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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Asherman Syndrome, Intrauterine Adhesion

Intervention / Treatment
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* Device: Womed Leaf


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Pre-operative criteria Post menopause 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Womed Leaf<br>IUA prevention: The novel intrauterine barrier film (Womed Leaf) is inserted immediately after completion of the hysteroscopic adhesiolysis | Device: Womed Leaf<br>* 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.<br>|
| No Intervention: Control<br>No IUA prevention - no placebo after adhesiolysis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Safety - Adverse events | The number, severity and type of adverse events at second look hysteroscopy. | At second look hysteroscopy between 4 and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from IUA | Rate of IUA | At second look hysteroscopy between 4 and 8 weeks | 
| IUA severity at second look | Average of AFS scores at second look hysteroscopy | At second look hysteroscopy between 4 and 8 weeks | 
| IUA severity after adhesiolysis | Average of AFS scores post adhesiolysis | Just after adhesiolysis | 
| AFS score components | Average of each component of AFS score: extent of IUA, type of IUA and menstrual pattern | At second look hysteroscopy between 4 and 8 weeks | 
| Change in AFS score components | Average of the change in each component of AFS score between post-adhesiolysis and second look hysteroscopy | At second look hysteroscopy between 4 and 8 weeks | 
| Change in AFS score | Change of AFS score between post-adhesiolysis and second-look hysteroscopy | At second look hysteroscopy between 4 and 8 weeks | 
| IUA severity according to ESGE classification | Median of ESGE stage at second look hysteroscopy | At second look hysteroscopy between 4 and 8 weeks | 
| Reintervention rate | Reintervention rate, during second look hysteroscopy or scheduled later up to one year | 1 year | 
| Number of re-intervention procedures | Number of adhesiolysis procedures after second look up to one year | 1 year | 
| Pregnancy rate | Pregnancy rate defined as presence of foetal sac or heartbeat by ultrasound, whether spontaneous or IVF | 1 year | 
| Pregnancy rate | Pregnancy rate defined as presence of foetal sac or heartbeat by ultrasound, whether spontaneous or IVF | 2 years | 
| Live birth | Live birth rate | 1 year | 
| Live birth | Live birth rate | 2 years | 
| Pregnancy complication | Pregnancy complication rate | 2 years | 
| Time to pregnancy | Time to pregnancy (i.e. time between the second look hysteroscopy and pregnancy start) | 2 years | 
| Improvement of IUA severity | Percentage of patients who have improvement on the IUA severity according to Clinical Category: Percentage of patients who have Mild adhesions or no adhesion at second look Percentage of patients who improved from Severe to Moderate or from Moderate to Mild Percentage of patients who improved from Severe to Mild | At second look hysteroscopy between 4 and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asherman Syndrome, Intrauterine adhesion, Hysteroscopy, Adhesiolysis, Adhesion prevention, Infertility