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

NCT ID: NCT04963179

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-29
• Study Completion Date: 2026-12-31

Brief Summary

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

Detailed 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.

Conditions

Asherman Syndrome; Intrauterine Adhesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Womed Leaf

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

Group Type: EXPERIMENTAL

Womed Leaf

Intervention Type: DEVICE

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.

Control

No IUA prevention - no placebo after adhesiolysis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Womed Leaf

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Womed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gent UZ

Ghent, , Belgium

Guangdong Maternal and Child Health Hospital

Guangzhou, , China

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, , China

The Obstetrics & Gynecology Hospital Affiliated to Fudan University

Shanghai, , China

Gynprenatal

Ostrava, , Czechia

CHU Bicêtre

Le Kremlin-Bicêtre, , France

CHU de Lille

Lille, , France

Hopital La Conception

Marseille, , France

CHU Lariboisière

Paris, , France

Clinique Mutualiste La sagesse

Rennes, , France

A.O.U Federico II

Napoli, , Italy

Aso Mauriziano Umberto I

Torino, , Italy

Hospital Clinic Barcelonna

Barcelona, , Spain

Ramon y Cajal Hospital

Madrid, , Spain

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Countries

Belgium; China; Czechia; France; Italy; Spain; Switzerland

References

Fernandez H, Miquel L, Sroussi J, Weyers S, Munmany M, Luo X, Kovar P, Wang Y, Zizolfi B, Surbone A, Delporte V, Moratalla E, Sauvan M, Perrini G, Sui L, Mara M. Effectiveness of degradable polymer film in the management of severe or moderate intrauterine adhesions (PREG-2): a randomized, double-blind, multicenter, stratified, superiority trial. Fertil Steril. 2024 Dec;122(6):1124-1133. doi: 10.1016/j.fertnstert.2024.07.020. Epub 2024 Jul 22.

Reference Type: DERIVED

PMID: 39048019 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PREG2

Identifier Type: -

Identifier Source: org_study_id