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

Womed

Status: Active, not recruiting

Conditions: Intrauterine Adhesion; Asherman Syndrome

Treatments: Device: Womed Leaf

Study type: Interventional

Funder types: Industry

Identifiers

NCT04963179

PREG2

Details and patient eligibility

About

PREG2 is a randomized controlled trial that aims to evaluate efficacy in preventing intrauterine adhesion recurrence after hysteroscopic adhesiolysis of a novel intrauterine barrier film named Womed Leaf

Full description

PREG2 is a prospective, multi-center, randomized, controlled, two arm clinical study. The objective is to evaluate the efficacy of Womed Leaf in preventing intrauterine adhesion recurrence after adhesiolysis compared to adhesiolysis alone.

The study will be performed on women with moderate or severe adhesions (AFS score >=5) scheduled for adhesiolysis. Indeed, the risk of intrauterine adhesion is very high (up to 60%) in this population of patients.

A follow-up diagnostic hysteroscopy will be performed 6-8 weeks after the adhesiolysis procedure to determine the presence and severity of IUAs according to the American Fertility Society and European Society of Gynecologic Endoscopy classification systems of adhesions. Fertility-related outcome will include live pregnancy at 1 year, 2 years and 3 years and will be reported as secondary endpoints. 154 women are planned to be included in the PREG2 study.

Enrollment: 160 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Subjects who agree to refrain from intercourse or use a reliable form of barrier contraception to prevent unintended pregnancy until the follow-up hysteroscopy.
• Subjects who agree to avoid all intrauterine devices (IUDs) until the follow-up hysteroscopy.

Exclusion criteria

Pre-operative criteria

• Post menopause
• Pregnant (confirmed by a positive pregnancy test) or lactating
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Womed Leaf

Experimental group

Description:

IUA prevention: The novel intrauterine barrier film (Womed Leaf) is inserted immediately after completion of the hysteroscopic adhesiolysis

Treatment:

Device: Womed Leaf

Control

No Intervention group

Description:

No IUA prevention - no placebo after adhesiolysis