Intrauterine Insemination In HIV-Discordant Couples

• Register: ClinicalTrials.gov
• Last refreshed on: 14 March 2016
• Main ID: NCT01173276
• Date of registration: 28/07/2010
• Prospective Registration: No
• Primary sponsor: Boston Medical Center
• Public title: Intrauterine Insemination In HIV-Discordant Couples ARTEMIS
• Scientific title: Intrauterine Insemination In HIV-Discordant Couples
• Date of first enrolment: September 2009
• Target sample size: 10
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01173276
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Margaret M Sullivan, MD
• Affiliation: Boston Medical Center

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV-1

Infertility

Fertility

Intervention(s)

Other: Sperm Washing with Intrauterine Insemination (IUI)

Primary Outcome(s)

Pregnancy [Time Frame: Sixteen days after IUI]

Secondary Outcome(s)

Female Subject HIV-1/HIV-2 Serology [Time Frame: Three, six, nine (pregnant only) and twelve months after insemination]

Infant HIV-1/HIV-2 Serology [Time Frame: Three months of age]

Post-IUI HIV Infection of Female Subject [Time Frame: Four weeks after IUI]

Secondary ID(s)

ARTEMIS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors