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

Yu Wang15 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

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.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

IUD Expulsion Rate

Rate of GyneFix-LNG-IUS expulsion during follow-up in high-risk patients with adenomyosis, uterine cavity enlargement, or cervical laxity.

Time frame: 12 months post-insertion

Secondary Outcomes

Clinical Efficacy

Improvement of dysmenorrhea and abnormal uterine bleeding after GyneFix-LNG-IUS placement, evaluated by patient-reported symptoms and menstrual volume.