HELP Fertility?
Research type
Research Study
Full title
Hysteroscopic Excision of Leiomyoma and Polyp in Infertility - two randomised controlled trials
IRAS ID
283141
Contact name
Mostafa Metwally
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN91356224
Duration of Study in the UK
8 years, 8 months, 31 days
Research summary
Submucous fibroids and endometrial polyps are commonly detected in women seeking treatment for infertility and recurrent miscarriage. Currently, such uterine abnormalities are routinely removed by hysteroscopic resection, but there is limited evidence to suggest that their removal improves the chances of the woman achieving a pregnancy and live birth. The trial aims to examine the clinical and cost effectiveness of hysteroscopic resection of submucous fibroids and endometrial polyps in women presenting with infertility and recurrent miscarriage.
This will be an 'umbrella' randomised controlled trial (RCT) in which there are two multicentre RCTs running in parallel; one where women with polyps of less than 3cm are randomly allocated to either have their polyps removed by hysteroscopic resection (intervention arm) or not removed (control arm with no hysterscopic resection). Within the second trial, women with fibroids of less than 3cm are randomised into the same intervention and control arms i.e. hysteroscopic resection of fibroids versus no hysteroscopic resection.
Each trial will include a 9-month pilot phase to determine whether or not recruitment of patients into the trials is feasible. Target recruitment for each trial is 560, totalling 1120 participants over a 30 month period (including the pilot phase). Participants will be recruited from approximately 30 centres within the United Kingdom (e.g. general gynaecology units, recurrent miscarriage and IVF clinics and smaller District General Hospitals).
There is current uncertainty whether resection of fibroids and polyps is beneficial or indeed possibly harmful to patients wishing to conceive. Given how common fibroids and polyps are in this population, there is a potential for wide spread benefit to patients and the wider NHS to be gained from the findings of this study.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0013
Date of REC Opinion
10 Feb 2021
REC opinion
Further Information Favourable Opinion