A randomized controlled trial of focused ultrasound ablation surgery for submucous leiomyomas and the influence on the microenvironment of uterine cavity

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100046041

Enrollment

Unknown

Registered

2021-05-02

Start date

2021-05-01

Completion date

Unknown

Last updated

2021-12-13

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

Conditions

Submucous leiomyoma

Interventions

Experimental group:focused ultrasound ablation surgery

Control group:tanscervical resection of myoma

Eligibility

Sex/Gender

Female

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Patients with type 1 or type 2 symptomatic submucosal fibroids diagnosed by pelvic color Doppler ultrasound, pelvic magnetic resonance and hysteroscopy >= 3cm and = 8g/L; 5. Agree to receive focused ultrasound ablation surgery, hysteroscopy, hysteroscope resection and endometrial biopsy; 6. Informed consent, understand and approve this randomized controlled trial.

Exclusion criteria

Exclusion criteria: 1. Type 2-5 uterine fibroids; 2. Absolute contraindications for focused ultrasound ablation surgery and hysteroscopy; 3. Patients who have language communication barriers and cannot be in prone position; 4. Pregnant and lactating women; 5. Acute pelvic inflammatory disease or systemic disease that cannot be controlled without control; 6. Patients with pelvic malignant tumors.

Design outcomes

Primary

Measure	Time frame
uterine fibroid symptom and quality of life score(UFS-QOL Score);	—

Secondary

Measure	Time frame
additional reintervention rate;	—

Countries

China

Contacts

Public ContactQu dacheng

Affiliated Hospital of North Sichuan Medical College

5252624@qq.com+86 13890745770

Outcome results

None listed

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