Study focus: removing fibroids to aid fertility
In this article, we look at a trial we are supporting into whether removing fibroids in the womb aids fertility.
The ‘Hysteroscopic Excision of Leiomyoma and Polyp in Infertility’ (HELP Fertility?) trial is recruiting women with infertility or recurrent miscarriage who have small growths in their womb, known as fibroids or polyps, three centimetres or less, at the John Radcliffe Hospital, Oxford.
About 7% of women with unexplained infertility have fibroids, while 15-25% have polyps. Small fibroids and polyps do not usually have physical symptoms and also affect one in three women at some point in their life, usually aged 30 to 50.
Surgical removal of fibroids and polyps has become widely accepted practice. However, the evidence that this improves fertility is mostly from small observational studies but not trials where removing the growths is compared to leaving them. Removal carries risks including perforation of the uterus and scar tissue formation, which may have a negative effect on fertility. Surgery is also costly to the NHS and can cause patient anxiety.
A total 1,120 women are being sought to take part from 30 UK fertility and gynaecology units, including the John Radcliffe.
They will be randomly allocated to have growths removed via hysteroscopy or left alone. A hysteroscopy is a procedure whereby a thin telescope is used to examine the inside of the womb and the growths can be removed by attached small surgical instruments. All will be asked to complete a questionnaire about their involvement.
The trial’s Chief Investigator, Professor Mostafa Metwally, said: “We know that resection or removal of fibroids and polyps is often seen as positive.
“What patients may fail to realise is there is no significant evidence to support resection of fibroids or polyps of less than three centimetres. We hope to answer this very important question for patients of the future.”
The trial, led by researchers at Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield, is funded by the National Institute for Health and Care Research Health Technology Assessment (NIHR HTA) Programme.