GyneFix IUD Plus LNG-IUS for Adenomyosis

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.

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.