GyneFix IUD Plus LNG-IUS for Adenomyosis (GYNEFIX-AM)
Clinical Efficacy and Safety of Indomethacin-GyneFix IUD Combined With a Levonorgestrel-Releasing Intrauterine System in Patients With Adenomyosis and Different Uterine Cavity Depths
Adenomyosis is a common gynecological condition that can cause menstrual pain, heavy menstrual bleeding, anemia, and reduced quality of life. The levonorgestrel-releasing intrauterine system is commonly used as a conservative treatment, but displacement or expulsion of the device may occur, especially in patients with an enlarged uterus or a deep uterine cavity.
This study evaluated whether combining an Indomethacin-GyneFix intrauterine device with a levonorgestrel-releasing intrauterine system could improve device stability in patients with adenomyosis. Eligible participants were randomly assigned to receive GyneFix IUD plus LNG-IUS, ring IUD plus LNG-IUS, or LNG-IUS alone. Participants were followed for 6 months after device placement. The main outcome was device displacement or expulsion at 6 months. Other outcomes included menstrual pain, menstrual blood loss, uterine volume, hemoglobin, CA125, adverse events, and treatment acceptance.
研究概览
地位
条件
详细说明
This was a single-center, prospective, parallel-group, randomized controlled trial conducted at Wenzhou People's Hospital in patients with adenomyosis. The study was designed to compare three intrauterine treatment strategies for improving the stability of a levonorgestrel-releasing intrauterine system in patients with different uterine cavity depths.
Eligible patients were women diagnosed with adenomyosis who had no current desire for pregnancy, had no contraindications to intrauterine device placement, and were able to complete scheduled follow-up. After written informed consent was obtained, participants were randomly assigned in a 1:1:1 ratio to one of three groups: GyneFix IUD plus LNG-IUS, ring IUD plus LNG-IUS, or LNG-IUS alone.
In the GyneFix IUD plus LNG-IUS group, the Indomethacin-GyneFix IUD was used as an anchoring device to stabilize the LNG-IUS. The anchoring knot of the GyneFix IUD was placed in the uterine fundal myometrium under ultrasound guidance, allowing the LNG-IUS to remain suspended and stabilized within the uterine cavity. In the ring IUD plus LNG-IUS group, a ring IUD was placed together with the LNG-IUS to provide passive mechanical support. In the LNG-IUS-alone group, the LNG-IUS was inserted according to the standard procedure.
All procedures were performed under real-time ultrasound guidance by experienced gynecologists. Participants were followed at approximately 1 month, 3 months, and 6 months after device placement. Follow-up assessments included symptom evaluation, gynecological examination, ultrasound assessment of device position and uterine parameters, laboratory testing, adverse event monitoring, and treatment acceptance assessment.
The primary outcome was intrauterine device displacement or expulsion at 6 months. Secondary outcomes included changes in dysmenorrhea measured by visual analogue scale, menstrual blood loss measured by pictorial blood loss assessment chart, uterine volume, hemoglobin, serum CA125, adverse events, and patient acceptance. A subgroup analysis was planned according to uterine cavity depth.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Zhejiang
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Wenzhou、Zhejiang、中国、325000
- Wenzhou People's Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Female patients aged 20 to 55 years.
- Diagnosed with adenomyosis by transvaginal ultrasound.
- No current desire for pregnancy and willing to receive conservative intrauterine treatment.
- No contraindications to intrauterine device placement.
- Able to understand the study procedures and voluntarily provide written informed consent.
- Able and willing to comply with scheduled follow-up visits and study assessments.
Exclusion Criteria:
- Pregnancy or suspected pregnancy.
- Concurrent malignant tumor of the reproductive system.
- Severe cervical lesions or uterine malformations.
- Severe coagulation disorder.
- Severe hepatic or renal insufficiency.
- Known hypersensitivity to levonorgestrel, copper, indomethacin, or related device components.
- Uncontrolled pelvic inflammatory disease or untreated vaginal infection.
- Uterine prolapse grade II or higher.
- Any condition judged by the investigator to make intrauterine device placement unsuitable.
- Inability to complete follow-up or incomplete key clinical data.
- Withdrawal of consent during the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：GyneFix IUD Plus LNG-IUS
Participants received Indomethacin-GyneFix IUD combined with a levonorgestrel-releasing intrauterine system.
The GyneFix IUD was used as an anchoring device to stabilize the LNG-IUS.
