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GyneFix IUD Plus LNG-IUS for Adenomyosis
Sponsor: Wenzhou People's Hospital
Summary
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.
Official title: Clinical Efficacy and Safety of Indomethacin-GyneFix IUD Combined With a Levonorgestrel-Releasing Intrauterine System in Patients With Adenomyosis and Different Uterine Cavity Depths
Key Details
Gender
FEMALE
Age Range
20 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2023-07-20
Completion Date
2025-12-31
Last Updated
2026-07-02
Healthy Volunteers
No
Conditions
Interventions
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.
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.
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.
Locations (1)
Wenzhou People's Hospital
Wenzhou, Zhejiang, China