New FDA regulations will hurt egg and embryo donation

On May 25, 2005, new FDA guidelines for the donation of human cells, tissues, and cellular and tissue-based products (HCT/Ps), will go into effect. Reproductive tissue such as sperm, eggs and embryos will be affected by these testing guidelines.

Sperm which are frozen and quarantined for several months already will not be adverseley affected. However, eggs, which are currently donated "fresh" and embryos that are designated for cryopreservation will be significantly affected.

7-Day Testing Requirement

The new FDA guidelines require donor testing for a number of communicable diseases such as HIV (AIDS) and hepatitis seven days prior to (oocyte) egg retrieval . This 7-day window poses a large problem. Most women who are taking fertility medications for in vitro fertilization - IVF cycles need 9 to 10 days before the hCG trigger injection. The (oocyte) egg retrieval follows two days later. The same time course applies to egg donors.

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Americans support preimplantation genetic diagnosis - PGD

These are the results of what is the largest public opinion survey ever conducted of American attitudes toward preimplantation genetic diagnosis -PGD. The study conducted by the Genetic and Public Ploicy Center shows that more than 67% of Americans approve of preimplantation genetic diagnosis - PGD of embryos during in vitro fertilization - IVF procedures to select those embryos free of a fatal disease-causing gene mutation's.

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2/18/2005 Infertility increases risk of neonatal death

A study just published in the British Medical Journal indicates that couples who take longer to conceive, are at greater risk for having babies that die. This is a very important study.

The study looked at Danish women who were enrolled in a large cohort study. The authors studied 27,329 births over a three year period. Only first born births were counted. In that group there were 66 babies who died within the first 28 days. This is known as the neonatal death rate. (The neonatal period is from birth to 28 days).

The mothers had been interviewed during their pregnancies and asked about pregnancy planning and other factors. Women who reported having planned or partly planned their pregnancy were asked how long it had taken them to conceive. If the answer was six months or longer, they were further asked whether they had
received infertility treatment.

They were then separated into 5 groups based on how long it took them to conceive:

Two months or less;

3-12 months;

More than 12 months but with no infertility treatment;

More than12 months and also had fertility treatment

Those women who had unplanned pregnancies (weren't trying)

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Study: Blastocyst transfer for repeated IVF failures

An ongoing debate in the treatment of infertility is how to manage patients who have failed to conceive after multiple In vitro Fertilization - IVF failures.
A recent study out of Spain, published in the medical journal Fertility and Sterility attempted to determine whether using blastocyst transfer may work better for these patients.

Some Definitions:

Cleavage stage embryo: An embryo which has begun to divide. Cleavage stage transfers are typically performed on the third day after egg retrieval. This is known as a Day 3 transfer

Blastocyst stage embryo: An embryo which has divided into hundreds of cells. The cells have separated into those that represent the fetus (inner cell mass) and those cells which will go on to produce other tissues like placenta (trophoblast).

Part of the problem with cleavage stage embryos is that it is more difficult to determine which ones have the greatest likelihood for implantation. Even if they look healthy under a microscope, they may not develop well after the third day. To compensate for this shortcoming, in vitro Fertilization - IVF programs will increase the number of embryos they place in the uterus. This will occasionally work but it also increases the chances for a multiple pregnancy.

By waiting for 5 or six days, the in vitro Fertilization - IVF laboratory staff can better pick those embryos which are likely to produce a pregnancy. Typically, less embryos are required and this will also reduce the multiple pregnancy rate.

In this recent study, the researchers identified 148 women who had failed to conceive after at least three in vitro Fertilization - IVF failures. The patients underwent another In vitro Fertilization - IVF attempt but this time planning to use blastocyst transfer. They compared the pregnancy rate for patients who had > blastocysts develop by Day 5 to those in which > blastocysts developed only by day 6.

91% of the patients had at least one blastocyst to transfer and 73% had at least two. For those patients who had Day 5 > blastocysts, the pregnancy rate was 38%. For those who had a day 6 transfer, the rate was only 11%

What does this study show? Well, you could conclude the doing a > blastocyst transfer is a reasonable treatment option even for women with repeated in vitro fertilization - IVF failures. We cannot say that doing a blastocysttransfer would have worked better than simply performing another cleavage stage transfer because there was no cleavage stage control group. A major shortcoming of this study.

We can also state that at least in patients with recurrent in vitro fertilization - IVF failure, that a Day 5 transfer seems to work better than a day 6 transfer.

As far as studies go, this one is pretty weak.

Single embryo transfer in IVF- in vitro fertilization- may be equal to transfer of 2 embryos

The chance for pregnancy in in vitro fertilization - IVF is affected by numerous factors. One important modifiable factor is the number of embryos transferred into the uterus. The data tell us that placing two embryos into the uterus will produce more pregnancies than placing one. Unfortunately, it also increases the risk of multiple pregnancy.

Multiple pregnancy, even twin pregnancy, is associated with greater risks than a singleton pregnancy. In fact, every complication that occurs in pregnancy occurs more often in twins. This includes, premature birth, gestational diabetes, hypertensive disorders of pregnancy (pre-eclampsia), birth defects and even death of the baby. The greater the number of babies in a multiple pregnancy, the greater the risk.

Unfortunately, many in vitro fertilization - IVF programs still transfer high numbers of embryos in an attempt to boost or maintain their pregnancy rates. This may make the program look better but it puts both mother and baby in greater jeapordy.

It has been questioned, over the years, whether you can get just as many women pregnant if you put one embryo in over two different attempts compared to putting both in at once.

Recently, researcher from Sweden put that question to the test. They looked at a specific group of women undergoing in vitro fertilization - IVF. These women are generally considered to be good prognosis patients.

All under 35 years of age

On their 1st or 2nd in vitro fertilization - IVF attempt

Had at least two good quality embryos for transfer into the uterus

They divided these women into two groups at random. One group received transfer of two embryos. The other group had transfer of a single embryo with cryopreservation (freezing) of the remaining embryos. If not pregnant, this secoond group were brought back for transfer of a single frozen embryo.

The results were looked at in two ways. The pregnancy rate for each attempt or the per cycle pregnancy rate and the cumulative pregnancy rate over two cycles.

In the double-embryo-transfer group, 142 (42.9%) of 331 women had pregnancy resulting in at least one live birth compared with a cumulative live birth rate of 29.6% after the first and 38.8% after the second transfer for the single-embryo group. It should also be pointed out that 38 women did not receive a second transfer because they did not have a viable embryo after thawing.

However, multiple births occurred in a whopping 33.1% of women in the double-embryo-transfer group and in only 0.80% of women in the single-embryo-transfer group (basically one twin pregnancy).

The difference in live birth rate between the groups was about 4% on this study. Doing some statistical analysis we can say that any reduction in the rate of live births with the transfer of single embryos is unlikely to be greater than 11.6 percentage points.

What can we conculde from all this? Well in a well selected group of good prognosis patients, transferring one embryo at a time is just about as successful as putting two embryos in at once but with a fraction of the risk for multiple pregnancies.

The costs to the patient will initially be higher because of the extra expense of embryo cryopreservation, storage, thawing and preparation of the uterus for the second transfer. However, the financial and social costs down the road will be considerably lower due to the avoidance of multiple pregnancy.

At our program, we are well known because we do very well but transfer very few embryos. We have done single embfyo transfers but for the most part patients have been resistant to them. This is in part due to the fact that patients talk on the internet and in support groups and say "My doctor recommended transferring four embryos" Instead of running as fast as they can away from that program, they create the illusion that you have to transfer many embryos to get pregnant.

Another problem results from failed cycles. Patients have a tendency to demand larger and larger numbers of embryos be transferred after failed attempts even though there is no data that this will improve their chances for becoming pregnant.

We cannot continue like this for much longer. Some countries already have passed laws limiting the number of embryos that can be transferred. I don't believe we are too far from that happening here.

Indiana legislature rules in favor of lesbian couples using donor insemination

In a landmark decision, the Indiana Court of Appeals has ruled that lesbian partners who agree to conceive a child through artificial insemination are both the legal parents of any children born to them.

In a unanimous ruling, the court said that "no (legitimate) reason exists to provide the children born to lesbian parents through the use of reproductive technology with less security and protection than that given to children born to heterosexual parents through artificial insemination."

This case arose when the two partners split up and one wanted visitation rights for the child. The lower court initially ruled that one partner had no parental rights because she was not a biological parent.

Now, I'm no lawyer but, it seems to me that this ruling is important not just for gay couples but for all my Indiana patients who use donor egg, donor sperm or donor embryos. If the lower court could negate the parental rights of a partner in a gay relationship, the same would apply for those in a heterosexual relationship who use donated gametes.

In my opinion, the Indiana court made the right decision and one which will benefit all of my patients who live there.