Trial Outcomes & Findings for PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film. (NCT NCT04963179)

Results Overview

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

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

160 participants

Primary outcome timeframe

At second look hysteroscopy between 4 and 8 weeks

Results posted on

2025-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Womed Leaf IUA prevention: The novel intrauterine barrier film (Womed Leaf) is inserted immediately after completion of the hysteroscopic adhesiolysis 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.	Control No IUA prevention - no placebo after adhesiolysis
Overall Study STARTED	75	85
Overall Study COMPLETED	71	82
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Womed Leaf n=75 Participants IUA prevention: The novel intrauterine barrier film (Womed Leaf) is inserted immediately after completion of the hysteroscopic adhesiolysis 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.	Control n=85 Participants No IUA barrier - No placebo	Total n=160 Participants Total of all reporting groups
Age, Continuous	35.0 years STANDARD_DEVIATION 5.2 • n=5 Participants	35.9 years STANDARD_DEVIATION 5.1 • n=7 Participants	35.5 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	85 Participants n=7 Participants	160 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants n=5 Participants	80 Participants n=7 Participants	151 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	52 Participants n=7 Participants	99 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Belgium	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment Czechia	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants
Region of Enrollment China	11 participants n=5 Participants	13 participants n=7 Participants	24 participants n=5 Participants
Region of Enrollment Italy	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment France	37 participants n=5 Participants	42 participants n=7 Participants	79 participants n=5 Participants
Region of Enrollment Switzerland	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Spain	4 participants n=5 Participants	8 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	Womed Leaf n=75 Participants Womed Leaf resorbable barrier is inserted right after adhesiolysis.	Control n=85 Participants No IUA barrier
Efficacy - IUA Severity	5.2 score on a scale Standard Deviation 2.8	4.2 score on a scale Standard Deviation 3.2

PRIMARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Adverse events up to second look hysteroscopy.

Outcome measures

Outcome measures
Measure	Womed Leaf n=77 Participants Womed Leaf resorbable barrier is inserted right after adhesiolysis.	Control n=86 Participants No IUA barrier
Safety - Adverse Events	6 Participants	3 Participants

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Percentage of patients who have improved from severe to mild adhesions or from severe to no adhesions or from moderate to no adhesions

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Average of AFS score component "extent of cavity involved"

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Average of AFS score component "extent of cavity involved"

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Average of AFS score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Average of the change of the AFS score component "Extent of IUA"

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Average of the change of the AFS score component "type of IUA"

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Average of the change of the AFS score component "Menstrual Pattern"

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Percentage of patients who have AFS \< 5

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Rate of patients who don't have adhesion

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Rate of ECGE stage

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Level of post-operative pain on a numeric rating scale, with 0 = no pain and 10 = the worst pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Level of discomfort related to vaginal discharge on a numeric rating scale, with 0 = no discomfort and 10 = extremely disturbing

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Timing of vaginal discharge as recalled by the patient

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Duration of the vaginal discharge as recalled by the patient

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Qualitative description of the vaginal discharge as recalled by the patient

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks, 1 year, 2 years

Change of menstrual pattern

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy or scheduled later up to one year

Reintervention rate, during second look hysteroscopy or scheduled later up to one year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After second look to one year

Number of adhesiolysis procedures after second look to one year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year, 2 years, 3 years

Pregnancy rate defined as presence of foetal sac or heartbeat by ultrasound at 1 year and 2 years, whether spontaneous or IVF

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year 2 years, 3 years

Live birth rate at 1 year and 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Pregnancy complication rate

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Time to pregnancy (i.e. time between the second look hysteroscopy and pregnancy start)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

IUA severity according to Chinese scoring system (for patients enrolled in China only)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Percentage of patients with an improvement of one clinical category i.e from Severe to Moderate or from Moderate to Mild

Outcome measures

Outcome data not reported

Adverse Events

Womed Leaf

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Womed Leaf n=77 participants at risk IUA prevention: The novel intrauterine barrier film (Womed Leaf) is inserted immediately after completion of the hysteroscopic adhesiolysis	Control n=86 participants at risk No IUA prevention - no placebo after adhesiolysis
Gastrointestinal disorders Abdominal pain	0.00% 0/77 • 8 weeks	1.2% 1/86 • Number of events 1 • 8 weeks
General disorders Pyrexia	0.00% 0/77 • 8 weeks	1.2% 1/86 • Number of events 1 • 8 weeks
Nervous system disorders Neuralgia	0.00% 0/77 • 8 weeks	1.2% 1/86 • Number of events 1 • 8 weeks
Injury, poisoning and procedural complications Uterine perforation	1.3% 1/77 • Number of events 1 • 8 weeks	0.00% 0/86 • 8 weeks
Investigations Liver function test abnormal	1.3% 1/77 • Number of events 1 • 8 weeks	0.00% 0/86 • 8 weeks
Renal and urinary disorders Urethral pain	1.3% 1/77 • Number of events 1 • 8 weeks	0.00% 0/86 • 8 weeks
Reproductive system and breast disorders Vulvovaginal pruritus	1.3% 1/77 • Number of events 1 • 8 weeks	0.00% 0/86 • 8 weeks
Reproductive system and breast disorders Cervix disorder	1.3% 1/77 • Number of events 1 • 8 weeks	0.00% 0/86 • 8 weeks
Skin and subcutaneous tissue disorders Pruritus	1.3% 1/77 • Number of events 1 • 8 weeks	0.00% 0/86 • 8 weeks

Additional Information

Director of Clinical Affairs

Womed

Phone: 0785225561

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place