Abnormal uterine bleeding (AUB) affects at least 1 in 3 women of reproductive age and accounts for around 20% of gynaecology referrals. A common finding in women with AUB is the presence of suspected endometrial polyps on ultrasound scan. However, it remains unclear whether polyps are the cause of the abnormal bleeding.
The OPAL Study (Hysteroscopy and polyp removal versus medical management for the improvement of abnormal uterine bleeding in premenopausal women) is a feasibility randomised pilot trial, with embedded mixed-methods evaluation, investigating whether a larger study comparing hysteroscopy and polyp removal with medical management alone is practical and acceptable for premenopausal women with AUB and suspected endometrial polyps.
The study will recruit 50 women aged 18 - 45 years with AUB and suspected endometrial polyps across 5 UK sites and randomise them to either hysteroscopy and polyp removal or medical management. Participants will be followed up for six months.
The main aim is to assess recruitment, treatment adherence, and follow-up rates to inform a future definitive trial. Secondary outcomes include bleeding symptoms, pain, quality of life, treatment satisfaction, adverse events, healthcare resource use, and cost-effectiveness. The study also includes qualitative research to explore the experiences of participants and healthcare professionals.
The findings will help determine whether a larger trial is needed and may improve future management of women with AUB and suspected endometrial polyps.
The OPAL trial is funded by the National Institute for Health and Care Research Health Technology Assessment (NIHR HTA) Programme (NIHR175087) and is led by Dr Lucky Saraswat at NHS Grampian.
The trial is expected to open to recruitment early 2027. If you are interested in becoming a study site, please contact the Trial Manager at opal@abdn.ac.uk.
Contacts
- OPAL study email; opal@abdn.ac.uk