Risk factors of Asherman's syndrome
| ISRCTN | ISRCTN14987772 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14987772 |
- Submission date
- 26/02/2021
- Registration date
- 15/03/2021
- Last edited
- 02/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Asherman's syndrome is a condition that occurs when scar tissue forms inside the uterus and/or the cervix (the opening to the uterus) following surgery to the uterus. This scar tissue (adhesions) can cause the walls of the uterus to stick together and can reduce the size of the uterus. Asherman's syndrome can affect patterns of menstruation and fertility.
The aim of this study is to compare the cells of the lining of the uterus between patients with Asherman's syndrome and patients who have undergone surgery to the uterus and have not developed Asherman's syndrome.
Who can participate?
Patients with Asherman's syndrome and an equal number of patients a history of intrauterine surgery but without the formation of intrauterine adhesions.
What does the study involve?
Participants will undergo a standard hysteroscopy examination (an investigation using a camera on a thin tube that is inserted into the vagina to examine the cervix and inside of the uterus) during which an endometrial biopsy will be collected for analysis. Participants will be contacted for information about their reproductive outcomes for the following two years.
What are the possible benefits and risks of participating?
There are no special benefits or risks for patients in the study.
Where is the study run from?
The Department of Obstetrics and Gynecology of General Faculty Hospital (Czech Republic) and 1st Medical Faculty of Charles University in Prague (Czech Republic)
When is the study starting and how long is it expected to run for?
From January 2021 to December 2023
Who is funding the study?
Ministry of Health (Czech Republic)
Who is the main contact?
Dr Barbora Boudova
barbora.boudova@vfn.cz
Contact information
Public
Apolinářská 18
Prague
12808
Czech Republic
 ORCID ID |
0000-0003-0444-7160 |
|---|---|
| Phone | +420 224967004 |
| barbora.boudova@vfn.cz |
Study information
| Study design | Single-centre observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format. Available in paper form in Czech language. |
| Scientific title | Clinical, reproductive, and immunological aspects of patients with Asherman's syndrome |
| Study acronym | CRIAPAS |
| Study hypothesis | Patients undergoing surgical intrauterine procedures differ according to their inflammatory reactivity, cellular response, and clinical or anamnestic parameters in the incidence of intrauterine adhesion formation. |
| Ethics approval(s) | Approved 22/08/2019, Ethics Committee of General Faculty Hospital in Prague (Na Bojišti 1, Prague 2, 12808, Czech Republic; +420 224964131; eticka.komise@vfn.cz), ref: 1443/19 S-IV Grant |
| Condition | Asherman's syndrome |
| Intervention | After enrolment, a detailed medical history will be taken and during the indicated hysteroscopy, an endometrial biopsy will be collected for single-cell analysis. Standard medical care follows. Every 6 months patients will receive a questionnaire about reproduction for another 3 years. There is no special observation (only one endometrial biopsy), and then there is 3 years follow-up. |
| Intervention type | Other |
| Primary outcome measure | Characteristics of endometrial reactivity to insult measured using single-cell analysis during the indicated hysteroscopy at baseline |
| Secondary outcome measures | Reproductive outcomes of patients with Asherman's syndrome measured using questionnaires at baseline, 6, 12, 18, 24, 30, and 36 months |
| Overall study start date | 01/06/2019 |
| Overall study end date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 20 patients with Asherman's syndrome and 20 controls |
| Participant inclusion criteria | Clinical suspicion of Asherman's syndrome verified by hysteroscopy or previous intrauterine procedure with follow-up hysteroscopy without intrauterine adhesions |
| Participant exclusion criteria | 1. Other uterine pathology (e.g. submucosal leiomyoma, adenomyosis, and cervical lesion) 2. Hormonal therapy <1 month prior to the hysteroscopy 3. Gynecological malignancy in last 12 months |
| Recruitment start date | 01/01/2021 |
| Recruitment end date | 30/06/2022 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Apolinářská 18
Prague
12808
Czech Republic
Sponsor information
Hospital/treatment centre
U Nemocnice 2
Prague
12808
Czech Republic
| Phone | +420 224961111 |
|---|---|
| barbora.boudova@vfn.cz | |
| Website | http://www.vfn.cz/ |
"ROR" |
https://ror.org/04yg23125 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Other non-profit organizations
- Alternative name(s)
- General University Hospital in Prague, VFN
- Location
- Czech Republic
Government organisation / National government
- Alternative name(s)
- Ministry of Health of the Czech Republic, MZCR
- Location
- Czech Republic
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a impact peer-review journal and in local medical journals, PhD thesis, and presentation at medical conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Barbora Boudová (Barbora.boudova@vfn.cz) this will include medical history and reproductive outcomes. The results of single-cell analysis will be (already under study number, not under the name) will be shared with Biocev examining lab. Informed consent from all patients must be contained for storing the data. |
Editorial Notes
02/03/2021: Trial’s existence confirmed by Ethics Committee of General Faculty Hospital in Prague.
