Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/05/2020
Date assigned
19/05/2020
Last edited
18/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

globaledu@skolkovo.ru

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

Publication citations

Additional files

Editorial Notes

18/05/2020: Trial’s existence confirmed by Ethics Committee of the Saratov State Medical University named after V. I. Razumovsky.