PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film. (PREG2)
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|ClinicalTrials.gov Identifier: NCT04963179|
Recruitment Status : Recruiting
First Posted : July 15, 2021
Last Update Posted : May 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Asherman Syndrome Intrauterine Adhesion||Device: Womed Leaf||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.|
|Actual Study Start Date :||November 29, 2021|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||September 2024|
Experimental: Womed Leaf
IUA prevention: The novel intrauterine barrier film (Womed Leaf) is inserted immediately after completion of the hysteroscopic adhesiolysis
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.
No Intervention: Control
No IUA prevention - no placebo after adhesiolysis
- Efficacy - IUA severity [ Time Frame: At second look hysteroscopy between 4 and 8 weeks ]Change of AFS score between pre-adhesiolysis and second-look hysteroscopy (AFS) score
- Safety - Adverse events [ Time Frame: At second look hysteroscopy between 4 and 8 weeks ]The number, severity and type of adverse events at second look hysteroscopy.
- Freedom from IUA [ Time Frame: At second look hysteroscopy between 4 and 8 weeks ]Rate of IUA
- IUA severity at second look [ Time Frame: At second look hysteroscopy between 4 and 8 weeks ]Average of AFS scores at second look hysteroscopy
- IUA severity after adhesiolysis [ Time Frame: Just after adhesiolysis ]Average of AFS scores post adhesiolysis
- AFS score components [ Time Frame: At second look hysteroscopy between 4 and 8 weeks ]Average of each component of AFS score: extent of IUA, type of IUA and menstrual pattern
- Change in AFS score components [ Time Frame: At second look hysteroscopy between 4 and 8 weeks ]Average of the change in each component of AFS score between post-adhesiolysis and second look hysteroscopy
- Change in AFS score [ Time Frame: At second look hysteroscopy between 4 and 8 weeks ]Change of AFS score between post-adhesiolysis and second-look hysteroscopy
- IUA severity according to ESGE classification [ Time Frame: At second look hysteroscopy between 4 and 8 weeks ]Median of ESGE stage at second look hysteroscopy
- Reintervention rate [ Time Frame: 1 year ]Reintervention rate, during second look hysteroscopy or scheduled later up to one year
- Number of re-intervention procedures [ Time Frame: 1 year ]Number of adhesiolysis procedures after second look up to one year
- Pregnancy rate [ Time Frame: 1 year ]Pregnancy rate defined as presence of foetal sac or heartbeat by ultrasound, whether spontaneous or IVF
- Pregnancy rate [ Time Frame: 2 years ]Pregnancy rate defined as presence of foetal sac or heartbeat by ultrasound, whether spontaneous or IVF
- Live birth [ Time Frame: 1 year ]Live birth rate
- Live birth [ Time Frame: 2 years ]Live birth rate
- Pregnancy complication [ Time Frame: 2 years ]Pregnancy complication rate
- Time to pregnancy [ Time Frame: 2 years ]Time to pregnancy (i.e. time between the second look hysteroscopy and pregnancy start)
- Improvement of IUA severity [ Time Frame: At second look hysteroscopy between 4 and 8 weeks ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04963179
|Gent, Belgium, 9000|
|Contact: Steven Weyers +32 9 332 37 57 email@example.com|
|Le Kremlin-Bicêtre, France, 94270|
|Contact: Hervé Fernandez 0145217763 firstname.lastname@example.org|
|Hopital La Conception||Recruiting|
|Marseille, France, 13005|
|Contact: Aubert Agostini 0491383785 aubert.AGOSTINI@ap-hm.fr|
|Paris, France, 75010|
|Contact: Jean Louis Benifla 0149956236 email@example.com|