Handmade Frameless Levonorgestrel-Releasing Intrauterine System for Chinese Patients: A Retrospective Self-Controlled Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- IUD Expulsion Rate
研究概览
简要总结
This is a retrospective self-controlled observational study. We evaluated the safety and efficacy of a handmade frameless levonorgestrel-releasing intrauterine system (GyneFix-LNG-IUS) in patients at high risk of IUD expulsion. The device was constructed by combining the GyneFix IUD anchor system and a conventional LNG-IUS with the T-shaped arms removed. All data were collected from routine clinical records. The primary outcome was device expulsion or migration during follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 25-55 years
- •High risk of IUD expulsion, including adenomyosis, uterine cavity enlargement, cervical laxity, or heavy menstrual bleeding
- •Received handmade frameless GyneFix-LNG-IUS placement
- •Complete clinical follow-up data available
排除标准
- •Pregnancy or lactation
- •Severe systemic diseases
- •Contraindications for intrauterine device placement
- •Incomplete follow-up data
研究组 & 干预措施
High-Risk Patients with IUD Expulsion
Patients at high risk of IUD expulsion, including those with adenomyosis, uterine cavity enlargement, cervical laxity, or heavy menstrual bleeding, who received handmade frameless GyneFix-LNG-IUS placement.
干预措施: Handmade Frameless GyneFix-LNG-IUS (Device)
结局指标
主要结局
IUD Expulsion Rate
时间窗: 12 months post-insertion
Rate of GyneFix-LNG-IUS expulsion during follow-up in high-risk patients with adenomyosis, uterine cavity enlargement, or cervical laxity.
次要结局
- Clinical Efficacy(12 months post-insertion)
研究者
Yu Wang
Attending Physician, Department of Obstetrics and Gynecology
The Third People's Hospital of Bengbu