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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure
DeviceThe difference compared to other studies published in the past is that, in our trial, at the end of the robotic myomectomy-which will be performed using the same technique in both groups-an anti-adhesion gel will be applied in the intervention group to prevent the formation of intrauterine adhesions.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Anti-adhesion gel groupExperimental treatment 1 intervention
Group B: Standard of care groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Efficacy of intrauterine gel in reducing the formation of intrauterine adhesions
The primary objective of the study is to evaluate the efficacy of intrauterine gel in reducing the formation of intrauterine adhesions following robotic-assisted laparoscopic myomectomy. Intrauterine adhesions will be assessed during follow-up ultrasound performed one month after surgery and by diagnostic hysteroscopy two months after surgery. Adhesions will be classified according to an internationally recognized scoring system. The severity, extent, and type of adhesions will be documented using the American Fertility Society (AFS) / American Society for Reproductive Medicine (ASRM) classification system, which categorizes IUAs as mild, moderate, or severe based on the extent of cavity involvement, type of adhesions, and menstrual pattern.
Time frame
Up to two months after surgerySecondary outcomes
1
Clinical Pregnancy Rate
Presence of a gestational sac with fetal heartbeat detected on transvaginal ultrasound. Measurement: Confirmed by ultrasound between the 5th and 7th weeks of gestation and recorded in clinical data.
Time frame
Up to 24 months after surgery2
Live Birth Rate (LBR)
Percentage of patients delivering a live-born infant after conception. Measurement: Collected from hospital records or via follow-up phone interviews
Time frame
Up to 24 months post-surgery.3
Miscarriage Rate
Spontaneous pregnancy loss before 20 weeks of gestation. Measurement: Confirmed by ultrasound or clinical documentation in case of spontaneous abortion.
Time frame
Up to 24 months after surgery4
Pregnancy Complications
Adverse events during pregnancy, such as gestational hypertension, preeclampsia, gestational diabetes, or preterm birth. Measurement: Collected from medical charts, obstetric reports, or standardized questionnaires.
Time frame
Up to 24 months after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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