This article that appeared in American Medical News on February 15, 2009 written by Kevin B. O'Reilly featured commentary from Pasquale Patrizio. MD, MBE, HCLD, Yale Fertility Center Director.
What began in late January as a feel-good story of a California medical team's Herculean efforts to deliver octuplets after a 31-week pregnancy quickly morphed into a controversy over the medical ethics of fertility practices.
The octuplets' mother, 33-year-old Nadya Suleman, said in an interview on NBC's "Today" that her physician transferred six embryos and two split. Suleman is single, unemployed and has six other young children. All were conceived through in vitro fertilization at the same clinic, she said. For each pregnancy, her doctor transferred six embryos, Suleman said.
If that is true, the physician's actions went well beyond American Society for Reproductive Medicine guidelines, society president R. Dale McClure, MD, said in a statement. The Medical Board of California is investigating, and the ASRM has offered to aid the inquiry. The AMA referred requests for comment to the ASRM.
"What was done is clearly irresponsible, clearly unethical, and it placed the life and health of the mother as well as the fetuses at great risk," said Samuel H. Wood, MD, PhD, a La Jolla, Calif., reproductive endocrinologist. "It's simply the wrong thing to do."
For a woman younger than 35 with a previous successful IVF cycle, the ASRM recommends transferring one embryo -- two at most. The society says pregnancies with four fetuses or more pose huge risks, including a 95% chance of pre-term labor and delivery, and a greater than 60% chance of preeclampsia. One in 10 such pregnancies results in gestational diabetes mellitus.
Pasquale Patrizio, MD, director of the Yale Fertility Center in Connecticut, said he would not have transferred so many embryos in a patient "for any reason. I don't understand why such a decision was made. No matter how much a patient may insist on a transfer of such a large number of embryos, it is out of the question and the request should not be honored at all."
Suleman, who said she has occluded fallopian tubes, told "Today" she dreamed of having a "huge family" and her goal with this pregnancy was to have one more child. She refused to selectively reduce the embryos when she learned six had been implanted successfully.
As of early February, the eight low-birth-weight babies were being tube fed donated pasteurized breast milk and monitored in the Kaiser Permanente Medical Center in Bellflower, Calif., where they were born. The hospital said the babies were expected to remain for several more weeks.
Regulation the answer?
The fertility practice Suleman named in her interview, West Coast IVF Clinic Inc. in Beverly Hills, Calif., is a member of the Society for Assisted Reproductive Technology. SART is an ASRM affiliate that represents more than 85% of U.S. fertility clinics and describes itself as a "governmental watchdog for ART" with quality-assurance expertise.
SART has contacted the clinic's medical director, Michael M. Kamrava, MD,to learn more about the medical circumstances of the case before taking any action, which could include revoking the clinic's society membership. Dr. Kamrava, an ob-gyn who was shown treating Suleman in a 2006 Los Angeles TV news show, declined requests from AMNews for an interview.
The Suleman case shows the fertility industry's self-regulation is insufficient, said Debora L. Spar, PhD, author of The Baby Business: How Money, Science, and Politics Drive the Commerce of Conception, which examined the market for reproductive technology. She said government should set rules on how many embryos can be transferred.
"Most people are agreeing this was an extreme case," Spar said. "That is exactly what regulation is best suited for. It defines the extreme and unacceptable behavior. Even if you took the ASRM guidelines, I think what this case shows is that even reasonable guidelines are not necessarily followed by unreasonable practitioners, and it is those unreasonable practitioners that you have to worry about."
The California medical board's decision to investigate may not prevent similar cases, Spar said. "We don't want regulation after the fact. We want regulation beforehand."
Fertility doctors said the proportion of high-order multiple births has dropped, thanks to better methods of culturing embryos and ASRM guidelines on transfers. The percentage of IVF cycles resulting in triplets or more fell 69%, to 4.3%, from 1997 to 2005, the last year for which data are available from SART and the Centers for Disease Control and Prevention.
