Hervé Fernandez, Laura Miquel, Jérémy Sroussi, Steven Weyers, Meritxell Munmany, Xiping Luo, Petr Kovar, Yue Wang, Brunella Zizolfi, Anna Surbone, Victoire Delporte, Enrique Moratalla, Marine Sauvan, Gaetano Perrini, Long Sui, Michal Mara
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Information on the rate of no IUA and responder rate was collected as secondary effectiveness outcomes, while reported adverse events and patient-reported outcomes as safety and tolerability measures.</p><p><strong>Result(s): </strong>Between October 26, 2021, and September 28, 2023, a total of 160 women were randomized (Womed Leaf: n = 75 and controls: n = 85). The reduction in IUA AFS score on SLH was significantly higher in the intervention compared with the control group (mean 5.2 ± 2.8 vs. 4.2 ± 3.2). Similarly, the absence of adhesions on SLH was significantly higher in the intervention group (41% vs. 24%; odds ratio, 2.44; confidence interval, 1.161-5.116). 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引用次数: 0
摘要
目的研究新型宫内可降解聚合物薄膜（Womed Leaf®）治疗中重度 IUA 的有效性：PREG2研究是一项多中心、双盲、随机对照、分层、双臂优效临床试验，在7个国家的16个中心进行：因无症状性重度或中度粘连（根据美国生育协会（AFS）IUA评分）而计划接受宫腔镜粘连溶解术的≥18岁患者均符合研究条件：干预措施：宫腔粘连切除术后，患者按1:1的比例随机选择植入沃美德叶片（干预组）或不植入沃美德叶片（对照组）：研究的主要疗效终点是二诊宫腔镜检查（SLH）中 AFS IUA 评分与基线相比的变化，由独立评估员进行评估。收集无 IUA 率和应答率信息作为次要疗效指标，报告的不良事件和患者报告的结果作为安全性和耐受性指标：2021年10月26日至2023年9月28日期间，共有160名妇女接受了随机治疗（沃美叶：75人，对照组：85人）。与对照组相比，干预组在SLH上的IUA AFS评分降低幅度明显更高（平均值为5.2 ± 2.8 vs. 4.2 ± 3.2；P=0.0153）。同样，干预组在SLH检查中无粘连的比例也明显高于对照组（41% vs 24% OR 2.44 [CI 1.161 - 5.116]; p=0.0189）。报告的不良事件均不严重，也不认为与设备有关：结论：Womed Leaf 能有效、安全地治疗无症状的重度或中度宫腔粘连。
Effectiveness of degradable polymer film in the management of severe or moderate intrauterine adhesions (PREG-2): a randomized, double-blind, multicenter, stratified, superiority trial.
Objective: To study the effectiveness of a new intrauterine degradable polymer film (Womed Leaf) in the management of moderate to severe intrauterine adhesions (IUA).
Design: PREG-2 study was a multicenter, double-blind, randomized, controlled, stratified, two-arm superiority clinical trial conducted in 16 centers in seven countries.
Setting: Not applicable.
Patient(s): Patients ≥18 years scheduled for hysteroscopic adhesiolysis because of symptomatic severe or moderate adhesions (according to American Fertility Society [AFS] IUA score) were considered eligible for the study.
Intervention(s): After adhesiolysis, patients were randomized at a 1:1 ratio to either have a Womed Leaf film inserted (intervention group) or not (control group).
Main outcome measure(s): The primary effectiveness endpoint of the study was the change in AFS IUA score on second-look hysteroscopy (SLH), assessed by an independent evaluator, and compared with baseline. Information on the rate of no IUA and responder rate was collected as secondary effectiveness outcomes, while reported adverse events and patient-reported outcomes as safety and tolerability measures.
Result(s): Between October 26, 2021, and September 28, 2023, a total of 160 women were randomized (Womed Leaf: n = 75 and controls: n = 85). The reduction in IUA AFS score on SLH was significantly higher in the intervention compared with the control group (mean 5.2 ± 2.8 vs. 4.2 ± 3.2). Similarly, the absence of adhesions on SLH was significantly higher in the intervention group (41% vs. 24%; odds ratio, 2.44; confidence interval, 1.161-5.116). None of the reported adverse events were serious or considered related to the device.
Conclusion(s): Womed Leaf is effective and safe in the management of symptomatic severe or moderate IUAs.
期刊介绍：
Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.
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