 Good afternoon. On behalf of the McLean Center and the Department of Obstetrics and Gynecology and the Bucksbaum Institute, I welcome you to this, our 12th lecture in the 2016-17 series on reproductive ethics. As you know, this is a series that Julie Core was single-handedly responsible for. Julie, raise your hand so we can just acknowledge it. It's my pleasure now to introduce today's speaker, Susan Clark. Dr. Clark is Professor of Clinical Obstetrics and Gynecology and Psychiatry at Northwestern University's Feinberg School of Medicine. Prior to coming to Northwestern, Dr. Clark was an instructor and director of women's mental health services in the Department of Psychiatry at the Harvard Medical School. Dr. Clark has more than 20 years of experience in providing direct psychological counseling to infertile couples and in conducting research on multiple aspects of assisted reproduction, including psychological aspects of fertility preservation and gamete donation. Dr. Clark's primary research and clinical interest is on the impact of infertility on mood and functioning, as well as psychological aspects of oocyte donation. Dr. Clark has authored over 40 peer-reviewed papers and numerous monographs related to assisted reproduction and female infertility. One recent paper of Professor Clark's is entitled Perspective Study of Depression and Anxiety in Female Fertility Preservation and Infertility Patients. This paper was published in 2014 in the journal Fertility and Sterility. Dr. Clark's talk today, as you can see behind me, is entitled Ethical Issues in Gamete Donation. Please join me in giving a warm welcome to Professor Susan Clark. Well, good afternoon. Thank you, everyone, for inviting me here. It's my pleasure to be here today to talk about ethical issues in gamete donation. I am, as Dr. Stigler pointed out, a clinical psychologist in the section of reproductive endocrinology and infertility. And sometimes at the beginning of a talk like this, I like to just say, how did I get here today? And I got here on kind of a fluke. I was an intern in clinical psychology with a specialization in women's mental health. And I was working through all the different sections of the Department of OB-GYN at University of Connecticut. I did gynecologic oncology, maternal fetal medicine, general OB-GYN. And then the section chief of reproductive endocrinology called my supervisor and said, boy, we could really use a psychologist down here. Could you send her down? And so I went down there and I worked there. And I loved it. And I finished my internship. And he said, hey, do you want to stay? And I said, absolutely. And I stayed, met my husband, which was the best thing of all about being at University of Connecticut. And that's really what began my career and my interest in this field. So to begin with today, I first want to disclose I have no conflicts of interest or other disclosures to make. Today what I want to go through is talking about ethical controversies and gamete donation, particularly egg donation. But before we can do that, I want to bring you into my world of infertility and infertility treatment. So we'll have a little bit of overview of infertility, an overview of the clinical process of egg donation, which is very important to understand for our later discussions on the ethics, and then the ethical controversies that I will highlight, payment to donors, post-donation medical and psychological well-being of donors, and issues of informed consent, and last, privacy and disclosure to offspring about their gamete donation origin. 94% of Americans either have a child or want a child. We are in a very pro-baby, pro-reproduction culture, just like most other Western cultures. But unfortunately, about 12% of individuals of child-bearing years suffer from some kind of infertility. Infertility defined is 12 months of appropriately timed intercourse that does not result in a pregnancy. And you can see the causes of infertility are numerous and are really broken down as indicated on this graph. The bad news is for women, our fertility declines as we age. And this is just a graph of fertility trends over many decades. And as you can see, once we're at about 37, moving to 47, our chances of having a successful pregnancy approach zero. What this, the meaning of this in the world of egg donation is as women are delaying having children, their fertility is declining, so they need to get eggs from someone else. And so that's why this piece of information is important for the context of our discussion today. So a couple tries on their own for many, many months. They're struggling. They're very sad. They go see their doctor. The doctor says, go to a reproductive endocrinologist. They may try chlomaphine citrate in timed intercourse or interuterine insemination. They do that typically two to six months. If that doesn't work, they move on to a little bit more invasive, injectable fertility medicines and timed interuterine insemination. If that doesn't work, then they move on to in vitro fertilization, kind of the big guns of infertility treatment. If that doesn't work, then we move on to gamete donation. The reason I wanted to show you this progression is because as couples move through these treatment processes, if they don't get pregnant, their levels of depression, anxiety, and marital discord often increase, which is why I often see them somewhere along the lines in this process. In vitro fertilization was created in 1978. Actually, the first successful birth was Louise Brown in London. And this we credit to Steptoe and Edwards, who were able to take the egg from Mrs. Brown and inseminate it with the sperm of Mr. Brown in a petri dish and put it back in Mrs. Brown's uterus. People were just wild about this technology because they were very concerned about fertilization taking place outside the body. And it was really quite a big deal at the time. The reason why IVF is important is because that technology allows for egg donation to take place because an egg donor goes through these first steps of IVF and then gives her eggs to the intended mom. So the steps of in vitro fertilization are as followed. 