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

NCT04963179 | Active Not Recruiting Results

• 1 other identifier: PREG2
• Study Type: interventional
• Target: 160
• Locations: 7 countries
• Sites: 15

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

Conditions

Asherman Syndrome; Intrauterine Adhesion

Keywords

Asherman Syndrome; Intrauterine adhesion; Hysteroscopy; Adhesiolysis; Adhesion prevention; Infertility

Outcome Measures

Primary Outcomes (2)

• 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

  At second look hysteroscopy between 4 and 8 weeks

• Safety - Adverse Events

  Adverse events up to second look hysteroscopy.

  At second look hysteroscopy between 4 and 8 weeks

Secondary Outcomes (24)

• High-responder Rate

  At second look hysteroscopy between 4 and 8 weeks

• Change of "Extent of Cavity Involved" Component

  At second look hysteroscopy between 4 and 8 weeks

• Change in "Extent of Cavity Involved" Component Between Post-adhesiolysis and Second Look Hysteroscopy

  At second look hysteroscopy between 4 and 8 weeks

• AFS Score

  At second look hysteroscopy between 4 and 8 weeks

• Change of Extent of IUA AFS Score Component

  At second look hysteroscopy between 4 and 8 weeks

Study Arms (2)

Womed Leaf

EXPERIMENTAL

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

Device: Womed Leaf

Control

NO INTERVENTION

No IUA prevention - no placebo after adhesiolysis

Interventions

Womed Leaf 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.

Womed Leaf

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Womed: lead

Study Sites (15)

Gent UZ

Ghent, 9000, Belgium

Location

Guangdong Maternal and Child Health Hospital

Guangzhou, China

Location

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, China

Location

The Obstetrics & Gynecology Hospital Affiliated to Fudan University

Shanghai, China

Location

Gynprenatal

Ostrava, Czechia

Location

CHU Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

CHU de Lille

Lille, 59000, France

Location

Hopital La Conception

Marseille, 13005, France

Location

CHU Lariboisière

Paris, 75010, France

Location

Clinique Mutualiste La sagesse

Rennes, 35043, France

Location

A.O.U Federico II

Napoli, 80131, Italy

Location

Aso Mauriziano Umberto I

Torino, Italy

Location

Hospital Clinic Barcelonna

Barcelona, Spain

Location

Ramon y Cajal Hospital

Madrid, 28034, Spain

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 39048019 DERIVED

MeSH Terms

Conditions

Gynatresia; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Womed

pauline@womedtech.com

0785225561

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 15, 2021
• Study Start: November 29, 2021
• Primary Completion: November 11, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 27, 2025
• Results First Posted: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: immediately after article publication and during 5 years
• Access Criteria: researchers who provide a methodologically sound proposal

Locations

FR (5); IT (2); CN (3); CZ (1); ES (2); CH (1); BE (1)