PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.
- Conditions
- Intrauterine AdhesionAsherman Syndrome
- Interventions
- Device: Womed Leaf
- Registration Number
- NCT04963179
- Lead Sponsor
- Womed
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 160
- 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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Womed Leaf Womed Leaf IUA prevention: The novel intrauterine barrier film (Womed Leaf) is inserted immediately after completion of the hysteroscopic adhesiolysis
- Primary Outcome Measures
Name Time Method Efficacy - IUA Severity At second look hysteroscopy between 4 and 8 weeks 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 diseaseSafety - Adverse Events At second look hysteroscopy between 4 and 8 weeks Adverse events up to second look hysteroscopy.
- Secondary Outcome Measures
Name Time Method High-responder Rate At second look hysteroscopy between 4 and 8 weeks Percentage of patients who have improved from severe to mild adhesions or from severe to no adhesions or from moderate to no adhesions
Change of "Extent of Cavity Involved" Component At second look hysteroscopy between 4 and 8 weeks Average of AFS score component "extent of cavity involved"
Change in "Extent of Cavity Involved" Component Between Post-adhesiolysis and Second Look Hysteroscopy At second look hysteroscopy between 4 and 8 weeks Average of AFS score component "extent of cavity involved"
AFS Score At second look hysteroscopy between 4 and 8 weeks Average of AFS score
Change of Extent of IUA AFS Score Component At second look hysteroscopy between 4 and 8 weeks Average of the change of the AFS score component "Extent of IUA"
Change of Type of IUA AFS Score Component At second look hysteroscopy between 4 and 8 weeks Average of the change of the AFS score component "type of IUA"
Menstrual Pattern AFS Score Component At second look hysteroscopy between 4 and 8 weeks Average of the change of the AFS score component "Menstrual Pattern"
Percentage of Patients Who Have Mild Adhesions or no Adhesion At second look hysteroscopy between 4 and 8 weeks Percentage of patients who have AFS \< 5
Freedom From IUA At second look hysteroscopy between 4 and 8 weeks Rate of patients who don't have adhesion
ESGE Stage At second look hysteroscopy between 4 and 8 weeks Rate of ECGE stage
Level of Post-operative Pain At second look hysteroscopy between 4 and 8 weeks Level of post-operative pain on a numeric rating scale, with 0 = no pain and 10 = the worst pain.
Level of Discomfort Related to Vaginal Discharge At second look hysteroscopy between 4 and 8 weeks Level of discomfort related to vaginal discharge on a numeric rating scale, with 0 = no discomfort and 10 = extremely disturbing
Timing of Vaginal Discharge At second look hysteroscopy between 4 and 8 weeks Timing of vaginal discharge as recalled by the patient
Duration of the Vaginal Discharge At second look hysteroscopy between 4 and 8 weeks Duration of the vaginal discharge as recalled by the patient
Qualitative Description of the Vaginal Discharge At second look hysteroscopy between 4 and 8 weeks Qualitative description of the vaginal discharge as recalled by the patient
Change of Menstrual Pattern At second look hysteroscopy between 4 and 8 weeks, 1 year, 2 years Change of menstrual pattern
Reintervention Rate At second look hysteroscopy or scheduled later up to one year Reintervention rate, during second look hysteroscopy or scheduled later up to one year
Number of Adhesiolysis Procedures After second look to one year Number of adhesiolysis procedures after second look to one year
Pregnancy Rate 1 year, 2 years, 3 years Pregnancy rate defined as presence of foetal sac or heartbeat by ultrasound at 1 year and 2 years, whether spontaneous or IVF
Live Birth Rate 1 year 2 years, 3 years Live birth rate at 1 year and 2 years
Pregnancy Complication Rate 3 years Pregnancy complication rate
Time to Pregnancy 3 years Time to pregnancy (i.e. time between the second look hysteroscopy and pregnancy start)
IUA Severity According to Chinese Scoring System At second look hysteroscopy between 4 and 8 weeks IUA severity according to Chinese scoring system (for patients enrolled in China only)
Responder Rate At second look hysteroscopy between 4 and 8 weeks Percentage of patients with an improvement of one clinical category i.e from Severe to Moderate or from Moderate to Mild
Trial Locations
- Locations (15)
Guangdong Maternal and Child Health Hospital
🇨🇳Guangzhou, China
Gent UZ
🇧🇪Gent, Belgium
Women's Hospital School Of Medicine Zhejiang University
🇨🇳Hangzhou, China
The Obstetrics & Gynecology Hospital Affiliated to Fudan University
🇨🇳Shanghai, China
Gynprenatal
🇨🇿Ostrava, Czechia
CHU de Lille
🇫🇷Lille, France
Hopital La Conception
🇫🇷Marseille, France
A.O.U Federico II
🇮🇹Napoli, Italy
Clinique Mutualiste La sagesse
🇫🇷Rennes, France
Aso Mauriziano Umberto I
🇮🇹Torino, Italy
Hospital Clinic Barcelonna
🇪🇸Barcelona, Spain
Ramon y Cajal Hospital
🇪🇸Madrid, Spain
CHU Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
CHU Lariboisière
🇫🇷Paris, France