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Optimization of surgical procedures and technical innovations for mitigating uterine injury_Substudy 1: A multicenter clinical study of uterine reconstruction and fertility protection in PUSH surgery for diffuse uterine lesions

Optimization of surgical procedures and technical innovations for mitigating uterine injury_Substudy 1: A multicenter clinical study of uterine reconstruction and fertility protection in PUSH surgery for diffuse uterine lesions

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102323
Enrollment
Unknown
Registered
2025-05-13
Start date
2025-05-20
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Diffuse adenomyosis (DAD) and diffuse uterine leiomyomatosis (DUL)

Interventions

Diffuse uterine myomatosis group:NA
DAD group with intramuscular lesions:NA
DAD group with external muscle layer lesions:NA

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. disease severity: (1) clinical symptoms: severe dysmenorrhea, visual blur score >= 7, requiring analgesic drugs; (2) Degree of lesion: uterus with diffuse adenomyosis >= 70 days of gestation (volume>100cm^3), and the lesion involved more than 80% of the anterior and/or posterior myometrium, or the myometrium thickened by more than 6cm. 2. age and infertility history: (1) age 20-45 years old, married, with fertility requirements; (2) Infertility for more than 2 years, has tried various assisted pregnancy techniques without success; (3) Ovarian reserve function is normal (Note: AMH >= 1.09 is included in fertility assessment, and AMH decline can be included but fertility analysis is not conducted), and it is not complicated with uterine malformation, intrauterine model damage adhesion syndrome and other uterine infertility. 3. meet the above inclusion criteria, and voluntarily accept push surgery without contraindications.

Exclusion criteria

Exclusion criteria: 1. suffering from severe internal and external diseases, unable to tolerate surgery, in any acute stage of systemic inflammation, pregnancy, lactation or accompanied by malignant tumors; 2. none of the above inclusion criteria is included in the study.

Design outcomes

Primary

MeasureTime frame
Intravenous hysterography;

Secondary

MeasureTime frame
Dysmenorrhea;Tumor indicators;

Countries

China

Contacts

Public ContactChangzhong Li

Peking University Shenzhen Hospital

15168888909@163.com+86 15168888909

Outcome results

None listed

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