HELP Infertility? Trial

The main study research question is: What is the clinical and cost-effectiveness of hysteroscopic removal of submucosal fibroids and polyps in women presenting with infertility and recurrent miscarriage?

On

Background

Uterine fibroids remain the commonest benign tumours of the female genital tract, with intracavitary fibroids reported in around 5-18% of patients with infertility and about 7% of women with unexplained infertility. Endometrial polyps are also a common finding, occuring in an estimated 15-25% of women with unexplained infertility.

Evidence from small observational studies suggest that submucous fibroids may have a negative effect on reproductive performance by both distorting the endometrial cavity and possibly disrupting subendometrial blood flow. Endometrial polyps may have a negative effect on fertility as evidenced by a negative effect on markers of endometrial receptivity. However, removal is not without risks, some of which may have a negative effect on fertility and may cause the patient significant anxiety, affecting pain perception and satisfaction. Surgery also poses a significant economic burden on the National Health Service (NHS).

Despite lack of evidence from high quality randomised controlled trials, hysteroscopic removal of both submucous fibroids and endometrial polyps has become a popular intervention in women with fertility problems. Further research is therefore needed to determine whether removal of these uterine cavity abnormalities should be recommended.

The Study

The study aims to assess whether hysteroscopic removal (intervention) of submucous fibroids and endometrial polyps is a clinical and cost effective method of improving birth outcomes in women presenting with infertility and recurrent miscarriage when compared with no hysteroscopic removal (control). HELP Infertility? will consist of two pragmatic, multi-centre RCTs; women will be recruited to one of the two trials depending on their diagnosis of either submucous fibroids, or endometrial polyps. Participants will be randomised to the intervention arm, or the control arm, however, women in the control group will be permitted to receive the intervention after 6 months if they wish to.

Funder

This project is funded by the National Institute for Health Research, Health Technology Assessment (NIHR HTA) Programme.

Sheffield Teaching Hospitals NHS Foundation Trust.

More information

Central Trial Team
Name Role Institution Contact
Mostafa Metwally Chief Investigator Sheffield Teaching Hospitals NHS Foundation Trust mmetwally@nhs.net
Clare Pye Lead Research Nurse & Co-applicant Sheffield Teaching Hospitals NHS Foundation Trust clare.pye1@nhs.net
Kirsty McKendrick Trial Manager The University of Sheffield kirsty.mckendrick@sheffield.ac.uk
David White CTRU Lead The University of Sheffield d.a.white@sheffield.ac.uk
Robin Chatters Assistant CTRU Lead The University of Sheffield r.chatters@sheffield.ac.uk
Amy Barr Research Assistant The University of Sheffield amy.barr@sheffield.ac.uk
Tim Chater Data Management Lead The University of Sheffield t.chater@sheffield.ac.uk
Stephen Walters Lead Statistician The University of Sheffield s.j.walters@sheffield.ac.uk
Kerry Wilson Trials Support Officer The University of Sheffield kerry.wilson@sheffield.ac.uk
Co-applicants
Name Role Institution
Nicholas Latimer Health Economist The University of Sheffield
Tarek El-Toukhy Consultant Gynaecologist Guys & St Thomas NHS Foundation Trust
Dr Meenakshi Choudhary Consultant Gynaecologist The Newcastle upon Tyne Hospitals NHS Foundation Trust
Stuart Lavery Consultant Gynaecologist Imperial College Healthcare NHS Trust
Associate Professor Saad Amer Consultant Gynaecologist University Hospitals Derby and Burton NHS Foundaton Trust
Dr Priya Bhide Associate Specialist Homerton University Hospital NHS Foundation Trust
Professor Ying Cheong Professor of Reproductive Medicine and Surgery University of Southampton NHS Foundation Trust
Hany Mostafa Consultant Obestetrician and Gynaecologist North Tees and Hartlepool NHS Foundation Trust
Dr Lamiya Mohiyiddeen Consultant Gynaecologist Central Manchester University Hospitals NHS Foundation Trust
Anya Sizer Regional Organiser - Patient and Public Involvement Fertility Network UK
Clair Scaife Patient and Public Involvement member Sheffield Teaching Hospitals NHS Foundation Trust

Disclaimer

The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the sponsor (Sheffield Teaching Hospitals) or NIHR.

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