Under real-time ultrasound guidance, the anchoring knot of the GyneFix IUD was implanted into the uterine fundal myometrium, allowing the LNG-IUS to remain suspended and stabilized within the uterine cavity.
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The Indomethacin-GyneFix IUD was used as an anchoring device to stabilize the levonorgestrel-releasing intrauterine system.
The LNG-IUS was connected to the upper portion of the GyneFix IUD with non-absorbable surgical suture.
Under real-time ultrasound guidance, the anchoring knot of the GyneFix IUD was implanted into the uterine fundal myometrium, allowing the LNG-IUS to remain suspended and stabilized within the uterine cavity.
其他名称：
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有源比较器：Ring IUD Plus LNG-IUS
Participants received a ring IUD combined with a levonorgestrel-releasing intrauterine system.
The ring IUD and LNG-IUS were sequentially inserted into the uterine cavity under ultrasound guidance.
The ring IUD was positioned near the upper uterine cavity or fundal region to provide passive mechanical support for the LNG-IUS.
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The ring IUD and the levonorgestrel-releasing intrauterine system were sequentially inserted into the uterine cavity under real-time ultrasound guidance.
The ring IUD was positioned near the upper uterine cavity or fundal region to provide passive mechanical support for the LNG-IUS.
The LNG-IUS was then released in the conventional manner with its transverse arms extended.
其他名称：
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有源比较器：LNG-IUS Alone
Participants received LNG-IUS alone.
The levonorgestrel-releasing intrauterine system was inserted according to the standard procedure under ultrasound guidance, with the transverse arms fully extended and the device positioned at the uterine fundus.
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The levonorgestrel-releasing intrauterine system was inserted according to the standard procedure under real-time ultrasound guidance.
Correct placement required full extension of the transverse arms and positioning of the device at the uterine fundus.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Device Displacement or Expulsion Rate at 6 Months
大体时间：6 months after device placement
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The proportion of participants with intrauterine device displacement or expulsion at 6 months after device placement.
Device displacement or expulsion was assessed by gynecological examination and ultrasound evaluation according to predefined criteria for intrauterine device position.
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6 months after device placement
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Dysmenorrhea VAS Score
大体时间：Baseline, 1 month, 3 months, and 6 months after device placement
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Change in dysmenorrhea severity measured by the visual analogue scale.
The VAS score ranges from 0 to 10, with higher scores indicating more severe pain.
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Baseline, 1 month, 3 months, and 6 months after device placement
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Change From Baseline in PBAC Score
大体时间：Baseline, 1 month, 3 months, and 6 months after device placement
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Change in menstrual blood loss measured by the pictorial blood loss assessment chart.
Higher PBAC scores indicate greater menstrual blood loss.
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Baseline, 1 month, 3 months, and 6 months after device placement
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Change From Baseline in Uterine Volume
大体时间：Baseline, 3 months, and 6 months after device placement
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Change in uterine volume measured by gynecological ultrasound.
Uterine volume was calculated using three-dimensional uterine measurements.
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Baseline, 3 months, and 6 months after device placement
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Change From Baseline in Hemoglobin Level
大体时间：Baseline, 3 months, and 6 months after device placement
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Change in hemoglobin level measured from venous blood samples to evaluate improvement in anemia associated with heavy menstrual bleeding.
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Baseline, 3 months, and 6 months after device placement
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Change From Baseline in Serum CA125 Level
大体时间：Baseline, 3 months, and 6 months after device placement
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Change in serum cancer antigen 125 level measured by laboratory testing.
CA125 was used as an indirect marker of adenomyosis disease activity.
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Baseline, 3 months, and 6 months after device placement
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Incidence of Adverse Events
大体时间：Up to 6 months after device placement
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Incidence of adverse events during follow-up, including irregular vaginal bleeding, low back pain, lower abdominal discomfort, increased vaginal discharge, pelvic inflammatory disease, ovarian cysts, breast tenderness, acne, weight gain, device removal for symptoms, uterine perforation, device displacement, and device expulsion.
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Up to 6 months after device placement
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Treatment Acceptance at 6 Months
大体时间：6 months after device placement
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Treatment acceptance assessed by questionnaire at 6 months, including willingness to choose the same treatment again and willingness to recommend the treatment to others with similar conditions.
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6 months after device placement
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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其他研究编号
- WPH-KY-2023-200
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