- Pioneering study will investigate ways to improve women’s chances of a successful pregnancy and increase live birth rates for those undergoing treatments for infertility and recurrent miscarriages
- University of Sheffield’s Clinical Trials Research Unit to support the trial with Sheffield Teaching Hospitals NHS Foundation Trust
- Although tumours are linked to problems with getting pregnant, there is limited evidence to demonstrate that removal increases live birth rates and improves fertility
- 1,120 women are set to take part in the study, across 30 gynaecology and fertility centres in the UK
A pioneering study to evaluate ways to improve women’s chances of a successful pregnancy and increase live birth rates in those undergoing treatments for infertility and recurrent miscarriages is being led by the University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust.
The study, funded by the National Institute for Health Research, will be the first to assess if removing smaller fibroids and endometrial polyps less than 3cm is an effective way to improve women’s chances of having a baby.
Fibroids and endometrial polyps, or non-cancerous tumours of the uterus, are very common, especially in reproductive-age women. They are currently routinely diagnosed, treated and removed using an internal investigation of the womb, known as a hysteroscopy.
Around 20 to 40 percent of women with unexplained infertility are found to have fibroids and around 15 to 20 percent have endometrial polyps. Although these tumours have long been linked to problems associated with getting pregnant, there is limited clinical evidence to demonstrate that their removal increases live birth rates and improves fertility.
The findings of the £1.8 million trial - called HELP Fertility? - aims to determine if smaller fibroids and endometrial polyps should be removed during fertility treatment.
The grant award is the third successive multi-million pound grant obtained by the team of gynaecologists and researchers based at the University of Sheffield’s Clinical Research Trials Unit - who are supporting the trial - and Sheffield Teaching Hospitals NHS Trust.
The trial, which will involve 1,120 women across 30 gynaecology and fertility centres in the UK is due to commence on 1 April 2021.
Mr Mostafa Metwally, Chief Investigator and Consultant Gynaecologist and Sub-specialist in Reproductive Medicine and Surgery at Sheffield Teaching Hospitals NHS Foundation Trust, said: “We are delighted to be leading on this £2 million study. Hysteroscopy is an optional additional treatment offered to women with smaller fibroids and endometrial polyps as part of their fertility treatment. Yet there is little clinical evidence to support its use in those undergoing IVF or assisted conception.
“This gold standard study will provide women with much-needed answers as to its benefit, enabling them to make an informed decision as to whether they should delay fertility treatment to have these smaller fibroids and polyps removed or leave them in place. As well as demonstrating the clear benefit of hysteroscopy as an optional add-on fertility treatment, we will also assess if there is a potential negative impact on women’s fertility of hysteroscopy, which some women find invasive and painful.”
The team, which recently demonstrated that the endometrial scratch did not improve live birth rates in women undergoing IVF for the first time, said the consecutive grant award underpinned their reputation as the UK’s premier research centre for reproductive health studies aiming to improve the care of women who plan, provide or receive infertility care and treatment from the NHS.
David White, Portfolio Lead at the Clinical Trials Research Unit, said "This important new grant is the continuation of a successful collaboration with our clinical colleagues, led by Mostafa Metwally at Sheffield Teaching Hospitals NHS Foundation Trust. Given how common fibroids and polyps are in this population, there is potential for widespread benefit to patients and the wider NHS to be gained from the findings.”
Clare Pye, Lead Research Nurse for the study at Sheffield Teaching Hospitals NHS Foundation Trust, said: “All our research is designed with patients in mind, so we are delighted to be at the forefront of yet another major funding award which will provide women with the high quality evidence they need to make informed decisions about their care when they plan and receive fertility treatment.”
The study is expected to take around two and a half years, with initial findings due to be published in summer 2025.
