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Clinical study of high-intensity focused ultrasound ablation combined with different drugs in the treatment of adenomyosis

Clinical study of high-intensity focused ultrasound ablation combined with different drugs in the treatment of adenomyosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047983
Enrollment
Unknown
Registered
2021-06-28
Start date
2021-06-28
Completion date
Unknown
Last updated
2022-03-07

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

Conditions

Adenomyosis

Interventions

experimental group1:HIFU + dienogest.
experimental group2:HIFU+GnRHa+Mirena

Sponsors

Shenzhen Maternity and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. A woman aged from 30 to 55 years with a diagnosis of adenomyosis; 2. All patients have progressively worsening dysmenorrhea (VAS>=3); 3. Ultrasound and MRI diagnosed as adenomyosis, the thickness of single-layer muscle wall is >=3 cm; 4. The sound channel organization hierarchy is clear and safe; 5. Persons with clear consciousness, barrier-free communication, and willing to cooperate with treatment; 6. No other surgical treatment for half a year before and after superablation treatment; 7. Exclude other gynecological diseases; 8. No HIFU treatment contraindications and willingly accept HIFU treatment; 9. Patients and their families informed consent; 10. No birth requirements.

Exclusion criteria

Exclusion criteria: 1. People with coagulation dysfunction; 2. Pregnant or lactating women; 3. Patients with heart, liver, kidney and other serious medical diseases; 4. Menstrual period or heavy vaginal bleeding; 5. Unable to maintain prone position and keep the bladder full; 6. Acute pelvic inflammation; 7. Suspected malignant lesions.

Design outcomes

Primary

MeasureTime frame
The patient's postoperative pain relief (Visual analogue scoring VAS scoring method);Quality of life (SF-36) score;Extent of lesion reduction;

Secondary

MeasureTime frame
Menstrual flow improvement (menstrual loss assessment chart PBAC);

Countries

China

Contacts

Public ContactJin Ping

Shenzhen Maternal and Child Health Hospital

pingjin66@126.com+86 13925206896

Outcome results

None listed

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