Clinical Observation of Hysteroscopy-Assisted Placement of Handmade Frameless GyneFix-LNG-IUS (Retrospective Cohort)

This is a retrospective self-controlled observational study. We evaluated the safety and efficacy of a handmade frameless levonorgestrel-releasing intrauterine system (GyneFix-LNG-IUS) in patients at high risk of IUD expulsion. The device was constructed by combining the GyneFix IUD anchor system and a conventional LNG-IUS with the T-shaped arms removed. All data were collected from routine clinical records. The primary outcome was device expulsion or migration during follow-up.

NCT Number	NCT07518693
Lead Sponsor	Yu Wang Collaborators: Zhejiang University, Women's Hospital School Of Medicine Zhejiang University
Conditions	Intrauterine Device Expulsion, Adenomyosis, Endometriosis, Menorrhagia, Dysmenorrhea, Abnormal Uterine Bleeding
Enrollment	15 participants
Start Date	2024-02-01
Primary Completion	2024-10-31 (estimated)
Study Completion	2024-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-08