1. A healthy woman in her late 30’s or even in her 40’s, will have the fertility of a younger woman.
   Although it is always better to be healthy, especially when it comes to carrying a pregnancy, the likelihood of conception is tied to the age of a woman’s eggs and is not closely related to her general health.
2. You should have sex every other day during the fertile window.
   For most men, sperm recovery is very rapid. Sometimes when an IVF cycle is done and there are many eggs to fertilize, we ask for a second semen sample. We are often amazed when the second sample, collected just 2 hours after the first sample, has even better numbers. So, rather than attempting to “save up good sperm” by having less frequent intercourse during the most fertile time period, we recommend more frequent intercourse. A home ovulation predictor kit is useful to time sex to ovulation. When using the ovulation predictor kit, we recommend sex on the first day of the LH surge and the next day too.
3. Fertility medications are associated with a higher risk of cancer.
   In the early 1990’s, some concerns were raised that taking fertility medications might be associated with a higher lifetime risk of ovarian cancer. Since then, several studies have been published that did not find this to be true. Because of this thorough and extensive research we feel comfortable using these medications not only on patients, but our egg donors as well.
4. Fertility medications (especially injectable fertility medications) cause women to be emotional wrecks.
   Although Clomid (clomiphene citrate) has well-known side effects related to its anti-estrogen effects, the injectable fertility medications do not tend to cause the same negative mood alterations. These drugs increase estrogen levels, a hormone which tends to have positive affects on mood.
5. Using fertility drugs and getting multiple eggs might use up my future eggs and cause me to go into menopause earlier than expected.
   Humans usually only ovulate one mature egg each month. This egg is contained in the dominant follicle and grows in one ovary or the other. For each dominant follicle that develops in any particular cycle, there are several other follicles/potential eggs available that are also trying to become that dominant follicle. The number of these other “antral” follicles varies from woman to woman and to lesser degree, from cycle to cycle. In general, the number of antral follicles declines with female age. Once the dominant follicle has been selected and the egg ovulated, the menstrual period or a pregnancy begin, and the other antral follicles, undergo programmed cell death, called atresia. The use of fertility medications rescues this group of antral follicles from atresia. For this reason creating multiple mature follicles and obtaining multiple eggs in any one cycle does not use up future eggs. We are simply rescuing eggs that would have otherwise died that month.
6. Having a miscarriage is a good sign that a woman is fertile.
   Approximately 70% of miscarriages are due to abnormal chromosomes (DNA) in the embryo. As a woman ages, more and more of her eggs become abnormal In fact, at age 40, only 1 in 10 eggs on average has normal chromosomes; so a woman at that age may only ovulate one normal egg per year. While a miscarriage may indicate that fertilization and implantation can occur, it doesn’t necessarily mean that overall egg quality is good. Egg quality is the best indicator of the ability to produce a viable pregnancy.
7. Stress is a major cause of infertility.
   There is enough circumstantial evidence to indict stress as a collaborator when it comes to fertility; however, there is very little evidence to convict stress as a major perpetrator. Usually there is some other underlying cause to the problem, even if it is just age-related sub-fertility (decline in fertility due to female age and therefore higher numbers of abnormal eggs). Stress, however, can compound the problem and possibly negatively impact egg quality and uterine lining quality. Look for a new addition to our website, the Domar Fertility Stress Questionnaire, to assess your stress levels.
8. In Vitro Fertilization can help women in their late 40’s and even 50’s to conceive with their own eggs.
   Despite the number of celebrities having babies in their mid-forties and beyond, these babies may not necessarily have been the result of an in vitro fertilization process using their own eggs. While we respect a woman’s right to privacy and their decision not to divulge this little detail, the perception left with the public is that fertility treatments can extend one’s reproductive life. Unfortunately, this simply is not true. There is a very, very low probability of improving one’s success of conceiving after age 43 by using assisted reproduction, unless the woman considers using donor eggs.
9. In Vitro Fertilization success rates are low.
   Across the United States, including patients of all ages, the delivered success rates for in vitro fertilization have risen from about 20% in the mid-1990s to about 35% in the mid-2000s. During this same period, fewer embryos were being transferred to the uterus per cycle and the triplet and higher-multiple pregnancy rates dropped dramatically. Though it may take more than one attempt to conceive, the majority of patients are successful.
10. Very few people ever experience infertility.
    Many fertility patients feel they are the only ones in their circle of friends and acquaintances suffering from infertility. At times, it seems as though everyone else is having a baby. Actually, one in six couples is having trouble with conception, they just may not talk about it. Since they are not pushing a stroller, there is no outward visible sign of their fertility status. When couples decide to share the story of their fertility quest, they often find there are many of their peers experiencing similar difficulties. They discover friends who can not only relate but also provide valuable support.

In late October of this year, our first patient who underwent embryo transfer with embryos created from vitrified and warmed donor oocytes has successfully delivered. The baby was born at term and appears to be perfectly healthy.

Three other pregnancies are ongoing and are expected to deliver in 2008. We congratulate our new parents and the parents-to-be who have participated in this ground breaking program.

PFC has ended enrollment of patients into this program, but expects to continue research efforts with respect to oocyte vitrification.

The American Society for Reproductive Medicine (ASRM) is the largest organization in the United States for medical professionals in the field of Reproductive Endocrinology and Infertility. In 2002, ASRM published medical and psychological guidelines for ovum donation. The psychological recommendations for donors are general guidelines for addressing moral, ethical and psychosocial issues that may confront ovum donors. Included are standards for what should be included in a psychosocial screening of donors and reasons to exclude donors. A few of the objective reasons for donor exclusion include known substance abuse, positive family history of heritable psychiatric disorders such as schizophrenia or bipolar disorder, or instability in donors’ lives. To determine “inclusion” I take a psychosocial history and administer a psychological test that informs me about the donor’s personality profile, including just how much they are trying to impress me – the “fake good” factor. I am also assessing motivation to donate and the donor’s “need” versus “desire for” the compensation. Stability, stress levels, and reproductive history are also part of an ASRM assessment of donors.

Although I would like to base my entire decision on objective information, much of my decision on donor acceptance must, in fact, be based on intuition. Throughout my 25 years as a therapist, I have found that my intuition is quite accurate, but it is not fool proof.

There is one major controversy in the field that may hinder a psychotherapist’s ability to screen donors. That is the hotly debated topic on compensation of donors. In August 2000, the Ethics Committee of The American Society for Reproductive Medicine concluded that there is no consensus on the precise payment that oocyte donors should receive. It was suggested, “sums of $5,000 or more require justification and sums above $10,000 go beyond what is appropriate.” Due to costs of living and the scarcity of available donors, there are significant regional variations that affect these rates.

The Society for Assisted Reproductive Technology (SART) has attempted to assist clinics and patients by creating a list of Egg Donor Agencies that have signed an agreement stating that they will abide by the Ethics Committee Guidelines governing the compensation of egg donors.

The debate centers on the fact that donors could feel undue inducement and exploitation in the process if the fee is so high as to be coercive. Part of the job of the mental health professional is to provide donors with informed consent. Might donors conceal pertinent medical information that could be important for themselves or offspring if the monetary incentive is so high? Will donors discount risks to themselves? How can the donor actually give informed consent about the medical procedure and pay attention to the risks if $$ signs are floating before their eyes?

Ethicists and some in the field of women’s health advocacy express concern “that lucrative payments are enticing young women with credit-card debt and steep tuition bills to sell eggs without seriously evaluating the risks.” Can the payment cloud someone’s judgment and can we assess that? How much is too much? Where is that line?

When I began working with PFC in 1998, we were paying first time egg donors $2,500. Nine years later, the compensation is $6,500 for a first time donor and $7,000 for any subsequent donations. Even adjusted for inflation, the payment is rising at a phenomenal rate. Competition, supply and demand govern these rises.

As part of my objective/intuitive approach to interviewing donors, I discuss money with them. What would she use the compensation for? How does she support herself? What kind and how much debt does she have? While $25,000 in student loans points to a person’s drive toward positive goals, the same amount in credit card debt speaks to me of impulsive behavior. How much have they educated themselves on ovum donation? Whom have they talked with about their desires? Do they have their own children? Are they science majors who may be more likely to view gametes as DNA and not their own children? Are their answers well thought out?

My goal is to provide the recipients of donated eggs with intelligent, healthy, and thoughtful young women who understand the implications of ovum donation both for themselves and for the recipients. Donors who are motivated by the “need” for money are more likely to provide inaccurate information on their applications, or leave out information that could be pertinent to the recipients or their offspring. It is my job and the job of the Egg Donor Agency to determine motivation.

Although impossible to attain, we would all like donors to be motivated altruistically. We may diminish altruism by making the donation about eggs for money. However, I believe we can increase altruism by helping the donors to have a greater understanding of who the recipients are and what their struggles have been.

Peggy Orlin, MFT

Ms. Orlin served as 2006-7 chair of ASRM’s Executive Committee of the Mental Health Professional Group, is a member of Resolve’s National Mental Health Advisory Board. She co-teaches PFC’s Mind/Body workshops.

To register for the September 8th Mind/Body@PFC Workshop, please phone 415-834-3095.

DonateYourEggs.com

Pacific Fertility Center provides an in–house egg donor agency as a convenient way for our patients to find carefully screened egg donors. Our Egg Donation Agency is always looking for new egg donors to add to our registry. Do you know a college graduate, a student, a young professional or an exceptional woman who might be willing to make a life-altering difference? She could be a young woman who has chosen to delay childbearing or has decided to be childless and wants to help others become parents, or she could be a mother who wants to share the joy of parenthood through the gift of egg donation.

Please send them to our agency’s Egg Donor website. The website has more information about becoming an egg donation and also has an online application.

Please note: Because age is a critical factor in the success of IVF with egg donation, egg donors must be healthy and between the ages of 21 and 29.

Click here: PFC Egg Donor Agency for information about the services we provide egg donor recipients.

We are pleased to announce that our egg donor registry is now available on-line to both current and prospective PFC patients. For many intended parents, having an on-line donor registry affords optimum privacy and convenience when it comes to the egg donor search—an intimate, private, and time-consuming experience. The on-line donor registry is valuable for intended parents living outside of the San Francisco-Bay Area as well. Those wanting to view our donor registry in-person can still do so by contacting our agency in order to schedule an appointment.

The on-line donor registry provides a wealth of information about the egg donor to both current and prospective PFC patients. Prospective patients are eligible to receive “Level 1” access, which allows you to view a donor’s photo along with basic information about the donor. “Level 2” access is available to current PFC patients only and allows you access to additional photos and the donor’s application. Both “Level 1” and “Level 2” access allow the intended parent to search for donors based on criteria such as eye and hair color, ethnicity, region, as well as by certain keywords. The interface is highly intuitive, providing a convenient drop-down menu allowing the intended parent to narrow down the search to meet their particular preferences. For instance, if the intended parent is looking for a blonde donor with blue eyes, the drop-down menu will narrow down the search accordingly. “Level 2” access, however, gives the intended parents the opportunity to review the donor’s entire application and multiple donor photos. Information on the application includes the donor’s personal and family medical history, educational background, and personality traits. The EDA works with PFC’s medical board to cautiously screen each of our donors to increase your chances of having a healthy baby.

In order to access our on-line registry, visit pacificfertilitycenter.com, then select the Egg Donor Agency link to the left, then select Search Egg Donor Registry. The intended parent will be prompted for a username and password. If the intended parent does not have this information, they should call our Egg Donor Agency at 1-800-734-2015. Given the private and personal nature of egg donation—for both intended parents and donors—we have gone to great lengths to ensure that our on-line donor registry has met our rigorous internet security standards.

If someone would like to learn more about our egg donation services and egg donor registry, the first step in the process is to call our Egg Donor Agency or visit our website. Egg donation can be an outstanding family building option for those wanting to conceive but are unable to use their own eggs. Our new on-line egg donor registry will streamline the process of selecting an egg donor, making it easier for intended parents while ensuring privacy for all parties involved.

