Pioneering study to investigate if pregnancy success rates improved by removing small fibroids in womb
Fertility experts will evaluate 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, in a new study funded by the NIHR.
The multi-centre trial, led by researchers from Sheffield Teaching Hospitals NHS Foundation Trust, is to be run across 30 gynaecology and fertility centres across the UK and 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 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 £1.8m HELP Fertility? trial will help to determine if smaller fibroids and endometrial polyps should be removed during fertility treatment. More than one thousand 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 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.
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.
The project was funded by the NIHR Health Technology Programme.