It’s a very expensive gamble!

BUT - childless couples are trying

reproductive therapy in record numbers.

Test Tube Babies

IT IS IMPLANTATION DAY FOR SOME OF THE TOUGHEST CASES at the Sher Institutes for Reproductive Medicine in Las Vegas, Nevada.. The couples that pass through this place, headquarters for one of the largest chains of infertility clinics in America, are seasoned pros in the quest to make babies. They have tried shots and surrogates and have graduated to advanced treatments beyond their wildest calculations. Most of them have already undergone two or more in vitro fertilization attempts with other doctors, and some 75 % of them have traveled from out of state to try again. It is an arduous process, not without its embarrassments. One couple speaks of feeling ridiculous racing through rush-hour traffic to deliver sperm gathered at home to the clinic; another describes an earlier treatment when the doctor, in a lame effort at humor, dressed in a bunny suit on egg retrieval day, in preparation for his “Easter hunt.” It is also expensive. The couples in this waiting room have spent tens-and hundreds-of thousands of dollars on infertility treatments. They have gambled big, won, and lost. Robert and Bernadette from Fort Lauderdale, Florida, have spent $200,000 so far on doctors and medicine, and are back in the city for another IVF attempt. They have flown so often to Las Vegas that a friend unaware of their plight confronted them because he feared they had a serious gambling problem. “In a way,” Robert ventures, “we do.”

IT IS INDEED A GAMBLE but one an increasing number of couples are willing to take. A quarter century after the first “test tube” baby, the use of assisted reproduc-tive technology (ART) has risen astronomically. In the past decade alone, the number of ART babies has quadrupled, from 10,924 in 1994 to 40,687 in 2001, the most recent figure available. Today 1 in 100 children in this country is conceived with such treatments, but the industry itself remains largely unregulated, sparking calls for more rigorous reporting of data and more research on the possible risks of ART. BUT THE REWARDS ARE GREAT —the joys of parenthood make any sacrifice seem worthwhile to the many childless couples passing through the Sher Institutes’ doors. Take Steven and Mary Crespi. They have a daughter, Jay Cee, 2, from a previous IVF attempt. Etched beneath a heart tattooed on Steven’s arm is Daddy’s Girl. Now they’re trying for a sibling. When Mary, 40, miscarried twins during her last IVF pregnancy, Steven, a bartender and host at a club in town, was devastated. “He didn’t talk for two days,” says Mary. Steven nods vigorously. “I didn’t.” For almost a year, Mary adds, “he’s been really angry. Steven nods again, this time more slowly. “I swore,” he says, “that I would never. Do this. Again.” And yet, they have taken out a second mortgage on their house and are back at Sher.

So are Irene and her husband, Peter, from Chicago. They estimate they have spent nearly $300,000 on several surrogates as well as IVF . In their case, medical insurance paid half of their IVF bills, a rarity in the United States, where 85 % of insured Americans have policies that will not cover that treatment. Over the past several years, Irene and Peter have had three IVF treatments per year. Today they are tense as they file out of the room where Irene’s eggs, fertilized with her husband’s sperm, have just been implanted in their surrogate. Irene had wanted four eggs implanted, to increase the odds of a success, while her husband wanted three, to decrease the chances of the complications that come with multiple births. They argued, but Irene prevailed, and now she clutches a photograph of one of their newly fertilized eggs. As its cells have divided it has grown to look like a beautiful flower, she says. Peter disagrees. “What it looks like,” he says from his seat on the other side of the waiting room, “is a nuclear bomb.” For the estimated 1 in 6 American couples trying unsuccessfully to have a child each year, that’s just what infertility can be, as they put their relationships, their finances, and, perhaps, their family’s health on the line to make a baby. In deed, there remains surprisingly little agreement about the future health implications on the offspring that parents are trying so desperately to create through ART. “I started reading the literature, and pretty soon I was completely confused,” says Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University. A molecular biologist who formerly served as the assistant director of the Human Genome Project at the National Institutes of Health, Hudson encountered studies that seemed to indicate that there were slightly higher rates of birth defects, cancer, and genetic diseases associated with certain IVF techniques. Others seemed to point to no dif- ference at all. “I couldn’t tell you whether IVF kids run faster and jump higher than their non-IVF peers or not,” Hudson says. In a significant step to begin bridging that knowledge gap, the center, in partnership with the American Society of Reproductive Medicine and the American Academy of Pediatrics, will next month present the most comprehensive study yet undertaken to examine the im- pact of ART on the health of children. It’s a vital undertaking, as the business of infertility gets bigger and more complicated. Spending on lVF alone is up 50 % in the past five years, to over $1 billion last year. What’s more, incentives such as multiple IVF attempts for one fee and money-back guarantees (the Sher clinic offers up to 100 percent off for failed IVF attempts) are bringing patients to clinics in greater numbers than ever before. But increasingly, doctors, expert advisers to the government, and the patients themselves are wondering what, exactly, would-be parents are getting for their money. Statistics surrounding reproductive technologies can be confusing. “It is impossible to know how many individuals undergo assisted reproduction procedures in a given year, how many patients achieve success in the first (or second or third) cycle, how many women fail to conceive,” the President’s Council on Bioethics said in a report released this year. The concern is centered on figures collected by the Society for Assisted Reproductive Technology— the accrediting body for reproductive physicians— mandated by law in 1992 and published since 1996 by the Centers for Disease Control and Prevention. “I think there are a host of changes that you could make to make the [reporting process more rigorous, in terms of protecting consumers, says Sen. Ron Wyden, a Democrat from Oregon who wrote the first legislation.

TEST-TUBE MIRACLE. Reproductive medicine has been stung by controversy from the start. A century ago, physicians reacted to news of the first artificial insemin- ation in 1909 with equal parts outrage and disbelief. Even if the news was true-though that, they tended to agree, was highly unlikely—it was sure to be “ridiculously criminal.” When a wealthy Philadelphia couple entered the offices of a well-regarded physician in 1884, desperate to have a baby, the husband privately confessed to battling a bout of gonorrhea. The doctor decided to take matters in his own hands, writes Robin Marantz Henig in Pandora’s Baby: How

the First Test Tube Babies Sparked the Reproductive Revolution. He tapped the best-looking member of his class of medical students to provide sperm and injected it into his anesthetized patient. Some nine months later, the couple welcomed a baby boy into the world. It was not until after the child was born to the couple that the doctor told the husband the truth. The man was unfazed but made the doctor promise not to tell his wife.

Still, for decades, desire for children far outpaced the medical community’s ability to do anything about it. “Even as man walked on the moon, no one knew when a woman ovulated,” said Dr. Robert Edwards, the British fertility pioneer who delivered the world’s first test-tube baby, Louise Brown, in July 1978.

TODAY SCIENCE HAS CAUGHT UP. In the lab at the Sher Institutes, Madonna’s Like a Prayer is playing on the radio as the lab technicians cut the tails off sperm to keep them from darting away. They are drawn up into a thin needle and injected directly into the eggs of their patients; this procedure is known as 1CS1. Then the technicians and the patients wait. Couples know in about three days whether their incubating eggs will be good enough to implant.

Test Tube Babies

On the other side of the wall, Mary Crespi has taken a Valium, and her bladder is full, to better prepare her body for implantation. She and Steven also had sex the night before, as they had been encourad by their doctor to do. It was not easy, she says, with her anxiety about today and his bad back. She’s wearing Steven’s jacket—it’s cold in the operating room—and the same socks she wore the day her eggs were retrieved. Steven carries a letter he has written to their fertilized eggs. “I can’t wait to meet you, it reads. “Go give me my babies,” Steven cheers. Mary tells Steven that he’s making her nervous. Steven starts praying. Mary tries to relax. “I look nicer when I’m pregnant,” she muses. Mary’s chances of conceiving today are a long shot. Even in the best circumstances, at age 40-Mary’s age—-pecialists estimate that between 40 and 70 % of women’s eggs show evidence of abnormalities. Of the nine eggs that doctors were able to harvest and fertilize, three will be implanted today. Six more of Mary’s eggs will continue to grow, and with any luck, one or two will make it to the blastocycst, or 108-cell stage. They will then be frozen for later use . Generally, fewer than a third of all eggs make it that far.

Their doctor enters the room and hugs Steven. He is Geoffrey Sher, the founder and medical director of the institutes. Then a window that connects the lab and the operating room slides open. Through it, a technician passes a catheter filled with Mary and Steven’s fertilized eggs. The implantation is over in a couple of minutes. Mary hugs her knees to her chest-she will remain lying down for about a half-hour.

“These are gorgeous embryos. Absolutely gorgeous,” Sher assures them. “They don’t make them any better.” The perfect egg. Looks, however, matter less than once thought. In the past, reproductive specialists would score eggs based on criteria like smooth cell walls and good symmetry. But they were often surprised -eggs that seemed quite attractive simply stopped growing, and those that appeared to be duds became healthy babies nine months later. They simply didn’t know what made some embryos develop and others not. Now they have more than an inkling. In a paper published in the journal Reproductive BioMedicine Online in May, researchers at the Sher Institutes announced that they had discovered a genetic marker in the fluid surrounding each embryo—a molecule called sHLAG that is produced by the embryo during pregnancy. “We can now look at an embryo,” says Sher, “and say if that marker is present” there is a 70 % chance that it will make a baby in women under age 39 and an over 50 % chance in women 39 to 44 years old. “It’s huge, huge,”he adds. “This systern is going to allow us to have one baby, one woman. That’s because the better the accuracy in predicting embryo viability, the fewer embryos that need to be implanted in patients in the first place. And that brings reproductive specialists closer to their holy grail: the birth of a single healthy baby. Indeed, it is multiples that pose the single greatest risk to the health of patients and families using assisted reproductive technologies, says Marcelle Cedars, the director of reproductive endocrinology and infertility at the University of California-San Francisco. And though there has been a decline in the number of cases of three or more fetuses carried by IVF patients, twin births are still on the rise.

