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  Seeking a Safe Path Toward Fatherhood

By Lisa Frazier
Washington Post Staff Writer
Sunday, April 18, 1999; Page A1

Sperm Washing
In the sperm washing procedure, sperm is separated from seminal fluids and cells using a centrifuge. Some researchers believe that doing so can isolate the sperm from the HIV virus, but the process is not foolproof.

1. Semen is placed inside a centrifuge tube that also contains a solution more dense than semen.

Sperm Washing

2. The tube is spun by the centrifuge until the specimen divides into three parts: Seminal fluids, Other cells, Sperm.

3. Additonal Step*: Tests are conducted on each of the three parts of the separated sample.

Sperm Washing

-- If any part of the sample tests positive for HIV, the entire semen specimen is discarded.

-- The patient is asked to keep providing semen samples until tests cannot detect the virus. HIV-positive men sometimes produce samples that have undetectable levels of the virus.

-- Once all three portions of a specimen fail to show detectable levels of the virus, the frozen sperm from that specimen can be used for standard in vitro fertilization.

*Standard sperm washing procedures do not include this step, which in this case is taken specifically to assure that no detectable trace of the HIV virus exists in the sample.

SOURCE: Ann A. Kiessling, Laboratory of Reproductive Biology, Harvard Medical School

One year after learning her husband was infected with the virus that causes AIDS, Carol Madeiros came to a daring realization: She wanted to have a baby.

It was April 1996, and Larry Madeiros, 36, was taking new drugs that made him feel healthier, more hopeful. The South Florida couple ruled out unprotected sex because of the risks to Carol, a 35-year-old pharmaceutical company representative, and to any child they might conceive. There had to be a safer way.

Six months later, they said they found it: an experimental use of a relatively inexpensive technique called sperm washing.

A process that separates sperm from seminal fluids for artificial insemination, sperm washing has been used for at least two decades in the United States as a treatment for male infertility. But spurred by successful results in Europe, researchers here are experimenting with it in an attempt to isolate sperm from the cells that carry HIV.

Researchers in Boston and New York City are recruiting HIV-infected men and their partners for medical trials. A doctor at Columbia University says he has inseminated 13 women with the "washed" sperm of their HIV-positive spouses, resulting in three pregnancies. One is pending, one woman miscarried, and the third pregnancy concluded with both baby and mother HIV-free.

But some determined couples such as the Madeiroses are convincing their doctors to perform the experimental procedure, using a protocol practiced since 1992 by an Italian doctor, Augusto E. Semprini.

It is unclear how many doctors in the United States are quietly offering HIV-positive men the procedure, which may be risky both medically and legally. In at least two states, Florida and California, doctors are forbidden by law from transferring HIV-contaminated blood or human tissue from one person to another. Doctors worry that this could cover sperm.

"There are a lot of issues," said Charles Burton, an assistant state attorney in Palm Beach County, Fla. "Certainly, there is a statute that on its face appears to prevent this. But their defense could be, 'Well, I'm no longer transmitting an infected sample.' Generally, I think we would be in a position of having to prove the procedure is ineffective for removing the virus."

The Madeiroses say they found a sympathetic doctor willing to work with them despite the legal risks, but they agreed not to publicly identify him.

Like most other assisted reproductive technologies, sperm washing is virtually unregulated. It is outside the authority of the federal Food and Drug Administration, which regulates drugs and medical devices but not medical procedures. The federal Centers for Disease Control and Prevention issued a warning in 1990 against using the procedure with HIV-positive men, because the CDC found that the washing did not always eliminate the virus. But the agency has no regulatory powers.

Now, because of the new data from Europe and growing interest from doctors in the United States, the CDC has decided to revisit the issue and possibly revise its 1990 warning.

"We think there is additional information that should be brought to bear on this situation," said Helene Gayle, director of the CDC's National Center for HIV, STD and TB Prevention.

Most of the new information comes from Italy, one of three European countries offering sperm washing to men infected with HIV. As of last month, Semprini had attempted nearly 2,000 inseminations on 550 women, using "washed" sperm from their HIV-infected partners. Of those attempts, Semprini said, 184 children have been born, 12 of them to couples who live in the United States. None of the mothers or children have contracted HIV, the doctor said in an interview via e-mail.

Semprini's results have made their way to the United States as new treatments for HIV and AIDS are lifting a cloud of doom that once surrounded many patients.

Supporters of sperm washing say it is much safer for HIV-positive men and their partners than making a baby the old-fashioned way. There is still an element of risk for mother and child, since doctors can't say for sure that sperm washing completely cleanses the sperm of HIV, even when the level of the virus is undetectable.

Larry and Carol Madeiros considered it a risk worth taking.

Larry first brought up the subject of children on April 12, 1996, a year after the couple learned he was infected with HIV. Born with hemophilia, a blood disorder requiring transfusions, he had contracted the virus from contaminated blood.

But powerful new drugs, supplements and exercise had restored his health -- and his dreams. A baby was one of the things he wanted most.

That night, Carol opened her pastel, cloth-covered diary and spilled her feelings onto the page:

"I told him I was scared and money was tight," Carol wrote in her diary. "And he said if he had to sell his truck and get some used things, he would. He is just one of a kind. And I'm the lucky one to have him. God, I want a child so bad, but I also want Larry to be well."

The next day, the couple began their search. They called hemophilia associations, fertility clinics and medical schools. They scoured newspapers, magazines and the Internet.

Six months later, they found an article in a British medical journal about Semprini's work in Italy. They considered a trip to Milan to meet him but could not afford it. Instead, Semprini's staff sent them a description of his methods, and the couple began looking for a doctor closer to home who was willing to try the technique.

At least a half-dozen fertility specialists said no. An 11-year-old Florida law, passed during the height of the AIDS crisis, made it illegal for doctors to transfuse or transplant blood, organs, skin or other human tissues contaminated with HIV, except for research or to save the life of another with the recipient's consent.

Eventually, Carol's gynecologist suggested a young specialist new to the area. "We got lucky because we ended up finding a practice in the states 20 minutes from our house," Larry said.

The doctor initially was skeptical. But Larry and Carol presented Semprini's data and made their pitch: They promised not to sue if things went wrong and even signed a liability waiver. He agreed to try.

"I didn't go into it blindly," Carol said. "I knew the risks. But at the same time, I knew I could get hit by a car backing out of my driveway. My risk of that was higher than my risk of getting HIV."

Using Larry's "washed" sperm, the couple made four attempts at artificial insemination. Then, they switched to in vitro fertilization, a more complicated and expensive procedure in which Carol's eggs were fertilized in a laboratory dish using cleaned sperm. Fertilized eggs were to be implanted, but that effort failed, too, at a cost of nearly $10,000. Hoping for better results, Larry and Carol moved to a larger, more experienced clinic. But at their first session, the doctor who had agreed to help them backed out after learning about the Florida law and the possibility of prosecution.

The couple returned to their original doctor, who tried in vitro again. Two weeks later, Carol's doctor gave her the news. When she saw Larry that evening, she told him, "You're going to be a daddy."

Ann Kiessling says she always believed this day would come.

In 1989, while the nation was still panicking over the devastation of AIDS, the Harvard professor was predicting that HIV would become more manageable and that many young victims, struck in their child-bearing years, would want to have children.

"This will be a controversial area with much social debate about the wisdom of parenting by virus-infected people," she wrote in a May 1989 publication of the American Fertility Society.

A year later, controversy focused on a Richmond doctor accused of infecting the wife of a hemophiliac during an insemination attempt with her husband's "washed" sperm. The Virginia Board of Medicine later reprimanded and fined the doctor, who moved to North Carolina.

The case drew the attention of the CDC, which investigated and issued a report warning that sperm washing was unreliable. But a CDC survey of 40 hemophilia treatment centers indicated growing interest. Twenty-six centers reported receiving inquiries from HIV-positive men or their wives about artificial insemination.

For a while, the CDC warning had a chilling effect on doctors, said Kiessling, director of the Reproductive Biology Laboratory at Harvard University Medical School. But reports of Semprini's research in the early 1990s rekindled interest.

Most of the doctors use what is known as the "sperm swim up" method: Semen is placed on top of a dense solution in a centrifuge tube, which spins quickly and separates the semen, with seminal fluids on top, other cells in the center and sperm on the bottom.

The top two layers are removed, leaving the sperm at the bottom of the tube. Another solution is put in the tube. Within 30 minutes, the most active sperm swim to the top and are used for insemination.

Backed by Semprini's results, Kiessling raised private funds and fashioned her own program. But she has had trouble finding a home for it. Two Harvard teaching hospitals rejected her request for support. A third hospital has given initial approval, and Kiessling said she expects to begin this summer.

So far, she has enrolled 10 HIV-positive men and their spouses and is screening three dozen more couples. Kiessling said she will use in vitro fertilization and will test the sperm for HIV.

Deborah Anderson, an associate professor at Harvard who works in the Department of Obstetrics and Gynecology at Brigham and Women's Hospital, has tested Semprini's method and found it reliable. Sperm washing can reduce the level of virus in a man's semen 10,000-fold, she said.

But she worries that some doctors are moving too fast, putting women and children at risk without clear CDC guidelines.

"I'm very concerned that people will just start doing this without scientific proof," she said.

Mark V. Sauer, professor of obstetrics and gynecology at Columbia University, has begun an experimental program for HIV-positive men. He uses sperm washing with another procedure called intracytoplasmic sperm injection (ICSI).

With that procedure, a single sperm -- after being washed -- is injected directly into a single egg. This reduces the risk to a woman by exposing her to significantly fewer sperm, Sauer said.

"We're doing something we understand people are reluctant to do," he said. "But we're not afraid of the controversy. We see this as part of our mission."

He said he is now screening couples for a second cycle.

"I feel in my heart it's the right thing to do," he said. "There are increasing numbers of young couples who are in this dilemma, and telling them they have to remain childless is cruel."

After her mother endured nearly 18 hours of labor, Ashley Taylor Madeiros slid into the world last May 18. With fine brown hair, big eyes and dimples, the seven pound, 21-inch baby was wide-eyed and healthy. "I just can't believe you're here," Carol kept repeating as she kissed the baby girl's head.

But mother and daughter were not out of danger until Ashley was 3 months old and both tested negative for HIV. A second test when Ashley was 6 months old showed the same result.

But as Larry's female offspring, she automatically is a carrier for hemophilia, which means she is very unlikely to develop the disease herself but has a 50-50 chance of passing it on to her offspring.

Larry said he and his wife considered those odds but are confident that hemophilia "will be a thing of the past" by the time Ashley is old enough to bear children.

For now, Larry, a home health care lobbyist, is healthy, too. He considers his HIV as chronic as the hemophilia.

"I have every intention of walking my baby girl down the aisle," he said.

The couple is so hopeful about Larry's health that they decided to have another child.

"We're not trying to push our luck," Larry said. "We just wanted another sibling for Ashley."

Carol is two months pregnant.

© Copyright 1999 The Washington Post Company

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