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A randomized controlled study of clinical efficacy evaluation of oxytocin combined with MRgFUS in the treatment of uterine fibroids and adenomyoma

A randomized controlled study of clinical efficacy evaluation of oxytocin combined with MRgFUS in the treatment of uterine fibroids and adenomyoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066692
Enrollment
Unknown
Registered
2022-12-14
Start date
2022-12-24
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

uterine fibroids and adenomyoma

Interventions

Oxytocin group:Oxytocin
Non-oxytocin group:Non-oxytocin

Sponsors

Xijing Hospital, Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1). At least 18 years old, non-menopausal or perimenopausal patients (within 12 months of menopause); 2). MR combined with clinically diagnosed uterine fibroids or adenomyoma; 3). The longest diameter of fibroids or adenomyoma is more than 3cm and less than or equal to 10cm; 4) Sign the written informed consent; 5). Able to participate in all study visits; 6). Ability to communicate personal feelings during treatment; 7). The lesion is within the reach of focused ultrasound; 8). The lesions are clearly visible on non-contrast MR images; 9). Uterine fibroids or adenomyomas can be enhanced on contrast MR images.

Exclusion criteria

Exclusion criteria: 1). Pregnant women, confirmed by serum/urine test at screening, or urine pregnancy test on the day of treatment; 2). Uterine size > 24 weeks; 3). Lactating patients; 4). Patients with acute pelvic inflammatory disease (PID); 5). Patients with local or systemic infection in acute phase; 6). Contraindications to MRI scanning: severe claustrophobia, weighing more than 250 IBS (lbs) (113Kg), implanted with ferromagnetic materials and/or contraindicated devices for MR scanning, known intolerance to MRI contrast agents (such as , gadolinium or magenvir), any other contraindications to MRI scanning; 7). Extensive abdominal scars on the sound beam path; 8). There is ovarian teratoma on the treatment path; 9). Known pelvic malignant or precancerous lesions; 10). Those who have an intrauterine device (IUD) on the treatment path and cannot be removed; 11). Those who are allergic to oxytocin; 12). Patients with heart disease should be used with caution.

Design outcomes

Primary

MeasureTime frame
pain score;

Countries

China

Contacts

Public ContactWen Luo

Xijing Hospital, Air Force Medical University

lwdd1234@fmmu.edu.cn+86 15029058962

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026