Having a better handle on which embryos will make healthy pregnancies would help to bring down costs of IVF as well. The majority of infertile couples who seek treatment conceive through drug regimens like Clomid or intrauterine insemination —insurance companies generally insist that their clients exhaust these avenues before they move on to IVF. For many infertile couples, the size of their pocketbook determines whether they can have a family, says Diane Clapp, the medical information director at Resolve, a nationwide infertility association. Indeed, for the roughly 1 million patients per year who would benefit from IVF, some 120,000 receive it, according to Sher. And with a 70 % average failure rate per IITF attempt, most patients need more than a single treatment—which can cost anywhere from $7,000 to $15,000. Robert and Bernadette from Fort Lauderdale paid out of pocket for their IVF regimen after Bernadette had a negative reaction to Clomid. The Crespis, too, are paying for IVF treatment on their own. Sher sees many patients who “are really mauled. “They’re financially and emotionally bank- rupt by the time they end up with you.” But he says insurance companies are not to blame; it’s the industry that needs to grow more accountable. “Until we get our house in order, “ Sher says, it is understandable that coverage is not forthcoming. He would like someday to see insurance coverage that provides incentives for fertility clinics, with penalties for triplets and bonuses for single, healthy births, he says.

WILD WEST. It is also an industry that bears the burden of its association with controversial stem cell research and cloning. Since much infertility research falls into the category of research on embryos, the National Institutes of Health is largely prevented from underwriting experiments in reproductive science-a restriction that robs the field of an oversight process. “We hear people whining and yapping about it and trying to blame the IVF medical practice,” says Elizabeth Blackburn, a cell biologist and professor at the University of California-San Francisco, who served on the bioethics council. “On the other hand, well, hello, there hasn’t been federal funding, dummies, and federal funding is a very good mechanism because it has built into it transparency and peer review.” In its absence, the industry is often described as a medical Wild West—with its share of snake oil salesmen.

But perhaps the biggest risk of all for couples embarking on reproductive therapies is the emotional backlash they often experience. Alice Domar, director of the Mind/Body Center for Women’s Health at Boston IVF and an assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, has seen couples who blame themselves for being infertile-for being too selfish, for waiting too long to start a family. She has counseled worried wives convinced that their husbands will leave them for a fertile woman. “Men and women respond to infertility very differently,” says Domar. “Women who have never been jealous a day in their lives may all of a sudden get unbelievably jealous when someone else gets pregnant. And the husband may respond, ‘Ew, what’s wrong with you? You’re jealous that my sister’s pregnant.’ “At the Mind/Body Center, men often meet with male therapists to vent. “They need to hear that their wife is normal, that she’s not being a basket case, says Domar.

 Steven and Mary Crespi say that while it has been a grueling experience, it has also brought them closer as a couple, as a family. Domar says studies have found that despite the considerable strain, the divorce rate in infertile couples is lower than in married couples with children. But in the thick of treatment, it is hard not to feel overwhelmed. Irene and Peter are worried because not one of their four embryos implanted that afternoon in the clinic became a viable pregnancy. Several weeks later, their surrogate walked out of the process in the middle of another attempt —after Irene had paid to fly her to Vegas and had spent nearly $20,000 for insurance and other medical expenses. Irene vows to keep trying. “Until I go through menopause, I need to exhaust this option,” she says.

As for Robert and Bernadette from Fort Lauderdale, they married last December, in the hopes that God might look more favorably on their attempts to make a baby as husband and wife. But after two tries, the Crespis’ struggle to have a second baby is looking up. Days after the implantation, they have good news —Mary’s progesterone levels have shot up from 15 to 51 in two days. She’s not feeling any morning sickness, she says, in a voice that sounds disappointed; then she reminds herself that she rarely felt queasy when she was carrying her daughter, either. Two weeks later, they have an ultrasound, and they know for sure. They will have a baby boy.”Our family is complete,’ says Mary. “And you know what? I don’t want to go through this again.”.




September 27, 2004, (pgs. 60-67 + Cover)

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