I can remember the day I decided to make the phone call to PFC to inquire about becoming an Egg Donor. I was so excited at the idea of “making some money”. Though, it took me about a month to work up the courage to complete the application and return it with my pictures. I kept thinking who would want to receive my eggs? Maybe I was too short or too blonde? I was also worried about who would see my pictures/profile and if they would recognize me or know someone in my family. It was not until I heard a story about a couple who was having a hard time trying to conceive their first child. Their story broke my heart, because I had always assumed that getting pregnant and carrying a child to term was supposed to be easy. After their story, I knew that I needed to do something besides “making some money.” Instantly I spoke with my family and asked for their support and then returned my completed application.

It was only a few weeks later that I heard from a PFC Egg Donor Coordinator, Bridgett. I thought how lucky I am to be “chosen” by this couple! Bridgett was so professional and took care of all the details for my initial process. I soon realized what a bigger issue this was when I met the first recipient couple. They were just as anxious as I was about the experience, but when they told me their story something bonded between us and by the end of the meeting, I knew there was a greater reason for why I was donating my eggs. I saw how much it meant to them and I was surprised by how much it affected me. I walked out of the meeting knowing something wonderful was going to happen and I was lucky to be apart of that process with them.

Before the first recipients selected me, I thought that PFC worked only for the benefit of the parties wanting to get pregnant. It was only after my first cycle donation, that I realized how much I received from the experience. The experience changed how I looked on life and how precious the gift of life is. All I could think about was how I “flushed” away my eggs every month because I was not ready to start a family of my own and how precious those eggs are for some people. Words cannot describe how amazing it felt to help others, with something that seemed so small and was ‘flushed’ away.

In the beginning, I was full of mixed emotions. I was very excited to meet the PFC staff and start my first cycle. Yet, I was nervous about the process and how it would affect my day-to-day life. But every member of PFC was kind and professional, and put me immediately at a sense of ease. Since I was apprehensive about needles, I had decided I would administer all of the shots, except the HCG shot, to myself and found that it was an easy experience. The medications were gentle on my body and the side effects were very minimal. There were no outward indications that I was going through the process, the worst side effect was minor bloating towards the end of the cycle.

At every appointment, the entire staff was amazing and so supportive. I had decided to take my mother with me for support for the last appointment and retrieval, when we left the procedure she turned to me and said she was so proud at what I was doing and wished that she had done something similar. It was then that I felt I was making a difference in the world. The actual retrieval was so easy; I think the worst part of the process was having an IV inserted in my hand. The best part was the Retrieval Nursing Staff, Ann, Olga and Carol; they made me feel like I was so special. The way they treated me made me feel like I was a part of a unique club. I knew that I wanted to do more after that first cycle. With each cycle, the process seemed easier. The staff began to remember me and always made a point to remind me how appreciative they were for my donations.

It was just a few months ago that I finished my last cycle (6th), and I was full of mixed emotions when I left the final retrieval. On one hand I was excited that I could help another couple. But on the other, I was sad because it would be the last time I donated and the last time I would see the staff at PFC. Throughout all six of my cycles, I had the privilege to get to know the staff and Doctors at PFC. I would recommend PFC to anyone in need of their services or wanting to become an egg donor. The staff is the most remarkable group of individuals. Their professionalism exceeds what you would expect to receive. They change lives and make dreams come true for everyone involved!

Donating your eggs requires you and your family to be selfless and unconditionally giving of yourself. You must not connect with the idea of a child in the world with your features, rather you must see it as a gift you have given a deserving couple. To be an egg donor was an honor that I will always hold in my heart. The feeling you get from helping others is more of a reward than you will ever realize.

– Donor remains anonymous

Is the Future of Egg Freezing Here?
On the surface, it sounds remarkable that one can now shop for frozen oocytes through a start-up company called Cryo Eggs International, which offers single frozen oocytes for sale for $2,500 apiece via mail order. Based in Arizona, the company offers no guarantees whatsoever. The company claims that couples can save money and reduce their risk by choosing individual frozen eggs over the more involved and expensive process of working with a donor to produce fresh oocytes for fertilization.

Oocyte cryopreservation technologies have been evolving since 1986, and there is little doubt that there is a strong future in egg freezing. Young women are expected to have the choice of “banking” a cache of their genetic material for later use. Infertile women may indeed turn to a frozen egg bank, much the way that frozen sperm is marketed, to choose available eggs.

But is that time now?
A handful of infertility clinics are offering female patients a chance to undergo an IVF cycle and freeze their eggs for future use. Eventually PFC expects to offer this. Yet the majority of these clinics insist on prominently displaying the disclaimer that egg freezing technologies are still evolving and are highly “experimental”.

Indeed, as of early 2005, less than 1% of eggs that had been frozen and thawed had resulted in live born infants. (Keeping Egg Freezing in Perspective). Most certainly, egg-freezing technologies advancing cryopreservation of oocytes are evolving rapidly. (A Few Good Eggs). Yet the research community is still weighing the advances of different freezing mediums and methodologies, such as rapid vs slow freezing and thawing.

Responsible researchers/authors publishing their work in the global body of scientific literature are calling for several more years of studies with larger numbers of participants. Most of the current research is based on very small groups.

Cryo Eggs International attributes its success to the advances of Dr. Jeff Boldt, an associate professor of medical and molecular genetics and scientific director of Assisted Fertility Services at the Community Health Network, Indianapolis. He is also reportedly the scientific director at Cryo Eggs International. Yet Boldt’s primary published work in a scientific journal reported the results of a study that only involved 11 women. He is quoted in the media as having a larger number (33) of cycles from which results were comparable to standard IVF procedures, yet this study has not yet been published in a peer-reviewed science journal.

Can one tell if an egg is good or bad upon thawing?
Unlike sperm, of which mainly healthy ones are frozen, there is no sure way to determine quality control of a donor’s eggs short of conducting a DNA analysis of the resulting embryo. In this regard, Cryo’s customers are essentially asked to purchase single oocytes not knowing if they are viable.

Associated Costs with Frozen Eggs
After oocytes have been frozen they may have a thicker outer wall, otherwise known as the zona pellucida. This generally requires the embryologist to apply additional costly methodologies such as assisted hatching and ICSI.

Healthy Quarantine
The six months of freezing that is required before the frozen eggs can be released is no different than the six month testing requirement that a typical donor must go through to test for infectious diseases. In this regard, it is misleading for the Cryo Eggs International web site to claim that this process is any safer than conventional donor cycles.

Successful Approach
A donor cycle at Pacific Fertility Center has yielded a consistent 65% or greater success rate for many years. A key point here is this record has improved incrementally over the years after decades of experience and applying evolving technologies.

It is every physician’s wish for his/her infertile clients’ to have inexpensive choices to tackle their life dream of conceiving. It is also important for people to be as well informed as possible so their money may be spent for the most cost-effective and successful method for their particular situation.

– Carolyn Givens, MD

Pacific Fertility Center takes great pride in its pregnancy success rates resulting from oocyte donations to women who are unable to provide their own high-quality eggs. An oocyte donation procedure involves much more than screening and scheduling. Both the donor and the recipient’s bodies have to be “synchronized” carefully and deliberately, matching the donor’s oocytes to the recipient’s uterus, as if there were one body making the egg and growing the embryo. This article describes the synchronization steps that match the oocyte to the uterus.

After all parties have completed the required screening, the donor and recipient are typically started on low-dose oral contraceptive pills. While the menstrual cycles of donor and recipient may begin on different days, the pills cause the ensuing menstrual flows to match. Depending on how far apart their menstrual cycles occur, it can take up to two weeks for their respective cycles to be synchronized. Additionally, the pills help prevent the women from developing ovarian cysts, fluid sacs in the ovary, which can delay the start of the cycle.

After a minimum time of at least 14 days of the pill a medication called “Lupron” or “Synarel” is prescribed for both parties. These medications turn off the fertility hormones produced by the pituitary gland and, in essence, shut down the ovaries. Lupron is taken as a subcutaneous injection. Synarel is administered as a nasal spray. Once it is determined that both women’s pituitary glands are adequately suppressed, stimulation of the donor’s ovaries and the recipient’s endometrium may be initiated respectively. Both donor and recipient continue with Lupron injections or Synarel sprays to help prevent early ovulation.

