Comparing surgery and IVF for treating colorectal endometriosis and subfertility

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

This study is testing whether surgery for colorectal endometriosis helps women with fertility issues and severe pain have more babies compared to using IVF or ICSI.

Quick facts

• Study type: Observational
• Enrollment: 339 (estimated)
• Ages: 21 Years to 40 Years
• Sex: Female
• Sponsor: Leiden University Medical Center (other)
• Locations: 10 sites (Eindhoven and 9 other locations)
• Trial ID: NCT05677269 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of laparoscopic resection of colorectal endometriosis in improving cumulative live birth rates (CLBR) compared to a treatment trajectory involving in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). It focuses on women with colorectal endometriosis who are experiencing subfertility and severe pain symptoms. The study will assess both spontaneous and assisted reproductive outcomes, as well as patient-reported outcome measures (PROMs). By analyzing these factors, the study seeks to determine the optimal management strategy for affected women.

Who should consider this trial

Good fit: Ideal candidates for this study are women diagnosed with colorectal endometriosis who have an active desire to conceive and have experienced difficulties in achieving pregnancy.

Not a fit: Patients who do not have colorectal endometriosis or those who are not actively seeking to conceive may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective treatment options for women with colorectal endometriosis and subfertility, potentially improving their chances of conception.

How similar studies have performed: Previous studies have shown promising results for surgical interventions in improving fertility outcomes in women with endometriosis, suggesting that this approach may be effective.

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.

Where this trial is running

Eindhoven and 9 other locations

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

Study contacts

• Principal investigator: Mathijs D. Blikkendaal, MD, PhD — Nederlandse Endometriose Kliniek (NEK), Reinier de Graaf Gasthuis
• Study coordinator: Mathijs D. Blikkendaal, MD,PhD

Conditions: Endometriosis, Rectum, Endometriosis of Colon, Subfertility, Female, Colorectal endometriosis, Subfertility, Surgery, In vitro fertilisation, Live birth rate