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

26 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

270

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.
Autres noms:
  • GyneFix IUD Plus LNG-IUS
  • GyneFix IUD Combined With LNG-IUS
  • Mirena Plus GyneFix IUD
Comparateur actif: 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.
Dispositif: 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.
Autres noms:
  • Ring IUD Combined With LNG-IUS
  • LNG-IUS Plus Ring IUD
  • Support-Based IUD Fixation
Comparateur actif: 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.
Dispositif: 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.
Autres noms:
  • Miréna
  • Système intra-utérin libérant du lévonorgestrel
  • SIU-LNG

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Device Displacement or Expulsion Rate at 6 Months
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change From Baseline in Dysmenorrhea VAS Score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Wenzhou People's Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

20 juillet 2023

Achèvement primaire (Réel)

30 décembre 2025

Achèvement de l'étude (Réel)

31 décembre 2025

Dates d'inscription aux études

Première soumission

26 juin 2026

Première soumission répondant aux critères de contrôle qualité

26 juin 2026

Première publication (Réel)

2 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • WPH-KY-2023-200

Plan pour les données individuelles des participants (IPD)

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OUI

Description du régime 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.

Délai de partage IPD

Beginning after publication with no fixed end date.

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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