Feb. 5, 2001 -- The last thing Kelli Gora ever expected to hear was that she might be a mother. That was a dream the Californian, now 38, had given up on years earlier, when several in vitro fertilization (IVF) attempts costing her more than $15,000 failed to produce a child. It was a painful experience she had worked hard to accept and put behind her.
But the wound was reopened last year when a lawyer investigating allegations against the University of California, Irvine's now-closed Center for Reproductive Health -- where Gora had her IVF procedures in the early 1990s -- told her that records indicated a woman who had traveled from South America to the clinic had received one or more of Gora's "donated" embryos. "At the time, the possibility of something like that happening never even occurred to me. I was told those embryos had died," Gora tells WebMD.
It's a possibility that Sean Tipton, director of public affairs for the Society of Assisted Reproductive Medicine, says others seeking IVF procedures needn't worry about. The Irvine clinic scandal -- which first came to light in 1994 and may involve hundreds of patients -- was an isolated incident, he says, and today, fertility centers follow stricter ethical codes around embryo use.
But Gora's lawyer, Melanie R. Blum, isn't so sure, and would like to see stiffer laws regarding the handling of eggs and embryos in IVF and other procedures. Blum, a reproductive-law specialist who has represented clients in more than 120 lawsuits against the Irvine clinic, including Gora, tells WebMD: "The clinic at Irvine isn't the only one where things like this have happened. I hear about similar cases all the time, from all over the country."
As a result of the Irvine scandal, the university closed the clinic, fired the three physicians who ran it, and sued them as well as the clinic to obtain patient and financial records. Two of the physicians - including Ricardo H. Asch, MD, who treated Gora -- are believed to have fled the country; the third physician remained in the U.S. and eventually was convicted of insurance fraud.
Medical miracles or mad science?
Developed in 1978, IVF is a technique in which an egg is fertilized with sperm in a laboratory setting and then implanted in a woman's uterus. It has given new hope to thousands of infertile couples for whom sperm and egg for some reason cannot meet on their own. For example, women with blocked or missing fallopian tubes, and men whose sperm are not vigorous or plentiful enough to make the trip to the egg, now have a chance to become parents.
After suffering two episodes of ectopic pregnancy (an embryo developing in the wrong place, commonly the fallopian tube instead of the uterus) by the age of 25, Gora had lost one of her tubes and found that her other was too badly scarred to allow passage of a fertilized egg to her uterus. "I worked in a hospital at the time, and all the doctors said to me, 'Ectopic pregnancies are dangerous. You should really consider having your eggs fertilized outside your body and just bypass your tubes so you don't have to worry about that happening,' " she says. "And I was told I could store the embryos and have children whenever I wanted."
On the advice of a friend, she made an appointment at the Irvine clinic with Asch, at the time considered one of the leading IVF doctors in the nation. Gora's first impression: "He was very busy. All over his desk there were piles of books and papers. You could tell there was a lot going on."
Gora says Asch suggested she could cut the cost of the procedure in half by participating in a clinical trial studying the effectiveness of a drug used to induce ovulation (egg maturation and release). She thought it over for a few months and agreed.
Ripening, retrieving, fertilizing, implanting
IVF is a complex and highly controlled process involving a team of more than 10 nurses, doctors, lab technicians, and embryologists, says Anthony Luciano, MD, a professor of obstetrics and gynecology at the Center for Fertility and Reproductive Endocrinology in New Britain, Conn. Today, the procedure typically involves the woman getting daily injections of drugs, beginning a few days into her cycle, that stimulate the development of many eggs at once. Doctors monitor the process through blood tests and ultrasound.
About 12 days later, when the developing egg follicles (structures containing the egg and supportive fluid) reach a diameter of 17 millimeters or more, another drug is given to trigger the final stage of egg development. But before the follicles have a chance to release them, the doctor harvests the eggs with a laparoscope (a long tube with a camera and retrieving device on the end), which reaches the ovary by passing through the vagina, uterus, and fallopian tube on that side. Monitoring the laparoscope's journey by ultrasound, the doctor targets the maturing follicles, inserts a fine needle into them, and withdraws their contents. "We look to get at least four eggs, but 12 or more would not be bad either," Luciano says.
