Status:
TERMINATED
Intrauterine Insemination In HIV-Discordant Couples
Lead Sponsor:
Boston Medical Center
Conditions:
HIV-1
Fertility
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
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 w...
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01173276
Start Date
September 1 2009
End Date
October 1 2013
Last Update
February 22 2016
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118