Science Pulse
President's Council Takes on the Ethics of ART
Many physicians working in the field of Assisted Reproductive Technologies (ART) braced for the release of the latest and fifth report by the President's Council on Bioethics, which takes an in-depth look at the practices and results of ART in the US. Now that the document has been finalized, we are instead pleasantly surprised.
A bevy of questions, recommendations and opinions emerge out of Reproduction and Responsibility: The Regulation of New Biotechnologies, leaving readers potentially baffled about what steps might be taken from its analysis. (See www.bioethics.gov) Yet the report stops short of recommending drastic or unreasonable changes, and instead calls for limitations to about a half-dozen of the most questionable practices (see below). In a reasoned and logical fashion, the report turns out to be a compendium of suggestions for federal monitoring, tracking and long-term research into the health implications of IVF babies and mothers.
The legislative limitations focus on those areas of research that are potentially driven by the promise of embryonic stem cell therapy, and/or cloning. Even in this politically charged area, the Council's recommendations mainly address the kind of obscure research that tinkers with, or attempts to defy the basic building blocks of procreation involving egg and sperm, such as:
 - No transfer of human embryos into animals
- No hybrid human-animal embryos
- No human embryos into women without live-born child intent
- No conception other than by means of uniting egg and sperm
- No conception from gametes obtained from fetus or stem cells
- No conception by fusing the blastomeres from 2 or more embryos
- No human embryos for research beyond 10-14 day stage
Given that these suggested prohibitions in the draft report evoked little outcry, the scientific and medical community appear to be palliated by this report. The last item in particular suggests a maximum 10-14 day development stage for leftover embryos donated to research. By making sure that the embryos are donated for research early in their development, this notion gently disarms the politically prevailing view that no new embryos should be used by federal-funded research to develop new lines of embryonic stem cells.
It is well known that bioethics investigations around the world are driven out of concern that human cloning research is galloping ahead, outpacing the public's capacity to understand, let alone react to this brave new world. Media headlines announcing rat and cat cloning, and the creation of embryos from materials other than eggs and sperm seem to appear regularly in the news.
At the same time, public support for therapeutic research involving stem cells is spreading like wild-fire, prompting a majority of senators, as well as more than 200 members of Congress, including some with anti abortion views, to petition President Bush to lift the ban on new embryonic stem cell lines for federally-funded research. This should come as no surprise; 100 million Americans have various diseases that could eventually be cured by the regenerative capacities of stem cells (i.e. therapeutic cloning), even though sound science to this effect remains elusive.
The Council's report also devotes considerable space describing the need for monitoring, testing and oversight. But again, it stops short of recommending strict new operational standards for ART practitioners, admitting that the current regulations work, notwithstanding the need for a little improvement.
Indeed, infertility practitioners are proud of the high standards they've established through peer-participating professional associations including the Association of Reproductive Medicine (ASRM) and the Society of Reproductive Technologies (SORT).
At the same time, the report's recommendation for a massive and ambitious long-term monitoring project of IVF patients' health is well founded. A 20-40 year federally funded study, following both mothers and their ART assisted children into later years, could reveal new insights into all infertility procedures and outcomes, especially if the research compliments what is already considered science.
The only caveat is additional costs of government monitoring, research and/or regulations have historically fallen back onto the consumer.
To conclude, the majority of ART physicians are in support of reining in the few rogue infertility researchers who have crossed an ethical line attempting to recreate and manipulate some of the core ingredients of procreation (i.e. reproductive cloning) with dangerous and unproven techniques. Reproduction and Responsibility is not expected to cause enormous ripples of change in the ART community. It does an excellent job of presenting the wide breadth of views on the topic, not squelching contrary opinions, but rather maintaining a healthy dialogue. We do not expect to see significant governmental controls emerge for the vast majority of couples who simply want our help in making a baby.
 Dr. Herbert was involved
with one of the first assisted reproductive technology programs
in the USA. He continues to be involved with reproductive research
and maintains an active interest in the ethical dilemmas, which
confront reproductive technologists in the 21st century.
Carl Herbert, MD
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From Us to You
Acquisition of Laser Technology
A recent development in the laboratory at PFC is the acquisition of a laser for use in key procedures. The laser will be used to assist in the processes of Assisted Hatching (AH), Intracytoplasmic Sperm Injection (ICSI), and Pre-implantation Genetic Diagnosis/Screening (PGD/PGS).
All of these procedures require us to make a small opening in the outside shell of the egg called the Zona Pellucida (zona). Prior to laser technology this opening was made with an Acidified Solution, which would slowly dissolve away part of the zona until a small opening was achieved. Now with the laser, a beam of light creates a precise opening in the zona.
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Laser use for PGD: The red "pilot light" marks target for the laser. The white circle marks a “safe zone”. The laser is usually fired 3 times for assisted hatching and 5 times for PGD embryo biopsy.
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The zona pellucida is a non-living, but important part of the egg. It specifically allows only 1 sperm through to fertilize the egg, and then immediately hardens, preventing other sperm from getting in. After fertilization, the egg divides into 2 cells, and then these divide again into 4 cells. As the embryo continues through these rounds of cell division, the zona keeps all the cells together, since it encloses the embryo. After 5 or 6 days, the embryo has enough cells to begin forming a placenta and the embryo hatches from the zona and attempts to implant in the uterine lining.
Assisted hatching (AH) is a procedure that has been around for about 15 years and it is something that is often performed in the laboratory just prior to an embryo transfer procedure. It is a simple and precautionary procedure where we create a small hole in the zona just before transferring embryos to the uterus. Since the zona is not a living part of the embryo, making a hole does no harm, and in fact facilitates the embryo in hatching from the zona once it's in the uterus. A normal embryo should be able to hatch all by itself, but in some patients we perform this procedure just to make sure a problem doesn't arise when the embryo tries to escape from its shell. For AH, the laser will allow us to refine the procedure considerably. Firstly, we will be able to make a hole of an exact size, and secondly, the procedure will be performed more quickly and we will therefore further reduce the amount of time that an embryo is being handled. Traditionally, AH takes about 5 minutes per embryo, but with the laser this time will be reduced to less than a minute. For the process of embryo biopsy for PGD/PGS, an extremely precise opening is made in the zona to facilitate the removal of one cell. Again, the laser will speed the procedure up considerably and reduce the time that we're working on each embryo.
By now you might be wondering if there are any harmful effects of using laser light on embryos. According to several studies and expert opinions, laser-assisted hatching is superior to chemical-assisted hatching as seen by improved development of "hatched" embryos to the blastocyst stage (the stage at which an embryo will implant in the lining of the uterus). Furthermore, laser-assisted biopsy of cells from embryos for PGD analysis does not appear to have a detrimental effect on the continued development of the embryos versus embryos not undergoing any biopsy procedures. This indicates that using a laser to do the biopsy procedure appears to be safe.
Current lasers have several built-in safety features. The laser system is equipped with a second non-laser beam of light, similar to a penlight, which allows the embryologist to observe where an opening of the zona would be created prior to firing the laser. Also, the temperature that the embryo is exposed to is controlled by the use of Isotherm rings. Isotherm rings help the embryologist prevent potential harmful thermal effects on cells adjacent to the zona due to heat from the laser beam. The rings indicate both the drill hole size and the safety region based on temperature. With this interactive feature, the user can predetermine the hole size and eliminate practically all risk of impacting cells within the embryo.
PFC's new laser system has been tested for both accuracy and precision. In addition, the lab staff is undergoing training with Laser professionals on its use and maintenance. They will have unlimited practice time, ensuring the highest level of safety and technique when it comes time to use it on human embryos.
Jean M. Popwell, PhD TS (AB, PFC Lab Embryologist)
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Ask the Experts
Twins and Triplets
Q. Considering how much trouble we're going through to get pregnant, I don't mind if we have twins, or even triplets. What do you think?
A. Many parents undergoing infertility treatment are open to, or even welcome the idea of having more than one baby without fully understanding the risks that a multiple gestation pregnancy poses to the mother and infants. You are wise to research this thoroughly before entering into your cycle.
Let's first look at the facts:
- Over 50% of twin pregnancies result in preterm births;
- Over 90% of triplet pregnancies result in preterm births;
- Virtually all pregnancies of quadruplets (and greater) result in premature labor;
- Compared to a singleton pregnancy, a twin is seven times more likely, and a triplet is
over 20 times more likely to die in the first month of life.
Even with medical advances to handle early birth trauma, premies are more likely to suffer from respiratory distress syndrome, intra-cranial hemorrhage, cerebral palsy, blindness and neonatal morbidity. These stark statistics and more have been compiled by the American Society for Reproductive Medicine (www.asrm.org), and distributed in a patient's fact sheet.
Because these facts are undisputed, infertility specialists with the help of our professional associations began a campaign to actively educate couples about the risks of multiple gestations, and to make responsible decisions. Fortunately, this work is now showing results. Research published in the April 14th 2004 New England Journal of Medicine revealed a drop since 1997 in the number of high-order multiple pregnancies. In 1997, women under 35 faced nearly a 14 percent chance of having triplets or more! Today that figure has dropped to 8.1 percent, which is still higher than the natural incidence of multiple gestation.
Couples who share the goal of conceiving a single, healthy child generally end up as happy, and with far fewer complications, as those couples that have more. If the embryos are of good quality, our doctors will transfer no more than two embryos in a first IVF cycle for women under 35. Bear in mind that identical twins are possible, since an embryo can split in two. If a couple is opposed to selective reduction, a single embryo transfer is sometimes the best choice, especially if a young donor's eggs are used.
With our guidance and your understanding, we trust you will make the right decision for your health and the health of your baby.
Philip Chenette, MD
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PFC Spot Light
An IVF Nurse's Perspective
 I
started on my merry ride down this road 41 years ago. Back in Ireland,
the career choices for young ladies were very limited. Teaching or
Nursing. I chose the better part, nursing. The teaching aspect has
somehow also gotten its hooks into me along the way. My entry to IVF
Nursing was via many years of practice in the Acute Care setting,
staff nurse, then on to nurse manager for Med Surg., then Nurse Manager
for Post Partum, Peds and Nursery till I could not take it any more.
Budget cuts. Decreased staffing. Managed Care. Totally burned-out
and exhausted, I quit. However, through all those years I learned
some valuable lessons. Allow me to share them with you.
The most valuable lesson, and the lesson that led me to quit, was that I needed to take care of myself first. Then taking care of others would not be such a chore.
So... one of my colleagues told me that a position was coming available at the infertility clinic where she worked. What had I to lose? So, recharged, I interviewed, was offered the position and eleven years later, here I am.
The next lesson I learned was to accept that we live in an "out of control" world. A typical day as an IVF Coordinator is a perfect example of that. But that doesn't mean that we can't influence the situation into something manageable and positive. As professionals, we have come a long way. The first IVF baby in the USA was born in 1981. The role of the IVF nurse has changed dramatically since then. As our roles have evolved and expanded, we have come to be in an excellent position to empower our patients. We can do this by providing information, education, and support that enables them to make decisions in what most patients see as a very difficult process. By empowering our patients, we allow them to regain some control of their personal situation and feel that they are part of the team.
As new developments and scientific advances continue, keeping informed is not only a challenge but also our responsibility. Networking and attending symposiums provide a unique opportunity for us to learn and share ideas. It is reassuring to talk with other nurses and discover that they too have days in the clinic when they are "running around like ants on a sticky bun"! In fact, many of us thrive in that kind of environment. Just know that each ant on that sticky bun has a specific goal and a plan for achieving that goal.
The IVF team is comprised of many disciplines and each professional brings a specific area of expertise and skill to the team. As a nurse on the team, our challenge is to demystify the world of Assisted Reproductive Technology for our infertility patients. We, as nurses, spend more time with the patients than any member of the IVF team and act as the "guide" through their treatment maze.
Another lesson I learned was that it is imperative we recognize our worth and accept the fact that the support and skill we bring to our patients and colleagues may very likely change and enhance their lives. What we do matters. We touch the lives of so many people and influence them in so many ways. Empathy, kind words, a positive attitude, respectful interaction, taking the time to listen, maintaining a healthy sense of humor and remembering to smile are contributions we can make every day.
There will always be a need for nurses and I for one enjoy the daily face-to-face interaction with patients and colleagues in the clinic. The best and most rewarding aspect about my day is the patient. They are all a pleasure and bring unique needs and challenges. Being able to meet and exceed those needs is our most precious reward.
About the author:
Ann McGovern, BSN is currently a Clinical Nurse Coordinator at Pacific Fertility Center in San Francisco. Ann did her initial nurse training in Dublin, Ireland and received her BSN from California State University. Ann has been a practicing nurse for 40 years with the last 11 years specialized in infertility. Ann is an active member of ASRM and a member of ivpcare's Nursing Advisory Board. Ann wrote this story for ivpcare's Fertility Nurses First newsletter. Ivpcare is a specialty pharmacy, which provides patients with information on resources, medication and treatment options.
Ann McGovern, BSN
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-- Best regards from all of us at Pacific Fertility Center.
Copyright © 2004 Pacific Fertility Center and Its Licensors. All rights reserved.
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