Intrauterine Adhesion Clinical Trial
— PREG2Official title:
PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.
Verified date | February 2024 |
Source | Womed |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Womed |
Belgium, China, Czechia, France, Italy, Spain, Switzerland,
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 |
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