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Efficacy of GyneFix combined anchoring in reducing expulsion of levonorgestrel-releasing intrauterine system in patients with adenomyosis: a prospective cohort study

Efficacy of GyneFix combined anchoring in reducing expulsion of levonorgestrel-releasing intrauterine system in patients with adenomyosis: a prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077919
Enrollment
Unknown
Registered
2023-11-23
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

adenomyosis

Interventions

Exposure group: Clinical placement of Ginkgo ring combined with anchoring of Manyule in women
Non exposure group: Clinical routine placement of meniscus in women:NA

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 49 Years

Inclusion criteria

Inclusion criteria: ?20-49 years old female, sexual life history, no fertility requirements within 1 year. ? Moderate to severe dysmenorrhea, VAS=4 points and/or bleeding score =100 points. ?Ultrasound or MRI were consistent with the diagnostic criteria for adenomyosis of uterus. ? Refusal of hysterectomy, placement of Mirena or Gini ring combined with Mirena long-term management. ? The patient agrees to join the clinical study, sign the informed consent voluntarily, and agree to participate in all visits, examinations, and treatments according to the requirements of the research protocol.

Exclusion criteria

Exclusion criteria: ? Severe coagulation dysfunction: Coagulation dysfunction criteria: International standardized ratio (INR) =1.5, or prothrombin activity is less than 40%. ? Subjects are unable or unwilling to complete the study procedure.

Design outcomes

Primary

MeasureTime frame
The levonorgestrel-releasing intrauterine system expulsion;

Secondary

MeasureTime frame
Visual Analogue Scale/Score ,VAS);Pictorial blood loss assessment chart,PBAC;Uterine volume and hemoglobin level;

Countries

China

Contacts

Public ContactQicai Hu

Peking University Shenzhen Hospital

aa13255599860@126.com+86 182 0767 9259

Outcome results

None listed

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