Comparing surgery and IVF for treating colorectal endometriosis and subfertility

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Mathijs D. Blikkendaal, MD, PhD — Nederlandse Endometriose Kliniek (NEK), Reinier de Graaf Gasthuis
• Study coordinator: Mathijs D. Blikkendaal, MD,PhD
• Email: M.Blikkendaal@rdgg.nl
• Phone: 088 979 44 89

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.