"This particular case is a big problem, but I don't think we have a big problem generally," said James A. Grifo, MD, PhD, program director of the New York University Fertility Center. He said regulation could have unintended consequences, contending that a 1992 law requiring the CDC to publicly track clinics' success rates perversely encouraged physicians to increase the number of embryos they transferred to improve the odds.
"We passed the guidelines and made recommendations for what doctors should do, adjusting for the fact that not all patients are the same," said Dr. Grifo, a past president of SART. "Medicine is not formulaic. If it were, then why do we need doctors? We should just go to a computer."
Screening patients
Others said the case -- Suleman now is the sole parent to 14 children younger than 8 -- highlighted the need for more screening of prospective parents seeking reproductive technology services.
"I would like to see a mandatory psychological evaluation," said Arthur L. Caplan, PhD, director of the University of Pennsylvania Center for Bioethics. Caplan noted that such screening is standard for living organ donors and patients seeking bariatric surgery. "We need to look at what steps we can take to ensure they will be competent parents."
The ASRM published guidelines in 2004 saying fertility clinics could "withhold services from prospective patients on the basis of well-substantiated judgments that those patients will be unable to provide or have others provide adequate child rearing for offspring." The guidelines do not call for routine screening or home studies.
Fertility specialist Dr. Wood said he has referred a number of prospective parents for psychological counseling. At the same time, some doctors fear trampling on their patients' autonomy.
"I don't feel comfortable being in a position to tell a couple, or a woman, 'You're not going to do any more, because you have enough kids,'" said Yale's Dr. Patrizio. "It's not morally correct because it's not my reproductive right; it's her reproductive right. If she wants to have a large family -- do it one at a time or, at the max, two at a time. But it's her choice."
Wednesday, February 18, 2009
Friday, February 13, 2009
The Octuplets Saga
Malleability and fragility of human ethics is exemplified in the recently unraveled octuplet saga. The community in general and reproductive endocrinologists in particular are striving to comprehend the circumstances that fostered the practitioner’s poor judgment, deviance from guiding principles of practice and above all, an utter disregard to the wellbeing of a clearly “vulnerable” patient and her family!
Disregard of the woman’s psychological wellbeing and social circumstances are unpardonable, and yet pale against the reckless act of transferring multiple (six!!) embryos in a young woman of proven fertility for whom selective embryo reduction was not an option. Not only were the subspecialty specific guidelines (The American Society for Reproductive Medicine Society for Assisted Reproductive Technology offer clear guidelines regarding the number of embryos to transfer in an ART cycle to ensure against undue risk of high order multiple pregnancies) ignored, but also dismissed was the essence of the Hippocratic oath! While detailed explanations may never be available for the case under study, a need for introspection is quite apparent. In a consumer driven society where service is expected, nay demanded for a fee, these events may very well reflect thoughtless compliance to a pressing customer’s demands.
In times when economic successes more than intellectual prowess or integrity may define progress, it is simplistic to expect the medical community to stay immune to social pressures and be self shepherded within practice “guidelines”. Indeed, in a society where irrational demands of a few may be met by an occasional, the case of octuplets following assisted reproductive technology identifies a need for moving beyond the realm of “guidelines” to incorporate “reasonable requisites” to ensure wellbeing of an emotionally vulnerable population, i.e. those coping with a spectrum of psychological, social and economic stresses that remain intrinsic to a diagnosis of infertility.
Disregard of the woman’s psychological wellbeing and social circumstances are unpardonable, and yet pale against the reckless act of transferring multiple (six!!) embryos in a young woman of proven fertility for whom selective embryo reduction was not an option. Not only were the subspecialty specific guidelines (The American Society for Reproductive Medicine Society for Assisted Reproductive Technology offer clear guidelines regarding the number of embryos to transfer in an ART cycle to ensure against undue risk of high order multiple pregnancies) ignored, but also dismissed was the essence of the Hippocratic oath! While detailed explanations may never be available for the case under study, a need for introspection is quite apparent. In a consumer driven society where service is expected, nay demanded for a fee, these events may very well reflect thoughtless compliance to a pressing customer’s demands.
