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Objective: To investigate the effects of levonorgestrel-releasing intrauterine system (LNG-IUS) for symptomatic adenomyosis.
Methods: From December, 2006 to December, 2014, symptomatic patients of adenomyosis diagnosed (with dysmenorrhea and/or menorrhea) by transvaginal ultrasound in outpatient or inpatient clinics of Peking Union Medical College Hospital were given the treatment of LNG-IUS. Before and after placement of LNG-IUS, during each following period, all the parameters were recorded prospectively, including carrying status of IUS, symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation patterns and adverse effects.
Primary outcome measures: symptoms and scores of dysmenorrhea and menorrhea
Second outcome measures: carrying status of IUS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with LNG-IUS | Other | Placement of levonorgestrel-releasing intrauterine system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placement of levonorgestrel-releasing intrauterine system | Procedure | All the patients accepted treatment of levonorgestrel-releasing intrauterine system |
|
| Measure | Description | Time Frame |
|---|---|---|
| improvement of symptoms of adenomyosis assessed by change from baseline visual analogue scale at 5 years after placement of levonorgestrel-releasing intrauterine system | visual analogue scale for pain | 5 years after placement of levonorgestrel-releasing intrauterine system |
| Measure | Description | Time Frame |
|---|---|---|
| unplanned taking-out rate in percent of levonorgestrel-releasing intrauterine system | 5 years after placement of levonorgestrel-releasing intrauterine system | |
| spontaneously expulsion rate in percent of levonorgestrel-releasing intrauterine system | 5 years after placement of levonorgestrel-releasing intrauterine system |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leng Jinghua, MD | Peking Union Medical College Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31194884 | Derived | Li L, Leng J, Jia S, Lang J. Treatment of symptomatic adenomyosis with the levonorgestrel-releasing intrauterine system. Int J Gynaecol Obstet. 2019 Sep;146(3):357-363. doi: 10.1002/ijgo.12887. Epub 2019 Jun 27. |
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IPD will be shared with researchers via online database
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 21, 2017 | |
| Reset | Mar 9, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 21, 2017 | Mar 9, 2017 |
| ID | Term |
|---|---|
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| improvement of symptoms of adenomyosis assessed by verbal rating scales for pain | verbal rating scales for pain | 5 years after placement of levonorgestrel-releasing intrauterine system |
| improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea | hemoglobin for menorrhea | 5 years after placement of levonorgestrel-releasing intrauterine system |
| improvement of symptoms of adenomyosis assessed by pictorial chart scores for menorrhea | visual analogue scale for pain | 5 years after placement of levonorgestrel-releasing intrauterine system |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |