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NCT07518693

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

Sponsor: Yu Wang

View on ClinicalTrials.gov

Summary

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.

Official title: Handmade Frameless Levonorgestrel-Releasing Intrauterine System for Chinese Patients: A Retrospective Self-Controlled Observational Study

Key Details

Gender

FEMALE

Age Range

25 Years - 55 Years

Study Type

OBSERVATIONAL

Enrollment

15

Start Date

2024-02-01

Completion Date

2024-10-31

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DEVICE

Handmade Frameless GyneFix-LNG-IUS

A handmade frameless levonorgestrel-releasing intrauterine system, constructed by combining the GyneFix IUD anchor system and a conventional LNG-IUS with the T-shaped arms removed, for placement in high-risk patients to reduce IUD expulsion.

Locations (1)

The Third People's Hospital of Bengbu

Bengbu, Anhui, China