GyneFix IUD Plus LNG-IUS for Adenomyosis

NCT07680985 · ctgov completed

Enrollment: 270
Start: 2023-07-20
Completion: 2025-12-31
Last updated: 2026-07-02
Has results: False
Countries: China

Conditions

Adenomyosis

Tagged with

adenomyosis

Interventions

Indomethacin-GyneFix IUD Plus LNG-IUS DEVICE
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.
Ring IUD Plus LNG-IUS DEVICE
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.
LNG-IUS Alone DEVICE
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.

Eligibility criteria

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.

License: public-domain-us · commercial use OK · attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine