Compares surgery for bowel endometriosis with IVF or ICSI in women struggling to conceive
Compares keyhole surgery to remove bowel endometriosis with IVF or ICSI in subfertile women.
Plain-language title generated from the registry record
Registry title: The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
Key facts
- Where
- Eindhoven, Enschede, Groningen, Leiden, Maastricht, Nijmegen, Rotterdam, The Hague, Utrecht, and Voorburg, NetherlandsSee the 10 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 40 years old?
Source: NCT05677269, who can take part
Where in Netherlands
- Catharina ZiekenhuisEindhoven, NetherlandsTaking people
- Medical Spectrum TwenteEnschede, NetherlandsTaking people
- University Medical Center GroningenGroningen, NetherlandsTaking people
- Leiden University Medical CenterLeiden, NetherlandsTaking people
- Maastricht University Medical CenterMaastricht, NetherlandsTaking people
- Radboud University Medical CenterNijmegen, NetherlandsTaking people
- Erasmus Medical CentreRotterdam, NetherlandsTaking people
- Haaglanden Medical CenterThe Hague, NetherlandsTaking people
- Utrecht Medical CenterUtrecht, NetherlandsTaking people
- Nederlandse Endometriose Kliniek (Reinier de Graaf Gasthuis)Voorburg, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Leiden University Medical Center
- Trial code
- NCT05677269
- Record updated
- 21 November 2024
- Original description
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.Read full original descriptionShow less
The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
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.
Inclusion: 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: 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 diagnosed with other diseases causing infertility (e.g. recurrent miscarriages, antiphospholipid syndrome); 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 with deep endometriosis without colorectal involvement; Not able to read and understand Dutch or English.