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NCT Number: NCT05257213

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

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.

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Key information

Conditions

Intrauterine Adhesion Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynatresia Urogenital Diseases

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nadezhda Women's Health Hospital, Sofia, Bulgaria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heparin solution

Drug

3 ml saline solution containing 5000 IU heparin.

Other names: HEP

Anti-adhesion barrier gel

Drug

2 ml biodegradable barrier gel containing sodium hyaluronate (10 mg/ml), sodium chloride (8.5 mg/ml), disodium hydrogen phosphate (0.34mg/ml), sodium dihydrogen phosphate (0.14 mg/ml) and water for injection (QS to weight).

Other names: AAB

Primary outcomes

  1. Number of patients with post-operative intrauterine adhesion formation

    Time frame: 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

  2. Number of patients with need for subsequent operative hysterectomy

    Time frame: 4 tot 8 weeks post treatment

    Pathological findings at second-look hysteroscopy taken as indication for successive uterine surgery

  3. Number of patients with persistent irregular menstrual bleeding

    Time frame: up to 12 months post treatment

    Recurring abnormal menstrual cycle patterns identified post initial surgery

Secondary outcomes

  1. Number of patients with fertility improvement

    Time frame: up to 12 months post treatment

    Successful pregnancy post surgical procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Georgi Stamenov

CONTACT

[email protected]

+359888269839

Sponsors and collaborators

Lead sponsor

Nadezhda Women's Health Hospital

Other

Registry information

Official study title

Intrauterine Adhesions Prevention: the Use of Heparin Solution Compared to Application of Anti-adhesion Barrier Gel After Operative Hysteroscopy

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2022
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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