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

NCT05257213 | Recruiting

• 1 other identifier: 3/11022022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Intrauterine Adhesion

Keywords

operative hysteroscopy; heparin; anti-adhesion barrier gel; intrauterine adhesion; hyaluronic acid

Outcome Measures

Primary Outcomes (3)

• Number of patients with post-operative intrauterine adhesion formation

  Incidence and severity of intrauterine adhesions identified at follow-up diagnostic hysteroscopy as assessed according to Valle and Sciarra's classification of intrauterine synaechia

  4 to 8 weeks post treatment

• Number of patients with need for subsequent operative hysterectomy

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

  4 tot 8 weeks post treatment

• Number of patients with persistent irregular menstrual bleeding

  Recurring abnormal menstrual cycle patterns identified post initial surgery

  up to 12 months post treatment

Secondary Outcomes (1)

• Number of patients with fertility improvement

  up to 12 months post treatment

Study Arms (2)

Heparin solution

ACTIVE COMPARATOR

Administration of 3 ml heparin solution into the uterine cavity via a syringe immediately post operative hysteroscopy.

Drug: Heparin solution

Anti-adhesion barrier gel

ACTIVE COMPARATOR

Intrauterine application of 2 ml biodegradable anti-adhesion barrier gel immediately post operative hysteroscopy.

Drug: Anti-adhesion barrier gel

Interventions

Heparin solution DRUG

3 ml saline solution containing 5000 IU heparin.

Also known as: HEP

Heparin solution

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).

Also known as: AAB

Anti-adhesion barrier gel

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nadezhda Women's Health Hospital: lead

Study Sites (2)

Nadezhda Women's Health Hospital

Sofia, Sofia, 1330, Bulgaria

RECRUITING

Nadezhda Women's Health Hospital

Sofia, 1373, Bulgaria

RECRUITING

Related Publications (5)

• Healy MW, Schexnayder B, Connell MT, Terry N, DeCherney AH, Csokmay JM, Yauger BJ, Hill MJ. Intrauterine adhesion prevention after hysteroscopy: a systematic review and meta-analysis. Am J Obstet Gynecol. 2016 Sep;215(3):267-275.e7. doi: 10.1016/j.ajog.2016.05.001. Epub 2016 May 10.

  PMID: 27173082 BACKGROUND

• Valle RF, Sciarra JJ. Intrauterine adhesions: hysteroscopic diagnosis, classification, treatment, and reproductive outcome. Am J Obstet Gynecol. 1988 Jun;158(6 Pt 1):1459-70. doi: 10.1016/0002-9378(88)90382-1.

  PMID: 3381869 BACKGROUND

• Nappi C, Di Spiezio Sardo A, Greco E, Guida M, Bettocchi S, Bifulco G. Prevention of adhesions in gynaecological endoscopy. Hum Reprod Update. 2007 Jul-Aug;13(4):379-94. doi: 10.1093/humupd/dml061. Epub 2007 Apr 23.

  PMID: 17452399 BACKGROUND

• van Wessel S, Hamerlynck T, Schutyser V, Tomassetti C, Wyns C, Nisolle M, Verguts J, Colman R, Weyers S, Bosteels J. Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol. Hum Reprod Open. 2021 Feb 16;2021(1):hoab001. doi: 10.1093/hropen/hoab001. eCollection 2021.

  PMID: 33623830 BACKGROUND

• Lee WL, Liu CH, Cheng M, Chang WH, Liu WM, Wang PH. Focus on the Primary Prevention of Intrauterine Adhesions: Current Concept and Vision. Int J Mol Sci. 2021 May 13;22(10):5175. doi: 10.3390/ijms22105175.

  PMID: 34068335 BACKGROUND

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Georgi Stamenov

CONTACT

+359888269839; g.stamenov1@abv.bg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be under general anaesthesia during surgical procedure when the allocated treatment will be administered.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison between two active intrauterine treatments administered immediately post surgery

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 25, 2022
• Study Start: February 14, 2022
• Primary Completion: February 14, 2026
• Study Completion: February 28, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BU (2)