As the donor is initiating stimulation of her ovaries, the recipient starts taking estrogen to prepare the endometrium or uterine lining. The lining is very thin after the menstrual flow. Estrogen stimulates the thickening and development of the lining in preparation for implantation of the future embryo. In a natural cycle, estrogen comes from the follicle developing in the ovary. Since the recipient’s ovaries are suppressed, the estrogen comes from medication. An ultrasound will determine the thickness of the uterine lining and some supplementation may be administered to ensure the best possible environment for implantation. She will have between 10 days and two weeks before the implantation.

High tech methods of administering estrogen have been developed. Pure estradiol is very similar to cholesterol, and is very poorly absorbed when taken orally. Injectable estradiol is closest to natural estrogen. It is most easily administered in an oil base, as estradiol valerate. Small amounts of estrogen can also be given through a patch, since estradiol can be absorbed through the skin. Vivelle and Estraderm are examples of estrogen patches. While oral estrogen is not easily absorbed, special manufacturing tricks can improve absorption. Estrace is a pill form in which the estradiol is specially manufactured in microcrystals that have a higher surface area to improve absorption through the intestinal tract.

The donor will begin intramuscular injections of fertility medications that gradually stimulate the growth of numerous follicles on her ovaries. This process is known as controlled ovarian hyperstimulation.

While the donor is administering the fertility medications, she begins to be monitored by routine blood tests that determine estradiol levels to monitor the development of the follicles.

At the same time, the recipient is being monitored by periodic estradiol levels and ultrasound evaluations for endometrial thickness.

After five to seven days of stimulation the donor’s follicles are measured. In a typical stimulation, both the left and right ovaries reveal multiple maturing follicles. Ideally the eggs mature at the same rate so they are all about the same size and have similar capacity to be fertilized.

When the physician determines the optimal timing of the egg retrieval, the donor will receive a final injection called hCG, which will mature the eggs for retrieval.

On the morning of egg retrieval, the male finally comes into play. Ideally a fresh collection of sperm by the recipient’s male partner or sperm donor is produced to fertilize the retrieved eggs. A masturbated sperm sample is enhanced by a highly specialized process prior to being placed with the eggs, generally involving washing of the sperm to remove the less viable ones.

Approximately 72 hours following ovum retrieval, selected embryo(s) are transferred to the recipient’s uterus. If there are embryos of sufficient quality remaining, they may be cryopreserved for subsequent transfers.

The embryo transfer procedure into the recipient usually requires no anesthesia. A catheter is inserted through the cervix into the uterus, and the embryos are gently and carefully placed into the uterine cavity. The recipient is maintained in a recumbent position for approximately five minutes and then discharged. The recipient will need to take daily progesterone hormone injections in order to sustain an optimal environment for the embryo implantation. This post-implantation or post embryo transfer time is called the luteal phase. Ideally, the embryo begins developing and implants in the lining of the uterus.

Approximately two weeks after the embryo transfer a pregnancy test is performed. If the pregnancy test is negative, all hormonal treatments are discontinued and menstruation will usually ensue within two weeks. If the Beta-hCG titer is rising, as determined by a second test, this indicates that implantation has taken place. Hormone injections will then be continued until 12 weeks of gestation at which time the placenta will supply all the hormones necessary to sustain the pregnancy. In the interim, ultrasound examination(s) will be performed to definitively diagnose pregnancy between 5 to 6 weeks after the embryo transfer.

The donor by this time will begin to return to her regular cycle, and will most likely have her period about 10 days after retrieval.

– Philip E. Chenette, MD

I was a culinary student looking on the Internet for a part time job to help pay for tuition when I stumbled on the possibility of donating my eggs. I liked the idea of being able to help someone else while helping myself. The center was conveniently located and I could still work during the process. It seemed like a win-win situation.

It took me a while to think it through. I came to realize that there were a lot of people who needed this kind of help. After a while, I talked it through with some of my friends and discussed it with my mother. She was very supportive and helped me fill in the family medical history part of the application.

