Intrauterine Insemination In HIV-Discordant Couples (ARTEMIS)

Boston Medical Center (BMC)

Status

Terminated

Conditions

Infertility

HIV-1

Fertility

Treatments

Other: Sperm Washing with Intrauterine Insemination (IUI)

Study type

Interventional

Funder types

Other

Identifiers

NCT01173276

ARTEMIS

Details and patient eligibility

About

This study aims to assess the feasibility of a novel standard of care technique for intrauterine insemination (IUI) in HIV-discordant couples in the United States. This study will involve couples in which the male partner is HIV positive, but the female partner is negative. The investigators will institute a protocol similar to those used presently throughout Europe with good success. To date, no HIV seroconversions have occurred in over 4000 inseminations performed in HIV serodiscordant couples. All male subjects will be on stable HAART, and have undetectable serum viral loads prior to insemination. Semen samples will be subjected to a stringent sperm wash procedure and screened for HIV RNA. Female subjects will be followed post-insemination for seroconversion and pregnancy. Infants will be followed for seroconversion at birth through 4 months of age.

Full description

The investigators will institute a protocol similar to those used presently throughout Europe with good success. To date, no HIV seroconversions have occurred in over 4000 inseminations performed in HIV serodiscordant couples.

All male subjects will be on stable HAART and have undetectable serum viral loads prior to insemination. For semen samples, seminal fluid will be separated from sperm using a density gradient/swim-up separation technique. The purified sperm sample will be washed, and screened for HIV RNA using sensitive real-time RT-PCR. Samples with detectable traces of HIV RNA will not be used for insemination. Samples with no detectable traces of HIV RNA will be used for a standard intrauterine insemination of the female partner.

Female subjects will be followed post-insemination for seroconversion and pregnancy. Infants will be followed for seroconversion at birth through 3 months of age.

The data being collected in this pilot feasibility study will be mostly descriptive, lacking sample size to achieve statistical power for testing. However, the investigators will use case-control analysis to compare couples who achieve pregnancy with those who do not across demographics and markers of HIV disease progression. Additionally, the investigators have developed a 14 item, 5-point Likert scale to assesses the psychosocial impact of reproductive health issues stemming from HIV-discordance in both the female and male participants.

The expected duration for any unique subject couple is 3 to 12 months, depending on pregnancy. It is expected that the interventional portion of this study will continue for up to 2 years, depending on pregnancies.

Enrollment

10 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Couples with HIV discordance with an HIV seronegative female partner and HIV seropositive male partner
Men must be HIV positive with an undetectable viral load (<75 copies/ml)
Men must be clinical stable on antiretroviral therapy for 6 months
Men must have a CD4 count > 250 at screening
Men must be between 18-50 years of age
Men must have a baseline test sperm preparation demonstrating at least 10 million motile sperm per sample
Men must have a letter of medical clearance specific for this procedure from primary care physician stating that subject is in good health and psychologically stable
Men must be willing to have constituent follow-up of HIV care throughout study participation
Women must have an HIV-1/HIV-2 negative serology at screening
Women must be between 18-40 years of age
Women must have a body mass index (BMI) less than 30
Women must be a non-smoker
Women must be ovulatory (as determined by LH tracking)
Women must have normal uterine cavity with at least one documented patent fallopian tube (as determined by hysterosalpingogram)
Women must have adequate day 3 ovarian reserves: FSH,12 mlU/ml and estradiol<80pg/ml
Women must have no evidence of active urogenital infection at screening
Women must have a normal PAP smear and GC/Chlamydia at screening
Women must have a letter of medical clearance specific to this procedure from subject's primary care physician stating that subject is in good health and psychological stable.

Exclusion criteria

Subjects with untreated sexually transmitted diseases (syphilis, GC, CT)
Men with detectable viral load (>75) at screening
Subjects with any condition (including, but not limited to alcohol and drug use), which, in the opinion of the investigator, could compromise the subject's safety or adherence to the protocol
Subjects with any uncontrollable medical or psychiatric condition that,in the opinion of the investigator, cannot be adequately stabilized and could be considered a contraindication to participation