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Clinical study of HIFU combined with MHT treatment on uterine fibroids in perimenopausal women

Clinical study of HIFU combined with MHT treatment on uterine fibroids in perimenopausal women

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048823
Enrollment
Unknown
Registered
2021-07-18
Start date
2021-07-17
Completion date
Unknown
Last updated
2022-03-28

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

Conditions

Uterine fibroids

Interventions

control group:MHT treatment
experimental group:MHT + HIFU treatment

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Perimenopausal women aged 40-60; 2. Ultrasound or MRI diagnosis of combined uterine fibroids; 3. Single uterine fibroids, and the largest diameter is less than 5cm; 4. No symptoms related to uterine fibroids; 5. Have MHT indications and are willing to accept MHT treatment.

Exclusion criteria

Exclusion criteria: 1. MHT treatment contraindications: (1) Known or suspected pregnancy; (2) Unexplained vaginal bleeding; (3) Known or suspected breast cancer; (4) Known or suspected sex hormone-dependent malignant tumors; (5) Active venous or arterial thromboembolic disease in the past 6 months; (6) Severe liver and kidney dysfunction; (7) Hematoporphyria, otosclerosis; (8) Currently suffering from meningioma (progesterone is prohibited); 2. HIFU treatment contraindications: (1) Combined with serious organic diseases of vital organs: uncontrollable hypertension, history of cerebrovascular accident, history of myocardial infarction, severe arrhythmia, heart failure, renal failure and liver failure, etc, accompanied by collagen connective History of tissue disease and radiotherapy of lower abdomen; (2) Acoustic channel abnormality: the width of the lower abdomen scar is >=1cm, the acoustic channel is abnormal in the localization check; there is a foreign body in the acoustic channel, etc; (3) Acute inflammation of the pelvic cavity or reproductive tract; (4) Patients with other gynecological malignant diseases, cervical or endometrial precancerous lesions or cancerous changes, and ovarian tumors; (5) Those who have language communication difficulties and cannot cooperate with sedation and analgesia programs; (6) Those who cannot lie on their stomachs for 1 hour.

Design outcomes

Primary

MeasureTime frame
Fibroid volume;

Countries

China

Contacts

Public ContactHe Xiaojing

The Second Hospital of Hebei Medical University

962013280@qq.com+86 15933601356

Outcome results

None listed

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