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

Recruiting now

Conditions studied: Endometriosis, Rectum, Endometriosis of Colon, Subfertility, Female

In brief

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.

Key facts

Study ID

NCT05677269

Run by

Leiden University Medical Center

People needed

339

Starts

2023-02-17

Expected to finish

2029-01-01

Last updated by the study team

2024-11-21

Who can join

Age: 21 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Catharina Ziekenhuis — Eindhoven, Netherlands (enrolling)
• Medical Spectrum Twente — Enschede, Netherlands (enrolling)
• University Medical Center Groningen — Groningen, Netherlands (enrolling)
• Leiden University Medical Center — Leiden, Netherlands (enrolling)
• Maastricht University Medical Center — Maastricht, Netherlands (enrolling)
• Radboud university medical center — Nijmegen, Netherlands (enrolling)
• Erasmus Medical Centre — Rotterdam, Netherlands (enrolling)
• Haaglanden Medical Center — The Hague, Netherlands (enrolling)
• Utrecht Medical Center — Utrecht, Netherlands (enrolling)
• Nederlandse Endometriose Kliniek (Reinier de Graaf Gasthuis) — Voorburg, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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