HIV-discordant Couple Intrauterine Insemination

NO_LONGER_AVAILABLE

Conditions studied: Infertility, HIV Infections

In brief

The investigators propose to treat couples who wish to have a child in which the man is HIV-positive and the woman is HIV-negative. The investigators call these couples HIV-discordant. On the average, an HIV-positive man, who does not participate in high-risk activities, will transmit HIV to a female partner one in every one thousand acts of intercourse without a condom. To reduce transmission of HIV, HIV-discordant couples are counseled to avoid intercourse altogether, or to use condoms during every act of intercourse. In order to have a child, these patients can use donor insemination. If they wish to have a natural child of the infected man, they can use a combination of medication of the man to reduce the amount of virus in his semen, and condom use except at the time of ovulation when the woman produces an egg. This reduces the chance of infecting the woman, but studies have shown that about 4% of women will be infected with HIV using this approach. Alternatively, they can use vitro fertilization (IVF) with intra cytoplasmic sperm injection (ICSI) in which eggs are collected from the woman after hormone-stimulation and are fertilized in the laboratory by injecting a single washed sperm from her husband into each egg. The resulting embryos can be transferred to the wife's uterus and/or frozen for later use. These procedures are believed to minimize the risk of HIV transmission (although the number of cases is low), but IVF-ICSI is very expensive and are not an option for everyone. A simpler method used for over 15 years in Europe is to collect the man's semen, wash the sperm in the laboratory, and test the sperm sample for HIV before placing it in the woman's uterus (intrauterine insemination; IUI). Although the risk of HIV transmission to the woman is presumably not zero with this method, over 4000 inseminations reported have not resulted in infection of any female patients or resulting children.

Key facts

Study ID

NCT00975546

Run by

University of Missouri-Columbia

Last updated by the study team

2015-12-02

Who can join

Age: 18 and older, up to 38. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Missouri Center for Reproductive Medicine & Fertility — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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