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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
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Asherman Syndrome Intrauterine Adhesion Device: Womed Leaf Not Applicable

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 and 2 years and will be reported as secondary endpoints. 154 women are planned to be included in the PREG2 study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Freedom from IUA [ Time Frame: At second look hysteroscopy between 4 and 8 weeks ]
    Rate of IUA

  2. IUA severity at second look [ Time Frame: At second look hysteroscopy between 4 and 8 weeks ]
    Average of AFS scores at second look hysteroscopy

  3. IUA severity after adhesiolysis [ Time Frame: Just after adhesiolysis ]
    Average of AFS scores post adhesiolysis

  4. 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

  5. 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

  6. 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

  7. 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

  8. Reintervention rate [ Time Frame: 1 year ]
    Reintervention rate, during second look hysteroscopy or scheduled later up to one year

  9. Number of re-intervention procedures [ Time Frame: 1 year ]
    Number of adhesiolysis procedures after second look up to one year

  10. Pregnancy rate [ Time Frame: 1 year ]
    Pregnancy rate defined as presence of foetal sac or heartbeat by ultrasound, whether spontaneous or IVF

  11. Pregnancy rate [ Time Frame: 2 years ]
    Pregnancy rate defined as presence of foetal sac or heartbeat by ultrasound, whether spontaneous or IVF

  12. Live birth [ Time Frame: 1 year ]
    Live birth rate

  13. Live birth [ Time Frame: 2 years ]
    Live birth rate

  14. Pregnancy complication [ Time Frame: 2 years ]
    Pregnancy complication rate

  15. Time to pregnancy [ Time Frame: 2 years ]
    Time to pregnancy (i.e. time between the second look hysteroscopy and pregnancy start)

  16. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

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


Locations
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Belgium
Gent UZ Recruiting
Gent, Belgium, 9000
Contact: Steven Weyers    +32 9 332 37 57    steven.weyers@uzgent.be   
France
CHU Bicêtre Recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Hervé Fernandez    0145217763    bureau.fernandez.bct@aphp.fr   
Hopital La Conception Recruiting
Marseille, France, 13005
Contact: Aubert Agostini    0491383785    aubert.AGOSTINI@ap-hm.fr   
CHU Lariboisière Recruiting
Paris, France, 75010
Contact: Jean Louis Benifla    0149956236    jlbenifla@gmail.com   
Sponsors and Collaborators
Womed
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Responsible Party: Womed
ClinicalTrials.gov Identifier: NCT04963179    
Other Study ID Numbers: PREG2
First Posted: July 15, 2021    Key Record Dates
Last Update Posted: May 4, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the result that will be reported in an article and study protocol may be made available to researchers who provide a methodologically sound proposal, immediately after article publication and during 5 years
Supporting Materials: Study Protocol
Time Frame: immediately after article publication and during 5 years
Access Criteria: researchers who provide a methodologically sound proposal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Womed:
Asherman Syndrome
Intrauterine adhesion
Hysteroscopy
Adhesiolysis
Adhesion prevention
Infertility
Additional relevant MeSH terms:
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Gynatresia
Tissue Adhesions
Pathologic Processes
Cicatrix
Fibrosis