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

26 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

270

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Altri nomi:
  • GyneFix IUD Plus LNG-IUS
  • GyneFix IUD Combined With LNG-IUS
  • Mirena Plus GyneFix IUD
Comparatore attivo: 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.
Dispositivo: 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.
Altri nomi:
  • Ring IUD Combined With LNG-IUS
  • LNG-IUS Plus Ring IUD
  • Support-Based IUD Fixation
Comparatore attivo: 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.
Dispositivo: 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.
Altri nomi:
  • Mirena
  • Sistema intrauterino a rilascio di levonorgestrel
  • GNL-IUS

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Device Displacement or Expulsion Rate at 6 Months
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Dysmenorrhea VAS Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Wenzhou People's Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 luglio 2023

Completamento primario (Effettivo)

30 dicembre 2025

Completamento dello studio (Effettivo)

31 dicembre 2025

Date di iscrizione allo studio

Primo inviato

26 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 giugno 2026

Primo Inserito (Effettivo)

2 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • WPH-KY-2023-200

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

Beginning after publication with no fixed end date.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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