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

NCT07280286 | Not Yet Recruiting FDA Device

• 1 other identifier: KE5DXJL9Z1F5
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Myoma;Uterus; Adhesion; Uterus, Internal

Keywords

intrauterine adhesions; myomectomy

Outcome Measures

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.

  Up to two months after surgery

Secondary Outcomes (5)

• Clinical Pregnancy Rate

  Up to 24 months after surgery

• Live Birth Rate (LBR)

  Up to 24 months post-surgery.

• Miscarriage Rate

  Up to 24 months after surgery

• Pregnancy Complications

  Up to 24 months after surgery

• Mode of delivery

  Up to 24 months after surgery

Study Arms (2)

Anti-adhesion gel group

EXPERIMENTAL

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

Standard of care group

NO INTERVENTION

Women will not receive any anti-adhesion methods

Interventions

Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure DEVICE

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.

Anti-adhesion gel group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Related Publications (19)

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MeSH Terms

Conditions

Myofibroma; Tissue Adhesions; Gynatresia

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Brunella Zizolfi, Dr.

CONTACT

+39 3381651272; brunellazizolfi@hotmail.it

Danilo Borrelli, Dr.

CONTACT

+39 3488277581; danil.borrelli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Model Details: The study will be conducted as a prospective, randomized, non-profit trial

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 12, 2025
• Study Start: December 9, 2025
• Primary Completion: April 6, 2026
• Study Completion (Estimated): November 20, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share