PREG2

Study synopsis

Rationale for study:

Intrauterine adhesions (IUA) can lead to recurrent pregnancy loss, infertility, abnormal placentation, menstrual abnormalities, and pain. Treatment by hysteroscopic lysis is recommended if the patient has clinical symptoms. However, one of the greatest challenge is the recurrence of adhesive disease: the recurrence rate after intrauterine synechiae lysis is up to 60% in the case of severe adheions. 

There is a need for an evidence based secondary prevention method. 

Objective of the study

Evaluate the efficacy of Womed Leaf in preventing intrauterine adhesions after hysteroscopic adhesiolysis (secondary prevention).

Design

Prospective, multi-center, stratified randomized, controlled, two-arm superiority clinical trial. 

Subjects will be followed up at 6 weeks as per AAGL/ESGE guidelines.

Target population: 

Women with moderate or severe intrauterine adhesions scheduled for hysteroscopy adhesiolysis.

Study group:

IUA prevention: Womed Leaf is inserted immediately after completion of the hysteroscopic adhesiolysis. 

Control group:

No IUA prevention - no placebo after adhesiolysis. 

Primary endpoint

Severity of IUA at second look hysteroscopy according to American Fertility Society (AFS) score

Investigator profile

Center specialized in Asherman syndrom / intrauterine adhesions. 
High volume of hysteroscopic adhesiolysis
European or Chinese center

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