Clinical trial NCT04963179: PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.
Official title: PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asherman Syndrome
Intrauterine Adhesion
Keywords: Asherman Syndrome
Intrauterine adhesion
Hysteroscopy
Adhesiolysis
Adhesion prevention
Infertility
Lead sponsor: Womed
Sponsor class: INDUSTRY
First posted: 2021-07-15
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Efficacy - IUA Severity
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Safety - Adverse Events
timeFrame: At second look hysteroscopy between 4 and 8 weeks
Secondary outcomes:
measure: High-responder Rate
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Change of "Extent of Cavity Involved" Component
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Change in "Extent of Cavity Involved" Component Between Post-adhesiolysis and Second Look Hysteroscopy
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: AFS Score
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Change of Extent of IUA AFS Score Component
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Change of Type of IUA AFS Score Component
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Menstrual Pattern AFS Score Component
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Percentage of Patients Who Have Mild Adhesions or no Adhesion
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Freedom From IUA
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: ESGE Stage
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Level of Post-operative Pain
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Level of Discomfort Related to Vaginal Discharge
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Timing of Vaginal Discharge
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Duration of the Vaginal Discharge
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Qualitative Description of the Vaginal Discharge
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Change of Menstrual Pattern
timeFrame: At second look hysteroscopy between 4 and 8 weeks, 1 year, 2 years
measure: Reintervention Rate
timeFrame: At second look hysteroscopy or scheduled later up to one year
measure: Number of Adhesiolysis Procedures
timeFrame: After second look to one year
measure: Pregnancy Rate
timeFrame: 1 year, 2 years, 3 years
measure: Live Birth Rate
timeFrame: 1 year 2 years, 3 years
measure: Pregnancy Complication Rate
timeFrame: 3 years
measure: Time to Pregnancy
timeFrame: 3 years
measure: IUA Severity According to Chinese Scoring System
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Responder Rate
timeFrame: At second look hysteroscopy between 4 and 8 weeks
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Gent UZ
city: Guangzhou
country: China
facility: Guangdong Maternal and Child Health Hospital
city: Hangzhou
country: China
facility: Women's Hospital School Of Medicine Zhejiang University
city: Shanghai
country: China
facility: The Obstetrics & Gynecology Hospital Affiliated to Fudan University
city: Ostrava
country: Czechia
facility: Gynprenatal
city: Le Kremlin-Bicêtre
country: France
facility: CHU Bicêtre
city: Lille
country: France
facility: CHU de Lille
city: Marseille
country: France
facility: Hopital La Conception
city: Paris
country: France
facility: CHU Lariboisière
city: Rennes
country: France
facility: Clinique Mutualiste La sagesse
city: Napoli
country: Italy
facility: A.O.U Federico II
city: Torino
country: Italy
facility: Aso Mauriziano Umberto I
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelonna
city: Madrid
country: Spain
facility: Ramon y Cajal Hospital
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
Study officials:
References: