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

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.

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Key information

Conditions

Human Microbiome Contraception Cytokine Inflammation Metagenome Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Changes in vaginal, cervical and uterine bacterial species with levonorgestrel intrauterine device placement

Time frame: 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 outcomes

Inflammatory cytokine changes with levonorgestrel intrauterine device placement

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

Bayer

Registry information

Official study title

Vaginal Microflora and Inflammatory Markers Before and After Levonorgestrel Device Insertion

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2013
First posted: Dec 21, 2011
Registry last updated: Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed