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Comparing two antiadhesive agents for the prevention of relapse of Asherman's syndrome

4Synless – 4DryField vs Hyalobarrier gel as antiadhesive agents used in secondary prevention of Asherman's syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15630617
Enrollment
20
Registered
2022-02-05
Start date
2022-02-01
Completion date
Unknown
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of secondary development of intrauterine adhesions in patients after hysteroscopic treatment of Asherman's syndrome Urological and Genital Diseases

Interventions

Patients eligible for the trial will be divided into two groups (group A = study group, group B = control group) with a 1:1 allocation ratio by pulling the letter A or B out of the envelope. Patients

Sponsors

Charles University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women aged 18-45 years 2. Seeking pregnancy in the future 3. Confirmed Asherman's syndrome by hysteroscopy 4. Consent to their participation in the trial

Exclusion criteria

Exclusion criteria: 1. Do not wish to participate in the study 2. Women out of the age range from 18 to 45 years 3. Do not meet the diagnostic criteria of Asherman's syndrome 4. Known hypersensitivity to the components of Hyalobarrier gel or 4DryField 5. Inability to perform a sufficient surgical treatment during the initial hysteroscopy

Design outcomes

Primary

MeasureTime frame
The overall assessment of the uterine cavity during the second-look hysteroscopy (1 month after the primary hysteroscopic adhesiolysis) will be done by three skilled surgeons participating in the trial. The presence and severity of de-novo adhesions will be measured using the American Fertility Society score of intrauterine adhesions at that point.

Secondary

MeasureTime frame
Reproductive outcomes of all study patients will be recorded (annual check-ups) and evaluated for 2-5 years. The following reproductive parameters will be observed: pregnancy rate, abortion rate, live-birth rate, pregnancy complication rate), time to conception, mode of conception.

Countries

Czech Republic

Contacts

Public ContactZdenka Lisa
zdenka.lisa@vfn.cz+42 (0)224967003

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026