In times when economic successes more than intellectual prowess or integrity may define progress, it is simplistic to expect the medical community to stay immune to social pressures and be self shepherded within practice “guidelines”. Indeed, in a society where irrational demands of a few may be met by an occasional, the case of octuplets following assisted reproductive technology identifies a need for moving beyond the realm of “guidelines” to incorporate “reasonable requisites” to ensure wellbeing of an emotionally vulnerable population, i.e. those coping with a spectrum of psychological, social and economic stresses that remain intrinsic to a diagnosis of infertility.
Tuesday, January 13, 2009
Yale Egg Donor/Surrogacy Program
Yale Fertility Center has extensive experience helping an infertile or same-sex couple finding an appropriate egg donor. Finding the right donor may take some time, but YFC offers flexibility during the process. “We make sure that you’ve got the donor you’re comfortable with,” says Dorothy Greenfeld, LCSW, Clinical Professor and psychological counselor at YFC. Couples meet with Greenfeld and discuss donor traits that are important to them. She then goes over YFC’s donor profiles with the intended parents. Though donation is strictly anonymous, the intended parents receive a great deal of information about the egg donor. In addition to health information, height, weight, and hair and eye color, as well as those of the donor’s relatives, couples learn about her education, her occupation, and her reproductive history, including details of any previous egg donations.
In contrast to the practice at some other egg-donation programs, couples at YFC are not placed on a waiting list for eggs, and they may decline a particular donor if they wish. What is the typical egg donor like? “They’re women who have often been touched by infertility in some way,” says Greenfeld. “They have a godmother who was infertile or they’ve worked with women who are infertile.” Successful egg donors tend to be active, educated young women who are in school or who are young mothers themselves. They know they face a months-long process that involves uncomfortable procedures, but they want to help others have babies, and they view donating eggs not as “giving away a baby” but as a way of giving the gift of a family to a couple in need.
Potential egg donors must be aged 21–30, in good physical and psychological health, and have at least a high school education. All potential YFC donors undergo extensive health screening by YFC faculty, as well as a psychological evaluation by Greenfeld.
In contrast to the practice at some other egg-donation programs, couples at YFC are not placed on a waiting list for eggs, and they may decline a particular donor if they wish. What is the typical egg donor like? “They’re women who have often been touched by infertility in some way,” says Greenfeld. “They have a godmother who was infertile or they’ve worked with women who are infertile.” Successful egg donors tend to be active, educated young women who are in school or who are young mothers themselves. They know they face a months-long process that involves uncomfortable procedures, but they want to help others have babies, and they view donating eggs not as “giving away a baby” but as a way of giving the gift of a family to a couple in need.
Potential egg donors must be aged 21–30, in good physical and psychological health, and have at least a high school education. All potential YFC donors undergo extensive health screening by YFC faculty, as well as a psychological evaluation by Greenfeld.
In Vitro Fertilization
In vitro fertilization(IVF) involves fertilization outside the body in an artificial environment. This procedure was first used for infertility in humans in 1977 at Bourne Hall in Cambridge, England. To date, thousands of babies have been delivered worldwide as a result of IVF treatment. Over the years, the procedures to achieve IVF pregnancy have become more successful and affordable.
To accomplish pregnancy as a result of IVF, several steps are involved:
- Stimulation of the ovary to produce several fertilizable oocytes (eggs)
- Retrieval of the oocytes from the ovary (from the vagina)
- Fertilization of the oocytes and culture of the embryos in the IVF Laboratory
- Placement of the embryos into the uterus for implantation (embryo transfer or ET)
What Types of Infertility Might Be Helped by IVF? Absent fallopian tubes or tubal disease that cannot be treated successfully by surgery. Endometriosis that has not responded to surgical or medical treatment. A male factor contributing to infertility, in which sperm counts or motility are low but there are enough active sperm to allow fertilization in the laboratory. Unexplained infertility that has not responded to other treatments. Infertility secondary to sperm antibodies. Due to the high success of IVF and intrauterine embryo transfer, GIFT (Gamete Intra Fallopian Transfer) and ZIFT (Zygote Intrafallopian Transfer) techniques are rarely used in current practice. Intracytoplasmic Sperm Injection (ICSI) is a relatively new micromanipulation technique developed to help achieve fertilization for couples with severe male factor infertility or couples who have had failure to fertilize in a previous in vitro fertilization attempt. The technique involves very precise maneuvers to pick up a single live sperm and inject it directly into the center of a human egg. The procedure overcomes many of the barriers to fertilization and allows couples with little hope to achieve a successful pregnancy. At Yale the ICSI procedure was first used in 1994 and the first successful birth was achieved in 1995.
