Changes in Vaginal, Cervical and Uterine Microflora With Levonorgestrel Intrauterine Device Placement

Study Overview
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Brief Summary
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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: Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis. Samples will be collected up to 1 week before and 2 months after IUD insertion. Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to and after LNG IUD placement using human RNA microarray analysis. Samples will be analyzed from up to one day before and three weeks after IUD insertion. Establish a tissue bank of vaginal, cervical and uterine specimens for future research.

Official Title
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Vaginal Microflora and Inflammatory Markers Before and After Levonorgestrel Device Insertion

Conditions
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Cytokine, Metagenome, Human Microbiome, Contraception

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Not currently pregnant No use of hormonal birth control for at least three months prior to enrollment Desiring levonorgestrel IUD for birth control Greater than 6 months postpartum Greater than 6 weeks after miscarriage No antibiotic use in the past 6 weeks Exclusion Criteria: Uterine Abnormalities Current use of hormonal contraceptives or use less than 3 months ago Unexplained vaginal bleeding Irregular menses Cervical dysplasia Cervical or vaginal infection in the last 6 weeks Douching within the week prior to sample collection Use of vaginal lubricants within the week prior to sample collection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal, Microflora, Cervical, Uterine, Inflammation, Cytokine, Intrauterine Device, Levonorgestrel