PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film. (PREG2)

This is an interventional prevention trial for Asherman Syndrome focused on measuring Asherman Syndrome, Intrauterine adhesion, Hysteroscopy, Adhesiolysis, Adhesion prevention, Infertility Read More

Inclusion Criteria:

• Women with moderate or severe intrauterine adhesions according to the AFS classification, i.e AFS score >=5, confirmed by hysteroscopy right before adhesiolysis
• Scheduled for hysteroscopic adhesiolysis
• Age above or equal to 18
• Subjects who are willing to provide a written informed consent.
• Subjects who can comply with the study follow-up (second look hysteroscopy) and other study requirements

Exclusion Criteria:

Pre-operative criteria

• Post menopause
• Abnormal uterine cavity according to ESHRE classification I to V such as unicornis, bicornis, septate, duplex
• Known or suspected endometrial hyperplasia
• History of cervical or endometrial cancer
• Active pelvic infection or history of pelvic peritonitis
• History of endometrial ablation
• Known contraindication or hypersensitivity to Womed Leaf component
• Current participation in another clinical investigation that has not yet received the primary endpoint.
• Any other condition that makes participation in the study contrary to the patient's best interests.

Intra-operative criteria, post adhesiolysis:

• Perforation during adhesiolysis
• Uterine depth < 5cm or > 10cm