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

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Cytokine; Contraception; Human Microbiome; Metagenome

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01496898

uufpf 43416

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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