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| Sponsor: | Boston Medical Center |
|---|---|
| Information provided by: | Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT01173276 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV-1 Fertility Infertility |
Other: Sperm Washing with Intrauterine Insemination (IUI) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intrauterine Insemination In HIV-Discordant Couples |
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Desiree Jones-Eaves, RN | 617-414-5923 | Desiree.Joneseaves@bmc.org |
| Contact: Margaret M Sullivan, MD | 617-414-3574 | Meg.Sullivan@bmc.org |
| United States, Massachusetts | |
| Boston Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Margaret M Sullivan, MD 617-414-3574 meg.sullivan@bmc.org | |
| Principal Investigator: Margaret M Sullivan, MD | |
| Sub-Investigator: Deborah J Anderson, PhD | |
| Sub-Investigator: Joseph A Politch, PhD | |
| Sub-Investigator: Chong Xu, MD | |
| Sub-Investigator: Jennifer B Dwan, MD | |
| Principal Investigator: | Margaret M Sullivan, MD | Boston Medical Center |
More Information
| Responsible Party: | Margaret M. Sullivan, MD, Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT01173276 History of Changes |
| Other Study ID Numbers: | ARTEMIS |
| Study First Received: | July 28, 2010 |
| Last Updated: | July 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Acquired Immune Deficiency Syndrome Assisted Reproductive Technology Fertility HIV HIV Discordant |
Infertility Intrauterine Insemination Sexually Transmitted Diseases Sperm Washing |
|
Infertility Genital Diseases, Male Genital Diseases, Female |