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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 40
View:

• 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)

Locations
Other Locations
Netherlands
Catharina Ziekenhuis
RECRUITING
Eindhoven
Medical Spectrum Twente
RECRUITING
Enschede
University Medical Center Groningen
RECRUITING
Groningen
Leiden University Medical Center
RECRUITING
Leiden
Maastricht University Medical Center
RECRUITING
Maastricht
Radboud university medical center
RECRUITING
Nijmegen
Erasmus Medical Centre
RECRUITING
Rotterdam
Haaglanden Medical Center
RECRUITING
The Hague
Utrecht Medical Center
RECRUITING
Utrecht
Nederlandse Endometriose Kliniek (Reinier de Graaf Gasthuis)
RECRUITING
Voorburg
Contact Information
Primary
Mathijs D. Blikkendaal, MD,PhD
M.Blikkendaal@rdgg.nl
088 979 44 89
Backup
Rozemarijn de Koning, MD
r.de_koning@lumc.nl
Time Frame
Start Date: 2023-02-17
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 339
Treatments
Colorectal endometriosis patients
Subfertile women between 21 and 40 years with colorectal endometriosis facing the choice between IVF/ICSI or laparoscopic resection of (colorectal) endometriosis.
Related Therapeutic Areas
Sponsors
Collaborators: UMC Utrecht, University Medical Center Groningen, Catharina Ziekenhuis Eindhoven, Radboud University Medical Center, Maastricht University Medical Center, Reinier de Graaf Groep, Haaglanden Medical Centre
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov