NCT05677269 The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
| NCT ID | NCT05677269 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Endometriosis, Rectum |
| Study Type | OBSERVATIONAL |
| Enrollment | 339 participants |
| Start Date | 2023-02-17 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 339 participants in total. It began in 2023-02-17 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Mathijs D. Blikkendaal, MD, PhD
PRINCIPAL INVESTIGATOR
Nederlandse Endometriose Kliniek (NEK), Reinier de Graaf Gasthuis
Frequently Asked Questions
Who can join the NCT05677269 clinical trial?
This trial is open to female participants only, aged 21 Years or older, up to 40 Years, studying Endometriosis, Rectum. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05677269 currently recruiting?
Yes, NCT05677269 is actively recruiting participants. Contact the research team at M.Blikkendaal@rdgg.nl for enrollment information.
Where is the NCT05677269 trial being conducted?
This trial is being conducted at Eindhoven, Netherlands, Enschede, Netherlands, Groningen, Netherlands, Leiden, Netherlands and 6 additional locations.
Who is sponsoring the NCT05677269 clinical trial?
NCT05677269 is sponsored by Leiden University Medical Center. The principal investigator is Mathijs D. Blikkendaal, MD, PhD at Nederlandse Endometriose Kliniek (NEK), Reinier de Graaf Gasthuis. The trial plans to enroll 339 participants.