9 to 15 days of injectable fertility medicines. These are done subcutaneously once or twice a day. While a woman is taking these medicines, she's also being seen at the clinic for ultrasounds and blood tests every two to three days to see how her body is responding to the medicine. Once it's determined that she's reached the maximum development of the follicles that contain the mature eggs, she'll undergo an egg retrieval under sedation. And anywhere from three to over 20 eggs can be retrieved. Sperm is produced by the partner or obtained from a sperm bank. The eggs are fertilized in the lab. Over the course of three to five days, the embryologists watch their development. They pick the best one to transfer back into the uterus of the intended mom. She goes on injectable progesterone for 11 days, then comes in for a blood test to see if she's pregnant. All of this is about 30-plus days and $15,000 to $20,000. So let's just take a deep breath and understand another reason why couples who are going through this can be very stressed. Illinois is one of 13 states in the United States that provides some form of infertility coverage for most large insured groups. That can mean anything from a $10,000 lifetime limit up to kind of the Cadillac or the Rolls Royce of infertility coverage, which is four full cycles of IVF. The egg retrieval, and again, we want to consider this when we're thinking about an egg donor, the egg retrieval is done under sedation with ultrasound guidance with needle aspiration of the follicular fluid and the egg. And then that's sent to the embryology lab for the fertilization. In 1992, Congress passed the law, the Fertility Success Rate Act. That mandates that IVF practices report their success rates to the Society of Assisted Reproductive Technology, who then, in turn, gives it to the CDC. They compile it so consumers can look at each clinic across the country and see what their pregnancy rates are. There is usually a two-year lag, so the data that I'm showing here from the CDC that was published in 2016 is actually from 2014. Now, as you can see, the pregnancy rates are really good if you're under 35. And we'll remember that graph and we'll say, oh, yeah, that, of course, makes sense because you haven't had that drop in fertility yet. As we approach 40 and get past 40, the pregnancy rates are around 8% for a 43- or 44-year-old woman using her own eggs. In comparison for a donor egg cycle, the success rate is 67%. So when women are looking at these data and they see those numbers, after they've been through a couple of cycles of IVF and it doesn't work, you can see why they might think, oh, OK, I'm going to think about using a donor egg at this point. And again, the donor egg data is for all ages because the age of the recipient at this point doesn't matter because the success rate is tied to the age of the eggs. Most egg donors are between the ages of 21 and 28. And that's why we see those rates. So now that we know a little bit about infertility and its treatment, let's think about egg donation in terms of the actual clinical process. We can dig a little bit deeper. The practice guidelines are provided by the American Society of Reproductive Medicine, which is our professional society that guides how we practice. So every few years, they come up with their updated guidelines, the most recent of which is 2013. To become an egg donor, you need to find women who want to donate. This is an ad from an Ivy League university in America whose number I blocked out. And these ads are all over the place when you look at university newspapers, if you go on the internet. There's also a lot of word of mouth amongst donors about being donors. And they definitely showed the bright, shiny picture of a lovely young woman appealing to her altruism to help another woman have a baby. So what's going to happen next? Well, we only will take a woman between the ages of 21 and 30. Proven fertility is desired but not required because obviously, many women in that age range have not had a pregnancy yet. No owner, operator, lab director, or employee of a practice can serve as a donor. For this, we can thank Dr. Cecil Jacobson, who you will remember in 1993, was charged with 52 counts of felony and fraud for using his own sperm to inseminate dozens of his patients. Yes, I see a person, I see you not even in the audience. You remember that case. He lost his medical license. He served five years in prison and now runs a farm in Utah, in case anybody's wondering what happened to him. So what's going to happen if a woman wants to be a donor? She's going to call the agency and she's going to go through a very brief phone screening. How old are you? Are you healthy? Do you take any medicines on a routine basis? Do you smoke? If you smoke, you cannot be a donor. And it's just one of our hard and fast rules. Unfortunately, it's one of the things that women are not always candid about, and so they can get all the way through the screening. And when we do the toxicology screen and we find nicotine, they're out. So we have to be very cautious about that. If the phone screening goes well, the agency will send them a personal health history form, which is about 25 pages long. And it asks for information, your hair color, your eye color, your ethnicity, your weight, your hobbies, your interests, how far you went in school. Then it asks for any of your medical history. It asks for your sexual history, your reproductive history, your psychiatric history, your substance use history. And then all of that information that you might know about as many first degree relatives as you can. That information gets sent back to the agency. The agency staff looks it over. And if it looks good, they call the young woman in and say, well, let's sit down and meet and talk about what it's like to be a donor. They then take her through the steps of taking the injectable fertility medicines, doing the monitoring, and then