Uterine FibroidsNCT02914704
Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)
A study testing MRI-HIFU in people with Uterine Fibroids and Adenomyosis, run by Turku University Hospital at 1 site in Finland.
Trial summary
MRI-guided high intensity focused ultrasound (MRI-HIFU) has been proven to be a safe and effective method in treating uterine fibroids and also adenomyosis. However, systematic studies on the effect of this treatment on factors affecting fertility are still lacking. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroids, Adenomyosis
- What is being tested?
- MRI-HIFU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2016to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI < 35
- Premenopausal
- Uterine size <20 gw
- Willingness to participate to the research
- Uterine fibroids with typical symptoms
- Maximum of 4 treated fibroids
- Dominant fibroid >2.5cm
- >50% of the fibroid is treatable
Who cannot join
- Unspecified pelvic tumours or ovarian masses, PID
- Major corrective surgery to uterus (simple myomectomy excluded)
- Major uterine anomalies
- Unability to calculate the volume of uterine fibroids
- Marked uterine calcification
- Marked scarring of the lower abdomen
Show all 9Show fewer
- Suspicion of malignancy
- Marked general health problem contraindicating MRI
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
Kirsi M Joronen, PhD contact
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, 20521
Kirsi M Joronen, MD PhD, +35823130561, kirsi.joronen@tyks.fi
About this study
MRI-guided high intensity focused ultrasound (MRI-HIFU) has been proven to be a safe and effective method in treating uterine fibroids and also adenomyosis. However, systematic studies on the effect of this treatment on factors affecting fertility are still lacking. Also quite little is known about body's systemic response to MRI-HIFU. Thus the aim of this study is to obtain more information on the systemic response of the body to the HIFU-treatment when treating non-malignant disease as well as to study the effect of MRI-HIFU on factors affecting fertility. Women with symptomatic uterine fibroids or adenomyosis suitable for MRI-HIFU treatment are recruited to this study. The severity of symptoms will be assessed with UFS-QoL and the same questionnaire will also be used in follow-up 3, 6 and 12 months after treatment. Blood, urine and endometrium samples will be collected pre- and postoperatively and during follow-up 3, 6 and 12 months after the treatment. From these samples detailed analysis of the immunological, inflammatory and hormonal response will be performed. As this is the first study in Finland of treating uterine fibroids and adenomyosis using MRI-HIFU, also a report about the efficacy of the MRI-HIFU in treating the uterine disorders will be published, and a key tool in assessing the treatment outcome would be the UFS-QoL questionnaire.
Also new methods for improving patient selection as well as treatment efficacy will be evaluated in this study.
- Conditions
- Uterine Fibroids, Adenomyosis
- Being tested
- MRI-HIFU
- Medical subject headings
- Leiomyoma, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-HIFUDevice
Treatment of uterine fibroids with MRI-HIFU
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with MRI-HIFU | Experimental | Not described Receives: Device: MRI-HIFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kirsi M Joronen, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914704
- Sponsor's protocol ID
- GYN-HIFU
- Status last verified
- Apr 2019
- First submitted
- 5 Jan 2016
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Publications
Otonkoski S, Viitala A, Komar G, Sainio T, Yanovskiy A, Lehtonen I, Blanco Sequeiros R, Perheentupa A, Joronen K. Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) therapy of uterine fibroids effectively reduces both bleeding and bulk symptoms-A prospective single-center 12-month follow-up study. Acta Obstet Gynecol Scand. 2026 Sep;105(9):1840-1847. doi: 10.1111/aogs.70268. Epub 2026 Jun 15.
PubMed 42294814
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)
- ClinicalTrials.gov ID
- NCT02914704
- Acronym / sponsor ID
- GYN-HIFU
- Conditions
- Uterine Fibroids, Adenomyosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Jan 2016
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MRI-guided high intensity focused ultrasound (MRI-HIFU) has been proven to be a safe and effective method in treating uterine fibroids and also adenomyosis. However, systematic studies on the effect of this treatment on factors affecting fertility are still lacking. Also quite little is known about body's systemic response to MRI-HIFU. Thus the aim of this study is to obtain more information on the systemic response of the body to the HIFU-treatment when treating non-malignant disease as well as to study the effect of MRI-HIFU on factors affecting fertility. Women with symptomatic uterine fibroids or adenomyosis suitable for MRI-HIFU treatment are recruited to this study. The severity of symptoms will be assessed with UFS-QoL and the same questionnaire will also be used in follow-up 3, 6 and 12 months after treatment. Blood, urine and endometrium samples will be collected pre- and postoperatively and during follow-up 3, 6 and 12 months after the treatment. From these samples detailed analysis of the immunological, inflammatory and hormonal response will be performed. As this is the first study in Finland of treating uterine fibroids and adenomyosis using MRI-HIFU, also a report about the efficacy of the MRI-HIFU in treating the uterine disorders will be published, and a key tool in assessing the treatment outcome would be the UFS-QoL questionnaire.
Also new methods for improving patient selection as well as treatment efficacy will be evaluated in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with MRI-HIFU | Experimental | Device: MRI-HIFU |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- BMI < 35
- Premenopausal
- Uterine size <20 gw
- Willingness to participate to the research
- Uterine fibroids with typical symptoms
Key exclusion criteria (9 listed)
- Unspecified pelvic tumours or ovarian masses, PID
- Major corrective surgery to uterus (simple myomectomy excluded)
- Major uterine anomalies
- Unability to calculate the volume of uterine fibroids
- Marked uterine calcification
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI-HIFUTreatment of uterine fibroids with MRI-HIFU | Device | Patients treated with MRI-HIFU |
Primary outcome
Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score
Time frame: 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Derived from this study: PubMed 42294814Otonkoski S, Viitala A, Komar G, Sainio T, Yanovskiy A, Lehtonen I, Blanco Sequeiros R, Perheentupa A, Joronen K. Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) therapy of uterine fibroids effectively reduces both bleeding and bulk symptoms-A prospective single-center 12-month follow-up study. Acta Obstet Gynecol Scand. 2026 Sep;105(9):1840-1847. doi: 10.1111/aogs.70268. Epub 2026 Jun 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsi M Joronen, PhD contact
Kirsi M Joronen, PhD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI-HIFU in people with Uterine Fibroids and Adenomyosis, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirsi M Joronen, PhD (kirsi.joronen@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score (time frame: 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.