The harvested material is then delivered to an embryologist, who isolates the eggs and places them individually into petri dishes. The partner's sperm is combined with the eggs, and if all goes well, fertilized embryos develop.
Should that happen, the progress of the embryos is monitored for three to five days. Then the strongest two to four are transferred into the woman's uterus, where it is hoped they will implant. The rest are frozen for any future attempts. Hormones are given to inhibit menstruation, and a few weeks later, a pregnancy test confirms if the process was successful.
After two attempts that failed to produce any harvestable eggs, Gora's ovaries produced 28 on the third try.
Success rates tell the tale
"You would think that under such controlled conditions, it would work 100% of the time," Luciano says. But the rate of success is somewhere between 25% and 35%. In young women like Gora, the rate may be as high as 50%; in women over 40, it can be as low as 15%. "If a woman does not get pregnant by the third try, there is no reason to believe further attempts will be successful," says Luciano.
Indeed, Gora did not become pregnant, and decided to stop trying. "The doctors told me the success rates, but it didn't sink in," she says.
"People always think they are going to be in that 20-30% that gets a baby, not in the 70-80% group that fails. I would tell people to go in expecting that it won't work, and then if it does, it's a miracle."
Gora became depressed, and her marriage faltered. The stress caused by the invasive and intense treatments, and then by the letdown of her negative pregnancy tests, was more than she or her husband expected, she says, and they divorced. For the next two years, she made payments on the $8,000 credit card debt she had incurred to pay for the procedures. "That was torture. Every month, that bill was a reminder." After the bills were paid, she destroyed every document, check stub, and record that reminded her of the treatment, and tried to put the episode behind her.
Then the egg scandal broke.
The handling of eggs and embryos
In 1994, whistleblowers from the Irvine clinic alerted the university that the clinic's doctors allegedly were underreporting their income, importing fertility drugs not FDA-approved, and transplanting stored eggs into patients without consent from the donors. Gora's mother heard about it and urged her daughter to contact the clinic. "I told her I never wanted to see or talk to any of those people again, but if she wanted to call that would be fine with me," Gora says. So her mother contacted Blum.
At the time, there was no evidence that any of Gora's unfertilized eggs had been used. Then, last year, Blum finally gained access to the documents that tracked the handling of fertilized eggs, or embryos.Â She contacted Gora, and together they looked at the records.
Tacked onto the back of Gora's chart was a woman's name. Next to the name were some numbers -- the same numbers that had been assigned to the embryos Gora had been told were dead. To Blum, the records indicated that hundreds of couples had been similarly affected.
"Now I question everything about it - I'm not even sure that they ever implanted embryos in me at all," Gora says. "Maybe they thought I was young, I'd have other chances. I feel that every one of my embryos that was given to someone else was a chance to have a baby that was stolen from me."
The woman who received Gora's embryos has a common name in South America, with no address or contact information listed. Gora has little hope that she will ever find out whether the woman had a child with her embryos.
Laws still catching up
While the FDA approves the medicines and devices used in infertility procedures, the legal system has yet to catch up with the technology, says Blum. The ownership of stored eggs and embryos wasn't established in California until after the Irvine case, when the state passed a law that made mishandling of eggs or embryos a felony. In many states, there are no such laws.
"I don't want these laws to be so restrictive, people can't get the procedures," says Blum. But she would like them tough enough to prevent another Irvine-type incident.
Gora recommends that other couples considering IVF be especially careful. "If I had heard my story before getting the procedure, I would have approached it all differently," she says. "I would have asked more questions, not put the doctors up on pedestals, and never let those eggs out
of my sight."
Today, Gora is remarried and relies heavily on her faith to see her through the knowledge that she may have children she will never meet.
"I know that ultimately God is in control, not the doctors at Irvine," she says. "Maybe that woman needed a baby more than I did. Maybe I needed to tell this story. I don't know why. But I believe everything happens for a reason."
Michele Bloomquist is a freelance writer based in Brush Prairie, Wash. She writes frequently about consumer health.