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

Dong Yun Lee, Sa Ra Lee, Seul Ki Kim, Jong Kil Joo, Woo Shun Lee, Jung Ho Shin, SiHyun Cho, Joon Cheol Park, Sung Hoon Kim, Dong Yun Lee, Sa Ra Lee, Seul Ki Kim, Jong Kil Joo, Woo Shun Lee, Jung Ho Shin, SiHyun Cho, Joon Cheol Park, Sung Hoon Kim

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. NCT04007211).

Keywords: Hysteroscopy; hyaluronic acid; infertility; tissue adhesions; uterus.

Conflict of interest statement

Woo Shun Lee is an employee of Medytox Inc. The other authors have no potential conflicts of interest to disclose.

© Copyright: Yonsei University College of Medicine 2020.

Figures

Fig. 1. CONSORT flow diagram of participants.
Fig. 1. CONSORT flow diagram of participants.
Fig. 2. Number of patients assessed and…
Fig. 2. Number of patients assessed and enrolled in the clinical trial.
Fig. 3. The primary efficacy outcomes: intrauterine…
Fig. 3. The primary efficacy outcomes: intrauterine adhesions (IUAs) between ABT13107 and Hyalobarrier® assessed by independent evaluators at week 4. CI, confidence interval.

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