Heparin Solution Versus Anti-adhesion Barrier Gel for Intrauterine Adhesions Prevention After Operative Hysteroscopy

Not Applicable

Recruiting

• Conditions: Intrauterine Adhesion
• Interventions: Drug: Heparin solution; Drug: Anti-adhesion barrier gel

• Registration Number: NCT05257213
• Lead Sponsor: Nadezhda Women's Health Hospital

Brief Summary

The aim of this study is to compare the efficacy of intrauterine application of heparin solution to the use of hyaluronic acid barrier gel for the prevention of intrauterine adhesion formation after operative hysteroscopy.

Detailed Description

In this trial the investigators aim to evaluate and compare the effect of heparin solution to anti-adhesive hyaluronic barrier gel administration immediately after operative hysteroscopy on post-surgical complications (incidence, extent and severity of intrauterine adhesions, abnormal menstrual cycle pattern) and fertility.

Patients undergoing operative hysteroscopy will be identified and invited to participate in the trial. At 4 to 8 weeks after the initial surgery, a follow-up, diagnostic hysteroscopy will be performed to identify indications for subsequent operative procedure and classify intrauterine adhesions according to extent of uterine cavity affected and type of formation found. Data on subsequent persistent irregular menstrual bleeding and pregnancy success up to 12 months following treatment will also be collected.

Study Timeline

• Study Start: 2022-02-14
• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-02-14
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• female sex
• indication for operative hysteroscopy including one or more of the following:
• infertility,
• irregular bleeding,
• oligo-/amenorrhea,
• Asherman syndrome,
• G0-G3 fibroids,
• dysmorphic uterus.

Exclusion Criteria

• ongoing pregnancy,
• genital cancer,
• pelvic inflammatory disease,
• excessive uterine bleeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparin solution	Heparin solution	Administration of 3 ml heparin solution into the uterine cavity via a syringe immediately post operative hysteroscopy.
Anti-adhesion barrier gel	Anti-adhesion barrier gel	Intrauterine application of 2 ml biodegradable anti-adhesion barrier gel immediately post operative hysteroscopy.

Primary Outcome Measures

Name	Time	Method
Number of patients with persistent irregular menstrual bleeding	up to 12 months post treatment	Recurring abnormal menstrual cycle patterns identified post initial surgery
Number of patients with post-operative intrauterine adhesion formation	4 to 8 weeks post treatment	Incidence and severity of intrauterine adhesions identified at follow-up diagnostic hysteroscopy as assessed according to Valle and Sciarra's classification of intrauterine synaechia
Number of patients with need for subsequent operative hysterectomy	4 tot 8 weeks post treatment	Pathological findings at second-look hysteroscopy taken as indication for successive uterine surgery

Secondary Outcome Measures

Name	Time	Method
Number of patients with fertility improvement	up to 12 months post treatment	Successful pregnancy post surgical procedure

Trial Locations

Locations (1)

Nadezhda Women's Health Hospital; 🇧🇬 Sofia, Bulgaria