The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatme… (NCT05677269) | Clinical Trial Compass
RecruitingNot Applicable
The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
Netherlands339 participantsStarted 2023-02-17
Plain-language 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.
Who can participate
Age range21 Years – 40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 spontane…
What they're measuring
1
Cumulative live birth rate
Timeframe: At the end of the study period (live birth or after 3 IVF/ICSI attempts and/or surgery in the follow-up period (40 months) )