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

Last updated: May 20, 2025
Sponsor: Nadezhda Women's Health Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Heparin solution

Anti-adhesion barrier gel

Clinical Study ID

NCT05257213
3/11022022
  • Ages 25-50
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • ongoing pregnancy,

  • genital cancer,

  • pelvic inflammatory disease,

  • excessive uterine bleeding.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Heparin solution
Phase:
Study Start date:
February 14, 2022
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Nadezhda Women's Health Hospital

    Sofia, 1373
    Bulgaria

    Active - Recruiting

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