrecht,
    Netherlands

    Active - Recruiting

  • Nederlandse Endometriose Kliniek (Reinier de Graaf Gasthuis)

    Voorburg,
    Netherlands

    Active - Recruiting

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