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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The goal of this study is to examine changes in the bacterial ecology and inflammatory markers of the female genital tract with levonorgestrel intrauterine device placement.
The specific research objectives of this project include:
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in vaginal, cervical and uterine bacterial species with levonorgestrel intrauterine device placement | Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis | 1 week prior to IUD insertion to 2 months after IUD insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory cytokine changes with levonorgestrel intrauterine device placement | Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to and after LNG IUD placement using human RNA microarray analysis. | 1 day prior to IUD insertion to 3 weeks after IUD insertion |
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Inclusion Criteria:
Exclusion Criteria:
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Caucasian woman aged 18 to 45 seeking intrauterine contraception meeting inclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Janet C Jacobson, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24835828 | Derived | Jacobson JC, Turok DK, Dermish AI, Nygaard IE, Settles ML. Vaginal microbiome changes with levonorgestrel intrauterine system placement. Contraception. 2014 Aug;90(2):130-5. doi: 10.1016/j.contraception.2014.04.006. Epub 2014 Apr 21. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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A total of 648 samples will be collected from 12 participants for bacterial species and human cytokine analysis in 9 collection visits. Specimens will be collected up to one week prior to IUD insertion and two months after IUD insertion. Vaginal and cervical specimens will be collected using FLOQSwabs® (Copan) to maximize bacterial DNA sample collection. Uterine samples will be collected by uterine irrigation with sterile saline using an embryo replacement catheter.