Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception (CHIC)
|ClinicalTrials.gov Identifier: NCT01240811|
Recruitment Status : Completed
First Posted : November 15, 2010
Results First Posted : July 22, 2013
Last Update Posted : December 26, 2017
This pilot study is being performed to investigate the influence that starting contraception with an IUD has on the local immune cell populations and features, with a particular focus on the cells and cell-surface features that are important in HIV transmission (CD4 cells and CCR5 cell receptors).
Based on results from large epidemiologic studies there seems to be a consistent finding of slightly increased HIV acquisition in women who use hormonal contraception. It is not clear if this is due to a biological phenomenon or if it relates to a difference in sexual behaviors/risks of women on hormonal contraceptives.
The study hypothesis is that CD4 cells and CCR5 HIV-tropic receptor density increases within the upper and lower genital tract of women 2 months after placement of progestin-containing intrauterine devices for contraception as compared with women not using hormonal contraception.
|Condition or disease||Intervention/treatment||Phase|
|Genital Tract Mucosal Immunity Genital Tract Microflora||Drug: IUD placement Drug: Levonorgestrel IUD Drug: Copper T380A IUD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Impact of Intrauterine Contraception on the Immune Environment of the Female Genital Tract|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
No Intervention: Control-No IUD
Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
Experimental: Levonorgestrel IUS
Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
Drug: IUD placement
Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).Drug: Levonorgestrel IUD
Other Name: Mirena IUD
Experimental: Copper T380A IUD
Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
Drug: IUD placement
Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).Drug: Copper T380A IUD
Other Name: ParaGard IUD
- %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium [ Time Frame: 2 months ]Change in CCR5 expression on T-lymphocytes 2 months after insertion of IUD (either hormonal LNG-IUD or non-hormonal Cu-IUD) in cervix and endometrium as measured by flow cytomety
- Change in Vaginal Flora [ Time Frame: 2 Months ]Changes in vaginal flora as assessed by Nugent score The Nugent score is calculated by microscopically assessing for the presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0 to 4), and curved Gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2) and can range from 0 to 10. A score of 7 to 10 is consistent with bacterial vaginosis, 4-6 is consistent with intermediate vaginal flora, and 0-3 is normal vaginal flora.
- Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis [ Time Frame: 2 Months ]Changes in vaginal flora as assessed by qPCR quantitation of H2O2 producing Lactobacilli species and Gardnerella vaginalis. Quantitative PCR (qPCR) results are reported as log concentration of gene copies/swab specimen.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240811
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Sharon Achilles, MD, PhD||University of Pittsburgh|