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A Single-Center, Double-Arm, Randomized Controlled Clinical Study on the Treatment of Adenomyosis with Dienogest Combined with Magnetic Resonance-Guided Focused Ultrasound Ablation

A Single-Center, Double-Arm, Randomized Controlled Clinical Study on the Treatment of Adenomyosis with Dienogest Combined with Magnetic Resonance-Guided Focused Ultrasound Ablation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101137
Enrollment
Unknown
Registered
2025-04-21
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

adenomysis

Interventions

treatment group: Preoperative Pretreatment: Preoperative treatment with DNG (Dienogest ( manufactured by Bayer Weimar GmbH und Co. KG), 2mg/day orally for 3 months). Treatment Plan: After pretreatme
control group:Treatment regimen: choose to avoid pregnancy, lactation, and menstruation and take DNG 2mg/day orally for 6 months.
Blank control group:Healthy women aged between 18 and 45 years old were selected to meet the conditions of normal menstrual cycle and gynecological color ultrasound showing no organic lesions of adeno

Sponsors

Foshan Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for the Treatment Group and Control Group 1. Women aged between 18 and 45 years; 2. All enrolled subjects are diagnosed with adenomyosis (AM) via transvaginal ultrasound, with uterine size = 12 weeks; 3. Gynecological examination confirms uterine size = 12 weeks of pregnancy; 4. AM patients have not undergone surgical treatment, or recurrence occurred = 2 years after surgical treatment; 5. Patients express a desire for conservative treatment. Inclusion Criteria for the Blank Control Group 1. Women aged between 18 and 45 years; 2. 18 < BMI < 24; 3. Normal menstrual cycle, with gynecological color ultrasound showing no organic lesions; 4. No abnormalities in physical examinations of heart, liver, kidney, and other functions; 5. Ability to sign an informed consent form; 6. No history of smoking or alcohol consumption, and no special dietary habits.

Exclusion criteria

Exclusion criteria: 1. Inability to confirm adenomyosis (AM) through ultrasound examination; 2. Patients with coexisting uterine fibroids or endometriosis in other locations; 3. Cases where atypical endometrial hyperplasia or malignant tumors cannot be ruled out, or if diagnosed with such conditions, reversal has not been achieved, or follow-up time after reversal is less than 12 months; 4. Contraindications to magnetic resonance-guided focused ultrasound (MRgFUS, or "magnetic wave knife") or dienogest (DNG) treatment; 5. Patients who do not agree to participate in this study; 6. Patients who have continuously taken or used antibiotics, microecological regulators, or other medications affecting gastrointestinal function within the past month; 7. Patients who have participated in other clinical studies within the past 6 months.

Design outcomes

Primary

MeasureTime frame
Pictorial Blood Loss Assessment Chart;Visual Analog Scale;Imaging evaluation (B-ultrasound examination);Microbial spectrum of gut microbiota;

Secondary

MeasureTime frame
Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire;Cancer Antigen 125;hemoglobin;Pregnancy rate;

Countries

China

Contacts

Public ContactPang Zhuochao

Foshan Hospital of Traditional Chinese Medicine

22794618@qq.com+86 198 6617 7134

Outcome results

None listed

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