Tune your radios to KGO 810 AM, tonight. Dr. Givens will be the featured guest on the Pat Thurston Show from 10 – 11 p.m. PST. Dr. Givens will be discussing many fertility issues including treatments, outcomes, and ethical issues. She will also be taking questions from callers. You may also stream the show live on the KGO website.

This year’s flu season is certainly not your standard flu season. 2010 brings not only the current seasonal flu variety, but also the pandemic H1N1 virus, commonly known as Swine Flu. These are two separate viruses. H1N1 is not only of great concern for all members of the population, but also of particularly serious concern for pregnant women.

The single most important action, strongly recommended by the Centers for Disease Control (CDC), is for pregnant women to be vaccinated against both the seasonal flu and, most importantly, H1N1. Both the seasonal flu vaccine and the H1N1 vaccine can be administered at the same time, at separate injection sites. There are two methods of dispensing the flu vaccine; either by injection or by a nasal spray (Flu Mist).

For immunization of pregnant women, only the injectable vaccine should be administered. Ob/Gyn practices will be the first to receive the vaccine. Patients should plan to be vaccinated at their Ob office.

Above: Tis the season to be conscious about germs

In addition to the flu vaccines, there is medication available to treat those with symptoms of the flu or those who have been exposed to someone with the flu. Symptoms of the flu can include: cough, sore throat, runny or stuffy nose, body aches, headache, chills, fatigue, and sometimes diarrhea and vomiting. Fever is common, but it is important to note that not everyone with flu will have a fever. If you have symptoms or if you have been exposed to someone who has the flu, call your doctor right away.

Pregnant women with suspected influenza, or experiencing more severe symptoms such as evidence of lower respiratory tract infection or clinical deterioration should receive prompt empiric antiviral therapy, regardless of previous health or age. Most healthy persons who develop an illness consistent with uncomplicated influenza, or persons who appear to be recovering from influenza, do not need antiviral medications for treatment or prophylaxis.

Pregnant women exposed to someone with influenza should consider antiviral chemoprophylaxis. Chemoprophylaxis should generally be reserved for persons at higher risk for influenza-related complications who have had contact with someone likely to have been infected with influenza. However, early treatment is an emphasized alternative to chemoprophylaxis after a suspected exposure. Household or close contacts (with risk factors for influenza complications) of confirmed or suspected cases can be counseled about the early signs and symptoms of influenza, and advised to immediately contact their healthcare provider for evaluation and possible early treatment if clinical signs or symptoms develop. Early recognition of illness and treatment when indicated is preferred to chemoprophylaxis for vaccinated persons after a suspected exposure.

Go to the emergency room immediately if you have difficulty breathing, or shortness of breath, pain or pressure in your chest or abdomen, sudden dizziness or severe or persistent vomiting. Prevention is certainly the best defense–and there are a number of things we can all do to minimize the spread of flu this season.

Wash your hands! Frequent hand washing or use of alcohol-based hand sanitizers is a major preventative measure. Carry a hand sanitizer in your purse, in the car, even a small bottle in your pocket. You can use them just about anywhere at any time.

Cough into your elbow! This helps to keep your germs to yourself.

Keep your hands away from your face! You will not be infected with the flu by touching a contaminated surface — unless you then touch your eyes, nose, or mouth.

Stay away from sick people if you are healthy and from healthy people if you are sick! You do not want to knowingly expose yourself, but remember, if it does happen, call your doctor straight away.

You do not want to spread the flu if you have it. Stay home and stay away from other family members as much as possible and make sure to call your doctor as soon as you have symptoms.

The CDC will continue to update their website as there is new information:

For general information on 2009 H1N1 flu go to:
cdc.gov/h1n1flu/qa.htm

For more information on flu shots go to:
cdc.gov/h1n1flu/vaccination

In the press today we see that the “world’s oldest new mom dies” at age 69 (see our earlier blog post clarifying that PFC did not treat this patient), three years after giving birth to twins conceived through IVF. Maria del Carmen Bousada apparently lied about her age to the Los Angeles Physician who helped her become pregnant, creating a firestorm of criticism in the press.

The case demonstrates one of the most basic dilemmas that we face in helping women become pregnant: at what age is a woman too old to become a mother?

