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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-2024-K55 | Other Identifier | The Third People's Hospital of Bengbu |
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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
| Women's Hospital School Of Medicine Zhejiang University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Handmade Frameless GyneFix-LNG-IUS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| IUD Expulsion Rate | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Efficacy | Improvement of dysmenorrhea and abnormal uterine bleeding after GyneFix-LNG-IUS placement, evaluated by patient-reported symptoms and menstrual volume. | 12 months post-insertion |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third People's Hospital of Bengbu | Bengbu | Anhui | 233000 | China |
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| ID | Term |
|---|---|
| D062788 | Adenomyosis |
| D004715 | Endometriosis |
| D008595 | Menorrhagia |
| D004412 | Dysmenorrhea |
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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