Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Aleksei Petrenko
ORCID ID
http://orcid.org/0000-0003-1035-8025
Contact details
st. Holzunova 19
Saratov
410017
Russian Federation
+7 9033826430
Lesha.petrenko.66@mail.ru
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Role of intra-abdominal hypertension in the development and outcome of ovarian hyperstimulation syndrome
Acronym
IAHOHSS
Study hypothesis
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
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
Study design
Prospective single-center observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
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 trial start date
01/01/2015
Overall trial end date
31/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All women admitted to the hospital with clinical evidence of OHSS were asked to take part in the study
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
76
Total final enrolment
76
Participant exclusion criteria
Women who voluntarily refused to participate in the study
Recruitment start date
10/06/2018
Recruitment end date
20/09/2019
Locations
Countries of recruitment
Russian Federation
Trial participating centre
City Clinical Hospital №1 named after Yu.Ya. Gordeev
st. Holzunova 19
Saratov
410017
Russian Federation
Sponsor information
Organisation
Federal State Budgetary Institution “Center for the Development of Education and International Activities (“Inter-education”)
Sponsor details
House 8
Building 1
Bolshoi Chudov lane
Moscow
119021
Russian Federation
+7 (499) 246-86-39
anna_mikhailova@skolkovo.ru
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Federal State Budgetary Institution “Center for the Development of Education and International Activities (“Inter-education”).
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results will be published in a peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
01/09/2020
Participant level data
Other
Basic results (scientific)
Publication list