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A randomized controlled trial of hysteroscopic lesion excision combined with LNG-IUS for symptomatic adenomyosis

A randomized controlled trial of hysteroscopic lesion excision combined with LNG-IUS for symptomatic adenomyosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062505
Enrollment
Unknown
Registered
2022-08-10
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Adenomyosis

Interventions

combined group:Hysteroscopic lesion excision combined with LNG-IUS
LNG-IUS group :Intrauterine insertion of LNG-IUS

Sponsors

The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Age 30-50 years; 2. Subtype I, II, IV AM diagnosed by MRI, with dysmenorrhea or/and menorrhagia. 3. No fertility requirement and desire to preserve the uterus. 4. Signed informed consent and can comply with the study procedures.

Exclusion criteria

Exclusion criteria: 1. Contraindication to surgery. 2. Uterine cavity depth of 10 cm or uterine size>12 weeks gestation. 3. Established pregnancy or breastfeeding. 4. Steroid hormone therapy was taken the 3 months before surgery. 5. Atypical hyperplasia of the endometrium. 6. Combined with congenital uterine malformation, such as unicorns uterus, septate uterus, or duplex uterus. 7. Combined cervical dysplasia, acute infection of the pelvis, or acute attack of chronic infection. 8. Suspected or known malignancy or combined benign lesions requiring hysterectomy. 9. History of previous AM lesion resection.

Design outcomes

Primary

MeasureTime frame
VAS of dysmenorrhea;PBAC of menorrhagia;

Secondary

MeasureTime frame
Uterine volume;Serum Ca125;Expulsion rate of LNG-IUS;

Countries

China

Contacts

Public ContactJian Zhang

The International Peace Maternity and Child Health Hospital

ipmch@foxmail.com+86 18017316017

Outcome results

None listed

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