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

Intrauterine Adhesion Clinical Trial

— PREG2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04963179
• Other study ID #: PREG2
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Womed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 and 2 years and will be reported as secondary endpoints. 154 women are planned to be included in the PREG2 study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: January 2025
• Est. primary completion date: November 11, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asherman Syndrome
• Intrauterine Adhesion
• Tissue Adhesions

Intervention

Device:
• 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 during approximately 5 days. It is degraded and discharged naturally through the cervix and vagina in less than 30 days.

Locations

Country	Name	City	State
Belgium	Gent UZ	Gent
China	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
Czechia	Gynprenatal	Ostrava
France	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
Italy	A.O.U Federico II	Napoli
Italy	Aso Mauriziano Umberto I	Torino
Spain	Hospital Clinic Barcelonna	Barcelona
Spain	Ramon y Cajal Hospital	Madrid
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Womed

Countries where clinical trial is conducted

Belgium,  China,  Czechia,  France,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - IUA severity	Change of AFS score between pre-adhesiolysis and second-look hysteroscopy (AFS) score	At second look hysteroscopy between 4 and 8 weeks
Primary	Safety - Adverse events	Adverse events up to second look hysteroscopy.	At second look hysteroscopy between 4 and 8 weeks
Secondary	High-responder rate	Percentage of patients who have improved from severe to mild adhesions or from severe to no adhesions or from moderate to no adhesions	At second look hysteroscopy between 4 and 8 weeks
Secondary	Change of "extent of cavity involved" component	Average of AFS score component "extent of cavity involved"	At second look hysteroscopy between 4 and 8 weeks
Secondary	Change in "extent of cavity involved" component between post-adhesiolysis and second look hysteroscopy	Average of AFS score component "extent of cavity involved"	At second look hysteroscopy between 4 and 8 weeks
Secondary	AFS score	Average of AFS score	At second look hysteroscopy between 4 and 8 weeks
Secondary	Change of extent of IUA AFS score component	Average of the change of the AFS score component "Extent of IUA"	At second look hysteroscopy between 4 and 8 weeks
Secondary	Change of type of IUA AFS score component	Average of the change of the AFS score component "type of IUA"	At second look hysteroscopy between 4 and 8 weeks
Secondary	Menstrual pattern AFS score component	Average of the change of the AFS score component "Menstrual Pattern"	At second look hysteroscopy between 4 and 8 weeks
Secondary	Percentage of patients who have Mild adhesions or no adhesion	Percentage of patients who have AFS < 5	At second look hysteroscopy between 4 and 8 weeks
Secondary	Freedom from IUA	Rate of patients who don't have adhesion	At second look hysteroscopy between 4 and 8 weeks
Secondary	ESGE stage	Rate of ECGE stage	At second look hysteroscopy between 4 and 8 weeks
Secondary	Level of post-operative pain	Level of post-operative pain on a numeric rating scale, with 0 = no pain and 10 = the worst pain.	At second look hysteroscopy between 4 and 8 weeks
Secondary	Level of discomfort related to vaginal discharge	Level of discomfort related to vaginal discharge on a numeric rating scale, with 0 = no discomfort and 10 = extremely disturbing	At second look hysteroscopy between 4 and 8 weeks
Secondary	Timing of vaginal discharge	Timing of vaginal discharge as recalled by the patient	At second look hysteroscopy between 4 and 8 weeks
Secondary	Duration of the vaginal discharge	Duration of the vaginal discharge as recalled by the patient	At second look hysteroscopy between 4 and 8 weeks
Secondary	Qualitative description of the vaginal discharge	Qualitative description of the vaginal discharge as recalled by the patient	At second look hysteroscopy between 4 and 8 weeks
Secondary	Change of menstrual pattern	Change of menstrual pattern	At second look hysteroscopy between 4 and 8 weeks, 1 year, 2 years
Secondary	Reintervention rate	Reintervention rate, during second look hysteroscopy or scheduled later up to one year	At second look hysteroscopy or scheduled later up to one year
Secondary	Number of adhesiolysis procedures	Number of adhesiolysis procedures after second look to one year	After second look to one year
Secondary	Pregnancy rate	Pregnancy rate defined as presence of foetal sac or heartbeat by ultrasound at 1 year and 2 years, whether spontaneous or IVF	1 year, 2 years
Secondary	Live birth rate	Live birth rate at 1 year and 2 years	1 year and 2 years
Secondary	Pregnancy complication rate	Pregnancy complication rate	2 years
Secondary	Time to pregnancy	Time to pregnancy (i.e. time between the second look hysteroscopy and pregnancy start)	2 years
Secondary	IUA severity according to Chinese scoring system	IUA severity according to Chinese scoring system (for patients enrolled in China only)	At second look hysteroscopy between 4 and 8 weeks
Secondary	Responder rate	Percentage of patients with an improvement of one clinical category i.e from Severe to Moderate or from Moderate to Mild	At second look hysteroscopy between 4 and 8 weeks