CompletedNot Applicable

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

China15 participantsStarted 2024-02-01

Plain-language 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.

Who can participate

Age range25 Years – 55 Years

SexFEMALE

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Inclusion criteria

✓. Female patients aged 25-55 years
✓. High risk of IUD expulsion, including adenomyosis, uterine cavity enlargement, cervical laxity, or heavy menstrual bleeding
✓. Received handmade frameless GyneFix-LNG-IUS placement
✓. Complete clinical follow-up data available

Exclusion criteria

✕. Pregnancy or lactation
✕. Severe systemic diseases
✕. Contraindications for intrauterine device placement
✕. Incomplete follow-up data

What they're measuring

IUD Expulsion Rate

Timeframe: 12 months post-insertion

Trial details

NCT IDNCT07518693

SponsorYu Wang

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Intrauterine Device Expulsion trials