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

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Dec 22, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at whether surgery to remove colorectal endometriosis can help women achieve pregnancy more effectively than traditional fertility treatments like in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The goal is to see if women who have this surgery experience higher rates of successful pregnancies and better overall health outcomes compared to those who choose IVF/ICSI.

To take part in the trial, women must have confirmed colorectal endometriosis and a strong desire to become pregnant, especially if they have been trying for over a year or have severe pain that makes it hard to conceive. Eligible participants can be in heterosexual or same-sex relationships. The study is currently recruiting women aged 18 to 39 who are facing a choice between these two treatment options. Throughout the trial, participants can expect close monitoring of their health and pregnancy outcomes, providing valuable information for future patients dealing with similar issues.

Gender

FEMALE

Eligibility criteria

• 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=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)
• 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 and suspicion 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), untreated congenital uterine abnormalities, maltreated/untreated systemic or malignant disease or severe risk factors for oocyte aspiration);
• • Patients diagnosed with other diseases causing infertility (e.g. recurrent miscarriages, antiphospholipid syndrome);
• • Not able to read and understand Dutch or English.