Clinical Research Office. A partnership between Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield

Pioneering £1.8m study to investigate if pregnancy success rates improved by removing small fibroids in womb

Fertility experts from Sheffield Teaching Hospitals NHS Foundation Trust are to lead a pioneering study evaluating if removing smaller fibroids and endometrial polyps improves women’s chances of a successful pregnancy, and increases live birth rates, in those undergoing treatments for infertility and recurrent miscarriages.

The multi-centre study, funded by the National Institute for Health Research, which is to be run across 30 gynaecology and fertility centres across the UK, will be the first to assess if removing 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.

However, although these growths 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 £1.8m HELP Fertility? trial will help 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 Sheffield Teaching Hospitals’ Jessop Wing in the past few years. The research will be supported by the University of Sheffield’s Clinical Research Trials Unit.

1,120 women are set to take part in the study, which 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 this £2m 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, who 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 premiere 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.

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.”

Around 20 to 40 percent of women with unexplained infertility are found to have fibroids and around 15 to 20 percent endometrial polyps.

The study is expected to take around two and a half years, with initial findings due to be published in summer 2025.

ENDS

 

Photo: Lead Research Nurse for the study Clare Pye and Chief Investigator Mostafa Metwally at Jessop Fertility, the Assisted Conception Unit at Sheffield Teaching Hospitals NHS Foundation Trust