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

From time to time, PFC conducts clinical research aimed at improving IVF outcomes. Our newest clinical study involves the use of a new contraceptive device for ovum donors. Currently, we prescribe birth control pills to our ovum donors in the month preceding their IVF stimulation. We do this for several reasons.

First, we want to make sure the donor cannot get pregnant in the month prior to IVF at the time she needs to start Lupron. Also, hormonal contraceptives will usually prevent ovulation so that when the donor starts Lupron, there is less of a chance of inducing a cyst from the ovulation follicle. We also use birth control pills to get the donor’s and the recipient’s cycles in sync. Donors must remember to take one pill every day for anywhere from 14 to 35 days (usually 21 days).

A new contraceptive device manufactured by Organon is called NuvaRing. It is already FDA approved for contraception but to our knowledge, has not yet been used in ovum donors prior to IVF. This is a soft silastic ring containing estrogen and progesterone analogs. The patient places the ring in the vagina and removes it after 21 days. The potential advantage is that the donors will not have to remember to take a pill every day and therefore, help avoid any errors in a cycle.

We will be assessing by questionnaire whether or not the donor found the ring to be easy to use and whether or not they would consider using this method for future contraception. Because this is a randomized clinical trial, 15 donors will be randomly assigned to use the ring and 15 will be on our usual birth control pills. Organon will provide the pills or rings free of charge for donors in the study. For more information on NuvaRing and an interactive example of the ring’s flexibility go to www.nuvaring.com

Each couple must grapple with the decision about whether or not to meet their donor. For some it is a simple decision; for others it may be a longer process. There is no correct answer to the question of whether or not to meet her.

Some recipients feel concerned that by meeting the donor they will be giving up their anonymity or signing on for a long-term relationship with the donor. While it is true that the donor may then be able to identify you in public, there is no identifying information shared, no last names, addresses, college names, etc. And during each meeting we discuss how the recipients would like to handle an unexpected encounter.

Most importantly, there is no expectation of an ongoing relationship with the donor!

Some couples feel complete satisfaction with no face-to-face contact with the donor; for them, not meeting is the best choice.

For those of you considering it, here are some concrete reasons you might want to go forward:

• It will reassure you that your donor is as wonderful as you had hoped;
• It will reassure you that the donor is completely clear that YOU are the parents;
• It will offer you the opportunity to ask questions that weren’t answered on the bio: what kind of baby she was, what are her family members like, etc.;
• You will be able to say an “in person” Thank You to your donor;
• This is the time for a picture with your donor;
• You can discuss how the donor feels about your child contacting her when your child is grown;
• You will be able to tell your child that you met the donor.

At PFC, it has been our experience that the donors love the meetings. It personalizes the experience for them. Instead of a faceless recipient or couple, the donor is working for you, making an already positive experience more special.

The meetings can be enlightening, awkward, touching or funny. What they all share is that they are memorable!

After three failed IVF attempts, my partner, whom I’ll call “Sam”, and I decided to go the egg donor route. The choice actually reduced the degree of frenetic attention we had been paying to our “baby project”. All along, we had been racing against my biological clock as I went from age 38 to 41 with only disappointing results, including one early miscarriage. Curiously, our decision to use a donor evoked a peculiar calmness as I realized that as long as we chose a young egg donor, I could be almost any age!

We then spent some time looking at the various donor databases, yet weren’t truly happy with any of the candidates. Not that we could define the perfect donor profile, but none of the women felt just right. So I let our “baby project” sit on the back burner as life moved on, thinking autumn would be a good time to resume.

Given that the entire process can take up to three months, this past July, without too much expectation, I casually made a 2nd appointment to view PFC’s binders, which contain photos and essays of each egg donor. I was fully prepared to go through the motions and leave without finding the “right one” but one particular donor’s profile just leapt out.

Her photographs revealed a woman who just beamed with exuberance and yet seemed grounded. Other positive indicators included a completed college degree and a job in a field that interests me. Her intelligence, focus and motivation were good signals. I also noticed we shared the same favorite color, and had both played the flute and piano at one point.

A second woman, with a closer ethnic background also emerged as a good candidate. At age 21 she already had a child but no college whatsoever. I decided to return home with both profiles so that Sam could have some buy-in on our choice, although I had quietly decided on my favorite.

When Sam wholeheartedly chose my favorite, I felt an enormous wave of relief. The process started feeling less like an abstraction and I posted her portraits on my bulletin board and looked at her face on a daily basis. Her smile was actually encouraging and I grew increasingly comfortable with the notion of using her eggs and having her genetic material in my body and baby. After all, I am in a sense fusing with her.

We then had to decide whether to meet our donor. Sam opted out but I reluctantly decided yes. No doubt, the meeting would be awkward and my biggest fear was that I might change my mind after discovering an undesirable trait!

But the mediated 45-minute meeting went well and felt relatively natural even though there was a drastic limitation to our conversation. Imagine making small talk and not being able to say much about work, home and so forth! Her quiet and reserved demeanor offset my nervous energy, and she just let me babble on. I enjoyed hearing her mention a few anecdotal points about her own childhood, giving me a good sense of her family past. We agreed that it would be a good idea to meet again at some far-off point, if a child indeed developed. I definitely got the impression that she would respect boundaries and she affirmed this.

Soon we’ll know if our donor relationship is truly successful and results in a pregnancy. Sam and I have high expectations. He likes the favorable odds and I like the donor, so we hope for the best.

– JMT / San Francisco (name withheld upon author’s request)

I have learned that things in life do not always turn out the way you might have thought that they would. What seems to be the “standard” life may not be so easy to attain. I just turned 45 years old and have just found out that I am pregnant for the second time since working with Dr. Chenette. We have a four year old son who we conceived the “old-fashioned” way after Dr. Chenette removed a polyp from my uterus. We wanted a second child, and somehow I thought that if we did it once, we could do it again. I have of lost track of the cycles, but over several years, we have done IVF at least 3 times with several incomplete cycles and hysteroscopies in between. After failing the 2nd IVF, egg donation came up in our meeting with Dr. Chenette. My husband was ready to do it the next day because the odds were much better. I was more hesitant and felt that I needed to try a 3rd IVF cycle with “my eggs” first. In the meantime, we entered counseling and I joined a donor support group. The counselor was wonderful and so was the support group. The idea of egg donation grew comfortable for me as an option. After our 3rd cycle failed, we started looking for a donor. Although a strange process, something became clear. The look, the height, the intelligence etc., were not as important as just finding a nice, happy person who seemed to approach life the way that I do.

I looked for “nice eyes”- for I believe they tell you about a person. We found a donor and I really like her. Now, everyone probably works through this process in their own way, and that is the point. To find what you and your partner are comfortable with, and to take it one day at a time. I try not to worry – it’s easier and more fun to be positive. I envisioned myself at this point in my life to be like a Mrs. Cleaver with a couple of kids and a fancy hairdo like a grown-up. But I met my husband later in life (and learned a lot up until then…). I still feel young. I am healthy and we all really want a second child. We are hoping that it is meant to be, and we are grateful to Dr. Chenette, the special nurses (Sue, Ann, Pat, Carol and the rest), and the nice staff at PFC for their services and their support.

–A.W. in Oakland

Q:
If I use an egg donor, how many embryo transfers can I expect?

A:
PFC maintains detailed records of all treatment procedures and outcomes at our world class laboratory. Nevertheless, the answer to this question is not as straight forward as one might expect. Averages can be summarized, but there are wide swings in the first stage of this procedure – how many eggs a donor can produce. Also, the decision on how many fertilized eggs to implant and how many to freeze can be highly subjective according to the patient.

In 2002, each donor recipient received an average of 23 eggs. But one donor that year failed to produce even a single egg, whereas another donor produced a remarkable 52 eggs. Several successful pregnancies resulted from only a three egg retrieval, so remember, it only takes one healthy embryo to establish a pregnancy!

Once the eggs are retrieved, the fertilization rates are a tad bit more predictable, since most of the donors are in their 20s. In 2002, between 65% – 76% of the retrieved eggs from donors successfully fertilized, depending on whether the donated eggs underwent IVF or IVF-ICSI.

In the next step, the implantation stage, PFC transferred on average 2.3 embryos per patient, and froze on average 7.8 from a single donor cycle. (The average number for freezing would have jumped from 7.8 to nearly 10 if this figure had excluded the 20% of women who did not produce enough eggs for freezing.)

In other words, 80% of donor egg recipients had at least some remaining embryos to freeze after the initial implantation.

And the odds were good for those embryos that entered the deep freeze. Last year, 77% of all thawed embryos were transferred, an improvement over previous years.