HIV-discordant Couple Intrauterine Insemination
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00975546 |
Recruitment Status
:
No longer available
First Posted
: September 11, 2009
Last Update Posted
: December 2, 2015
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Condition or disease | Intervention/treatment |
---|---|
Infertility HIV Infections | Other: Sperm washing and testing for HIV contamination Procedure: Intrauterine Insemination |
Study Type : | Expanded Access |
Official Title: | Intrauterine Insemination for HIV-discordant Couples |

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Other: Sperm washing and testing for HIV contamination

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 38 Years (Adult) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
Couple must:
- attest to safe sex practices
- know the HIV-status of their partner
- be informed of risks of this procedure and alternatives, including donor insemination
- have the ability to provide informed consent
- been referred or self-refer to Dr. Schust for infertility treatment
Female must:
- be 18-38 years of age
- have a normal menstrual cycle before the IUI cycle
- be negative for HIV, gonorrhea, chlamydia, syphilis, hepatitis B and hepatitis C
- have a standard infertility evaluation and be a candidate for intrauterine insemination
Male must:
- be at least 18 years of age
- be HIV-seropositive
- be under the care of an infectious disease specialist
- disease must be under control without evidence of acquired immunodeficiency syndrome (AIDS), with viral load <50,000 copies/mL and CD4 count > 250 cells/mL for the preceding 6 month period
- have semen quality adequate for intrauterine insemination
If the couple does not achieve pregnancy after IUI, they may continue in the study for 5 additional treatment subsequent cycles. The man must continue to receive care for his HIV and the disease must continue to be under control. Before each cycle of insemination, the couple must each sign an attestation statement that he/she is following safe sex practices, and have repeat testing for sexually-transmitted infections.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975546
United States, Missouri | |
Missouri Center for Reproductive Medicine & Fertility | |
Columbia, Missouri, United States, 65201 |
Principal Investigator: | Danny J Schust, MD | University of Missouri-Columbia | |
Principal Investigator: | Erma Z Drobnis, PhD | University of Missouri-Columbia |
Publications:
Responsible Party: | Erma Drobnis, Clinical Asssistant Professor, University of Missouri-Columbia |
ClinicalTrials.gov Identifier: | NCT00975546 History of Changes |
Other Study ID Numbers: |
HIV-IUI |
First Posted: | September 11, 2009 Key Record Dates |
Last Update Posted: | December 2, 2015 |
Last Verified: | November 2015 |
Keywords provided by Erma Drobnis, University of Missouri-Columbia:
fertility HIV discordant HIV Infertility in HIV-discordant couples HIV seronegativity |
Additional relevant MeSH terms:
HIV Infections Infertility Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Genital Diseases, Male Genital Diseases, Female |