HELP Fertility? Trial

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, occurring 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 Fertility? 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.

Sponsor

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
Katie Ridsdale	Research Assistant	The University of Sheffield	k.ridsdale@sheffield.ac.uk
Amanda Loban	Data Management Lead	The University of Sheffield	a.loban@sheffield.ac.uk
Stephen Walters	Lead Statistician	The University of Sheffield	s.j.walters@sheffield.ac.uk
Liz Taylor	Senior Research Nurse	Sheffield Teaching Hospitals NHS Foundation Trust	liz.taylor15@nhs.net
Tony Stone	Trial Statistician	The University of Sheffield	tony.stone@sheffield.ac.uk
Nick Latimer	Lead Health Economist	The University of Sheffield	n.latimer@sheffield.ac.uk
Anju Keetharuth	Health Economist	The University of Sheffield	d.keetharuth@sheffield.ac.uk
Chris Turtle	Data Management	The University of Sheffield	c.turtle@sheffield.ac.uk
George Cleaver	Trials Support Officer	The University of Sheffield	g.j.cleaver@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 Foundation 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 Obstetrician 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.