Yonsei Med J.  2020 Oct;61(10):868-874. 10.3349/ymj.2020.61.10.868.

A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial

Affiliations
  • 1Department of Obstetrics & Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 2Department of Obstetrics & Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
  • 3Department of Obstetrics & Gynecology, Seoul National University Bundang Hospital, Seongnam, Korea
  • 4Department of Obstetrics & Gynecology, Pusan National University School of Medicine, Busan, Korea
  • 5Department of Dermatology, Medytox Inc., Seoul, Korea
  • 6Department of Obstetrics & Gynecology, Guro Hospital, College of Medicine, Korea University, Seoul, Korea
  • 7Department of Obstetrics & Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
  • 8Department of Obstetrics & Gynecology, Keimyung University School of Medicine, Daegu, Korea

Abstract

Purpose
To investigate the efficacy and safety of a newly developed thermo-responsive sol-gel, ABT13107, for reducing the formation of intrauterine adhesions (IUAs) after hysteroscopic surgery.
Materials and Methods
In this multicenter, prospective, randomized trial (Canadian Task Force classification I), 192 women scheduled to undergo a hysteroscopic surgery at one of the eight university hospitals in South Korea were randomized into the ABT13107 group or the comparator (Hyalobarrier ® ) group in a 1:1 ratio. During hysteroscopic surgery, ABT13107 or Hyalobarrier® was injected to sufficiently cover the entire intrauterine cavity.
Results
The patients returned to their respective sites for safety assessments at postoperative weeks 1 and 4 and for efficacy assessments at postoperative week 4. The post-surgery incidence of IUAs was 23.4% in the ABT13107 group and 25.8% in the comparator group; this difference met the criteria for ABT13107 to be considered as not inferior to the comparator. No differences were found in the extent of adhesions, types of adhesions, or the cumulative American Fertility Society score between the two treatment groups. Most adverse events were mild in severity, and no serious adverse events occurred.
Conclusion
ABT13107, a new anti-adhesive barrier containing hyaluronic acid, was not inferior to the highly viscous hyaluronic acid anti-adhesive barrier, Hyalurobarrier® in IUA formation after hysteroscopic surgery (Clinical trial registration No. NCT 04007211).

Keyword

Hysteroscopy; hyaluronic acid; infertility; tissue adhesions; uterus
Full Text Links
  • YMJ
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2021 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr