Couples undergoing infertility treatment in the European Union are routinely tested for HIV and hepatitis multiple times, but a new study suggests that this is unnecessary.
According to an EU directive issued in 2006, couples undergoing infertility treatment using their own eggs and sperm should be tested for HIV and the liver infections hepatitis B and C “at the time of donation.”
Different EU nations have interpreted that requirement in different ways. In Ireland, for instance, couples are re-tested before each and every cycle of in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) - which, for some, could mean three or four rounds of testing in a year; in the UK, most couples undergo yearly tests for as long as they receive infertility treatment.
Both IVF and ICSI involve joining a woman’s egg and a man’s sperm in a lab dish, then - if fertilization is successful - transferring one or more embryos to the woman’s uterus. If one or both partners have HIV or hepatitis B or C, there is a potential risk of passing the virus to the fetus or to the woman, if she is uninfected. There is also some concern about the theoretical risk of cross-contaminating other embryos in storage at the fertility treatment center.
Having HIV or hepatitis does not preclude couples from using their own eggs and sperm for assisted reproduction. But initial virus screening of couples seeking treatment allows unknown cases to be detected; in cases where a partner is infected, extra steps can be taken - such as “sperm washing” - to ensure that the virus is not transmitted.
However, there has never been a scientifically established reason for repeatedly testing couples, according to Drs. Mary Wingfield and Evelyn Cottell of the Merrion Fertility Clinic in Dublin, who conducted the new study.
Instead, Wingfield told Reuters Health in an email, the EU policy was part of broader legislation aimed at ensuring the safety of donated tissue, such as stem cells, corneas and heart valves, from “third party” donors. She said that EU regulatory authorities and fertility societies are now debating whether couples “donating” their own eggs and sperm for infertility treatment should be subject to the same viral screening requirements that apply to other types of donated tissue.
To help inform the issue, Wingfield and Cottell analyzed viral-testing results from 13,700 people seen at seven Irish fertility clinics between 2007 and 2009.
Based on initial testing, no patient was positive for HIV, while about 200 were positive for antibodies against hepatitis B and 16 had antibodies against hepatitis C.
Of those patients who went on to have fertility treatment, repeat testing over the course of treatment found no new cases of HIV or hepatitis infection.
“The evidence presented in our paper certainly shows that repeat screening is not necessary,” Wingfield said. She added that some couples were tested six times over two years, “which has to be excessive and a waste of resources.”
A better strategy, according to Wingfield, would be to perform initial viral screening, then during the course of treatment, ask couples about any changes in their risk factors for HIV or hepatitis since the last test - such as whether they had gotten a tattoo, used IV drugs or had any risky sexual activity - and re-test them if appropriate.
The researchers also reviewed the medical literature to assess the risks of virus transmission to the fetus, or to other frozen embryos stored in the same facility. They found no documented cases.
There have been a small number of reported cases of HIV or hepatitis transmission to an uninfected partner during fertility treatment. But nearly all occurred prior to the era of routine viral screening, and virtually all would be prevented with current fertility treatment practices, according to Wingfield and Cottell.
Wingfield said that couples should be reassured that there is “virtually no risk” of blood-borne virus transmission during fertility treatment, as long as “good clinical and laboratory practices” are followed.
As for the repeat-testing policies in Ireland and other EU nations, Wingfield said she hopes this paper will “provide the medical and scientific evidence to convince (authorities) that re-testing must be abolished or at least the frequency significantly reduced.”
Doing so, she noted, would cut down on costs as well. At 100 euros per test, the annual cost in Ireland of screening of all couples before every fertility-treatment cycle is about 1 million euros.
In the U.S., there is no legal requirement that couples using their own eggs and sperm for infertility be screened for HIV and hepatitis. However, it is standard practice for fertility clinics to do so.
SOURCE: Human Reproduction, online October 17, 2010.