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

NCT07518693 — Completed, 15 participants, Yu Wang

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

Registry	NCT07518693, acronym Gyne-LNG-IUS
Status	Completed
Study type	Observational
Enrollment	15 (Actual)
Sponsor	Yu Wang (Other gov); collaborators: Zhejiang University, Women's Hospital School Of Medicine Zhejiang University
Conditions	Intrauterine Device Expulsion, Adenomyosis, Endometriosis, Menorrhagia, Dysmenorrhea, Abnormal Uterine Bleeding
Interventions	Handmade Frameless GyneFix-LNG-IUS (Device)
Dates	start 2024-02-01, primary completion 2024-10-31, completion 2024-10-31, first posted 2026-04-08, last updated 2026-04-08
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
High-Risk Patients with IUD Expulsion		Device: Handmade Frameless GyneFix-LNG-IUS	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.

Handmade Frameless GyneFix-LNG-IUS (Device), also known as 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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: Female, ages: 25 Years to 55 Years

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

+Locations (1)

Facility	City	Country	Status
The Third People's Hospital of Bengbu	Bengbu, Anhui	China