The usefulness of assessing markers of severity among women with ovarian hyperstimulation syndrome
| ISRCTN | ISRCTN66235250 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66235250 |
- Submission date
- 12/05/2020
- Registration date
- 19/05/2020
- Last edited
- 14/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Ovarian hyperstimulation syndrome (OHSS) is the most severe and potentially life-threatening iatrogenic complication associated with assisted reproduction. Its pathophysiology and clinic are similar to the intra-abdominal hypertension syndrome being ovarian enlargement and ascites progression the main factors for the growth of intra-abdominal pressure. The aim of the present study is the assessment of the usefulness of markers of severity among women with OHSS.
Who can participate?
The study includes women admitted to the hospital with clinical evidence of OHSS were asked to take part in the study. All women had primary / secondary infertility and were in an in vitro fertilization program (IVF).
What does the study involve?
Seventy-six women with varying degrees of severity of OHSS were recruited in a single centre. All women underwent clinical and laboratory examination, and ultrasound measurement of the ovarian size and free abdominal fluid. Ovarian volumes were assessed using the prolate ellipsoid formula and ascites index was recorded. Intra-abdominal pressure was measured using an intravesical Foley Manometer catheter. Ovarian volumes, ascites index and intra-abdominal pressure were stratified according to the clinical severity of OHSS.
What are the possible benefits and risks of participating?
Possible benefits for patients are to clarify the stage of OHSS and the strategy for further treatment. The study carries no risks for patients; all research methods are non-invasive.
Where is the study run from?
City clinical hospital No.1 named after Yu.Ya. Gordeev, Saratov, Russian Federation.
When is the study starting and how long is it expected to run for?
January 2015 to December 2019
Who is funding the study?
Government of the Russian Federation
Who is the main contact?
Aleksei Petrovich Petrenko
Lesha.petrenko.66@mail.ru
Contact information
Scientific
st. Holzunova 19
Saratov
410017
Russian Federation
 ORCID ID |
0000-0003-1035-8025 |
|---|---|
| Phone | +7 9033826430 |
| Lesha.petrenko.66@mail.ru |
Study information
| Study design | Prospective single-center observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Role of intra-abdominal hypertension in the development and outcome of ovarian hyperstimulation syndrome |
| Study acronym | IAHOHSS |
| Study objectives | The development of moderate, severe, and critical OHSS is accompanied by an increase in intra-abdominal volume and intra-abdominal hypertension. Assessing the dynamics of ovarian volume, ascites and intra-abdominal pressure could be a useful tool in defining the severity of OHSS. |
| Ethics approval(s) | Approved 06/03/2018, Ethics Committee of the Saratov State Medical University named after V. I. Razumovsky, Saratov, Russian Federation (+7 9272777606). Naumova-L@yandex.ru P.№7 |
| Health condition(s) or problem(s) studied | Ovarian hyperstimulation syndrome (OHSS) |
| Intervention | Seventy-six women with varying degrees of severity of OHSS were recruited in a single centre. All women underwent clinical and laboratory examination, and ultrasound measurement of the ovarian size and free abdominal fluid. Ovarian volumes were assessed using the prolate ellipsoid formula and ascites index was recorded. Intra-abdominal pressure was measured using an intravesical Foley Manometer catheter. Ovarian volumes, ascites index and intra-abdominal pressure were stratified according to the clinical severity of OHSS. |
| Intervention type | Other |
| Primary outcome measure | Confirmed ovarian hyperstimulation syndrome measured using ultrasound, routine laboratory tests, and clinical examination including height, body weight, abdominal circumference, dehydration assessment, edema, heart rate, respiratory rate, blood pressure and diuresis at time of observation |
| Secondary outcome measures | 1. Ovarian volume measured using the prolate ellipsoid formula at time of observation 2. Ascites index measured using ultrasound by summing the sizes of the free fluid (in mm) in the largest free pockets of the external abdominal quadrants including inguinal regions and the liver and spleen areas at time of observation 3. Intra-abdominal pressure measured using an intravesical Foley Manometer catheter at time of observation |
| Overall study start date | 01/01/2015 |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 76 |
| Total final enrolment | 76 |
| Key inclusion criteria | All women admitted to the hospital with clinical evidence of OHSS were asked to take part in the study |
| Key exclusion criteria | Women who voluntarily refused to participate in the study |
| Date of first enrolment | 10/06/2018 |
| Date of final enrolment | 20/09/2019 |
Locations
Countries of recruitment
- Russian Federation
Study participating centre
Saratov
410017
Russian Federation
Sponsor information
Government
House 8
Building 1
Bolshoi Chudov lane
Moscow
119021
Russian Federation
| Phone | +7 (499) 246-86-39 |
|---|---|
| anna_mikhailova@skolkovo.ru | |
| Website | globaledu@skolkovo.ru |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/09/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Results will be published in a peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 22/02/2022 | No | No | ||
| Dataset | 03/11/2021 | 14/06/2023 | No | No | |
| Results article | 10/05/2022 | 14/06/2023 | Yes | No |
Additional files
Editorial Notes
14/06/2023: Publication reference and dataset added.
22/02/2022: The basic results have been uploaded as an additional file.
16/08/2021: Publication reference added.
15/03/2021: The intention to publish date was changed from 01/09/2020 to 01/09/2021.
18/05/2020: Trial’s existence confirmed by Ethics Committee of the Saratov State Medical University named after V. I. Razumovsky.
