Effectiveness of degradable polymer film in the management of severe or moderate intrauterine adhesions (PREG-2): a randomized, double-blind, multicenter, stratified, superiority trial
The result's identifiers
Result code in 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>
Alternative codes found
RIV/00216208:11110/24:10489219
Result on the web
<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>
Alternative languages
Result language
angličtina
Original language name
Effectiveness of degradable polymer film in the management of severe or moderate intrauterine adhesions (PREG-2): a randomized, double-blind, multicenter, stratified, superiority trial
Original language description
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 >= 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 & aacute; disponible en Espa & ntilde;ol al final del art & iacute;culo.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30214 - Obstetrics and gynaecology
Result continuities
Project
—
Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2024
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Fertility and Sterility
ISSN
0015-0282
e-ISSN
1556-5653
Volume of the periodical
122
Issue of the periodical within the volume
6
Country of publishing house
US - UNITED STATES
Number of pages
10
Pages from-to
1124-1133
UT code for WoS article
001374334700001
EID of the result in the Scopus database
2-s2.0-85200906333