Comparing Surgery Followed by IVF Versus IVF Alone in Women Under 39 with Advanced Endometriosis and Infertility A National Multicenter Randomized Trial Evaluating Live Birth Outcomes

What this Trial Is About

Endometriosis is a chronic condition affecting about 10% of women of reproductive age, often causing pelvic pain and infertility. Women with advanced endometriosis stage III-IV have significantly reduced fertility compared to the general population. This study is the first national multicenter randomized controlled trial comparing surgery followed by IVF with IVF alone to determine which approach better improves pregnancy outcomes in women with advanced endometriosis and infertility. Participants are women under 39 years with stage III-IV endometriosis seeking fertility treatment. They will be randomly assigned to either first undergo laparoscopic surgery to remove endometriosis lesions followed by IVF or to proceed directly to IVF without surgery. Surgery will be performed at specialized centers using laparoscopic techniques, while IVF treatment will involve up to three cycles of controlled ovarian stimulation and embryo transfers according to routine clinical protocols. During the study, participants will undergo ultrasound and possibly MRI to confirm endometriosis staging. Researchers will monitor pregnancy rates, live birth rates within three years, time to pregnancy, treatment complications, and quality of life using questionnaires. Data on healthcare costs and safety outcomes will also be collected. Long-term follow-up at ten years will assess fertility treatments, live births, and repeat surgeries. The total study duration for each participant is three years from first treatment.

First Line Surgery or First Line Fertility Treatment Using Assisted Reproductive Technologies in Patients With Advanced Endometriosis