Intrauterine Insemination In HIV-Discordant Couples (ARTEMIS)
|ClinicalTrials.gov Identifier: NCT01173276|
Recruitment Status : Terminated (The field has changed, and we have decided to develop a PrEP program.)
First Posted : August 2, 2010
Last Update Posted : February 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV-1 Fertility Infertility||Other: Sperm Washing with Intrauterine Insemination (IUI)||Not Applicable|
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. 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intrauterine Insemination In HIV-Discordant Couples|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||October 2013|
- Other: Sperm Washing with Intrauterine Insemination (IUI)
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.
- Pregnancy [ Time Frame: Sixteen days after IUI ]A serum pregnancy test will be performed 16 days after IUI if menses is missed.
- Post-IUI HIV Infection of Female Subject [ Time Frame: Four weeks after IUI ]The female subject will be tested for HIV by branch-DNA (b-DNA) test four weeks after each insemination.
- Female Subject HIV-1/HIV-2 Serology [ Time Frame: Three, six, nine (pregnant only) and twelve months after insemination ]If the female subject does not become pregnant, she will be tested for HIV-1/HIV-2 serology at 3 months, 6 months and 12 months after the insemination. If repeat inseminations are performed, the above-stated timeline will be followed based on the last insemination performed. If the female subject does become pregnant, she will be tested for HIV-1/HIV-2 serology at 3 months, 6 months and 9 months after the insemination, and again at 3 months postpartum.
- Infant HIV-1/HIV-2 Serology [ Time Frame: Three months of age ]For a successful birth, the infant will undergo an HIV-1/HIV-2 serology test at three months of age.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173276
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Margaret M Sullivan, MD||Boston Medical Center|