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

NCT07518693 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

  • Intrauterine Device Expulsion
  • Adenomyosis, Endometriosis
  • Menorrhagia, Dysmenorrhea
  • Abnormal Uterine Bleeding

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.

Sponsors & Collaborators

  • Zhejiang University

    collaborator OTHER

  • Women's Hospital School Of Medicine Zhejiang University

    collaborator OTHER

  • Yu Wang

    lead OTHER_GOV

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07518693 on ClinicalTrials.gov