Oxytocin in MRI-HIFU

NCT ID: NCT03937401

Last Updated: 2019-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Fibroid Adenomyosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients treated with oxytocin during MRI-HIFU

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Oxytocin infusion during MRI-HIFU treatment

Interventions

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Oxytocin

Oxytocin infusion during MRI-HIFU treatment

Intervention Type DRUG

Other Intervention Names

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MRI-HIFU

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing MRI-HIFU -treatment
* Patients assessed for suitability to MRI-HIFU treatment
* willingness to participate in trial

Exclusion Criteria

* Known allergy to Syntocinon/oxytocin
* Elevated blood pressure
* ischemic heart disease
* Long QT- interval
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 40302212 (View on PubMed)

Otonkoski 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.

Reference Type DERIVED
PMID: 33207939 (View on PubMed)

Other Identifiers

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T366/2017

Identifier Type: -

Identifier Source: org_study_id

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