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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Womed Leaf | Experimental | IUA prevention: The novel intrauterine barrier film (Womed Leaf) is inserted immediately after completion of the hysteroscopic adhesiolysis |
|
| Control | No Intervention | No IUA prevention - no placebo after adhesiolysis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Womed Leaf | Device | Womed Leafâ„¢ device is composed of a uterine anti-adhesion film pre-loaded inside a flexible inserter. Womed Leafâ„¢ 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. It is degraded and discharged naturally through the cervix and vagina. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - IUA Severity | 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),
The final score allows the following prognostic classification: 1-4 = mild disease, 5-8 = moderate disease 9-12 = severe disease | At second look hysteroscopy between 4 and 8 weeks |
| Safety - Adverse Events | Adverse events up to second look hysteroscopy. | At second look hysteroscopy between 4 and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change of "Extent of Cavity Involved" Component |
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Inclusion Criteria:
Exclusion Criteria:
Pre-operative criteria
Intra-operative criteria, post adhesiolysis:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gent UZ | Ghent | 9000 | Belgium | |||
| Guangdong Maternal and Child Health Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39048019 | Derived | Fernandez H, Miquel L, Sroussi J, Weyers S, Munmany M, Luo X, Kovar P, Wang Y, Zizolfi B, Surbone A, Delporte V, Moratalla E, Sauvan M, Perrini G, Sui L, Mara M. Effectiveness of degradable polymer film in the management of severe or moderate intrauterine adhesions (PREG-2): a randomized, double-blind, multicenter, stratified, superiority trial. Fertil Steril. 2024 Dec;122(6):1124-1133. doi: 10.1016/j.fertnstert.2024.07.020. Epub 2024 Jul 22. |
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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
immediately after article publication and during 5 years
researchers who provide a methodologically sound proposal
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| ID | Title | Description |
|---|---|---|
| FG000 | Womed Leaf | IUA prevention: The novel intrauterine barrier film (Womed Leaf) is inserted immediately after completion of the hysteroscopic adhesiolysis Womed Leaf: Womed Leafâ„¢ device is composed of a uterine anti-adhesion film pre-loaded inside a flexible inserter. Womed Leafâ„¢ 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2022 |
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|
Average of AFS score component "extent of cavity involved" |
| At second look hysteroscopy between 4 and 8 weeks |
| 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 |
| AFS Score | Average of AFS score | At second look hysteroscopy between 4 and 8 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| Freedom From IUA | Rate of patients who don't have adhesion | At second look hysteroscopy between 4 and 8 weeks |
| ESGE Stage | Rate of ECGE stage | At second look hysteroscopy between 4 and 8 weeks |
| 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 |
| 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 |
| Timing of Vaginal Discharge | Timing of vaginal discharge as recalled by the patient | At second look hysteroscopy between 4 and 8 weeks |
| Duration of the Vaginal Discharge | Duration of the vaginal discharge as recalled by the patient | At second look hysteroscopy between 4 and 8 weeks |
| 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 |
| Change of Menstrual Pattern | Change of menstrual pattern | At second look hysteroscopy between 4 and 8 weeks, 1 year, 2 years |
| 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 |
| Number of Adhesiolysis Procedures | Number of adhesiolysis procedures after second look to one year | After second look to one year |
| 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, 3 years |
| Live Birth Rate | Live birth rate at 1 year and 2 years | 1 year 2 years, 3 years |
| Pregnancy Complication Rate | Pregnancy complication rate | 3 years |
| Time to Pregnancy | Time to pregnancy (i.e. time between the second look hysteroscopy and pregnancy start) | 3 years |
| 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 |
| 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 |
| Guangzhou |
| China |
| Women's Hospital School Of Medicine Zhejiang University | Hangzhou | China |
| The Obstetrics & Gynecology Hospital Affiliated to Fudan University | Shanghai | China |
| Gynprenatal | Ostrava | Czechia |
| CHU Bicêtre | Le Kremlin-Bicêtre | 94270 | France |
| CHU de Lille | Lille | 59000 | France |
| Hopital La Conception | Marseille | 13005 | France |
| CHU Lariboisière | Paris | 75010 | France |
| Clinique Mutualiste La sagesse | Rennes | 35043 | France |
| A.O.U Federico II | Naples | 80131 | Italy |
| Aso Mauriziano Umberto I | Torino | Italy |
| Hospital Clinic Barcelonna | Barcelona | Spain |
| Ramon y Cajal Hospital | Madrid | 28034 | Spain |
| Centre Hospitalier Universitaire Vaudois | Lausanne | 1011 | Switzerland |
| FG001 | Control | No IUA prevention - no placebo after adhesiolysis |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Womed Leaf | IUA prevention: The novel intrauterine barrier film (Womed Leaf) is inserted immediately after completion of the hysteroscopic adhesiolysis Womed Leaf: Womed Leafâ„¢ device is composed of a uterine anti-adhesion film pre-loaded inside a flexible inserter. Womed Leafâ„¢ 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. |
| BG001 | Control | No IUA barrier - No placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy - IUA Severity | 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),
The final score allows the following prognostic classification: 1-4 = mild disease, 5-8 = moderate disease 9-12 = severe disease | The modified ITT (mITT) included all randomized patients, apart from 3, who were incorrectly randomized prior to, rather than after, their baseline hysteroscopy and were then excluded for not fulfilling the preset operative criteria without contributing any effectiveness data to the study. There were 163 patients randomized in total. The mITT population includes 163-3= 160 patients; 75 in the Womed Leaf group and 85 in the Control group. | Posted | Mean | Standard Deviation | score on a scale | At second look hysteroscopy between 4 and 8 weeks |
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| ||||||||||||||||||||||||||||
| Primary | Safety - Adverse Events | Adverse events up to second look hysteroscopy. | Posted | Count of Participants | Participants | 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 | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change of "Extent of Cavity Involved" Component | Average of AFS score component "extent of cavity involved" | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change in "Extent of Cavity Involved" Component Between Post-adhesiolysis and Second Look Hysteroscopy | Average of AFS score component "extent of cavity involved" | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | AFS Score | Average of AFS score | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change of Extent of IUA AFS Score Component | Average of the change of the AFS score component "Extent of IUA" | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change of Type of IUA AFS Score Component | Average of the change of the AFS score component "type of IUA" | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Menstrual Pattern AFS Score Component | Average of the change of the AFS score component "Menstrual Pattern" | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Have Mild Adhesions or no Adhesion | Percentage of patients who have AFS < 5 | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Freedom From IUA | Rate of patients who don't have adhesion | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | ESGE Stage | Rate of ECGE stage | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| 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. | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| 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 | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Timing of Vaginal Discharge | Timing of vaginal discharge as recalled by the patient | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Duration of the Vaginal Discharge | Duration of the vaginal discharge as recalled by the patient | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Qualitative Description of the Vaginal Discharge | Qualitative description of the vaginal discharge as recalled by the patient | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change of Menstrual Pattern | Change of menstrual pattern | Not Posted | At second look hysteroscopy between 4 and 8 weeks, 1 year, 2 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Reintervention Rate | Reintervention rate, during second look hysteroscopy or scheduled later up to one year | Not Posted | At second look hysteroscopy or scheduled later up to one year | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Number of Adhesiolysis Procedures | Number of adhesiolysis procedures after second look to one year | Not Posted | After second look to one year | Participants | ||||||||||||||||||||||||||||||||||
| 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 | Not Posted | Mar 2027 | 1 year, 2 years, 3 years | Participants | |||||||||||||||||||||||||||||||||
| Secondary | Live Birth Rate | Live birth rate at 1 year and 2 years | Not Posted | Mar 2027 | 1 year 2 years, 3 years | Participants | |||||||||||||||||||||||||||||||||
| Secondary | Pregnancy Complication Rate | Pregnancy complication rate | Not Posted | Mar 2027 | 3 years | Participants | |||||||||||||||||||||||||||||||||
| Secondary | Time to Pregnancy | Time to pregnancy (i.e. time between the second look hysteroscopy and pregnancy start) | Not Posted | Mar 2027 | 3 years | Participants | |||||||||||||||||||||||||||||||||
| Secondary | IUA Severity According to Chinese Scoring System | IUA severity according to Chinese scoring system (for patients enrolled in China only) | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Responder Rate | Percentage of patients with an improvement of one clinical category i.e from Severe to Moderate or from Moderate to Mild | Not Posted | At second look hysteroscopy between 4 and 8 weeks | Participants |
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Womed Leaf | IUA prevention: The novel intrauterine barrier film (Womed Leaf) is inserted immediately after completion of the hysteroscopic adhesiolysis | 0 | 77 | 0 | 77 | 6 | 77 |
| EG001 | Control | No IUA prevention - no placebo after adhesiolysis | 0 | 86 | 0 | 86 | 3 | 86 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Neuralgia | Nervous system disorders | Systematic Assessment |
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| Uterine perforation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Liver function test abnormal | Investigations | Systematic Assessment |
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| Urethral pain | Renal and urinary disorders | Systematic Assessment |
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| Vulvovaginal pruritus | Reproductive system and breast disorders | Systematic Assessment |
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| Cervix disorder | Reproductive system and breast disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Womed | 0785225561 | +33 | pauline@womedtech.com |
| Sep 4, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006175 | Gynatresia |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Czechia |
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| China |
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| Italy |
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| France |
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| Switzerland |
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| Spain |
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