Incidence of Intrauterine Adhesions After Myomectomy With Intrauterine Anti-Adhesion Gel

This prospective randomized study aims to evaluate whether the application of an intrauterine anti-adhesion gel reduces the incidence of intrauterine adhesions (IUAs) following robotic-assisted laparoscopic myomectomy. Intrauterine adhesions may develop after endometrial trauma during surgery and can negatively affect menstrual function, fertility, and future pregnancy outcomes. Robotic myomectomy offers a minimally invasive approach, but postoperative adhesion formation remains a concern. Sixty-two women undergoing myomectomy will be randomized to receive either intrauterine anti-adhesion gel (intervention group) or no adhesion-prevention method (control group). Adhesions will be assessed by ultrasound and hysteroscopy during follow-up. Secondary outcomes include reproductive results over a 24-month period, such as implantation rate, clinical pregnancy, miscarriage, live birth, pregnancy complications, and neonatal outcomes. The study seeks to determine whether combining a minimally invasive surgical approach with an intrauterine gel provides additional protection against adhesion formation and improves fertility-related outcomes.

NCT Number	NCT07280286
Lead Sponsor	Federico II University
Conditions	Myoma;Uterus, Adhesion; Uterus, Internal
Enrollment	62 participants
Start Date	2025-12-09
Primary Completion	2026-04-06 (estimated)
Study Completion	2028-11-20 (estimated)
Updated on ClinicalTrials.gov	2025-12-12