Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception

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