The study

What does the study involve?

The MYCHOICE study is a nationwide study aimed at comparing MR-HIFU treatment with a number of existing treatments for fibroids. These so-called ‘control group’ treatments are embolization, hysterectomy and myomectomy. If you participate in the study, a draw will determine which treatment you will receive. If you draw for the ‘control group’ treatment, you can choose which of these three treatments you want to undergo.

Randomization process of MYCHOICE studie: MR-HIFU treatment for uterine fibroids

Randomization process of MYCHOICE study

By participating in the MYCHOICE study, you can help research the treatment of fibroids. At this time we do not know whether the MR-HIFU treatment is as good as the existing treatments for fibroids. The MR-HIFU treatment is currently not covered by Dutch health insurance. Therefore, to have a chance of receiving the MR-HIFU treatment, participation in the MYCHOICE study is necessary.

Participating in the MYCHOICE study means, besides drawing lots for a treatment, that information from your patient file will be shared with the research team. This only concerns information you have shared with your gynecologist. Furthermore, you will be asked to fill out a questionnaire five times (digitally). We are particularly interested in your experiences with the treatment. After two years you will receive the last questionnaire and your participation in the study will automatically stop.

How can I participate in the study?

Women who have symptoms of their fibroid often have regular appointments with their gynecologist. The gynecologist will tell you what treatment options are available for you based on your personal situation. As part of this information, the gynecologist will also tell you about the MYCHOICE study and the MR-HIFU treatment. To participate in the MYCHOICE study you must be at least 18 years old, have symptoms of fibroids and not postmenopausal. If you do not want to undergo MR-HIFU treatment or do not want to take part in the study, you and your gynecologist can choose an alternative treatment. However, we will then ask you to complete a short questionnaire explaining why you do not want to take part in the study or do not want the MR-HIFU treatment. We also learn a lot from this information.

If your gynecologist does not work in one of the participating hospitals, you can ask for a referral. It is possible that based on your data a referral is not eligible for the MR-HIFU treatment, and then a referral is not possible for the MYCHOICE study.

What does participation in the MYCHOICE study mean for me?

How can I participate in the study?

If you and your gynecologist have decided to take part in the MYCHOICE study, the gynecologist will provide you with an information leaflet and report you to the research team. Someone from the research team will then make a separate appointment with you. During this appointment we will discuss in detail what participating in the MYCHOICE study entails and what the MR-HIFU treatment looks like.

After you have had the opportunity to ask questions, you will sign the consent form and an MRI scan will be made. Based on this MRI scan, the research team will determine whether you are suitable for the MR-HIFU treatment. If you are suitable, you will be registered for the study. A drawing of lots will determine which treatment group you will be assigned to and you will receive the first questionnaire. If you are not selected for MR-HIFU, you and your gynecologist can choose which of the three treatments you would like to undergo. If you do not qualify for MR-HIFU treatment, you will not be able to participate in the study. You can then undergo treatment in consultation with your gynecologist. The draw is set up so that twice as many women will be drawn for the MR-HIFU treatment than for the ‘control group’ treatments.

When am I eligible for the MYCHOICE study?

If you participate in the MYCHOICE study, you can be enrolled for the MR-HIFU treatment. In order to participate you must be eligible for the MR-HIFU treatment. Unfortunately, not all women with fibroids are eligible for this treatment. In addition, there are a number of criteria you must meet to participate in the MYCHOICE study.

To be eligible you must:

Be older than 18 years of age;
Have symptoms of your fibroids for which you also want to undergo treatment other than MR-HIFU;
Not be pregnant and have no desire to become pregnant in the next year;
Not be post-menopausal (not have gone through the menopause);
Have a BMI below 35kg/m2;
Not be allergic to contrast medium;
Not suffer from claustrophobia;
Not have any metal in your body that cannot or should not be removed;
Be able to sign the consent form.

You may not be able to undergo MR-HIFU treatment if you:

Have a fibroid that is too far away from your abdominal skin;
Have a lot of (small) fibroids;
Have scarring on your abdomen;
Have a fibroid smaller than 2cm in diameter;
Have a fibroid larger than 10cm in diameter, unless you want to use hormones beforehand (maximum 3 months);
Do not want to have an IUD removed beforehand;
Have a fibroid with certain characteristics on the MRI scan.

