Effectiveness of degradable polymer film in the management of severe or moderate intrauterine adhesions (PREG-2): a randomized, double-blind, multicenter, stratified, superiority trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F24%3A10489219" target="_blank" >RIV/00064165:_____/24:10489219 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11110/24:10489219

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=3iZIQBAbY~" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=3iZIQBAbY~</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.fertnstert.2024.07.020" target="_blank" >10.1016/j.fertnstert.2024.07.020</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Effectiveness of degradable polymer film in the management of severe or moderate intrauterine adhesions (PREG-2): a randomized, double-blind, multicenter, stratified, superiority trial

Popis výsledku v původním jazyce

Objective: To study the effectiveness of a new intrauterine degradable polymer fi lm (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 &gt;= 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 fi lm 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. Clinical Trial Registration Number: Clinicaltrials.gov identifier: NCT04963179. (Fertil Steril (R) 2024;122:1124-33. (c) 2024 by American Society for Reproductive Medicine.) El resumen est &amp; aacute; disponible en Espa &amp; ntilde;ol al final del art &amp; iacute;culo.

Název v anglickém jazyce

Effectiveness of degradable polymer film in the management of severe or moderate intrauterine adhesions (PREG-2): a randomized, double-blind, multicenter, stratified, superiority trial

Popis výsledku anglicky

Objective: To study the effectiveness of a new intrauterine degradable polymer fi lm (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 &gt;= 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 fi lm 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. Clinical Trial Registration Number: Clinicaltrials.gov identifier: NCT04963179. (Fertil Steril (R) 2024;122:1124-33. (c) 2024 by American Society for Reproductive Medicine.) El resumen est &amp; aacute; disponible en Espa &amp; ntilde;ol al final del art &amp; iacute;culo.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30214 - Obstetrics and gynaecology

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2024

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Fertility and Sterility

ISSN

0015-0282

e-ISSN

1556-5653

Svazek periodika

122

Číslo periodika v rámci svazku

6

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

10

Strana od-do

1124-1133

Kód UT WoS článku

001374334700001

EID výsledku v databázi Scopus

2-s2.0-85200906333