A trial evaluating active outpatient management to prevent hospital admission in women having fertility treatment who develop ovarian hyperstimulation syndrome

Not Applicable

• Conditions: Ovarian hyperstimulation syndrome; Pregnancy and Childbirth

• Registration Number: ISRCTN71978064
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38262643/ (added 24/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-07
• Last Update Posted: 18 March 2024
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

1. Women presenting with moderate or severe, early or late OHSS as defined by the trial (see trial protocol for full definitions)
2. Patients able and willing to attend weekly follow-up appointments in person or remotely, daily remote appointments/phone calls, and able to undertake self-monitoring at home

Exclusion Criteria

1. OHSS-related exclusion criteria:
1.1. Significant pain* or vomiting requiring hospitalisation
1.2. Pulmonary embolism
1.3. When in the judgment of the clinician, the patient’s condition is severe enough to warrant admission to a High Dependency Care Unit (such as Critical OHSS as defined in the Royal College of Obstetricians and Gynaecologists (RCOG) green-top guidelines) and therefore not suitable for outpatient management
2. Non-OHSS related medical conditions: a concurrent medical condition requiring immediate inpatient management
3. Patients who have been previously randomised but later present with moderate or severe OHSS symptoms in subsequent cycles after their initial trial involvement
4. Participation in other trials involving ovarian stimulation or ovarian response

*Significant pain will require clinical judgement but may be guided by whether the patient is able to cope at home using ’over the counter’ analgesia or if there are any clinical concerns regarding other conditions potentially contributing to the pain (e.g. ectopic pregnancy)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OHSS-related hospitalisation for at least 24 hours measured using data collected by staff at fertility units by contacting the participant by telephone during monitoring, at patient visits within 28 days of randomisation or collected from hospital notes after 28 days