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

N/AActive Not RecruitingNCT04963179

Womed160 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

160

Conditions

Asherman Syndrome Intrauterine Adhesion

Interventions

Womed LeafDEVICE

Womed Leaf™ device is composed of a uterine anti-adhesion film pre-loaded inside a flexible inserter. Womed Leaf™ is inserted in the uterine cavity by the gynecologist surgeon as a film folded into a 5 mm diameter flexible inserter. Once released, the film will unfold and swell into the uterine cavity to keep uterus walls separated. It is degraded and discharged naturally through the cervix and vagina.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

Gent UZ

Ghent, Belgium

Guangdong Maternal and Child Health Hospital

Guangzhou, China

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, China

Outcomes

Primary Outcomes

Efficacy - IUA Severity

Change of AFS score between pre-adhesiolysis and second-look hysteroscopy (AFS) score The scale used to assess the severity of intrauterine adhesions is the American Fertility Society score. It is a 12 points composite score that adds-up 3 subcomponents: - Extend of adhesions (1 = less than 1/3 of the uterine cavity involved with adhesions to 4 = more than 2/3 of the uterine cavity involved with adhesions), * Type of adhesions (1 = Filmy adhesions to 4 = dense adhesions) * Menstrual pattern (0= normal to 4 = amenorrhea). The final score allows the following prognostic classification: 1-4 = mild disease, 5-8 = moderate disease 9-12 = severe disease