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Comparing Surgery and IVFICSI for Treating Colorectal Endometriosis to Improve Live Birth Rates and Quality of Life
Led by Leiden University Medical Center · Updated on 2024-11-21
339
Participants Needed
10
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying subfertile women with colorectal endometriosis to determine whether laparoscopic surgical removal of this condition leads to higher chances of live births, both naturally and after assisted reproductive treatments like IVF or ICSI, compared to undergoing IVFICSI alone. The study also evaluates patient-reported outcomes to see if surgery improves quality of life. The trial addresses the challenge of managing fertility in women with colorectal endometriosis, which can cause pain and affect reproductive organs in multiple ways. The study compares two treatment paths laparoscopic excision of deep colorectal endometriosis performed at specialized centers, which may involve various surgical techniques depending on disease extent, and a treatment trajectory of up to three IVF or ICSI cycles, often preceded by hormone downregulation. Participants either choose or are awaiting one of these treatments at different stages of their fertility journey. The follow-up period extends up to 40 months, encompassing live birth outcomes and treatment attempts. Participants will undergo assessments of endometriosis-specific symptoms, pain, bowel symptoms, quality of life, and productivity costs at multiple time points up to 40 months, including before surgery if applicable. Medical complications and treatment costs will also be monitored. The main measure is the cumulative live birth rate after treatment or attempts. Data collection includes questionnaires and clinical monitoring to provide a comprehensive understanding of treatment impact over time.
CONDITIONS
Brief Title
The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
Research Team
M
Mathijs D. Blikkendaal, MD,PhD
R
Rozemarijn de Koning, MD
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