The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21-40
SponsorLeiden University Medical Center
About this trial
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
Qualifiers
Women in a heterosexual or in a same-sex relationship;
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)
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Laparoscopic excision of endometriosis, including colorectal endometriosis
- In vitro fertilisation or intracytoplasmic sperm injection
Treatment groups
339 Participants
are divided into 1 treatment groupSponsors and collaborators
Leiden University Medical Center
Lead sponsor
Haaglanden Medical Centre
Collaborator
University Medical Center Groningen
Collaborator
Maastricht University Medical Center
Collaborator
Radboud University Medical Center
Collaborator
Reinier de Graaf Groep
Collaborator
Catharina Ziekenhuis Eindhoven
Collaborator
UMC Utrecht
Collaborator
Source ClinicalTrials.gov