frontline: making babies

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interview: Dr. Samuel Wood
Dr. Samuel Wood is Medical Director at the Reproductive Sciences Medical Center in La Jolla, California.  His clinic is researching a number of cutting-edge infertility treatments. [Interview begins with tour of the lab]

Is an [embryo transfer] a delicate procedure? Is this something you have to be incredibly precise doing?

Absolutely. Embryo transfers are one of the most difficult procedures that we do. It's one of the least appreciated procedures too. [You need] a great deal skill at doing it and if you do a poor embryo transfer, you could take a perfect slam-dunk case and it's out the window immediately. If you do the right transfer, you can salvage some cases that may not have gotten pregnant with anything less than a perfect transfer.

In layman's terms what's going on in this procedure--what are your challenges?

Well, the upper and lower walls of the uterus are actually up against each other. Then, of course, the uterus ends at another wall. Your goal is to take this plastic catheter, get it through the cervix, into the uterus without touching any of those walls. As you might imagine, it's not easy to do. Without a road map, it can be virtually impossible to do, because every woman's cervix is a little different, every woman's uterus is a little different, they all have different lengths. If you don't know in advance where you're going, you're very unlikely to get there ...

I imagine you're bound to bump into walls, here and there, because it's just so small. What happens if you do that? The risk?

... If there's blood on the catheter or if there's bleeding after a uterine transfer, pregnancy rates may fall from 40 to 50% down to 5% It's extremely important that the transfer be done right.

This is one of our ultrasound monitoring rooms where we follow women in cycle. This will evaluate if our drug regimen is working ... This is another one of our ultrasound monitoring rooms ... Then this leads back to the operating room and laboratory area. This is where we do our embryo freezing and also our embryo storage. These tanks all have alarms on them so that if the liquid nitrogen level becomes low, we're informed of that. If the temperature rises above a certain level, we're informed of that. If anyone were to break in or attempt to tamper with any of this, then we and the police would also be informed of that.

... What do you mean embryo storage, what are you talking about?

There are embryos in each of these tanks. Many embryos. Hundreds and thousands of embryos.

Thousands of embryos. Whose embryos?

These are embryos from women that have previously done cycles and either have been successful and they're waiting to have another child, or perhaps a couple that failed to become pregnant and they have additional frozen embryos to use in another cycle.

So in these tanks are, potentially, thousands of children?

Sure. Potentially thousands of children in these tanks.

They look so rinky-dink.

They're actually very sophisticated. There's a number of monitoring systems on them that allows to tell what's going on inside. But you're right, it's hard to believe we can have an army of people just out of these tanks.

My belief is that in twenty years, no couple will be unable to have a baby ... genetically except for those few on the extremes of reproductive life. This is the machine that we use to actually freeze the embryos and they're stored at minus 298 degrees ... it's passed through a series of solutions that allow it to be frozen. You can't simply freeze and thaw a cell or an egg, or else it will essentially explode when you thaw it ... various substances have to be put inside the egg or the embryo before it can be frozen and thawed successfully.

So that's all done in this machine?

That's right ... and these are just liquid nitrogen tanks here and we're just beginning our pre-implantation genetics program and ...

What's that?

Pre-implantation genetics is kind of a new way, where you take an embryo and you biopsy it. You check it out genetically before you put it in. This is something that is going to be very commonly done over the next five to 10 years.

What's that let you do?

It lets us evaluate whether or not it has Down's or other chromosome abnormalities, whether it's male or female. In the future we'll be able to look at even finer details of the baby ... that's going to emanate from that embryo.

This is mind-boggling to people, right? Here you can take an embryo and you can do all this analysis on them, freeze them and pick out the goods ones. Does this seem other worldly to you at all?

No, it's a natural progression of the knowledge we have of how this works and the next step is going to be, make sure you know what you're putting back in. In the step after that I'm sure it's going to be, can we modify it? Can we correct problems in the embryo before we put it back in? It's going to be a fairly contracted period of time before we get to that.

So what does that mean? That we'll be able to eliminate certain genetic diseases?

Absolutely.

Such as?

I would think specific diseases that are due to some single gene defect are probably the most likely thing to be corrected first, and, hemophilia. Sickle cell, that's a bit down the line, but I don't think it's that far down the line. We just need to learn how to incorporate the correct gene into the DNA without causing any problems in that embryo.

Okay.

... This is where we do hormone [testing on] each patient going through an IVF [in vitro fertilization] cycle ... Each [patient] going through a cycle is evaluated both with ultrasound to make sure their follicles are growing correctly. We also do a variety of hormonal test to make sure that not only the follicles are growing as they should, but they're functioning as they should. By looking at ultrasound as well as hormone test, we have a good idea of whether or not the eggs ... are likely to lead to a pregnancy. So it's all the monitoring process. Each time a woman comes in, she has an ultrasound and she also has blood drawn.

Is this like a medical procedure where it's sort of down to the mechanics and in eight days she's going to take this pill or that pill. Is it sort of routine at this point?

Most patients are routine, but probably one out of every five does something unusual and that's why this monitoring is critical to make sure that you adjust what she does.

Just tell me how much monitoring you have to do to make the cycle [work], how delicate it is and how much attention?

These cycles take three weeks. Patients come in six to eight times over the three weeks. They have an ultrasound each visit and they have a blood test most visits. It's not uncommon to need to make adjustments in the medication protocol, and it's a very important decision when to actually remove the eggs, when to retrieve the eggs. You do it too early, you have immature eggs that aren't going to fertilize. If you do it too late, you get what we call post-mature eggs, they're of low quality and unlikely to implant.

... It's like you have your own hospital here.

That's right. With an operating room and the ability to evaluate blood test, do ultrasounds, do procedures. It's an accredited operating room ... This is an andrology area, where various tests are done on sperm. Everything from semen analysis to sperm survival to antibody testing and a variety of other things. So this is more a diagnostic area and we try to separate the diagnostic area from the treatment area, which is in back.

So here you're trying to figure if there's something wrong with the man.

That's right. A couple comes in, and roughly half the time [it's] the sperm factor and roughly half the time it's primarily something going on with the female. So this is the area that we use to evaluate the male's fertility.

Are there new things you do in terms of treating male fertility?

Well, one of the things that happened in IVF over the last 20 years--probably the most important thing is the ICSI [intracytoplasmic sperm injection] procedure. Now that we can inject single sperm into eggs, unfortunately, a lot of the research in this area has fallen by the wayside. You just pick a sperm up, you stick it in an egg and it fertilizes. People aren't that concerned about why it wouldn't have gotten in there if you hadn't stuck it in there. So it's just changed the face of male fertility.

It's truly amazing to look back, six to eight years ago, very low fertilization rates, very low pregnancy rates for male factor infertility and now, it's easy. In fact, virtually no couple will fail to become pregnant because of a sperm problem. It all boils down to the egg. If they're good eggs and we can find even a few sperm and we have many ways to find those few sperm, they're going to have an excellent chance of getting pregnant.

...

It's extraordinary that you're doing all these things that nature can't do ... how many [babies have you had here]?

Well, I know it's many hundreds, but I don't really keep track. Because to me, once the patient's pregnant, I'm not involved anymore, in a sense. I love to see them back and keep in contact with them, but ... as soon as you have a positive pregnancy test, there's another patient there who's trying to get pregnant. So it's a constant battle against fertility and infertility. Thinking about all the babies you helped someone have doesn't matter when you have someone new to deal with who's not pregnant. So it's not something I even think about.

So do you not think about the fact that you're making babies here?

Yeah, I think about the fact about making babies. But the fact that I helped someone have the baby last week, is not nearly as important to me as the person that's sitting in front of me right now trying to have a baby. So that's why I don't focus on that. Some clinics have long lists or pictures of everyone they've helped have a baby. To me that gives me a sort of false sense of security. I want to be a little on edge. I want to be out there helping the next one and not thinking about the last success that I have.

... What variety of walks of life and family dynamics do you see come through here? Doesn't that strike you?

Oh, absolutely. So many different kinds of parents. So many different kinds of relationships. So many people involved. Sometimes five or six different people have to be coordinated to make a family. It's amazing.

What do you mean five or six people?

You can be getting eggs from one or two different people, putting them into another uterus, using sperm from a husband but also having donor sperm back up. So you can have a ... number of gametes and uteri coming from here to there and you have to coordinate it all and make it all happen on the same day and make it happen in a successful way.

Does it seem like some sort of genetic grab bag?

No ... it seems well planned and it has to make sense to me. I do have people that come in and have ideas that just simply don't make sense to me. I don't do those. For example ... we had a couple and the wife had lost her uterus because of cancer. So they were going to use a surrogate along with her eggs to try and have a baby. Well, they were so distraught of having gone through this procedure that they wanted to make absolutely sure that it worked the first time. So their plan was to use three different surrogates at once. Given three shots at having a child. So things can get a little too complex and you have to look at the overall picture and what's in the best interest of the children as well as the couple.

How do you decide?

I think it's experience and really getting to know the couple and always keeping in mind the best interest of everyone involved. But, in particular, you have to think about the baby. So they're being brought up an optimal environment and a good environment. That's the thing that most ethical decisions really hinge on in this field.

Is it your job that ...

I don't know if it's my job, but I can't do something that I don't feel comfortable at. It's very clear if you talk to different fertility specialists that different ones have different views on these things. In fact, in the case I just mentioned, the couple I didn't feel comfortable working with, they went somewhere else, and somebody did feel comfortable working with them. There is not a very tight set of ethical guidelines in this field so sometimes it's just a case of finding the right fertility specialist.

It's such a personal process.

It's so personal that ... I don't feel that the infertility specialists should interfere in it in any substantive way, unless it transcends his ethical boundaries. Most of our ethical boundaries are rather wide, because we do feel that the couple should have wide latitude in determining how they have a child.

A key point is that you don't judge fitness of people that are trying to have a baby naturally. We don't say how much money do they make? What kind of house do they have? Do they have a good extended family? How much education do they have? We don't make those kinds of decisions of society for them, so we have to be very careful about making those decisions for people that happen to need help to become pregnant.

You were talking earlier about how it's the egg, the uterus, the sperm. How do you decide what the problem is, in a fertility situation?

There are diagnostic tests that are helpful in each of those areas. But that being said, there are certain times when the sperm looks fine, the eggs look fine, both if you looked them directly as well as the blood test, and the uterus looks fine--an unexplained infertility--you're not sure what's wrong.

In cases like that, you have to decide what's most likely to help. What can I change? What can I switch out? Would using a different uterus be better? Then you would go to surrogacy. Would using a different egg be better? Then you go with egg donation. And I mentioned, it's very uncommon for sperm to be the limiting factor, because if you can pick a sperm up and force it to fertilize the egg, that's very unlikely to be the reason that that couple doesn't get pregnant.

Do you find that couples start thinking they're just going to do a little and [then] they're using eggs from someone's sperm, from someone's uterus, from someone ...

Absolutely. Couples come in with the conception of how they'd like things to be. Many of them, particularly early in the process, just want to know, "Is there something we can do, just the two of us to help improve our chance of becoming pregnant," and when that doesn't work, it antes up a little bit. Something else is done and then another step. Then it's the eggs and you have to consider another egg and soon things may be far different than they expect it. But at the beginning and at the end, they have the same goal--have a baby. There are many couples that fall out along the way, and say, "I don't want to do it if I have take drugs," or "Okay, I'll take drugs, but I don't want to do it if my eggs are going to aspirated," and so each couple has some limit.

... once couples get involved in the process, there's a tendency to make it want to happen and they continue to do more and more aggressive procedures until it does happen. The truth is that with current technologies absolutely every couple could have a baby, there is no doubt about it. If you think about it, if the womb could use another egg or another uterus, it's going to happen for them. It's just a question what procedure it's going to take to accomplish it, and whether or not they're willing to do that procedure.

Are we doing something different than traditional infertility treatments?

Well, we're progressively taking care of different kinds of problems. We've largely eliminated, at least, male factor problems with ICSI, and then with newer procedures in which we take sperm from the testes, or procedures in which we activate eggs after a sperm is placed in the egg. [There's] almost nothing in the sperm area that we can't deal with. Most of their problems are also eliminated through the use of in vitro fertilization and other techniques. So we're down to just the last few things that keep us from succeeding on a consistent basis.

... It's a personal thing, maybe. I like being able to help couples that no one can help or very few other centers can help. I like to see a progressive chipping away at the number of couples that we can't help have a baby. So each new technique, depending on it's importance, may get rid of another 10% or 15% or 2%, but in each case, that's another one or two out of 100 babies that wouldn't have been born if that technique wasn't there.

What are these techniques? What are you doing?

Well, the ICSI procedure, in which a single sperm is injected into an egg, probably eliminated 30 or 40% of couples from the group that couldn't get pregnant, no matter what you did if you exclude using donor sperm.

Cytoplasmic transfer is a very useful technique for women whose eggs are not very good quality, who consistently fail because their eggs and their embryos just aren't good enough to implant. Right now, that's the biggest area that needs work. It's not the final procedure for that. We have a lot to do in that area, but it helps us do something for those couples, the most desperate kind of couple.

... What happens in cytoplasmic transfer ...

We take some of the fluid from inside the egg of a young, fertile woman and inject that fluid into an older woman or a woman whose eggs aren't as good a quality as those from whom we're getting the fluid to begin with.

Some people would say, why? That's it's engineering ... how do you feel about that response?

I don't understand the criticism.

... Because?

Everything we do is engineering. It's trying to change something. If there's something wrong with the fallopian tube, we reengineer the fallopian tube, the ovary, the uterus. The egg is just one more element in the process, just as the sperm is.

Do you think there's any place that we can stop?

We shouldn't do procedures that cause more harm than good. That's a very difficult definition to really pin down.

You see a lot of couples in here that have failed before. What is your approach to them?

When couples fail before, sometimes it's because the previous fertility center missed something. So the first thing you have to do is go through every record and try to find some clue as to why they failed before. Sometimes, they just failed because their prognosis is very poor and then you have to apply some of the new technologies that you have in an attempt to move them from the group that's not getting pregnant into the group the can get pregnant. That's the key, just getting someone into a group that can get pregnant. You can't guarantee anyone a pregnancy, you can't cause a pregnancy, but you have to put them into a position to succeed. Many of the patients I see who have failed before never had a chance.

They didn't have a chance, because?

They had no embryos to transfer or the embryos they had to transfer were very poor quality. They didn't even have a crack at it and that has to be your first goal. If someone has a legitimate chance at it and they're willing to work at it hard enough, the vast majority are going to succeed.

What are they like when they come to you?

Most of them are very tired of the process by the time they've come to me. It's extremely rare that I'll see anyone who's been trying for less than a couple of years, and usually, they've tried many different treatment techniques. They've all failed. In some way, they may be hopeless. At least, they've given up hope in those intermediate or beginning techniques. So you see a lot of fatigue from the process.

But there's some excitement, too, because everyone knows, in reading magazines, there are many people who have succeeded with these advanced techniques, so there's an excitement, fatigue, a wariness. It's a combination of different emotions and different couples have these emotions to varying extents.

Some people we've talked to just cannot understand peoples' desire for a child of their genetic heritage. Do you?

Absolutely. The desire to have a child is one of the most basic instincts that humans have. It's a lifelong dream for many people. When you're a child, you visualize what your future's going to be like. I'm sure there are some people whose ideal vision doesn't include a child, but the vast majority of people do have a child in their future. When they've accomplished even everything else in their life and that one little piece isn't there, isn't incomplete and they're incomplete as people until they accomplish that.

Are you seeing a lot of people that have put off child bearing?

Absolutely. It's one of the reasons that the number of couples seeking infertility care has gone up because the woman has waited until her fertility has significantly diminished. It's important to remember that at the same time, men's fertility also is reduced as they get older.

I remember one couple in particular, they came to me and said, "We both have the jobs we want. We're in the positions we want, we have the house we want, we both have these great cars, now we're ready to have a baby." I said, "How old are you?" She said, "I'm 46." He said, "I'm 48." They got everything in their life ready, but they waited too long to get one piece that they wanted and that was to have a biological child together.

What happened to them?

They ended up getting pregnant, but using donor eggs.

Is that fairly typical ...

Any woman who waits until she's 42 and then needs to see a fertility specialist has a very high probability of ending up with donor eggs.

And so, all of a sudden, you have one of the genetic [links sacrificed].

That's right. If you put everything else first, that's the thing you end up sacrificing. The female partner's genetics aren't going to be there if you wait to long, if you make sure you have everything else first that's what you give up.

What do you say to those people who say, "Why don't you adopt? There's thousands, millions of children in the world?"

Adoption is an extremely difficult process, time consuming, expensive. Perhaps many of the things you could say about what we do, but the loss of any genetic contribution by either partner is very devastating and the effect on the children in the two situations is very different.

When someone finds out they're adopted, by definition, it meant that someone rejected them. When they get pregnant, even through egg donation, sperm donation, it means somebody really, really wanted them and that's why they're there. So it's a lot easier for the parents and the children to deal with later.

With regard to adoption, also, one of the problems is you really can't select those characteristics that you want when you adopt. If you get picky at all in adoption, you're going to end up without a baby. But the beauty of egg donation is that you can select characteristics that are important to you. You can select someone who has similar interests to the female partner. You can select [someone] who looks like the female partner. She also gets to carry the baby and that's a tremendous factor in bonding that you miss if you do adoption ...

You told us a story about a person that was a backup singer for rock band. Could you tell us that story.

We've seen the role of surrogacy expand over the last several years and one couple we worked with, the female partner was a backup singer in a rock band and she was getting later in life. As I recall, she was 39 or 40 and was very concerned that she would lose the chance to have children that were hers biologically, so she chose to use a gestational surrogate in which her eggs and her husband's sperm were placed, after fertilization, into a surrogate. She could continue her career; yet, maintain her ability to have a biological child.

What do you think of that?

Couples should have a right to choose their method of reproduction and that unless it's outside the bounds of ethical and legal behavior, they should have the right to do that.

What is outside the bounds to you? Could you give us another example here?

... The ethical boundaries are indistinct right now and so each fertility center, each fertility specialist will probably give you a different answer to where those boundaries are. My boundary is, if I believe that a procedure may harm the baby or one of the participants is involved ...

Arguably, inserting donor eggs and eggs that have been substituted by cytoplasmic transfer could create a somewhat complex social situation. What do you think of that ...

Under circumstances, in which it's necessary, it's very helpful to mix donor embryos and the mother's embryos because I believe that there is evidence that the donor embryos may assist the mother's embryos in implanting and it enhances the overall probability of pregnancy. In the end, it's not known which actually implanted and subsequently led to a baby. It's been my experience the couples doing that always believe that at least one of the babies born under the circumstances is theirs biologically. It's a way of allowing them to achieve their dream, isn't it?

What do they say to you?

What I'm told is that at least one of these children looks exactly like I did when I was a baby. I'm certain it's mine. I don't need to do any genetic testing. I know.

What do you think about them doing genetic testing?

I don't favor it. I think genetic testing in that situation really shouldn't be done. The fact is, those babies are their children at that stage, it really doesn't matter where they came from biologically and I'm concerned that finding out may affect how that child is treated.

In what way?

In a situation where one child is theirs completely biologically and the other is only half theirs biologically, they may treat those two children differently and that concerns me. That child is 100% theirs regardless of the paternity and maternity of it.

Do you think they would always be looking?

That's not my experience. My experience is that they look carefully after birth and for perhaps some months after that. But with time, that really becomes a secondary issue. The same is true of egg donation. By a year or two, the thought that an egg donor was involved just simply doesn't enter their mind.

Where do you think all of this is heading for? Are we on the cusp on anything new ...

... Here's my thinking. What is going to happen in the future is that embryos are going to be evaluated before they're transferred into the woman. Within five to 10 years, virtually no couple will just put random embryos into the uterus. As the technologies are available to assess them, they're going to insist that they be assessed.

Why put in an embryo that would be a Downs syndrome, for example? It's pointless. So they're going to select among their embryos and place those that are healthy in the uterus. So that's going to be one important step.

Another is that we're going to understand implantation better so that we can, I believe, greatly increase the probably that those embryos will stick. So, ultimately, you'll have a situation where you know the embryo's okay and you can make it stick, except in very rare circumstances and that's coming in the next 20 years ...

What is the step after that ...

Well, somewhere in that process, maybe after, maybe while this is going on, couples are not going to be content with simply assessing the embryo, they're going to say, "Can I take care of problems within the embryo? Can I enhance the embryo?" They may be looking at specific genetic problems within the embryo that can be corrected at that stage. They may be looking at enhancing areas of the embryo that are a problem for the parent.

Where do you think the areas are that they most likely enhance?

Well, it may be, for example, identification of a gene or genes that predispose to alcoholism or depression. A couple wants to have a child that's theirs genetically, but if it's caused them a great deal of problems in their life, they may not want to pass on that particular aspect of themselves to their children. This would be an opportunity to go in and correct a genetic problem that they have, to make things better for the next generation, which is, I think, every parent's dream.

What about the likelihood that their male child will be very short?

It becomes more difficult when you look at other things. For example, height. It's say that a couple was, for genetic reasons, very short. Then it would be legitimate to make alterations that give them a normal height child. On the other hand, a couple who's normal, who has normal height, but feels that their children would have an advantage if they were considerably taller than other children, that's an ethical area that I probably wouldn't want to get into.

You probably wouldn't want to get into or you think that the sands will shift ...

Well, ultimately, what a reproductive endocrinologist does is dependent on the available technology, their personal ethics, and then the social milieu. Any one of those three things can limit what's done. It's almost certain that things are going to be done in this area 50 years from now that society wouldn't accept now ...

What sort of things ...

I'm thinking, in particular, of enhancing characteristics that children have that are average or above average to make them exceptional. That's an area that I'm not ready for, society's not ready for and the technology is not there. However, the technology will be there soon, and then it's going to depend on the individual specialist in this area and what society will allow.

Your attitude right now is on the cutting edge of the technology? You're quite willing to do as much as you can in terms of these technologies. Where do you think you will stand in 25 [years] ...

Right now, the benefits of going forward with these technologies vastly outweigh risks. It's hard to say where anyone is going to be on an issue in the future. Every ethical decision has to be made in its proper context, religious, socio-ethical and societal and so it's very difficult to make that assessment this far in advance.

... this history of infertility treatment, in fact, is it always an experimental technique? Has it been a grand experiment ...

Absolutely. IVF, from the beginning, has been one experimental technique after another and what happens is, after five, seven years, it's no longer experimental, but there are two or three other experimental techniques and that's how it's going to continue to go until this problem is completely solved. It's an amazing area of medicine in that way.

From the beginning, no one really knew if any of these techniques were going to prove to be effective or safe, so there's a grand leap of faith each time because the goal is so important, we feel like it's like worth that leap, but they are progressive leaps to achieve each new goal.

Is it unique medicine in that way?

This one area of medicine may be unique in that nothing seems very certain in advance. It's very difficult to test these ideas on other animals because other animals have different reproductive systems. What works in a mouse may not work in a human and what works in a monkey may not work in a human. You really have to try it in a human to be sure. That is one of the unique aspects of this area.

Does it draw a particular kind of person, because you see a lot of scholarship involved?

It's an area where you can become a star very easily. There's no problem when you have new technique with getting it on TV and that's unlike most area of medicine. So it does draw the kind of physician who wants to have a big impact. If you think about it, how can you have a bigger impact on someone's life as a physician than to create a family, than to give them new children. Something that affects everything they do, every day for the rest of their lives ... So many fertility specialists share that characteristic. They want to do something that matters, something that's important, something that's lasting.

When you see all these little babies, these couples come in ... you see them all the time at clinics ... how does that make you feel?

It's tremendously, tremendously satisfying. That's what's it's all about. The thing that I like best are cards we receive on the holidays and I look at these cards. What used to be a husband and wife is now a husband, wife, child and a dog. It's a family now and to create a family is much more than simply creating a baby. It has a tremendously positive impact on the live of the parents and can you imagine how well those children are taken care of by those parents? It's an extremely positive situation for all of them ...

People say that this is also a grand experiment on women with high-powered hormonal drugs. A lot of treatments that come and go and that we should sit back and evaluate ...

There's really no way to evaluate it more than to do it. If you stop doing a procedure to evaluate it, you can't evaluate it anymore. When you're in a largely experimental field, some things are going to work and some things aren't going to work. Certainly, women have gone through procedures that we subsequently learned were ineffective. But that's the price all of us have to pay, the specialists, the couple, in trying to reach our end goal, which is to wipe out infertility altogether.

... Do you think more studies should be done?

The only advantage to a trial is that the patient is well informed, ultimately. There are ethical questions about entering patients in trials in which they won't receive what might be a new effective procedure. Is it fair to them not to receive a new technique, not become pregnant and subsequently lose their chance to become pregnant altogether? So there's a price to be paid to be in the placebo group, in the no treatment group.

That's why it's very difficult, in this country, to do good trials. Couples are not going to allow themselves to be randomly assigned to any treatment group or a lesser treatment group. It doesn't make any sense to them to do that, particularly if they're paying for it, which is a requirement in this country.

What would they say?

When we tried to set up trials before, they'd say, "Great, I'd love to be in your trial, as long as I'm in the treatment group ... You want to put me in that other group, I'm not interested." So you can begin a trial and once they see that they're assigned or even if they suspect they're assigned to the wrong group, they just simply won't continue in the study.

I'm not sure it's really fair to them to put them in that kind of situation if there's some good evidence, either on an animal basis or in pretrial studies that it may be effective for them. You have be very careful of any patients you're going to put in a trial. You don't want to put a 42-year-old woman, who may only have three months of fertility left into a trial in which she receives sub-optimal treatment. It's simply not fair to her. So there are many ethical issues about trials and to simply say we should do more trials ignores practical aspects of it and ignores ethical aspects of it.

... To get back to the industry as a whole, you say this is a very competitive industry?

Extraordinarily competitive industry and getting more competitive ever year ... In most areas of the country, there are simply too many reproductive endocrinologists for the needs present in that area.

What are they using to compete against each other ...

Specialists in the field use three things to compete. They use success rates, they use the availability of new procedures and ... they use price.

Talk about success rates. What success rate [does your clinic have]?

Our overall success rate last year was 47% clinical pregnancy rate per cycle. Patients will frequently call a series of fertility centers and say, "What's your success rate?" If the fertility center gives a success rate considerably lower than others, they're simply not going to get a visit from that patient. That's probably the most important factor that fertility centers use other than generating the usual referral sources and things like that.

Do you have a problem with that?

Success rates are extraordinarily misleading and extremely easy to manipulate and the information that many couples are given over the phone is simply inaccurate or even when they visit, it's inaccurate because there is inadequate standardization as to what a pregnancy rate is, who's included in that pregnancy rate and over what time period that pregnancy rate was generated, how were patients selected to create that pregnancy rate? It's an almost useless number.

A 42-year-old woman comes in and says, "What's your pregnancy rate?" And someone says, "47%." That number has nothing to do with her. That number included women who were 21 years old, it included women that had gotten pregnant many times, and then lost their uterus due to surgery and subsequently used a surrogate. It includes so many different things that these overall statistics have noting to do with the person that you're talking to.

So I object to the overuse and the misuse of statistics, but it's absolutely rampant in this field because it is the main way that fertility centers compete.

You also raised [the issue] when I spoke to you a question about donor eggs ...

One of the easiest ways to manipulate the statistics, if you choose to, is to push women who are poor prognosis into using an egg donor. These are women who are unlikely to get pregnant if they use their own eggs and hurt your statistics; and very likely to get pregnant if they use an egg donor and help our statistics. So this inherent conflict in the mind of many fertility specialists about this situation. They don't want her to fail, in part, because of their statistics.

The question is: What does she want? What does she want to try? This is not about us.

You also talked about people being drawn into IVF itself ...

Another way that centers can manipulate their statistics is to encourage patients that don't need IVF to do IVF. These patients that could get pregnant with much simpler, less expensive techniques. Thus, if they do IVF, their pregnancy rate is going to be extremely high and if a situation is set up where they're induced to do that, it's another way of making your statistics look better. These are not really infertile patients, in the sense that most of the patients that come to an IVF center are infertile. They really haven't tried the conservative things before they go to the more advanced techniques.

What do you think about the financial plans, in particular, the money back guarantee ...

The money back guarantees, the so-called shared risk plans are of great concern to me, because they're an indication for fertility specialists to do the wrong thing. If a fertility specialist stands to lose money if someone doesn't get pregnant, it can alter their behavior in several way that are not in the patient's best interest. In and of itself, I don't think the money back guarantee, is unethical, but it provides so many ways for unethical conduct to occur that I personally am against it.

What kind of ways?

One thing that it can induce a center to do is to place more embryos back into a patient then they desire. In fact, some of these plans specifically indicate that the center, not the couple, decides how many embryos to replace. It can also lead to problems with inducing patients to do IVF that don't need to do IVF. And they're so financially complex that it's a rare patient who really understands that it's unusual for the patient to benefit from a money back guarantee.

Most of the centers that have money back guarantees specify what type of patient can be in their money back program. And what type of patient is that? The very patient who could have an outstanding chance of getting pregnant without a money back guarantee.

What do you think is the main problem in infertility medicine today?

One of the main problems in infertility medicine is an excessive number of multiple pregnancies. An important question to ask is: Why is there such a high incidence of multiple pregnancies? The reason is that centers are trying to maximize their pregnancy rate. It's one of the outgrowths of focusing on pregnancy rate itself and not focusing as much on the consequences of that pregnancy rate.

