Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT05677269
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.
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
40 Years
Study:
NCT05677269
Study Brief:
Protocol Section:
NCT05677269