The ICSI Process
ICSI is a tool available in the IVF laboratory to achieve fertilization. The initial steps in preparation for ICSI are the same as for IVF:
- Stimulation of the ovary to produce several fertilizable oocytes (eggs)
- Retrieval of the oocytes from the ovary (through the vagina
- Fertilization of mature oocytes with ICSI
- Placement of the embryos into the uterus for implantation (embryo transfer or ET)
Fertilization by ICSI means that the micromanipulation specialist picks up the single live sperm in a glass needle and injects it directly into the egg.
To accomplish pregnancy as a result of IVF, several steps are involved:
- Stimulation of the ovary to produce several fertilizable oocytes (eggs)
- Retrieval of the oocytes from the ovary (from the vagina)
- Fertilization of the oocytes and culture of the embryos in the IVF Laboratory
- Placement of the embryos into the uterus for implantation (embryo transfer or ET)
What Types of Infertility Might Be Helped by IVF? Absent fallopian tubes or tubal disease that cannot be treated successfully by surgery. Endometriosis that has not responded to surgical or medical treatment. A male factor contributing to infertility, in which sperm counts or motility are low but there are enough active sperm to allow fertilization in the laboratory. Unexplained infertility that has not responded to other treatments. Infertility secondary to sperm antibodies. Due to the high success of IVF and intrauterine embryo transfer, GIFT (Gamete Intra Fallopian Transfer) and ZIFT (Zygote Intrafallopian Transfer) techniques are rarely used in current practice. Intracytoplasmic Sperm Injection (ICSI) is a relatively new micromanipulation technique developed to help achieve fertilization for couples with severe male factor infertility or couples who have had failure to fertilize in a previous in vitro fertilization attempt. The technique involves very precise maneuvers to pick up a single live sperm and inject it directly into the center of a human egg. The procedure overcomes many of the barriers to fertilization and allows couples with little hope to achieve a successful pregnancy. At Yale the ICSI procedure was first used in 1994 and the first successful birth was achieved in 1995.
The ICSI Process
ICSI is a tool available in the IVF laboratory to achieve fertilization. The initial steps in preparation for ICSI are the same as for IVF:
- Stimulation of the ovary to produce several fertilizable oocytes (eggs)
- Retrieval of the oocytes from the ovary (through the vagina
- Fertilization of mature oocytes with ICSI
- Placement of the embryos into the uterus for implantation (embryo transfer or ET)
Fertilization by ICSI means that the micromanipulation specialist picks up the single live sperm in a glass needle and injects it directly into the egg.
Assisted Reproduction Options for Same-sex Couples
The Yale Fertility Center (YFC) has for many years helped men and women become parents—and that includes same sex parents. Both lesbians and gay men who want children can seek treatment at YFC, where the available services include artificial insemination, egg donors, and gestational surrogates, or carriers. “More and more gay men are choosing to become fathers through surrogacy and donation,” says Dorothy Greenfeld, LCSW, a counselor at YFC. In addition, marriage is legal between same-sex couples in Connecticut, and many same-sex couples within either partnerships or marriages feel ready for children.
Greenfeld is the first person potential parents meet at YFC (except for those needing help only with insemination). She administers a psychological evaluation and gives them a detailed picture of what to expect from the long process of achieving parenthood. Part of her job is to ask the questions that potential parents may not have asked themselves.
