Title: HELP Infertility? (Hysteroscopic Excision of Leiomyoma and Polyp in Infertility): two randomised controlled trials
Funder: Department of Health and Social Care

Abstract: This study aims to find out if having hysteroscopic removal of fibroids and polyps increases the live birth rate in women with infertility and recurrent miscarriage._x000D_ The womb (uterus) is the area of a woman’s body where an embryo embeds and then develops into a baby. Abnormalities in the cavity of the womb such as fibroids and polyps have long been linked to problems associated getting pregnant as well as increased rates of miscarriage. This is thought to be because the presence of fibroids or polyps interfere with the inside of the womb and get in the way of the embryo implanting and developing._x000D_ _x000D_ Fibroids are common benign growths in the muscle of the womb and polyps are benign growths in the lining of the womb. A routine hospital procedure called hysteroscopy is often used to diagnose or treat these abnormalities. Hysteroscopy is a simple procedure often performed in an outpatient setting whereby a small camera with or without the attachment of a surgical instrument (used to remove the fibroid/polyp) is passed through the cervix into the womb to directly visualise, and potentially remove the fibroid/polyp. _x000D_ _x000D_ Currently there is no good quality evidence that tells us whether or not removing these abnormalities improves pregnancy outcomes for these women. Current practice is varied amongst clinicians and treatment is largely dependent on your doctors’ preference as to whether or not to remove them. Some doctors believe, depending on the size of the fibroid or polyp that they should be removed while others believe removal is more harmful. Therefore a large high quality study is required in order to provide evidence that will help doctors make a decision. _x000D_ _x000D_ We will undertake a randomised controlled study, where women who agree to take part will have a 50% chance of having their fibroids or polyps removed during a hysteroscopy procedure. Women will be approached to take part if they have had polyps or fibroids diagnosed that are under 3cm in size and are receiving treatment for infertility or miscarriage. Those having the fibroid or polyps removed would be known as the “intervention group” and those who do not the “control group”. Both groups would then be followed up at regular intervals over two years to see whether or not the woman achieved a pregnancy and went on to have a healthy baby and did not have a miscarriage. Women will also have the option of agreeing for information about the outcome of any pregnancies and whether or not they have received the procedure to be followed up using routinely collected data over a minimum of five years, in order to assess the long term effects of hysteroscopy._x000D_ _x000D_ Women who are randomised into the ‘control group’ who do not get pregnant after 6 months will be able to cross-over to have their fibroids or polyps removed, if they wish. Taking part in this study will be entirely voluntary and the choice not to take part would not have any impact on the woman’s care.

Lay abstract: Research question: What is the clinical and cost-effectiveness of hysteroscopic removal of submucosal fibroids and polyps in women presenting with infertility and recurrent miscarriage?_x000D_ Background: Endometrial fibroids and uterine polyps are commonly detected in women seeking treatment for infertility and recurrent miscarriage. Currently, such uterine abnormalities are routinely removed by hysteroscopic resection, but there is limited evidence to suggest that their removal improves the chances of the woman achieving a pregnancy and live birth._x000D_ Aims and objectives: A) Assess the feasibility of conducting two multi-centre RCTs of hysteroscopic resection of endometrial polyps and submucous fibroids in women suffering from infertility or recurrent miscarriage, by conducting two RCT internal pilots; one for women with polyps and one for women with submucous fibroids; B) If feasible, determine the clinical and cost-effectiveness of the hysteroscopic removal of endometrial polyps and submucousal fibroids to improve fertility in women suffering from unexplained infertility or recurrent miscarriage; C) To determine patient experience and satisfaction, procedure related complications; D) To assess the long-term effect of hysteroscopic resection of endometrial polyps and submucous fibroids, by collecting and analysing routinely collected NHS data. _x000D_ Methods: An Umbrella RCT containing two RCTs run in parallel - one where women with polyps of less than 3cm are randomly allocated to either hysteroscopic resection or no resection (n=560), and another where women with fibroids of less than 3cm are randomised into the same intervention and control arms (n=560). Women randomised to the control arm will be given the option to cross over to receive the intervention 6 months after randomisation. The primary outcome of live birth rate will be collected at 15 months post randomisation. A long term follow up study will be undertaken using routine NHS data – each participant will be followed up for a minimum of 5 years to collect pregnancy outcomes and whether hysteroscopic resection of the abnormalities has been undertaken._x000D_ Timelines for delivery: M1-8 ethics approvals, RCT set-up; M9-17 RCT internal pilot; M18 stop/go assessment; M18-38 complete RCT recruitment; M39-62 follow up; M63-68 analysis and write up; M99-103 long-term follow up routine data collection and analysis._x000D_ Anticipated impact and dissemination: There is current uncertainty whether resection of fibroids and polyps is beneficial or indeed possibly harmful to patients wishing to conceive. Given how common fibroids and polyps are in this population, there is a potential for wide spread benefit to patients and the wider NHS to be gained from the findings. Dissemination will occur via patient groups, professional bodies, direct interaction with NHS Trusts, academic journal articles and conference presentations.

Research activity codes: 6.4 SURGERY
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH