Incidence of Intrauterine Adhesions After Myomectomy With Intrauterine Anti-Adhesion Gel
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorFederico II University
About this trial
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.
Eligibility criteria
Qualifiers
Age between 18 and 45 years;
BMI 18-35;
One or more fibroids diagnosed via ultrasound;
First myomectomy or uterine surgery;
Disqualifiers
Age under 18 years;
Age over 46 years;
Pregnancy or breastfeeding;
History of intrauterine adhesions;
Trial design
Treatments tested in this trial
- Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure
Treatment groups
62 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov