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

Intrauterine Adhesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05257213
• Other study ID #: 3/11022022
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: March 2024
• Source: Nadezhda Women's Health Hospital
• Contact: Georgi Stamenov
• Phone: +359888269839
• Email: g.stamenov1[@]abv.bg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2026
• Est. primary completion date: February 14, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intrauterine Adhesion
• Tissue Adhesions

Intervention

Drug:
• Heparin solution
3 ml saline solution containing 5000 IU heparin.
• Anti-adhesion barrier gel
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).

Locations

Country	Name	City	State
Bulgaria	Nadezhda Women's Health Hospital	Sofia
Bulgaria	Nadezhda Women's Health Hospital	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Nadezhda Women's Health Hospital

Country where clinical trial is conducted

Bulgaria, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Number of patients with persistent irregular menstrual bleeding	Recurring abnormal menstrual cycle patterns identified post initial surgery	up to 12 months post treatment
Secondary	Number of patients with fertility improvement	Successful pregnancy post surgical procedure	up to 12 months post treatment