How healthy is donated sperm?

U.S. deaths highlight problems screening donors and finding them if something goes wrong

Over a two-year period in the early 1990s, a young and healthy San Francisco sperm donor unknowingly passed on a potentially fatal genetic heart condition to nine of the 24 offspring he fathered.

One child died at age 2 from heart failure.

Two others, now teenagers, have developed symptoms of hypertrophic cardiomyopathy (HCM) – the often undetected disease that suddenly fells young athletes in mid-game – and could suffer an abrupt cardiac death. One has had a defibrillator implanted to prevent it from happening.

The remaining offspring who've tested positive, including one born to the donor's wife, are at increased risk of developing the condition. Six of the nine are boys. The unnamed donor didn't learn he had the disease himself until after the first child was diagnosed, according to a report last week in the Journal of the American Medical Association.

In the absence of U.S. government regulations on notification, it took a unique collaboration between the sperm bank, the donor and a genetic-testing facility to track down the recipient women and test the children.

It's a nightmare scenario, and not just for those who use sperm banks – single women, lesbian pairs, and the roughly 15 per cent of couples who have can't conceive because of male infertility.

Genetic diseases that are unwittingly transmitted raise "a largely ignored but potentially significant public health issue," say the report's authors.

But the situation occurred in the U.S., where regulations are voluntary and often ignored, and a study by the American Society for Reproductive Medicine found that the majority of the U.S.'s 110 sperm-donor clinics don't follow screening protocols.

Could it happen north of the border?

Yes, says Dr. Tamar Said, director of the sperm bank at ReproMed, the Toronto Institute for Reproductive Medicine.

"Most of the sperm available here is from the U.S.," he says. "That's why we need updated federal rules and guidelines."

The two other sperm banks operating in Canada – Outreach Health Services in Toronto and Hamilton's Can-Am Cryoservices Corp. – only use semen imported from U.S. parent firms who pay for donations. It's been estimated that 80 per cent of babies conceived here via donor insemination now have American DNA.

Said says an undetected heart condition couldn't happen with sperm provided by ReproMed because it's the only facility in the country to provide Canadian-only (actually Toronto-only) semen. And it requires donors to undergo electrocardiogram tests as part of periodic physician examinations.

"There is no genetic screening available for a condition like HCM," says Said, "but the electrocardiogram would pick up the defect itself. "

ReproMed also tests for infectious diseases, as required by federal regulations, but "pro-actively tests" for sperm motility (quality) and certain genetic diseases, neither of which are required by Ottawa.

"There is a double standard in place here," says Said. "American sperm banks only have to follow minimum regulations to be imported here. And they can pay – we can't."

Canada used to have some 24 sperm banks where donors, often university students looking for extra income, were plentiful. But since 2004, when "commercial reproduction transactions" were criminalized under the Assisted Human Reproduction Act, the donation business has collapsed.

Only ReproMed, founded in 1990, remains to collect and store locally donated sperm, and it's allowed only to reimburse donors for travel and other expenses, generally no more than $70.

Canadian donors undergo a rigorous process that starts with the evaluation of three generations of family history. Following extensive semen analysis, before and after the sperm is frozen and quarantined for six months, there is a final three-month screening before it is delivered to the recipient's physician.

The donor's blood is tested for sexually transmitted and infectious diseases, some of which, such as West Nile virus, are not conducted on imported U.S. sperm, says Said.

Genetic disorders tested include cystic fibrosis, Tay-Sachs disease (and the whole "Ashkenazi panel" of conditions which affects many Jewish people), a blood disease called thalassemia that's common among those of southern Mediterranean and Middle Eastern origin, and sickle-cell anemia/anaemia, which affects the black community.

"There isn't the technology to test for every genetic disorder," says Said. But the rate of birth defects with donor insemination is no different than from conceiving naturally, between 2 per cent and 4 per cent.

So stringent is the screening process that only five in 100 donors are accepted by ReproMed. That, coupled with lack of remuneration, is why it currently has just 65 donors on its books, an ethnically diverse group of men who donate out of altruism.

"We're fortunate to have people who are motivated," says Said, "because the time that elapses from when a donor shows up to distribution of the semen is a year to 18 months."

Canadian sperm donors are limited to three births in a population area of 100,000. When the San Francisco man was allowed to father 24 offspring, there was no restriction in the U.S. on the number of pregnancies allowed. Guidelines now try to limit a single donor to no more than 25 births per 800,000 population.

Is there a notification process in Canada if the unthinkable – an unwittingly transmitted genetic disorder – should ever happen?

Yes, though the rules overseen by Assisted Human Reproduction Canada, the regulatory agency set up in 2007, are primarily geared to infectious diseases.

The responsibilities are clearly outlined, says Said. "The sperm bank – well, us, as we're the only one collecting sperm here – would have to do a recall and everyone would be tested. The same procedure could be used for a genetic situation."

source: thestar