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

Completed

• Conditions: Human Microbiome; Metagenome; Contraception; Cytokine

• Registration Number: NCT01496898
• Lead Sponsor: University of Utah

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-08-21
• Primary Completion: 2011-12
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-21
• Study Completion: 2013-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in vaginal, cervical and uterine bacterial species with levonorgestrel intrauterine device placement	1 week prior to IUD insertion to 2 months after IUD insertion	Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis

Secondary Outcome Measures

Name	Time	Method
Inflammatory cytokine changes with levonorgestrel intrauterine device placement	1 day prior to IUD insertion to 3 weeks after IUD insertion	Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to and after LNG IUD placement using human RNA microarray analysis.

Trial Locations

Locations (1)

University of Utah Hospital; 🇺🇸 Salt Lake City, Utah, United States