Most of us might agree that a 25 year old woman is young enough to receive help, but that a 70 year old is too old. However, drawing the cut-off line at some point between these extremes is not easy. With the help of in vitro fertilization and donated oocytes, women like Maria can become pregnant at an age where nature would naturally prevent the possibility of conceiving. Typically, women run out of oocytes in their early 50’s and without oocytes and the granulosa cells that surround them, they lose their ability to make estrogen. This natural process, called menopause, can happen earlier or later for a given individual, but the ability to get pregnant and deliver a healthy baby declines rapidly for women in their late 30’s and on into their 40’s. The age of the woman is a determining factor of her since a 40 year old woman is trying to get pregnant with a 40 year old oocyte, and these older oocytes don’t perform well. For example, the older oocyte is not good at keeping track of its own DNA, as evidenced by the increasing incidence of genetic defects such as Down syndrome in older mothers. And as if this wasn’t bad enough, the rate at which oocytes are lost from the ovaries (also know as a woman’s biological clock) doubles at about age 38. If this doubling didn’t happen, we think that women wouldn’t reach menopause until their early 70’s. It is thought that the speeding up of the biological clock in the late 30’s is nature’s way of clearing out the remaining oocytes, so that women lose their ability to become pregnant but are then around to raise the children that they already have.

Based on nature’s model, we might consider limiting IVF treatment to women that are in their early forties or younger. But with donated oocytes, this limit can be pushed and there are no legal age limits for pregnancy. So, who gets to decide when it’s too late to become pregnant? As far as following “nature’s model”, is age different than other factors that lead to infertility? Do we make rules? And do the rules apply to men too, where nature doesn’t have limits?

Note: Pacific Fertility Center does have both lower and upper age limits in place.

News broke earlier today about the death of a 69 year old mother who had undergone fertility treatment at age 66. She gave birth to twins in December 2006.

This is a very unfortunate incident and we express condolences to the loved ones, especially the children who are left behind. However, it is necessary to clarify that Pacific Fertility Center was not involved in the treatment of this patient. The AP article printed the name of the clinic as “Pacific Fertility Center”, which is an error of ambiguity since there are two fertility clinics with similar names. The fertility clinic where this woman received services was Pacific Fertility Center-Los Angeles. Our center, which is located in San Francisco, has no affiliation with the clinic in Los Angeles. While our names are similar, our standards of practicing medicine are much different. To begin, here at Pacific Fertility Center in San Francisco, it is standard procedure to verify the identity and age of the persons being treated at every visit.  Our physicians would not have treated a woman at the age of 66, since we believe this to be unethical. At Pacific Fertility Center in San Francisco, we believe it is our foremost and ethical responsibility to assure the children that are a result of our services are provided loving and caring families.

The U.S. marketplace is punctuated with products and services trying to lure desperate parents into believing that somehow, someway, it must be possible to predict and even select the outcome of the baby’s gender through various hocus pocus methods. Perhaps not coincidentally, many products and services, such as www.fortunebaby.com, appear to be subsidiaries of companies based in China and India where male babies are prized over baby girls.

In the line-up of such products, Baby Gender Mentor blood test hit the marketplace with great Public Relations fanfare including a brief interview on the Today Show and a headline in the Boston Globe. Sadly, both of these popular press outlets focused squarely on the debate about gender selection ethics and never seriously questioned the accuracy of such a test. As a result, millions of viewers and readers may have assumed the expensive test results were accurate. Acu-Gen charges $275 to mail order the test.

This was in June. Now, three months later, enough women who were lured into buying the test and assured by the company’s guarantee that it will reimburse misdiagnoses with 200% of their money back, are asserting the test doesn’t work. Many women are trying to get refunds and are being told by Acu-Gen that a “vanishing twin” may have caused the test to fail.

National Public Radio, taking a more critical stand, recently broadcasted a story pointing out that Acu-Gen offers little proof of its claims and admits that it is not required to undergo FDA testing to verify accuracy. On its web site, the company describes how the process purportedly works.

Gender-specific DNA from the fetus floats around in the mother’s blood stream after having crossed over the placental walls. The presence of the Y chromosome in the female blood via a finger-prick blood tests indicates a “male-positive” baby.

A visit to Acu-Gen’s Gender Mentor test web site reveals some other questionable assertions. Men are not allowed to be anywhere near the pregnant woman as she is having her blood drawn for the test. Acu-Gen also lists on its web site the names and publications of noted experts on fetal DNA testing, some whom NPR interviewed and deny any involvement with the company.

The notion that just five weeks into a pregnancy a simple blood test can accomplish what amniocentesis or ultrasound can do much later in a pregnancy is at this point wishful thinking. A dedicated web site: www.in-gender.com takes a more comprehensive and critical look at the claims of many sex-prediction and selection techniques and includes descriptions of the high-tech methods that do work.

– Eldon Schriock, MD

As there has recently been extensive media coverage of an ongoing child custody case resulting from a mix-up of embryos transferred by another Bay area IVF Center, we want to convey to our readers just how serious we consider this matter. Recognizing the devastating consequences of such an embryo mistake, many years ago we developed and put in place a system of patient-embryo recognition we call Pacific Fertility Center’s SurTransfer^SM protocol. To help dispel any unwarranted fears surrounding your IVF cycle, we are presenting in this issue a detailed explanation of this important system of multiple checkpoints and special procedures for ensuring proper recognition of all reproductive materials.

All of us who work in the field of assisted reproduction recognize the potential for human error. We feel very fortunate at Pacific Fertility Center to have never had a known case of mistaken identity and gamete or embryo mix-up in our In Vitro Fertilization program. However, we continually look for new and better ways to ensure these errors never will occur. Please know if ever there should be any mishaps with eggs, sperm or embryos, we are committed to immediate, complete and total forthrightness and honesty with our patients.

We find it reassuring there have been over 100,000 babies born in the U.S. with the help of IVF since the first birth in 1979 and instances of embryo or gamete mix-up are extremely rare. At Pacific Fertility Center we plan to maintain our positive track record through the continued use of our proven SurTransfer^SM protocol. Our fertility team strongly believes that, along with providing safe and successful infertility care, maintaining correct laboratory procedures is an equally important responsibility.

Sincerely,
Joe Conaghan, PhD, Philip Chenette, MD, Carolyn Givens, MD,
Carl Herbert, MD, Isabelle Ryan, MD, Eldon Schriock, MD

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.

Each year Pacific Fertility Center® sends a delegation to the annual meeting of the ASRM the American Society for Reproductive Medicine. This prestigious conference draws researchers and practitioners from around the world, and this past event in San Antonio in October 2003 was no exception. Over 6,000 people attended from 32 different countries.

We have provided this summary of highlights to share with Fertility Flash readers. This tiny sampling by no means reflects the scope and depth of the 1800 scientific research papers that were presented. Human Nuclear Transfer From a popular press’s point of view, the most talked-about paper was Dr. Jamie Grifo’s research on human nuclear transfer. Each day of the conference, a new headline appeared with the world “clone” or “clone-like” even though Grifo and his Chinese colleagues, who reportedly tried the process unsuccessfully, insist that the process is not cloning. They fused the DNA from the oocyte of an infertile woman with a donor oocyte from which the DNA had been removed, and then fertilized the “reconstituted egg” with sperm. This experimental procedure has not yet produced a live birth, and the FDA prohibits this type of research in the U.S. It was recently banned in China as well. It is an incredibly complex procedure that is not likely to ever be commercialized due to the fact that so many embryos are rendered non-viable. OK to Go Patients who have just undergone Embryo Transfer after IVF are no less or more likely to conceive if they immediately go to the restroom. A study revealed that there was no difference in pregnancy rates between those women who had to go immediately and those who waited. Relax about SSRIs Women undergoing infertility treatment who take prescription medications in the category of Selective Serotonin Reuptake Inhibitors (Zoloft, Prozac, Paxil, etc.) have less to worry about. Children conceived by women on SSRI medication were no more or less likely to have problems. 911 Decline Infertility patients from New York treated in the midst of the September 11, 2001 tragedy suffered from a higher rate of pregnancy loss than those treated prior. The results of nearly 400 patients who underwent an IVF procedure before and after September 11 were examined. Individuals placed in the “before” or “after” groups showed no significant differences in age, number of eggs retrieved, or number of embryos transferred. Clinical pregnancy rates were also comparable between the two groups. However, there was a nearly 25% lower delivery rate for the patients with a pregnancy test after September 11. This study again points to the significance of psychological factors that impact outcomes of infertility therapy.

Telomeres Predict Poor Prognosis Scientists are noticing a correlation between short telomeres and egg quality. Telomeres are small pieces of DNA at the ends of chromosomes, that shorten naturally as we age. Telomere length could someday be used as a test of fertility potential.

Joe Conaghan, PhD	Eldon Schriock, MD

Drs. Joe Conaghan, PhD and Eldon Schriock, MD along with other PFC professionals attended the ASRM meeting and are committed to continually evaluating the latest research and using proven treatments to improve patient care.