Our Protocol

A review of the literature of safely using sperm from HIV-positive men for fertility purposes begins about 1992 in Milan, Italy.  Most of the HIV-positive men there were heterosexual former IV drug users who wanted to have children with their female partners.  So they went to the large fertility clinic in Milan headed by Dr. Augusto Semprini who perfected the technique called double washing. This process separated the sperm from the rest of the ejaculate which is where we now know HIV resided.  He used this double-washed sperm for intrauterine insemination (IUI) into the female partner’s cervix as there was no in vitro fertilization (IVF) at that time.  After none of the first 20 or so cases contracted HIV, he published his data and this became the gold standard for the use of sperm from HIV-positive men for fertility purposes.

The latest data on the safety of double-washed sperm from HIV-positive men for either IUI or IVF was collected in a meta-analysis published in 2016.  The researchers found over 11,000 cases worldwide and none transmitted HIV.

My protocol also requires that the sperm donor has been on a stable HIV regimen with an undetectable viral load (<200) for at least the last six months.  This requirement is based on the “Swiss Statement” published in 2008 by the national HIV Commission of Switzerland which stated that men who met the above criteria were no longer infectious.  As background, in 1996 the 3-drug HIV “cocktail” along with a test that could measure that amount of circulating virus became available.  This began the modern era of long-term HIV control.  And over time it was gradually observed that the HIV-negative partners of HIV-positive men with undetectable viral loads were not testing positive for HIV after anal intercourse where the condom broke or simply was not used.  The latest date for “U=U”, ie the public health message that undetectable means untransmittable, comes from the Partner-2 study in San Francisco where 783 gay couples were followed for 8 years.  One man was HIV-positive and undetectable on his HIV medications.  The partner was HIV-negative and they were not practicing safe sex or using PreP.  After over 77,000 events of intercourse between the partners were no cases of HIV transmission.  It should be noted that several of the negative partners did pick up HIV during this time, but the HIV strain was from a different partner.

In addition, some of the fertility doctors I work with also prescribe Truvada under my direction to give to the gestational surrogate in an abbreviated form of PreP.  It is started 2 days before embryo transfer and continues for 14 days.  Truvada is safe to use to use in first trimester pregnancy.

Also, it is important to note that there was one case of HIV transmission during IUI reported to the CDC in 1988. This happened here in the US – before double washing, HIV medications, viral load testing, or PreP existed.  It was a serodiscordant heterosexual couple where the man was HIV positive.  They went through 5 cycles of semen collection with some type of washing procedure available where they lived.  And after the 5^th round of IUI, the female partner picked up HIV.

This is the only case I have found in the medical literature but it does illustrate that we can never say this procedure is 100% safe.

Finally, to clear you to proceed with semen collection and embryo creation, I will be reviewing two years of your medical records which you will authorize your medical provider to send to me.  I will confirm your viral load has remained below 200 for at least 6 months and that you were not recently infected with syphilis.  We will then have a brief phone call or email exchange to review recent changes to your medical information and to answer any questions. Then at the time you start the semen collection process at your fertility clinic, they will check another viral load so they can confirm it remains less than 200.