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?
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 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.
This project is funded by the National Institute for Health Research, Health Technology Assessment (NIHR HTA) Programme.
Sheffield Teaching Hospitals NHS Foundation Trust.
- Central Trial Team
Name Role Institution Contact Mostafa Metwally Chief Investigator Sheffield Teaching Hospitals NHS Foundation Trust email@example.com Clare Pye Lead Research Nurse & Co-applicant Sheffield Teaching Hospitals NHS Foundation Trust firstname.lastname@example.org Kirsty McKendrick Trial Manager The University of Sheffield email@example.com David White CTRU Lead The University of Sheffield firstname.lastname@example.org Robin Chatters Assistant CTRU Lead The University of Sheffield email@example.com Amy Barr Research Assistant The University of Sheffield firstname.lastname@example.org Tim Chater Data Management Lead The University of Sheffield email@example.com Stephen Walters Lead Statistician The University of Sheffield firstname.lastname@example.org Kerry Wilson Trials Support Officer The University of Sheffield email@example.com
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
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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