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

December 3, 2025 updated by: Brunella Zizolfi, Federico II University

Incidence of Intrauterine Adhesions Following Myomectomies With the Use of an 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Intrauterine adhesions (IUAs), or uterine synechiae, are fibrotic bands that develop when the endometrium is damaged and the normal healing process is disrupted. Surgical trauma-particularly involving the basal layer of the endometrium-is one of the main triggers for adhesion formation. Myomectomy is recognized as the gynecologic procedure most frequently associated with the development of adhesions, which may compromise uterine function, menstrual regularity, fertility, and obstetric outcomes. Although minimally invasive approaches such as conventional or robot-assisted laparoscopy have reduced postoperative morbidity, they cannot eliminate the risk of adhesion formation, especially when the uterine cavity is entered or extensive suturing is required.

Adhesion formation results from excessive fibrin deposition and insufficient fibrinolytic activity during tissue repair. When fibrin persists on the injured surfaces, fibroblast proliferation and neovascularization may lead to permanent fibrotic bridges between areas that should remain separated. This process is particularly relevant following myomectomy, where the endometrium may be inadvertently injured. Several studies have reported high rates of intrauterine adhesions after open myomectomy and, to a lesser extent, after minimally invasive procedures. Adhesions may occur even when the cavity is not breached, suggesting that the myometrial trauma itself can contribute to this pathological process.

Anti-adhesion gels have been proposed as an adjunctive strategy to prevent postoperative synechiae. These sterile, absorbable, highly viscous hydrophilic gels-typically composed of sodium carboxymethylcellulose (CMC), polyethylene oxide (PEO), and electrolytes-act as temporary mechanical barriers, physically separating traumatized surfaces during the healing period. Evidence from previous studies suggests that intrauterine gel application after hysteroscopic procedures may reduce adhesion formation and improve postoperative reproductive outcomes. However, few trials have evaluated the efficacy of these gels after laparoscopic or robotic myomectomy.

This study is a prospective, randomized, controlled, non-profit clinical trial designed to assess whether the application of an intrauterine anti-adhesion gel at the end of robotic-assisted laparoscopic myomectomy reduces the incidence of IUAs compared with no adhesion-prevention method. Sixty-two women undergoing myomectomy will be randomized 1:1 into an intervention group (with gel application) or a control group (without gel). All participants will undergo standardized preoperative assessment, including ultrasound and office hysteroscopy. Postoperative follow-up includes ultrasound at one month to evaluate pelvic adhesions and diagnostic hysteroscopy at two months to assess intrauterine adhesions. Reproductive outcomes will be monitored for up to 24 months through spontaneous or assisted conception attempts.

The primary endpoint is the incidence of intrauterine adhesions at follow-up hysteroscopy. Secondary endpoints include clinical pregnancy rate, implantation rate, miscarriage rate, live birth rate, pregnancy complications, mode of delivery, and neonatal outcomes.

The study aims to clarify whether combining a minimally invasive robotic approach with an intrauterine gel can synergistically reduce adhesion formation and improve fertility outcomes. Results may contribute to optimizing postoperative management in women undergoing myomectomy and refining strategies to preserve reproductive potential.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 45 years;
  • BMI 18-35;
  • One or more fibroids diagnosed via ultrasound;
  • First myomectomy or uterine surgery;
  • Incomplete reproductive plans and/or infertility;
  • Adequate immune, respiratory, liver, cardiac, bone marrow, and kidney function;
  • Compliance and psychological ability to follow study procedures;
  • Acceptance and signing of informed consent.

Exclusion Criteria:

  • Age under 18 years;
  • Age over 46 years;
  • Pregnancy or breastfeeding;
  • History of intrauterine adhesions;
  • Diagnosis or suspicion of malignant gynecological pathologies and/or autoimmune diseases;
  • Completed reproductive plans;
  • Severe respiratory, bone marrow, liver, or kidney dysfunction preventing safe surgical access.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anti-adhesion gel group
Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure.
Device: Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure
The 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.
No Intervention: Standard of care group
Women will not receive any anti-adhesion methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of intrauterine gel in reducing the formation of intrauterine adhesions
Time Frame: Up to two months after surgery
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.
Up to two months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Pregnancy Rate
Time Frame: Up to 24 months after surgery

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.
Up to 24 months after surgery
Live Birth Rate (LBR)
Time Frame: Up to 24 months post-surgery.
Percentage of patients delivering a live-born infant after conception. Measurement: Collected from hospital records or via follow-up phone interviews
Up to 24 months post-surgery.
Miscarriage Rate
Time Frame: Up to 24 months after surgery
Spontaneous pregnancy loss before 20 weeks of gestation. Measurement: Confirmed by ultrasound or clinical documentation in case of spontaneous abortion.
Up to 24 months after surgery
Pregnancy Complications
Time Frame: Up to 24 months after surgery

Adverse events during pregnancy, such as gestational hypertension, preeclampsia, gestational diabetes, or preterm birth.

Measurement: Collected from medical charts, obstetric reports, or standardized questionnaires.
Up to 24 months after surgery
Mode of delivery
Time Frame: Up to 24 months after surgery
Type of delivery (spontaneous vaginal, assisted vaginal, cesarean section). Measurement: Recorded from birth certificates or hospital delivery records.
Up to 24 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 9, 2025

Primary Completion (Estimated)

April 6, 2026

Study Completion (Estimated)

November 20, 2028

Study Registration Dates

First Submitted

November 22, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KE5DXJL9Z1F5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myoma;Uterus

Clinical Trials on Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe