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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated December 12, 2025 (before its estimated April 6, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07280286
Lead Sponsor Federico II University
Conditions
(from sponsor)
Myoma;Uterus, Adhesion; Uterus, Internal
Related terms Gynatresia, Myofibroma, Tissue Adhesions
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov