Qiaoyun Zhou1, Xiaoyu Shi2, Sotirios Saravelos3, Xiaowu Huang1, Yuting Zhao1, Rui Huang1, Enlan Xia1, Tin Chiu Li4. 1. Department of Hysteroscopic Center, Fuxing Hospital, The Eighth Clinical Medical College, Capital Medical University, Beijing (Drs. Shi, X. Huang, R. Huang, Li, Zhou, and Zhao, and Ms. Xia). 2. Department of Hysteroscopic Center, Fuxing Hospital, The Eighth Clinical Medical College, Capital Medical University, Beijing (Drs. Shi, X. Huang, R. Huang, Li, Zhou, and Zhao, and Ms. Xia); Assisted Reproductive Technology Unit, Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR (Drs. Shi, Saravelos, and Li), China. 3. Assisted Reproductive Technology Unit, Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR (Drs. Shi, Saravelos, and Li), China; IVF Unit, Hammersmith Hospital, Imperial College, London (Dr. Saravelos), United Kingdom. 4. Department of Hysteroscopic Center, Fuxing Hospital, The Eighth Clinical Medical College, Capital Medical University, Beijing (Drs. Shi, X. Huang, R. Huang, Li, Zhou, and Zhao, and Ms. Xia); Assisted Reproductive Technology Unit, Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR (Drs. Shi, Saravelos, and Li), China. Electronic address: tinchiu.li@gmail.com.
Abstract
STUDY OBJECTIVE: To investigate auto-cross-linked hyaluronic acid gel for the prevention of intrauterine adhesion (IUA) recurrence after hysteroscopic adhesiolysis. DESIGN: A single-center, double-blinded randomized controlled trial. SETTING: A tertiary university hospital. PATIENTS: Two hundred seventy-two patients with moderate-to-severe (American Fertility Society [AFS] score ≥5) IUAs underwent hysteroscopic adhesiolysis. INTERVENTIONS: The patients were randomized to receive standard care along with auto-cross-linked hyaluronic acid gel after surgery (treatment group) or standard care only (control group). All patients had second-look hysteroscopy at 4 weeks and hormonal therapy for 2 cycles after surgery. MEASUREMENTS AND MAIN RESULTS:Two hundred sixty patients were eligible and randomized; 245 patients successfully completed the study (n = 122 in treatment group, and n = 123 in control group). The primary outcome measure was IUA recurrence at second-look hysteroscopy. The secondary outcome measures included an improvement in the AFS score and menstrual pattern. There was no significant difference with regard to IUA recurrence (31.1% vs 39.8%) or median AFS score at second-look hysteroscopy (2, interquartile range [2-4] vs 2, interquartile range [2-4]) or improvement in the menstrual pattern at 3-month follow-up (87.7% vs 76.4%), in the treatment and control groups, respectively. CONCLUSION: The application of auto-cross-linked hyaluronic acid gel did not seem to improve IUA recurrence after hysteroscopic adhesiolysis.
RCT Entities:
STUDY OBJECTIVE: To investigate auto-cross-linked hyaluronic acid gel for the prevention of intrauterine adhesion (IUA) recurrence after hysteroscopic adhesiolysis. DESIGN: A single-center, double-blinded randomized controlled trial. SETTING: A tertiary university hospital. PATIENTS: Two hundred seventy-two patients with moderate-to-severe (American Fertility Society [AFS] score ≥5) IUAs underwent hysteroscopic adhesiolysis. INTERVENTIONS: The patients were randomized to receive standard care along with auto-cross-linked hyaluronic acid gel after surgery (treatment group) or standard care only (control group). All patients had second-look hysteroscopy at 4 weeks and hormonal therapy for 2 cycles after surgery. MEASUREMENTS AND MAIN RESULTS: Two hundred sixty patients were eligible and randomized; 245 patients successfully completed the study (n = 122 in treatment group, and n = 123 in control group). The primary outcome measure was IUA recurrence at second-look hysteroscopy. The secondary outcome measures included an improvement in the AFS score and menstrual pattern. There was no significant difference with regard to IUA recurrence (31.1% vs 39.8%) or median AFS score at second-look hysteroscopy (2, interquartile range [2-4] vs 2, interquartile range [2-4]) or improvement in the menstrual pattern at 3-month follow-up (87.7% vs 76.4%), in the treatment and control groups, respectively. CONCLUSION: The application of auto-cross-linked hyaluronic acid gel did not seem to improve IUA recurrence after hysteroscopic adhesiolysis.
Authors: Luz Angela Torres-de la Roche; Véronique Bérard; Maya Sophie de Wilde; Rajesh Devassy; Markus Wallwiener; Rudy Leon De Wilde Journal: J Clin Med Date: 2022-02-11 Impact factor: 4.241