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Hysteroscopic resection in combination with LNG-IUS versus hysteroscopic resection alone in the treatment of symptomatic adenomyosis: a randomized controlled study

Hysteroscopic resection in combination with LNG-IUS versus hysteroscopic resection alone in the treatment of symptomatic adenomyosis: a randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108183
Enrollment
Unknown
Registered
2025-08-26
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Adenomyosis

Interventions

Hysteroscopic resection combined with LNG-IUS placement group:Hysteroscopic resection combined with LNG-IUS

Sponsors

China Welfare Institute International Peace Maternal and Child Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Premenopausal women aged 18-50 years; 2. No desire for future fertility and willing to preserve the uterus; 3. MRI-confirmed diagnosis of adenomyosis (junctional zone thickness >12 mm; if 8-12 mm, must meet at least one additional criterion: junctional zone/myometrial thickness ratio >40%, anterior-posterior junctional zone thickness difference >5 mm, or ill-defined junctional zone boundaries/high-signal foci on T1/T2 sequences); 4. With symptom of Menorrhagia (menstrual blood loss visual analogue scale [MVJ] >=5); 5. With or without dysmenorrhea (visual analogue scale [VAS] >0); 6. Uterine cavity depth <10 cm; 7. Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Malignant tumors; 2. Concomitant benign diseases requiring hysterectomy; 3. Endometrial atypical hyperplasia; 4. Pregnancy or lactation period; 5. Use of steroid hormones or GnRh-a within 3 months prior to enrollment ; 6. Any contraindications to hysteroscopic surgery or LNG-IUS placement, including: (1) Current or recurrent pelvic inflammatory disease; (2) Lower reproductive tract infections; (3) Congenital or acquired uterine abnormalities (including uterine tumors causing uterine cavity deformation); (4) Progesterone-dependent tumors (reproductive tract or breast tumors); (5) Allergy to active ingredients or excipients; 7. Previous hysteroscopic adenomyosis lesion resection; 8. Chronic use of analgesics due to underlying conditions; 9. Inability to comply with study procedures (e.g., language barriers, psychiatric disorders, inability to attend follow-ups, poor compliance); 10. Severe concurrent medical or surgical conditions; 11. Coexisting deep infiltrating endometriosis.

Design outcomes

Primary

MeasureTime frame
MVJ Score;

Secondary

MeasureTime frame
Patient satisfaction with treatment;Side effects;Uterine volume;MVJ Score;Serum CA125?CA199;VAS score of Dysmenorrhea;

Countries

China

Contacts

Public ContactJian Zhang

China Welfare Institute International Peace Maternal and Child Health Care Hospital

ipmch@foxmail.com+86 21 64070434

Outcome results

None listed

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