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

NCT01496898 | Completed DMC

• 1 other identifier: uufpf 43416
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Establish a tissue bank of vaginal, cervical and uterine specimens for future research.

Conditions

Human Microbiome; Metagenome; Contraception; Cytokine

Keywords

Microflora; Vaginal; Cervical; Uterine; Inflammation; Cytokine; Intrauterine Device; Levonorgestrel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inflammatory cytokine changes with levonorgestrel intrauterine device placement

  1 day prior to IUD insertion to 3 weeks after IUD insertion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Caucasian woman aged 18 to 45 seeking intrauterine contraception meeting inclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Bayer: collaborator

Study Sites (1)

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• Jacobson JC, Turok DK, Dermish AI, Nygaard IE, Settles ML. Vaginal microbiome changes with levonorgestrel intrauterine system placement. Contraception. 2014 Aug;90(2):130-5. doi: 10.1016/j.contraception.2014.04.006. Epub 2014 Apr 21.

  PMID: 24835828 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

A total of 648 samples will be collected from 12 participants for bacterial species and human cytokine analysis in 9 collection visits. Specimens will be collected up to one week prior to IUD insertion and two months after IUD insertion. Vaginal and cervical specimens will be collected using FLOQSwabs® (Copan) to maximize bacterial DNA sample collection. Uterine samples will be collected by uterine irrigation with sterile saline using an embryo replacement catheter.

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janet C Jacobson, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2011
• First Posted: December 21, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: July 1, 2013
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

US (1)