My first experience with Pacific Fertility Center was positive. I was struck by how welcoming they were. I was very curious to discover more about the whole process and they were happy to answer all my questions and to be sure I understood what I was agreeing to do.

Once I was selected as a donor, I learned how to give myself shots. It wasn’t as difficult as I thought it might be. (That part never really bothered me.) The doctors and the nurses were always ready to answer questions as they came up. After donating a few times, I think I met every one of them.

The actual cycles were easy for me except for occasional periods of grumpiness. I was able to maintain my work/class schedule. They really tried to work around my schedule and make it as easy as possible for me. I loved how friendly everyone was. I became friends with the nurses. We were on a first name basis. They were always asking me about my work and if I ran into them outside of work, we would stop and talk.

The best part of being a donor was receiving the thank you notes and flowers. You realize how important your contribution is for people who can’t get pregnant using their own eggs. It felt great to discover that 5 out of 6 got pregnant with my eggs. I really feel like I was able to make a difference in someone’s life. I would definitely recommend becoming an egg donor to others.

After donating the maximum number of cycles, I have now “graduated” from Pacific Fertility Center’s Egg Donor Agency. I miss the friends I made at the center, but am happy to report I am pregnant and starting a family of my own.

– Donor remains anonymous

On May 25, 2005 new FDA regulations go into effect that will drastically change certain areas of Assisted Reproductive Technology. At PFC, we feel it is important for our patients to understand the implications of these regulations and the effect they may have on their fertility care. We have created an in-house task force to not only ensure that PFC is in compliance with these new regulations, but also to provide patients with as much information as possible. While these new FDA laws will require more time and expense on the part of patients and clinics, federal law mandates that we adhere to them.

These new FDA requirements will affect the infectious disease screening of egg and sperm donors and individuals using gestational carriers. The law as currently written also will affect couples that may wish to donate their frozen embryos to another individual at some time in the future. The source of the eggs or sperm must be screened in accordance with the new rules if the eggs are retrieved or sperm collected on or after May 25, 2005 at any IVF clinic or sperm bank in the United States.

In compliance with California State laws PFC currently performs infectious disease testing on all individuals involved in IVF as well as sperm donors for intrauterine insemination (IUI). The FDA regulations apply to any situation in which eggs or sperm (or the resultant embryos) from an individual are being placed into another person with whom the source is not sexually intimate. The FDA requires screening for some diseases such as Jacob-Creutzfeldt disease and cytomegalovirus that California does not. Screening involves review of medical records, an interview, physical examination and testing.

The most difficult of the federal requirements is that testing must be performed within seven days of collecting the sperm or eggs. This means predicting the exact day that an egg retrieval or IUI will take place and relying upon sometimes slow outside reference laboratories to send test results back quickly.

The embryo transfer or IUI CANNOT OCCUR until the results are received and the donor(s) determined to be eligible. If results are not available by the day of scheduled embryo transfer, transfer may be postponed up to day 5 (blastocyst transfer) or ultimately cancelled. The embryos would be frozen for transfer at a later date. IUI’s with donor sperm would have to be cancelled if results are not available.

In an effort to minimize the likelihood that a retrieval or IUI will be cancelled and to maintain compliance with FDA and California regulations, PFC will continue to perform infectious disease testing on ALL IVF patients, egg donors and sperm sources (IVF & IUI) prior to cycle commencement. Individuals subject to FDA screening will complete the infectious disease questionnaire and physical examination. Within seven days of the anticipated egg retrieval or IUI, a second set of infectious disease tests will be done. Sperm sources will be requested to freeze a sperm sample within seven days of the initial screening as backup in case the second set of tests are not available on the day of retrieval or IUI. For couples wishing to maintain the option of donating their embryos in the future, the egg and sperm sources will need to be retested six or more months after the egg retrieval.

PFC staff are working to identify outside reference laboratories that meet the FDA criteria and that will provide quick turn around time at reasonable cost to our patients. Your clinical coordinator in conjunction with the PFC FDA Task Force will address any concerns you may have on this issue.

– PFC FDA Task Force