WASHINGTON - All the years of fertility drugs, low-tech intra-uterine insemination and higher-tech in vitro fertilization finally gave Pamela Madsen and her husband, Kai, exactly what they wanted: a family with two healthy children, Tyler, now 16, and Spencer, now 12.
But their journey into assisted reproduction also produced something they hadn't talked about or even thought about - four surplus embryos.
The embryos are still in deep freeze in a fertility center in New York, like an estimated 400,000 others across the nation that have been frozen and stored since the late 1970s.
As Congress debates expanding President Bush's policy on embryonic stem cell research, those on both sides of the volatile issue have noted that many of the ethical and moral issues troubling to opponents of embryonic stem cell research are also inherent in IVF - a process that Bush and much of the Christian conservative community support.
Just as embryonic stem cell research leads to the destruction of embryos, IVF, as it is practiced in the United States, leads to the loss of embryos that will never be implanted.
"There is a certain level of inconsistency in supporting IVF but opposing the use of embryos to gain stem cell lines," says Tom Mayo, director of the Maguire Center for Ethics and Public Responsibility at Southern Methodist University. "As long as there is in vitro fertilization, you will have some number of embryos that will either remain cryo-preserved forever, or until they start to come apart or are simply disposed of."
For his part, Bush has avoided that charge of inconsistency by saying he merely opposes using taxpayer money for embryonic stem cell research. Although he describes it as "destroying life," he has not called for a ban on such research.
But other opponents have not made such distinctions between public and private financing of the research. House Majority Leader Tom DeLay, a Republican, described embryonic stem cell research as "the dismemberment of living, distinct human beings for the purposes of medical experimentation."
Asked recently whether he would support tighter regulations on embryo creation through IVF, he said he would prefer to see doctors come up with their own codes of conduct but wanted to look at the issue of what happens to frozen embryos that are discarded by fertility labs.
According to a 2003 study by the Rand Corp., patients have designated about 2 percent of the 400,000 embryos in frozen storage for discard, about 2 percent for donation to other couples, about 3 percent for donation to private research and about 88 percent for future "family building."
But many of those "family building" cases turn out to be indefinite storage, like the Madsens' embryos. "We were, like everybody else, just trying to conceive," says Pamela Madsen, a former kindergarten teacher in the Bronx who leads the American Fertility Association.
For years the Madsens disagreed over what to do with the embryos. Pamela felt an emotional attachment to them and wanted to try for another child. Her husband felt no such bond and didn't want a bigger family. So, like many couples who cannot agree on what to do with embryos they no longer need, they did nothing.
"Many parents decide not to decide. That's why we have so many in the freezer," says Richard M. Doerflinger, deputy director of the Secretariat for Pro-Life Activities for the U.S. Conference of Catholic Bishops.
The Roman Catholic Church sees IVF through the same morally troubling lens as embryonic stem cell research and believes that it should be banned. Since 1987, the Vatican has opposed IVF on the grounds that "a child should arise out of an act of love between a husband and wife," Doerflinger says.
"That norm is violated by a process that substitutes for a man and woman with a lab procedure," he adds. "It's more like manufacturing a product. It's a technician who does the act of conception."
But, like the church's policy against contraception, it is "less well understood" - and less followed - by many Catholics, Doerflinger says.
In Italy, which is largely Catholic, new regulations that greatly restrict fertility procedures have been protested by many and will be put to a referendum - over the objections of Pope Benedict XVI and Italian bishops - June 12 and 13.
The rules set forth last year are the strictest regulations on medically assisted fertility in Europe and give embryos the same legal rights as fully developed human beings.
Under the regulations, the days-old cells cannot be frozen, screened for abnormalities or used for scientific purposes such as stem cell research. Those turning to IVF - only married heterosexual couples, under the Italian law - are permitted to create only three embryos at a time, and all three, no matter how viable they appear, must be implanted into the woman at the same time.
There are no proposals for such strict regulations in this country. Indeed, IVF has become an extremely popular and accepted procedure, responsible for slightly more than 1 percent of babies born each year.
"It is so broadly supported in a bipartisan way - across blue states and red states - that it would be very difficult to criticize IVF on moral grounds as a politician," says SMU's Mayo.
Even conservative bioethicists like Leon Kass, a vocal critic of the procedure in the late 1970s and now the head of the president's bioethics council, has become a supporter.
