Endo-SOFT: study protocol for a national multicentre randomised controlled trial - first-line surgery versus first-line assisted reproductive technologies in patients with advanced endometriosis - Pub
3 hours ago
- #Endometriosis
- #Clinical Trial
- #Reproductive Medicine
- Endo-SOFT is a national multicentre RCT comparing first-line surgery followed by ART versus first-line ART for infertility in stage III-IV endometriosis.
- 350 participants aged 18–38 will be randomized 1:1, with follow-up for 3 years from the first treatment.
- Primary outcome: cumulative live birth rate after 3 years; secondary outcomes include pregnancy rates, IVF cycle results, complications, pain, quality of life, and cost-effectiveness.
- The study aims to determine if surgery before ART improves reproductive outcomes compared to starting with ART directly.
- Protocol approved by Swedish Ethical Review Authority; interim analysis planned for safety; results will influence clinical guidelines.