STOP-OHSS study

Shaping and Trialling Outpatient Protocols for Overian HyperStimulation Syndrome.

On
STOP OHSS project logo

A feasibility study and randomised controlled trial, with internal pilot, to assess the clinical and cost-effectiveness of earlier active management of OHSS.

This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (NIHR128137). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.


Background

Ovarian hyperstimulation syndrome (OHSS) poses one of the greatest risks to women undergoing assisted reproductive treatments and Intra Uterine Insemination.

OHSS usually occurs in women who have over responded to ovarian stimulation drugs and is triggered by the effect of Human Chorionic Gonadotropin (hCG) either administered during the course of treatment to trigger maturation of the oocytes (the eggs) or produced naturally by a resulting pregnancy.

The ovaries become enlarged and cystic and fluid leaks into various body cavities. Currently, treatment is only usually provided once the condition has progressed to a severe state and the patient requires intensive inpatient treatment. In-patient management often includes drainage of ascitic fluid (paracentesis) which can result in a significant improvement of the condition.

There are potentially over 5,000 women suffering from severe OHSS each year, creating a burden on both the women being admitted to hospital for undetermined lengths of time and for the NHS.

The study aims to assess if earlier active outpatient management resolves OHSS earlier and avoids the need for hospital admission when compared with usual (conservative) management.

The study will give the same supportive treatment provided to women for severe ovarian hyperstimulation syndrome, but in an outpatient setting.

The study will also target women with moderate ovarian hyperstimulation syndrome who are not always actively treated at present, the hypothesis is that early intervention at this stage may decrease progression into severe ovarian hyperstimulation syndrome.

Gonadotropin releasing hormone (GnRH) antagonists have also shown promising results for the earlier treatment of moderate and severe OHSS, potentially leading to a resolution of symptoms, and their use will be included in the trial.

A separate study will take place looking at treatment of late OHSS, which usually occurs 10 days or more after the administration of hCG and is caused by endogenous hCG of a resulting pregnancy.

Connect with us on Twitter


The study

The main study research question is: What earlier active outpatient management interventions for women with moderate to severe, early or late ovarian hyperstimulation syndrome (OHSS) are acceptable and feasible, and what is the clinical and cost-effectiveness of such interventions compared to conventional conservative management?

The study aims to assess if earlier active outpatient management resolves OHSS earlier and avoids the need for hospital admission when compared with usual (conservative) management.

The study will give the same supportive treatment provided to women for severe ovarian hyperstimulation syndrome but in an outpatient setting.

The study will also target women with moderate ovarian hyperstimulation syndrome who are not always actively treated at present, the hypothesis is that early intervention at this stage may decrease progression into severe ovarian hyperstimulation syndrome.

Two outpatient treatment protocols have shown promise in small uncontrolled studies.

The first of these involves drainage of ascitic fluid (paracentesis) and the second involves administration of Gonadotropin releasing hormone (GnRH) antagonists. Both candidate interventions will be compared with usual care in a 3-arm randomised trial.

A separate study will take place looking at the treatment of late OHSS (which usually occurs 10 days or more after the administration of hCG and is caused by endogenous hCG of a resulting pregnancy) with outpatient paracentesis.


Watch: Introduction to the STOP-OHSS Project

Chief investigator Mostafa Metwally presents the project overview in the video below.


Study team

Name Role Organisation Contact
Mostafa Metwally Chief Investigator Sheffield Teaching Hospitals mmetwally@nhs.net
Jessica Wright Trial Manager University of Sheffield jessica.wright@sheffield.ac.uk
David White CTRU Lead University of Sheffield d.a.white@sheffield.ac.uk
Robin Chatters Assistant CTRU Lead University of Sheffield r.chatters@sheffield.ac.uk
Clare Pye Nurse Researcher Sheffield Teaching Hospitals clare.pye1@nhs.net
Munya Dimairo Statistician University of Sheffield m.dimairo@sheffield.ac.uk
Tracey Young Health Economist  University of Sheffield t.a.young@sheffield.ac.uk
Tim Chater Data Manager University of Sheffield t.chater@sheffield.ac.uk
Alicia O'Cathain Lead Qualitative Researcher University of Sheffield a.ocathain@sheffield.ac.uk
Sarah Drabble Qualitative Researcher University of Sheffield S.J.Drabble@sheffield.ac.uk
Elizabeth Lumley Qualitative Researcher University of Sheffield e.lumley@sheffield.ac.uk
Andrew Drakeley Clinical Expertise Liverpool Women's NHS Foundation Trust Andrew.Drakeley@lwh.nhs.uk
Ying Cheong Clinical Expertise University of Southampton Ying.Cheong@uhs.nhs.uk
Erica Wallis Sponsor Representative Sheffield Teaching Hospitals erica.wallis1@nhs.net
Katie Ridsdale Trials Support Officer University of Sheffield k.ridsdale@sheffield.ac.uk
Amy Barr Research Assistant University of Sheffield amy.barr@sheffield.ac.uk
Laura Flight Health Economist University of Sheffield l.flight@sheffield.ac.uk
Jamie Hall Research Assistant University of Sheffield jamie.hall@sheffield.ac.uk

Flagship institutes

The University’s four flagship institutes bring together our key strengths to tackle global issues, turning interdisciplinary and translational research into real-world solutions.