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

April 1, 2026 updated by: Yu Wang

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233000
        • The Third People's Hospital of Bengbu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female patients aged 25-55 years at high risk of intrauterine device (IUD) expulsion, including those with adenomyosis, uterine cavity enlargement, cervical laxity, or heavy menstrual bleeding, who received handmade frameless GyneFix-LNG-IUS placement at The Third People's Hospital of Bengbu.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Severe systemic diseases
  3. Contraindications for intrauterine device placement
  4. Incomplete follow-up data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High-Risk Patients with IUD Expulsion
Patients at high risk of IUD expulsion, including those with adenomyosis, uterine cavity enlargement, cervical laxity, or heavy menstrual bleeding, who received handmade frameless GyneFix-LNG-IUS placement.
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.
Other Names:
  • GyneFix-LNG-IUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IUD Expulsion Rate
Time Frame: 12 months post-insertion
Rate of GyneFix-LNG-IUS expulsion during follow-up in high-risk patients with adenomyosis, uterine cavity enlargement, or cervical laxity.
12 months post-insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Efficacy
Time Frame: 12 months post-insertion
Improvement of dysmenorrhea and abnormal uterine bleeding after GyneFix-LNG-IUS placement, evaluated by patient-reported symptoms and menstrual volume.
12 months post-insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yu Wang

Collaborators

Women's Hospital School Of Medicine Zhejiang University
Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBSYIRB-2024-K55
  • IRB-2024-K55 (Other Identifier: The Third People's Hospital of Bengbu)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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