Oxytocin in MRI-HIFU
Use of Oxytocin in MRI-HIFU Treatment
1 other identifier
interventional
100
1 country
1
Brief Summary
Capability of oxytocin in improving the efficacy of MRI-HIFU is studied. Patients undergoing MRI-HIFU treatment are given oxytocin during treatment and the efficacy of the treatment will be analysed by patient reported symptom questionnaires and imaging data.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 26, 2019
CompletedFirst Posted
Study publicly available on registry
May 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedMay 3, 2019
May 1, 2019
11 months
April 26, 2019
May 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
NPV
non perfused volume (percentage of fibroid destroyed)
up to one year
duration of MRI-HIFU
duration of MRI-HIFU treatment
up to one year
UFS-Qol
Uterine fibroid symptom severity and quality of life (patient quality of life questionnaire)
12 months after HIFU treatment
Study Arms (1)
Patients treated with oxytocin during MRI-HIFU
EXPERIMENTALInterventions
Oxytocin infusion during MRI-HIFU treatment
Eligibility Criteria
You may qualify if:
- Patients undergoing MRI-HIFU -treatment
- Patients assessed for suitability to MRI-HIFU treatment
- willingness to participate in trial
You may not qualify if:
- Known allergy to Syntocinon/oxytocin
- Elevated blood pressure
- ischemic heart disease
- Long QT- interval
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Turku University Hospital
Turku, 20521, Finland
Related Publications (2)
Otonkoski S, Viitala A, Komar G, Sainio T, Yanovskiy A, Blanco Sequieros R, Perheentupa A, Joronen K. Magnetic resonance guided high intensity focused ultrasound (MR-HIFU) effectively reduces fibroid-related symptoms and improves quality of life-A prospective single-centre 12-month follow-up study. Acta Obstet Gynecol Scand. 2025 Jun;104(6):1172-1180. doi: 10.1111/aogs.15086. Epub 2025 Apr 29.
PMID: 40302212DERIVEDOtonkoski S, Sainio T, Komar G, Suomi V, Saunavaara J, Blanco Sequeiros R, Perheentupa A, Joronen K. Oxytocin selectively reduces blood flow in uterine fibroids without an effect on myometrial blood flow: a dynamic contrast enhanced MRI evaluation. Int J Hyperthermia. 2020;37(1):1293-1300. doi: 10.1080/02656736.2020.1846792.
PMID: 33207939DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2019
First Posted
May 3, 2019
Study Start
February 1, 2019
Primary Completion
December 30, 2019
Study Completion
January 1, 2021
Last Updated
May 3, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared with other researchers