For example, male couples often decide before going to YFC which of them will be the sperm donor. But Nature might not cooperate, and Greenfeld wants them to be prepared. “You might be very clear about who’s going to produce the sperm, but you might also be the guy who can’t produce the sperm,” she points out.
The Center works with couples to come up with individual solutions for their particular situation. Some seek simply an egg donor, a gestational surrogate to carry the pregnancy, or sperm. But more complex scenarios are possible. One lesbian couple at YFC achieved the “dream scenario,” in which one partner provided the egg and the other carried the pregnancy. And one pair of fathers had twins—one twin from each father’s sperm—with the help of a surrogate mother. Whatever arrangement is made, YFC requires that at least one potential parent be biologically connected to the child, providing either eggs, sperm, or womb.
Prejudices persist about gay parents, including fears that they will be less nurturing or that their children are less likely to marry, but these are subsiding amid recognition that gay couples make good parents. Greenfeld has written about the need to overcome such myths. “So many [gay] men have spent their life dreaming about being dads,” said Greenfeld, “and often say things like ‘I just didn’t think it would be possible.’” But the children of the proud gay and lesbian parents who conceived with YFC are proof that it is.
Greenfeld is the first person potential parents meet at YFC (except for those needing help only with insemination). She administers a psychological evaluation and gives them a detailed picture of what to expect from the long process of achieving parenthood. Part of her job is to ask the questions that potential parents may not have asked themselves.
For example, male couples often decide before going to YFC which of them will be the sperm donor. But Nature might not cooperate, and Greenfeld wants them to be prepared. “You might be very clear about who’s going to produce the sperm, but you might also be the guy who can’t produce the sperm,” she points out.
The Center works with couples to come up with individual solutions for their particular situation. Some seek simply an egg donor, a gestational surrogate to carry the pregnancy, or sperm. But more complex scenarios are possible. One lesbian couple at YFC achieved the “dream scenario,” in which one partner provided the egg and the other carried the pregnancy. And one pair of fathers had twins—one twin from each father’s sperm—with the help of a surrogate mother. Whatever arrangement is made, YFC requires that at least one potential parent be biologically connected to the child, providing either eggs, sperm, or womb.
Prejudices persist about gay parents, including fears that they will be less nurturing or that their children are less likely to marry, but these are subsiding amid recognition that gay couples make good parents. Greenfeld has written about the need to overcome such myths. “So many [gay] men have spent their life dreaming about being dads,” said Greenfeld, “and often say things like ‘I just didn’t think it would be possible.’” But the children of the proud gay and lesbian parents who conceived with YFC are proof that it is.
Tuesday, November 18, 2008
The Emotional Rollercoaster
“Emotional rollercoaster” is a phrase often used to describe the ups and downs of infertility. As if the diagnosis and the treatment weren't difficult enough, the emotional turmoil surrounding infertility—while perfectly normal—is yet another source of anxiety and stress. Psychological support and counseling can be very helpful to couples going through this process.
Although infertility affects one in six couples in the United States, when faced with it most people feel isolated and alone. Especially difficult but normal feelings associated with infertility are:
- A loss of interest in usual activities
- Difficulty thinking of anything other than one's infertility
- Change in sleeping and/or eating patterns
- Fleeting thoughts of death and dying
- Difficulty making decisions
- Feelings of isolation and loneliness
At times these symptoms may lead to strained relationships with one's partner, family, friends, and/or colleagues at work. An open (but entirely confidential) discussion of these issues with a counselor can often be quite helpful. In fact, infertile couples face a number of issues that can be helped by a meeting with a mental health professional.
A counselor can provide important information about treatment options and help to facilitate discussion of such highly charged topics as whether or not to pursue a particular treatment; whether and how to pursue third party assistance (such as donor sperm, donor oocyte, and surrogacy); and whether or not to pursue adoption. The counselor can also help with questions about multiple pregnancy, pregnancy loss, and when and whether to stop treatment.
- Dorothy A. Greenfeld, LCSW
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