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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07518693

Acronym

Gyne-LNG-IUS

Enrollment

Registered

2026-04-08

Start date

2024-02-01

Completion date

2024-10-31

Last updated

2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

GyneFix-LNG-IUS, Frameless LNG-IUS, IUD expulsion, Adenomyosis, Menorrhagia, Retrospective study

Brief 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.

Interventions

DEVICEHandmade 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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
IUD Expulsion Rate	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.

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026