"We all know IVF babies and people who desperately wanted to build a family and needed some help in doing so," says Kathy Hudson, founding director of the Johns Hopkins University Genetics and Public Policy Center. "In 25 years it's gone from, 'How freakish is that?' to, 'Isn't it great that my cousin or my sister or myself was able to have a child?'"
And, unlike the Catholic Church, many conservative religious groups that oppose embryonic stem cell research have not had objections to IVF.
Douglas Johnson, executive director of the National Right to Life Committee, says, "The fact that some human individuals come into existence through a laboratory procedure is not troublesome."
But he believes that couples can - and should - enter into IVF without creating more embryos than they will use or that they should authorize the labs to donate any surplus embryos to other couples.
While embryo donation, promoted and funded by the Bush White House, is an attractive option for some, it has limited appeal because many couples are uncomfortable with the idea of a biological child out there who is not connected to them. While there are plenty of infertile couples willing to accept a donated embryo, there are far fewer couples willing to donate.
And many in the reproductive medicine field say that, in some cases, limiting the number of embryos created runs counter to the goal of a successful pregnancy. "To maximize success, you want to transfer more than one embryo, unless the patient is very, very young - in her 20s," says Dr. Marian Damewood, former president of the American Society for Reproductive Medicine and chairwoman of obstetrics and gynecology at York Hospital.
In the five months after the introduction of the restrictive laws in Italy, for instance, the success rate for IVF treatments dropped from one in four to one in nine, according to reports in the European press.
There are medical and financial reasons, too, why such a restriction could be problematic, doctors say.
Typically in an IVF procedure, a woman is injected with fertility drugs that stimulate ovulation and cause her to produce more eggs. About 10 eggs may be retrieved through a surgical procedure, eight of which may look healthy enough to be fertilized. Of those new embryos, six may look viable.
The patient and doctor may decide to implant two in the womb - or, if the woman is over 35, maybe three - in the hopes that at least one of the embryos will become a pregnancy.
The patient will generally freeze the remaining embryos for possible use.
Each such cycle costs about $10,000 to $15,000.
"The question of whether you could tailor the procedure so you would not end up with many or any excess embryos would be pretty tricky," said Hudson, of the Hopkins center.
For one thing, doctors don't know before an egg is fertilized whether the resulting embryo will be a healthy one.
"If you limit the number of eggs fertilized, a woman may end up with no embryos to transfer or just one or an embryo that's not very good, and then have to go through another $12,000 procedure and hormonal stimulation that's not pleasant, and another surgical procedure," says John A. Robertson, a bioethicist at the University of Texas law school.
Such a scenario raises another set of ethical quandaries, Hudson says, related to exposing women to unnecessary risk, pain and expense.
IVF is still an inexact science. After treatment with fertility drugs as an IVF patient, Barb Collura of Northern Virginia produced more than 35 eggs which, after fertilization, resulted in 15 embryos. But because her ovaries had been overstimulated by the drugs and produced too much fluid in her body, she had to wait several months before any of the embryos could be implanted. They all had to be frozen.
All of the embryos were thawed and implanted in Collura in three rounds of embryo transfers. But none of them resulted in a pregnancy.
"You have no control over how many eggs you produce, how many embryos result, how many are viable, or any of this," says Collura, who, with her husband, Chris, eventually adopted a boy who is now 4.
Some European countries, such as Belgium, allow only a single embryo to be implanted at a time in an attempt to reduce the number of multiple pregnancies that can endanger the mother and the fetuses. But in many of these places, national health plans cover the cost of the procedures.
Anti-abortion leader Johnson points to such European models. He says financial and other sorts of considerations become priorities only if the embryos are considered "tissue to be preserved" rather than children. "If you agree that you are creating your biological offspring, then you don't allow excess to be created," he says. "The premise that it's an unavoidable thing is untrue."
Pamela Madsen says she has seen couples come up with all sorts of solutions to the problem of surplus embryos: Some transfer the embryos to the woman's uterus at a time in her reproductive cycle when a pregnancy is unlikely as a "natural goodbye"; some couples bury their embryos with a ceremony to mark the end of their family-building journey; some, like Madsen, are hoping that one day they can donate their frozen embryos to federally funded stem cell research.
"These are very personal decisions," she says. "And some couples don't decide anything - because a decision is too difficult."