Actively Recruiting
The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
Led by Leiden University Medical Center · Updated on 2024-11-21
339
Participants Needed
10
Research Sites
306 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
H
Haaglanden Medical Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Colorectal endometriosis confirmed by ultrasound or MRI with Enzian classification C1, C2, C3 or FI
- Women in a heterosexual or same-sex relationship
- Active desire to conceive with at least one of the following: at least one year of no conception, inability to have timed intercourse due to pain, or severe symptoms requiring treatment
- Indication for IVF/ICSI according to Dutch guidelines, including failed intrauterine insemination, male factor subfertility, bilateral tubal pathology, age over 38 with unexplained subfertility, or severe endometriosis with subfertility
- Patient is deciding between IVF/ICSI or laparoscopic colorectal endometriosis surgery or is on the waiting list for these treatments at study start or after 1 or 2 unsuccessful IVF/ICSI cycles
You will not qualify if you...
- Deep endometriosis without colorectal involvement
- Spontaneous conception before intervention
- Need for urgent surgery preventing choice of IVF/ICSI
- Contraindications for IVF/ICSI, including diminished ovarian reserve, untreated uterine abnormalities, untreated systemic or malignant disease, or severe risks for oocyte retrieval
- Other infertility-causing diseases such as recurrent miscarriages or antiphospholipid syndrome
- Inability to read or understand Dutch or English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Catharina Ziekenhuis
Eindhoven, Netherlands
Actively Recruiting
2
Medical Spectrum Twente
Enschede, Netherlands
Actively Recruiting
3
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
4
Leiden University Medical Center
Leiden, Netherlands
Actively Recruiting
5
Maastricht University Medical Center
Maastricht, Netherlands
Actively Recruiting
6
Radboud university medical center
Nijmegen, Netherlands
Actively Recruiting
7
Erasmus Medical Centre
Rotterdam, Netherlands
Actively Recruiting
8
Haaglanden Medical Center
The Hague, Netherlands
Actively Recruiting
9
Utrecht Medical Center
Utrecht, Netherlands
Actively Recruiting
10
Nederlandse Endometriose Kliniek (Reinier de Graaf Gasthuis)
Voorburg, Netherlands
Actively Recruiting
Research Team
M
Mathijs D. Blikkendaal, MD,PhD
CONTACT
R
Rozemarijn de Koning, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here