Comparing two antiadhesive agents for the prevention of relapse of Asherman's syndrome
| ISRCTN | ISRCTN15630617 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15630617 |
| Secondary identifying numbers | 01012022 |
- Submission date
- 28/01/2022
- Registration date
- 05/02/2022
- Last edited
- 22/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Asherman's syndrome is a rare condition where scar tissue, also called adhesions or intrauterine adhesions (IUAs), builds up inside the uterus (womb). The main aim of this study is to compare two antiadhesive agents in the prevention of secondary developed IUAs after hysteroscopic treatment in women with Asherman's syndrome.
Who can participate?
Women aged 18-45 years with Asherman's syndrome who are seeking treatment and future pregnancy
What does the study involve?
The participants will follow the standard protocol of treatment - hysteroscopic resection (surgery) of IUAs will be performed with the addition of an antiadhesive barrier inside the uterine cavity at the end of the procedure, either 4DryField or Hyalobarrier gel. At 1 month after the procedure a second hysteroscopy will follow to evaluate the antiadhesive effect of the agents. Annual check-ups will be scheduled.
What are the possible benefits and risks of participating?
The participants will receive the antiadhesive agent free of charge as a benefit of study participation. The researchers do not anticipate any extra risks for participants because both medical preparations have excellent safety profiles and are well tolerated.
Where is the study run from?
General Faculty Hospital and 1st Medical Faculty of Charles University (Czech Republic)
When is the study starting and how long is it expected to run for?
November 2021 to January 2023
Who is funding the study?
Charles University (Czech Republic)
Who is the main contact?
Dr Zdenka Lisa
zdenka.lisa@vfn.cz
Contact information
Public
Apolinarska 18
Prague
12808
Czech Republic
 ORCID ID |
0000-0003-4961-7063 |
|---|---|
| Phone | +42 (0)224967003 |
| zdenka.lisa@vfn.cz |
Study information
| Study design | Single-center interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | 4Synless – 4DryField vs Hyalobarrier gel as antiadhesive agents used in secondary prevention of Asherman's syndrome |
| Study acronym | 4Synless |
| Study objectives | The primary objective of this study is to evaluate and compare the antiadhesive effect of 4DryField vs commonly used Hyalobarrier gel in the secondary prevention of intrauterine adhesions (IUAs) in patients with Asherman's syndrome. The secondary goal is to determine and compare reproductive outcomes in these two groups of patients. |
| Ethics approval(s) | Approved 30/11/2021, Ethics Committee of the General University Hospital, Prague (Na Bojisti 1, 128 00 Prague 2, Czech Republic; +42 (0)224964131; eticka.komise@vfn.cz), ref: 119/21 S-IV |
| Health condition(s) or problem(s) studied | Prevention of secondary development of intrauterine adhesions in patients after hysteroscopic treatment of Asherman's syndrome |
| Intervention | 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 from group A will be given 4DryField antiadhesive agent which will be applicated into the uterine cavity after the hysteroscopic resection of intrauterine adhesions (IUAs). Hyalobarrier gel will be used as an antiadhesive agent in patients in group B identically. Second-look hysteroscopy will be performed in all study patients 1 month after the primary procedure to evaluate the antiadhesive effect of the agents (4DryField vs. Hyalobarrier gel). |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 29/11/2021 |
| Completion date | 31/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | 20 |
| Total final enrolment | 23 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2022 |
| Date of final enrolment | 31/08/2022 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
General Faculty Hospital and 1st Medical Faculty
Apolinarska 18
Prague 2
12800
Czech Republic
Sponsor information
University/education
General Faculty Hospital and 1st Medical Faculty
U Nemocnice 499/2
Prague
12808
Czech Republic
| Phone | +42 (0)224961111 |
|---|---|
| martina.rackova@vfn.cz | |
| Website | https://www.vfn.cz |
"ROR" |
https://ror.org/024d6js02 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Charles University, Charles University in Prague, Univerzita Karlova, Karls-Universität zu Prag, UK
- Location
- Czech Republic
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in high-impact peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 21/05/2024 | 22/05/2024 | Yes | No |
Editorial Notes
22/05/2024: Publication reference and total final enrolment added.
13/12/2023: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2023 to 31/01/2023.
2. The intention to publish date was changed from 31/12/2023 to 30/06/2024.
3. The plain English summary was updated to reflect these changes.
22/12/2022: The recruitment end date has been changed from 31/12/2022 to 31/08/2022.
02/02/2022: Trial's existence confirmed by the Ethics Committee of the General University Hospital, Prague.