The research team will use the MRI scan to determine your final eligibility.

What does participating in medical scientific research entail?

What does participating in medical scientific research contains?

The MYCHOICE study is a medical scientific research. There are two types of medical research. If you have health problems you will go to a doctor for an examination. The doctor will examine you to find a cause for the symptoms. This is also called diagnostic research and is intended to make you better. In medical scientific research, the first goal is not to make you better, but to get information about, for example, better treatments for illness. In this study, we do research into different treatments for fibroids to see if the MR-HIFU treatment is as good as the existing treatments for fibroids.

If you participate in this study, you are a participant. As a participant, you have rights and obligations. For example, you must always be well informed about the study before you may participate and sign a consent form. You also have the right to stop participating whenever you want without having to indicate why you want to stop. Finally, you have the right to protection of your data. As a participant, you also have obligations. For example, you have to abide by the rules of the study. If you do not do so, we will not be able to carry out the study properly or you will run a health risk. If you register for the study, you will also receive additional information about the specific rights and obligations of this study.

More information about medical scientific research can be found in the brochure of the Ministry of Health, Welfare and Sport on their website.

Waiting list

There are no waiting lists for participation in the study. However, there may be waiting lists for a certain treatment. After you have drawn lots for a treatment, this treatment will be scheduled as soon as possible. The MR-HIFU treatment can only be performed in Isala Zwolle and the UMC Utrecht. It is therefore possible that the waiting list for this treatment is a bit longer. The waiting lists for the other treatments depends on the waiting lists in your hospital.

Information leaflet

Through this folder, you can view, download and possibly print the complete information leaflet of the MYCHOICE study.

Frequently asked questions

1. My gynecologist does not work in one of the participating hospitals; can I participate in the study?

In order to participate, you must be referred to one of the participating hospitals. You can ask your gynecologist to send you a referral letter. The necessary contact details can be found under the heading contact.

2. I would like the MR-HIFU treatment, but not participate in the study, is this possible?

The MR-HIFU treatment is only available in the Netherlands if you participate in the MYCHOICE study. It is therefore not possible to undergo the MR-HIFU treatment for your fibroid without participating in this study.

3. I might want to undergo the MR-HIFU treatment but I don’t know if I am eligible, what should I do?

Not everyone is eligible for the MR-HIFU treatment. For that reason, an MRI scan is always performed. The research team will look at your MRI scan and discuss whether you would be eligible. Only when you are eligible for the MR-HIFU treatment, you can participate in the MYCHOICE study.

4. Can I join the study if I have a pregnancy wish?

If you participate in the MYCHOICE study, you can be selected for the MR-HIFU treatment. A pregnancy after this treatment is usually possible. If you are lined up in the other treatment group, a treatment can be chosen together with you gynecologist after which pregnancy is possible. Therefore, you can participate in the study if you have a pregnancy wish. However, if you want to become pregnant in the short term (<1 year) you cannot participate in this study. This has to do with the data we want to collect for the study.

5. Can I participate in the study if I am pregnant?

It is not possible to participate in the study if you are pregnant. If you want to have a treatment for your fibroid after giving birth, you can participate.

6. I underwent an MRI scan to see if I am eligible for MR-HIFU, what now?

The MRI scan has to be discussed in the research team. The results of this discussion will be shared with your gynecologist. Your gynecologist will then discuss this with you. If you turn out to be eligible for the MR-HIFU treatment, the draw will also take place immediately. Your gynecologist will also tell you for which treatment group you have been drawn.

7. If I am undergoing MR-HIFU treatment and my symptoms do not diminish sufficiently, can I get another treatment?

It is known that the MR-HIFU treatment does not (sufficiently) reduce the symptoms in all women. By selecting in advance (including the MRI scan), we try to prevent this, but that does not always the case. Moreover, it is possible that fibroids grow back or a new fibroid can grow in a different place. Re-treatment may then be necessary. In that case, you can opt for another MR-HIFU treatment, but also for uterine surgery. You have to discuss this with your gynecologist.