drugset / Trial / NCT05257213
Heparin Solution Versus Anti-adhesion Barrier Gel for Intrauterine Adhesions Prevention After Operative Hysteroscopy
RandomizedParallel-groupSingle-blindPrevention
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.
Timeline
- Start
- 2022-02-14
- Primary completion
- 2026-02-14
- Completion
- 2026-02-28
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Heparin | Other / unclassified | 5000 iu | Other |
| Comparator | Sodium Hyaluronate | Other / unclassified | 10 mg/ml | Other |