- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01240811
Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception (CHIC)
Impact of Intrauterine Contraception on the Immune Environment of the Female Genital Tract
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Non-pregnant, healthy females who are seeking an IUD for contraception
- Age 18-40 years, inclusive at the time of enrollment
- History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days
- Willing and able to sign the informed consent and to comply with the study protocol
Inclusion criteria for healthy control subjects:
- Non-pregnant, healthy females
- Age 18-40 years, inclusive at the time of enrollment
- History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days
- Willing and able to sign the informed consent and to comply with the study protocol
- Prior surgical sterilization or heterosexually abstinent
Exclusion Criteria:
- Use of any hormonal or intrauterine contraceptive method within the past two months
- Use of DMPA within the past 10 months
Any of the following within the past two months:
- Pregnancy or breastfeeding
- Surgery/biopsy of the vulva, vagina, or cervix
- History of STI
- New sexual partner
Evidence of vaginal/pelvic infection on screening
- Abnormal wet mount (see description above)
- Pelvic exam findings clinically consistent with infection
- Positive screen for Gc, Ct, or HIV (will be excluded post randomization)
- Active HSV/ulcerative disease in the genital tract or perineum
- History of immunosuppression (diabetes, HIV, chronic steroid use)
- Use of vaginal product (N9, microbicide, douche, antifungal, steroid, or hormone) within the past 30 days
- Use of any systemic or vaginal steroid or antibiotic within the past 30 days
- Vaginal or anal intercourse within 1 week of sample collection
- Heterosexual vaginal intercourse since last menses without condom use
- History of hysterectomy
- History of malignancy in the uterus or cervix
- Uterine anomaly (bicornuate uterus, uterine septum, or uterine didelphys)
- Allergy to copper and/or intolerance to levonorgestrel
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Other Names:
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).
|
EXPERIMENTAL: Copper T380A IUD
Healthy volunteers seeking contraception with IUD.
Randomized to Copper T380A IUD.
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
%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
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 Months
|
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.
|
2 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sharon Achilles, MD, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO09100199
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Genital Tract Mucosal Immunity
-
John SundyCompleted
-
National Institute of Allergy and Infectious Diseases...RecruitingBlood Specimen Collection | Immunity, Mucosal | Immune System ProcessesUnited States
-
Peking University People's HospitalNingde City Hospital, Fujian, ChinaUnknownPulmonary Disease, Chronic Obstructive | Microbiota | Metabolism | Immunity, MucosalChina
-
National Cancer Institute (NCI)RecruitingMucosal Melanoma | Anal Melanoma | Bladder Melanoma | Cervical Melanoma | Esophageal Melanoma | Gallbladder Melanoma | Mucosal Melanoma of the Head and Neck | Mucosal Melanoma of the Urinary System | Oral Cavity Mucosal Melanoma | Penile Mucosal Melanoma | Rectal Melanoma | Recurrent Mucosal Melanoma | Sinonasal... and other conditionsUnited States, Canada
-
ATGen Canada IncTerminatedProstatic Neoplasm | Immunity, InnateCanada
-
University of California, Los AngelesAdvarraCompleted
-
Brugmann University HospitalCompleted
-
Shenzhen Precision Health Food Technology Co. Ltd...Recruiting
-
Shenzhen People's HospitalNot yet recruitingEndometriosis | NK Cell Mediated ImmunityChina
-
University Hospital, GenevaModernaTX, Inc.; University of Geneva, SwitzerlandActive, not recruitingSARS-CoV-2 Infection | RSV Infection | Influenza Viral Infections | Virus Shedding | Mucosal ImmunitySwitzerland
Clinical Trials on Levonorgestrel IUD
-
University of UtahCompleted
-
University of UtahCompletedEmergency ContraceptionUnited States
-
Mahidol UniversityCompletedEndometriosis | Dysmenorrhea | Pelvic PainThailand
-
Northwestern UniversitySociety of Family PlanningCompletedGlucose Intolerance | Type 2 Diabetes | Gestational Diabetes | Intrauterine ContraceptionUnited States
-
University of UtahCompleted
-
BayerCompleted
-
Tulane University School of MedicineTerminatedContraceptionUnited States
-
University of UtahEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedPregnancyUnited States
-
Center for Epidemiology and Health Research, GermanyBayerCompletedBreast CancerGermany
-
University of PittsburghCompleted