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GyneFix IUD Plus LNG-IUS for Adenomyosis (GYNEFIX-AM)

2026년 6월 26일 업데이트: Peipei Li, Wenzhou People's Hospital

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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

270

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 중국
    • Zhejiang
      • Wenzhou, Zhejiang, 중국, 325000
        • Wenzhou People's Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
장치: Indomethacin-GyneFix IUD Plus LNG-IUS
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.
다른 이름들:
  • GyneFix IUD Plus LNG-IUS
  • GyneFix IUD Combined With LNG-IUS
  • Mirena Plus GyneFix IUD
활성 비교기: 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.
장치: Ring IUD Plus LNG-IUS
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.
다른 이름들:
  • Ring IUD Combined With LNG-IUS
  • LNG-IUS Plus Ring IUD
  • Support-Based IUD Fixation
활성 비교기: 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.
장치: LNG-IUS Alone
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.
다른 이름들:
  • 미레나
  • 레보노르게스트렐 방출 자궁내 시스템
  • LNG-IUS

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Device Displacement or Expulsion Rate at 6 Months
기간: 6 months after device placement
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.
6 months after device placement

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Dysmenorrhea VAS Score
기간: Baseline, 1 month, 3 months, and 6 months after device placement
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.
Baseline, 1 month, 3 months, and 6 months after device placement
Change From Baseline in PBAC Score
기간: Baseline, 1 month, 3 months, and 6 months after device placement
Change in menstrual blood loss measured by the pictorial blood loss assessment chart. Higher PBAC scores indicate greater menstrual blood loss.
Baseline, 1 month, 3 months, and 6 months after device placement
Change From Baseline in Uterine Volume
기간: Baseline, 3 months, and 6 months after device placement
Change in uterine volume measured by gynecological ultrasound. Uterine volume was calculated using three-dimensional uterine measurements.
Baseline, 3 months, and 6 months after device placement
Change From Baseline in Hemoglobin Level
기간: Baseline, 3 months, and 6 months after device placement
Change in hemoglobin level measured from venous blood samples to evaluate improvement in anemia associated with heavy menstrual bleeding.
Baseline, 3 months, and 6 months after device placement
Change From Baseline in Serum CA125 Level
기간: Baseline, 3 months, and 6 months after device placement
Change in serum cancer antigen 125 level measured by laboratory testing. CA125 was used as an indirect marker of adenomyosis disease activity.
Baseline, 3 months, and 6 months after device placement
Incidence of Adverse Events
기간: Up to 6 months after device placement
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.
Up to 6 months after device placement
Treatment Acceptance at 6 Months
기간: 6 months after device placement
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.
6 months after device placement

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Wenzhou People's Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 7월 20일

기본 완료 (실제)

2025년 12월 30일

연구 완료 (실제)

2025년 12월 31일

연구 등록 날짜

최초 제출

2026년 6월 26일

QC 기준을 충족하는 최초 제출

2026년 6월 26일

처음 게시됨 (실제)

2026년 7월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 26일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • WPH-KY-2023-200

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

De-identified individual participant data underlying the results reported in this study may be made available from the corresponding author upon reasonable request, after publication and subject to approval by the study investigators and applicable institutional requirements.

IPD 공유 기간

Beginning after publication with no fixed end date.

IPD 공유 액세스 기준

Researchers with a scientifically sound proposal may request access to de-identified data. Requests will be reviewed by the corresponding author and study investigators, and data sharing will be subject to ethics, privacy, and institutional requirements.

IPD 공유 지원 정보 유형

  • 연구_프로토콜

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Indomethacin-GyneFix IUD Plus LNG-IUS에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Switzerland

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다