About the trial
Hysteroscopic Excision of Leiomyoma and Polyp in Infertility: A research trial look at whether removal of fibroids and polyps HELPs Infertility.
This page will give you more information about the trial, starting with a video explaining how it will work.
What is our research about?
Fertility is a very personal journey and there are many treatment options available that may affect your chances of having a baby.
Submucosal fibroids are common benign growths in the muscle of the womb (uterus) and endometrial polyps are benign growths in the lining of the womb. Both are commonly found in women seeking treatment for fertility and recurrent pregnancy loss.
Fibroids or polyps can vary in size and most doctors advise removing large ones (greater than 3cm in size). If you have small fibroids or polyps (less than 3cm) then one option is to have them removed is hospital by a surgical procedure called 'hysteroscopic resection'. Another option is to leave them alone. Currently, we do not know whether removing or leaving small fibroids or polyps is going to improve your chances of having a baby. This is because, currently, there is insufficient strong scientific evidence telling us whether the procedure has a positive or negative effect on fertility.
This trial has been designed to provide that scientific evidence and answer the following question:
Which treatment, A) removing or B) leaving small submucosal fibroids or endometrial polyps in place, has the best effect on the chances of having a baby, for women who are seeking treatment for fertility or recurrent pregnancy loss?
Who is carrying out this research?
This trial is being led by the Sheffield Teaching Hospitals NHS Foundation Trust.
We plan to recruit 1120 women who are seeking help for fertility problems over 2.5 years. This will take place across approximately 30 fertility or gynaecology units in the UK.
Who is sponsoring and funding the research
The trial is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) and sponsored by Sheffield Teaching Hospitals NHS Foundation Trust.
It is organised, managed and coordinated by the University of Sheffield, and data will be be collected and stored by this institution.
Additionally, the trial will be supervised on a regular basis by a Data Monitoring and Ethics Committee (DMEC) and a Trial Steering Committee (TSC). The primary function of the DMEC is to ensure the absolute safety of all participants.
About the procedure
Hysteroscopic resection is a diagnostic procedure as well as an operative one where a thin telescope (hysteroscope) and small surgical instruments are used to remove fibroids and polyps. The procedure is often carried out under general anaesthetic, although local anaesthetic may be used instead and you can usually go home on the same day as the procedure.
This procedure is relatively simple but is not without risks. These include pain during or after the procedure, feeling/being sick, fainting, bleeding, uterine perforation and scarring of the womb afterwards, which may affect fertility.
What will happen if I take part in the trial?
Women taking part in the trial will be randomly allocated (randomised) to participate in one of two groups:
Group A - The intervention group will have the submucosal fibroids and/or endometrial polyps removed via hysteroscopy
Group B - The control group will not have their submucosal fibroids and/or endometrial polyps removed.
If you decide to take part this mean that neither you nor your doctors can decide which treatment you will receive. There is an equal chance of being placed in either treatment group A or B.
What happens to you if you are randomised to the intervention group?
If you are randomised to the intervention group, you will receive hysteroscopic removal of fibroids or polyps as either an outpatient or an inpatient. You will be seen by a doctor or nurse in outpatients prior to the procedure. They will explain the procedure and answer any questions you may have. The procedure must not be performed if there is any chance that you are pregnant. To avoid this possibility, it is important to use contraception or avoid sex between your last period and your appointment. You may be offered a urine pregnancy test on arrival at your appointment. if you are expecting to receive any other fertility treatments e.g. In vitro fertilisation (IVF), ovulation induction, intrauterine insemination (IUI), Donor Sperm Insemination, intracytoplasmic sperm injection (ICSI), or medications e.g. clomid you will be able to commence with this treatment as soon as possible following the hysteroscopic resection.
If the fibroid or polyp cannot be fully removed you may be asked to come back and undergo a second procedure; this is completely normal and happens in a small number of cases.
For some women, it is not possible to complete an outpatient hysteroscopy. In these cases, you may undergo an inpatient hysteroscopy, where the procedure is carried out under a general anaesthetic and you may need to stay in hospital for a few hours afterwards. If you are unsure of whether you should have an outpatient or an inpatient hysteroscopy, you should discuss this further with your doctor or nurse at your appointment or by contacting the hospital/clinic using the contact details at the end of this information sheet.
You will be asked to complete a short questionnaire within 1-2 weeks of having the hysteroscopic procedure.
What happens to you if you are randomised to the control group?
If you are randomised to the control group, the fibroid/polyp will not be removed. If you are expecting to receive any other fertility treatments you will be able to commence with this treatment as soon as planned.
Some hospitals are able to perform a diagnostic hysteroscopy as well as a resection of the fibroid/polyp at the same time if they have the appropriate equipment If your local hospital has this facility then you will be randomised as explained above but during the hysteroscopy procedure and not prior to it.
What will happen next if I decide to take part?
If you wish to take part in the trial you may be asked to consent to a screening procedure to measure the size of your fibroids and polyps. This is likely to involve an ultrasound scan or other method listed below. These will be explained by your doctor of nurse.
An ultrasound scan - this is a painless scan that uses a probe to produce high frequency sound waves to create an image of the inside of your uterus. This will be done either by moving an ultrasound probe over the outside of your tummy or by inserting a small ultrasound probe into your vagina.
An MRI scan (Magnetic Resonance Imaging scan) - you will lie on a flatbed that is moved into a large tubular scanner.
A diagnostic hysteroscopy or sonohysterography - a narrow tube is placed in the vagina, through the cervix, and into the womb. Sterile saline (a safe fluid of salt water) is gently pumped into the womb and images are transmitted to a monitor.
Some women may already have had these scans performed as part of their fertility treatment and therefore will not require for them to be performed again.
For the purpose of this trial, if the screening shows that your fibroid and or/polyp is larger than 3cm in size, you will not be able to continue in the trial. This is because this trial is looking at the effect of removing, or leaving in place small fibroids or polyps, this will have no effect on your usual clinical care.
Providing information and data as part of the trial
Regardless of which group you are in, you will be followed up to see whether or not you get pregnant and have a healthy baby. This will involve completing a short questionnaire either in person during a clinic appointment, by telephone, in the post or online at 6, 15 and 24 months after you gave consent to take part in the trial.
Information will also be collected from your medical notes about the fertility treatments you receive and the outcome of those treatments.
If you start receiving treatment as another NHS Trust or private facility, this information may also be requested from those organisation. We will ask your permission to do this.
The trial will also look at the long-term effect of the trial on fertility, recurrent miscarriage and pregnancy loss over at least a 5-year period. To do this we would like to access data about fertility treatments, pregnancy and related clinical/hospital appointments from your medical notes and NHS Digital. This information can only be accessed with your permission using your name, postcode, date of birth, NHS number.
The research team will compare the pregnancy outcomes for the intervention group and control group at the end of the trial. This will help us to determine whether hysteroscopic removal of fibroids and polyps improves the long-term changes of successful pregnancy for women experiencing fertility problems.
What are the possible disadvantages and risks of taking part?
Hysteroscopic removal of fibroids and polyps is a relatively safe, routine procedure, but there are some risks, which have been described, which you should discuss with your doctor/nurse.
What will happen to the results of the research trial?
The results of this trial will be published in scientific journals and presented at scientific meetings, as well as shared directly with NHS Trusts, professional bodies and patient groups. You will not be identified in any report or publication. If you would like to receive a summary of the trial results a copy of the research report we will send this to you.
Who has reviewed the trial?
Research in the NHS is looked at by an independent group of people called a Research Ethics Committee to protect your interests. This trial has been reviewed and given a favourable opinion by the West Midlands - Edgbaston Research Ethics Committee.