Asherman SyndromePREG2NCT04963179
PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.
A study testing Womed Leaf in people with Asherman Syndrome and Intrauterine Adhesion, run by Womed at 15 sites in 7 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Asherman Syndrome, Intrauterine Adhesion
- What is being tested?
- Womed Leaf
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 15 sitesin 7 countries
- Study dates
- 29 Nov 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
15 sites in 7 countries.
15 sites in 7 countries
France5 sites
CHU Bicêtre
Le Kremlin-Bicêtre, 94270
CHU de Lille
Lille, 59000
Hopital La Conception
Marseille, 13005
CHU Lariboisière
Paris, 75010
Clinique Mutualiste La sagesse
Rennes, 35043
China3 sites
Guangdong Maternal and Child Health Hospital
Guangzhou
Women's Hospital School Of Medicine Zhejiang University
Hangzhou
The Obstetrics & Gynecology Hospital Affiliated to Fudan University
Shanghai
Spain2 sites
Hospital Clinic Barcelonna
Barcelona
Ramon y Cajal Hospital
Madrid, 28034
About this study
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
Read the 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.
- Conditions
- Asherman Syndrome, Intrauterine Adhesion
- Being tested
- Womed Leaf
- Keywords
- Asherman Syndrome, Intrauterine adhesion, Hysteroscopy, Adhesiolysis, Adhesion prevention, Infertility
- Medical subject headings
- Gynatresia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Womed LeafDevice
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. It is degraded and discharged naturally through the cervix and vagina.
| Study group | Role | What they receive |
|---|---|---|
| Womed Leaf | Experimental | IUA prevention: The novel intrauterine barrier film (Womed Leaf) is inserted immediately after completion of the hysteroscopic adhesiolysis Receives: Device: Womed Leaf |
| Control | No intervention | No IUA prevention - no placebo after adhesiolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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),
- 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 disease
Measured: At second look hysteroscopy between 4 and 8 weeks
Safety - Adverse Events
Adverse events up to second look hysteroscopy.
Measured: At second look hysteroscopy between 4 and 8 weeks
Secondary outcomes (24)
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
Measured: At second look hysteroscopy between 4 and 8 weeks
Change of "Extent of Cavity Involved" Component
Average of AFS score component "extent of cavity involved"
Measured: 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"
Measured: At second look hysteroscopy between 4 and 8 weeks
AFS Score
Average of AFS score
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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
Measured: At second look hysteroscopy between 4 and 8 weeks
Freedom From IUA
Rate of patients who don't have adhesion
Measured: At second look hysteroscopy between 4 and 8 weeks
ESGE Stage
Rate of ECGE stage
Measured: 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.
Measured: 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
Measured: At second look hysteroscopy between 4 and 8 weeks
Timing of Vaginal Discharge
Timing of vaginal discharge as recalled by the patient
Measured: At second look hysteroscopy between 4 and 8 weeks
Duration of the Vaginal Discharge
Duration of the vaginal discharge as recalled by the patient
Measured: 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
Measured: At second look hysteroscopy between 4 and 8 weeks
Change of Menstrual Pattern
Change of menstrual pattern
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year, 2 years, 3 years
Live Birth Rate
Live birth rate at 1 year and 2 years
Measured: 1 year 2 years, 3 years
Pregnancy Complication Rate
Pregnancy complication rate
Measured: 3 years
Time to Pregnancy
Time to pregnancy (i.e. time between the second look hysteroscopy and pregnancy start)
Measured: 3 years
IUA Severity According to Chinese Scoring System
IUA severity according to Chinese scoring system (for patients enrolled in China only)
Measured: 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
Measured: At second look hysteroscopy between 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start29 Nov 2021
- Primary completion11 Nov 2023
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asherman SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Womed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963179
- Sponsor's protocol ID
- PREG2
- Acronym
- PREG2
- Status last verified
- Mar 2025
- First submitted
- 5 Jul 2021
- Last updated
- 27 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 39048019
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.
- ClinicalTrials.gov ID
- NCT04963179
- Acronym / sponsor ID
- PREG2 / PREG2
- Conditions
- Asherman Syndrome, Intrauterine Adhesion
- Keywords
- Asherman Syndrome, Intrauterine adhesion, Hysteroscopy, Adhesiolysis, Adhesion prevention, Infertility
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- WomedIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 11 Nov 2023 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Posted 27 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Womed Leaf | Experimental | Device: Womed LeafIUA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Womed LeafWomed 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. It is degraded and discharged naturally through the cervix and vagina. | Device | Womed Leaf |
Primary outcome
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 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 disease
Safety - Adverse Events
Time frame: At second look hysteroscopy between 4 and 8 weeks
Adverse events up to second look hysteroscopy.
24 secondary outcomes
High-responder Rate
Time frame: At second look hysteroscopy between 4 and 8 weeks
Change of "Extent of Cavity Involved" Component
Time frame: At second look hysteroscopy between 4 and 8 weeks
Change in "Extent of Cavity Involved" Component Between Post-adhesiolysis and Second Look Hysteroscopy
Time frame: At second look hysteroscopy between 4 and 8 weeks
AFS Score
Time frame: At second look hysteroscopy between 4 and 8 weeks
Change of Extent of IUA AFS Score Component
Time frame: At second look hysteroscopy between 4 and 8 weeks
Change of Type of IUA AFS Score Component
Time frame: At second look hysteroscopy between 4 and 8 weeks
Menstrual Pattern AFS Score Component
Time frame: At second look hysteroscopy between 4 and 8 weeks
Percentage of Patients Who Have Mild Adhesions or no Adhesion
Time frame: At second look hysteroscopy between 4 and 8 weeks
Freedom From IUA
Time frame: At second look hysteroscopy between 4 and 8 weeks
ESGE Stage
Time frame: At second look hysteroscopy between 4 and 8 weeks
Level of Post-operative Pain
Time frame: At second look hysteroscopy between 4 and 8 weeks
Level of Discomfort Related to Vaginal Discharge
Time frame: At second look hysteroscopy between 4 and 8 weeks
Timing of Vaginal Discharge
Time frame: At second look hysteroscopy between 4 and 8 weeks
Duration of the Vaginal Discharge
Time frame: At second look hysteroscopy between 4 and 8 weeks
Qualitative Description of the Vaginal Discharge
Time frame: At second look hysteroscopy between 4 and 8 weeks
Change of Menstrual Pattern
Time frame: At second look hysteroscopy between 4 and 8 weeks, 1 year, 2 years
Reintervention Rate
Time frame: At second look hysteroscopy or scheduled later up to one year
Number of Adhesiolysis Procedures
Time frame: After second look to one year
Pregnancy Rate
Time frame: 1 year, 2 years, 3 years
Live Birth Rate
Time frame: 1 year 2 years, 3 years
Pregnancy Complication Rate
Time frame: 3 years
Time to Pregnancy
Time frame: 3 years
IUA Severity According to Chinese Scoring System
Time frame: At second look hysteroscopy between 4 and 8 weeks
Responder Rate
Time frame: At second look hysteroscopy between 4 and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39048019Fernandez 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Womed Leaf in people with Asherman Syndrome and Intrauterine Adhesion, run by Womed at 15 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, China, Italy, Spain, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy - IUA Severity (time frame: At second look hysteroscopy between 4 and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04963179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.