In addition, by the time a couple gets to a fertility center, they want to get pregnant and for many of them, they're not concerned about whether it's one, two or three. They don't believe they can get pregnant at all and so they're not concerned if a fertility specialist says, let's put in six or seven. They've been trying for 10 years and couldn't get pregnant. They just want to see any kind of pregnancy ...

Do you think something should be done about this?

... it would be a big mistake to limit the number of embryos that are placed into a woman by legislation or any other regulatory body. Some women need large numbers of embryos before they can become pregnant and if you set the cutoff at three or four or five, some couples will not be able to have a child because you did that. That's unfair to them.

Ultimately, the problem is not the number of embryos that are placed in the uterus, it's the percent multiple gestation. The center should be evaluated on how they do in limiting that ...

But do couples ... know about the problems of [prematurity]?

Infertile couples probably minimize the significance of complications that come from multiple gestation. They do so because they're so desperate to have children that I don't think they pause very long to think about that. They have in their mind a certain view, a certain vision. When they think of twins, what they see are two toddlers running about in a room with their parents. What they don't see is a trip to the neonatal intensive care unit when those twins are 28 or 30 weeks and all the sleepless nights that they might spend worrying about what problems are going to result from that prematurity, that hospitalization and the costs and other problems that are associated with it.

So it's very important for the fertility specialist to let these couples know that these problems are real and are serious. The fertility specialist has to have a lot of input on the number of embryos that are [re]placed, so that they're not putting large numbers of couples at risk for multiple gestation simply to help them have one.

Do you talk to your couples about prematurity?

Absolutely. Before a couple decide on the number of embryos to replace, we tell them our impression as to their chance of pregnancy, their chance of multiple gestation. The effects of multiple gestation are significant. We discuss with them the problems associated with multiple gestation, including prematurity, so that they can make a decision, because we know that they're in a vulnerable position where they may or may not fully realize that problems associated with that, we limit the number of embryos that they can replace to some range.

I normally like to say, we'll put in two or three, for example, with two being conservative and three being aggressive. I feel their input is important in the decision, but I don't want to put them in a position where they have a serious pregnancy complication because they were so desirous of having a pregnancy that they overdid the number of embryos that they replaced.

A client of yours is 29, 30 years old, had four embryos put in fairly recently. Why did you do that?

I'd have to know who it was ... If a woman had a history of poor quality embryos or has a history of failed in vitro fertilization in the past, then one of the right things to do, is to increase the number of embryos that you replace. That's exactly a situation that legislation or limiting of number of embryos to be transferred would harm. Some women aren't going to succeed when you put two in, when you put three in ... You may have to put five in before they're going to succeed. They have a right to succeed just as much as the woman who's going to get pregnant when you put two in.

You're lucky ... in a way, that she ended up with two healthy babies.

Whenever you put in more than one embryo, you're taking a risk of a multiple gestation. And no center has a 0% multiple gestation rate. If they did, they'd have a very low pregnancy rate. So there are definitely risks in putting in multiple embryos and the methods we have right now to assess the quality of embryos are incomplete or inconclusive in some ways. Sometimes you look at an embryo, look at set of embryos and you put too few in and sometimes you put too many in.

In a neonatal intensive care unit we ran into a couple who had four embryos put in. One of the embryos did not [make it], so they had triplets. At 14 weeks, they reduced the triplets to twins ... at that point, the woman's uterus had stretched so much, she was threatened with miscarrying all of them at 19 weeks ... she had those babies at 26 weeks and they're very ill. What do you think about that ...

The important question is: Are you doing the right thing? You can't always tell if you're doing the right thing by the outcome. You can choose to go to a restaurant, not drink and get killed in an accident on the way home. Does that mean it was wrong not to drink any more than it means it was right to drink if you did drink and got home safely? You have to use criteria other than outcome in any individual case to decide whether or not the right thing was done.

By necessity in this field, because there are so many unanswered questions, sometimes you're going to miscalculate and put too few in and cause a couple that could have gotten pregnant not to get pregnant; or put too many in and cause a couple that would have gotten pregnant easily with fewer to get pregnant with a multiple gestation.

It's something that you have to accept in this field. It's a difficult part of the field. None of us wants these couples to have premature children or to do reductions or to do a reduction and lose the entire pregnancy. None of us want that, but unfortunately, it's a chance you have to take in order to help them have a baby at all.

The obstetrician who was looking after this woman said it was a very depressing day for him when those babies were born at 26 weeks. He tried so hard to keep them in, but he said, "... We [the doctors] need to get together and confront this problem because the infertility specialist may not even know that this problem is happening."

It's very important that the infertility specialist follow up with the couples and find out what happened. I personally have gone to intensive care units on a number of occasions. You can lose contact easily. You can feel that your job is done once there's a positive pregnancy test and not even learn what happened. To the extent that there's a disconnect between ones' actions and the consequences of ones' actions, I think that's a negative thing.

Some people would say ... we are getting quite close to the time when cloning will become an option.

These techniques, particularly nuclear transfer, are closely related to cloning. The technology to at least attempt cloning in humans is readily available. That's not what's keeping it from happening. Right now, society isn't ready for it and fertility specialists are unwilling to do it in a face of society's resistance to the procedure. But it's not really a technological problem to begin to do human cloning. It may or may not work. There may need to be many adjustments in the protocol, but somebody could tomorrow attempt to make it work. So I don't think that these techniques by any stretch of the imagination will cause cloning to occur. But they'll further the technology that will be necessary to do cloning in the future.

Is there interest amongst you and your colleagues ...

Much of it's probably good-natured chatting, but at meetings there's certainly those that indicate they wouldn't have any aversion to being a first person cloned and suggested other people think that that would be a waste of the cloning technique. That sort of banter.

So it would actually be a perfect thing for a ...

I have no doubt after talking to others in the field that there is a temptation to do it. But the cost is so high and the ethical questions are so large that I don't think that any of the well established [clinics] are likely to try that type of technique.

...

But there's a point, let's say 25 years from now, where it's more accepted, where a couple pays you and this is really the only technique that would give them a baby. Can you see yourself saying this is a technology that you wouldn't use?

Cloning is really not a very useful technique to treat infertility. It's hard to imagine a situation where that would be the optimal choice. And couples, I don't think, at least I've never run across one that came in and said, "We'd like to clone me, or clone her." That's not why they're there. They want to do something unique with each other. They want to create some new being that is the result of their union. So I really don't see the utility of cloning in infertility.

To get back to an issue ... do you think you're crossing natural boundary [lines]? There is some concern. We interviewed a couple ... the husband was infertile because of [Kartagener's syndrome] ... What do you think about possibly passing on a genetic syndrome to his child ...

Couples in this country have a right to reproduce under natural circumstances without regard to their genetic component. For example, if a woman has adult onset diabetes, there's a considerably higher chance that their child will have diabetes. Society doesn't say, "No, you can't have a child because there's a higher than usual chance you're going to pass on diabetes to that child." I don't think that it's fair to these couples to place restrictions society doesn't place on them in a natural setting, in this more artificial setting.

So here we're creating children. It's something slightly different than normal reproduction. People would say there's needs to be some regulation and debate, and some following of these children in this situation, because it's not normal reproduction. That sperm would have not gotten to the egg without [help].

It would be irresponsible for a couple or for fertility specialists to help create a child that would have some serious medical problems for which there is no treatment. Most are not that clear cut. They may cause some disability, but it may not be a serious illness or they may not cause it in all children who are born under those circumstances. These are ethical issues that have to be dealt with on an individual basis and I could certainly see that in some situations there should be overall ethical guidelines about helping couples that are very likely to pass on significant medical problems to the children. But this needs to be viewed in an overall societal concept. If we're going to do that with these couples, we also need to do it with couples in society, in general, who have a chance of passing on other types of disorders. But the mere fact that they're infertile, I don't think should cause them to be treated differently from other people in society.

A doctor said to us that there is such enormous amount of money and care going into treat infertility ... should we be raising questions [such as] the money should be going to prenatal care for poor people ... It is quite staggering ... the amount of care and the amount of money in this specialty. What do you think of that?

Without a doubt I'm biased about this issue, but it's hard for me to imagine anything more important to spend resources on than to create the very backbone of our society, which is healthy family. People like to talk about how much money spent on infertility. How much money is spent on treating colds every year? Colds never caused a marriage to break up. Colds never caused someone's career to go down the drain, caused anyone to commit suicide, caused all the problems that infertility causes. Yet, I'm sure the same amounts of money are spent on that.

Nothing affects quality of life like infertility of those couples that want to have a baby. There's nothing better to spend money on then something that that's positive. Something that generates good for the society. Rather than eliminating a cold, you're actually doing something that can have a great benefit to society for many years to come. So, yes, we need to prioritize healthcare dollars in this country, but infertility healthcare dollars, you need to be near the top.

But people who are proponents in strong family values, religious [organizations like] the Catholic Church, say we're fooling with nature and we're fooling with God's design.

Medicine itself is fooling with nature. When you take an antihistamine, you're fooling with nature. The essence of nature is that something went wrong, someone got an infection, someone got a disease and you're attempting to cure that. It's absolutely no difference between a diseased ear drum that needs an antibiotic and a diseased fallopian tube that needs to be either fixed or circumvented with in vitro fertilization. It's baffling to me that people don't seem to understand that infertility is just another medical problem. Something is wrong, and the body of one or either of those two individuals, and if it didn't relate to infertility, no one would have any problem treating it. But because it's related to that, it's considered to be of less importance. It's just nonsensical.

But treating disease is treating disease. This is creating life and this is where these religious observers have a real question that we are creating life here ...

Why do we treat disease? We treat disease to improve the quality of life for that individual. Having children, creating a family is the ultimate improvement in the quality of life. If treatment of disease results in a child, does that make it any less valuable than treatment of a disease that doesn't result in anything except the absence of disease?

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