Changes in Vaginal, Cervical and Uterine Microflora With Levonorgestrel Intrauterine Device Placement
| Status: | Completed |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | January 2011 |
| End Date: | July 2013 |
Vaginal Microflora and Inflammatory Markers Before and After Levonorgestrel Device Insertion
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:
1. 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.
2. 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.
3. Establish a tissue bank of vaginal, cervical and uterine specimens for future research.
markers of the female genital tract with levonorgestrel intrauterine device placement.
The specific research objectives of this project include:
1. 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.
2. 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.
3. Establish a tissue bank of vaginal, cervical and uterine specimens for future research.
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
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