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NCT07518693Completed

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

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

Source: ClinicalTrials.gov · Last updated 8 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
15 (actual)
First submitted
1 Apr 2026
Start date
1 Feb 2024
Primary completion date
31 Oct 2024
Lead sponsor
Yu Wang
NCT number
NCT07518693

What you commit to

  • Study type: Observational
  • Participants enrolled: 15
  • From 1 Feb 2024 to the primary completion date, 31 Oct 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Severe systemic diseases

Other

  • Pregnancy or lactation
  • Contraindications for intrauterine device placement
  • Incomplete follow-up data

Who the study is looking for

  • 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

Age in the registry: 25 years to 55 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The third people's Hospital of Bengbu
Coordinator of this site? Confirm its status
BengbuChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.