undergoing the egg retrieval. And oftentimes, women leave that office and they never come back. And so we see some attrition there. If that all goes OK, they send them on for the psychological screening. The psychological consultation, and this one of the things I've done, so many of these, they start to have a certain pattern to them. You do a basic psychological clinical interview, get their history, get to understand why they want to be a donor, what they're using the money for because they will all be compensated. We just talk about how they learned about being a donor. Do they know anybody who's had infertility? It's very interesting to me that many women who are donors often have had a pregnancy termination. And they will come in and they'll say, you know, I really want to be a donor because I feel like it's going to just set the universe unequal again. And if I can do this for someone else, it will somehow help me in the previous pregnancy that I ended. So that always is a very interesting motivation, I think. After they do the psychological consultation, we then have them do psychological testing. We use the MMPI-2, which is the Minnesota Multiphazic Personality Inventory. It is the most widely used psychological test in the world. And it's used particularly in employment screening settings, firefighters, police officers, airline pilots, and then we added ag donors. And so one of the programs of my research was my colleague Sharon Covington was to collect normative data on donors so we could get a sense of the MMPI profile for a successful donor and the MMPI profile of a donor that is not successful or is not someone that we would want to donate. Other programs use personality assessment inventory and the others use the Milan. I'm very comfortable with the MMPI because I know if there's ever any kind of controversy, I have all kinds of empiric data to back me up. And I know that I could defend that decision if I ever needed to. Donor exclusion criteria are all very clear. And these are, again, in the ASRM guidelines. Significant psychopathology on interview is an immediate rule out. Family history of a heritable psychiatric disorder also a rule out. And it's interesting with this because if you have that information, for example, that maybe the donor's mom had manic depressive illness, that has to be disclosed to the recipient couple. And that donor will never be chosen. And so we just kind of rule it out at the beginning. Substance abuse or dependence, current use of a psychoactive medication, including any of the SSRIs or any of the medicines that are pretty highly prescribed in this population. A history of sexual or physical abuse without treatment. And this you have to be very careful with. You don't want to re-traumatize a person who has been a victim of a sexual or physical assault, impaired cognitive functioning, or inability to give informed consent. And you may say, what do you mean impaired cognitive functioning? Sometimes people come to these consultations under the influence of a substance. And it's very obvious. It makes the decision very easy, because obviously, if they are coming to a medical appointment under the influence of a substance, they're not going to be an appropriate donor. It's difficult to recruit donors. And so this is a study that German and her colleagues did a long time ago. But I'm pretty sure the numbers are true even now. If you get over 1,100 phone calls from women who say they want to be a donor, from those, they'll send out about 364 questionnaires, those personal and health history questionnaires I talked about. Of those that they receive back, they will only interview 89 women. So either they didn't get the questionnaire back, or there was something on the questionnaire that ruled that woman out. Of those 89, 53 dropped out, 36 remained, and 14 completed a donation. So that's the level of attrition that we get as you go through the donor screening process. This will be important when we start thinking about supply and demand and payment. ASRM has said that donors can only donate six times. We have studied donors across the country and have found that most donors donate once or twice. Agencies are very interested in figuring out what are the predictors of women who will donate more than once, because recruiting donors is such a resource-intensive process, they would love to have a way to figure out who could stick in with it for a few more cycles. To my knowledge, no one has ever been able to discern what those predictors would be. So most, I'm sorry? Did somebody have a question? Oh, I'm sorry. So most donors donate once or twice. So here's Sally and Bob. Now we're turning to the recipient or intended parent's side of the equation. And in real life, Sally and Bob don't look nearly this happy or nearly this rested. They are typically pretty sad and pretty tired and very anxious to begin their treatment process. So on the intended parent's side, when the physician makes the recommendation for egg donation, what happens on their side of things? Well, the first thing, again, is the psychological consult. We do a psychosocial history, again, talking to them about their history as a couple, their plans that they had for having children, how their infertility treatment had gone. Then we talk to the woman about how far she is in the grieving process of grieving the loss of a genetic connection to her potential child. Most women, this takes a good three to six months. It's a very active grieving process because she has in her mind the idea of the child that she's going to have. And now we're changing that plan a bit. And so it takes a little time for her to really adjust to that idea. We review the egg donation treatment process just in terms of mapping out the cycle, having the donor get stimulated and doing the actual transfer. I assess for depression. We discuss privacy and disclosure. And we discuss donor selection. And donor selection is probably the thing we spend the most time on. And I've heard it from all kinds of different perspectives. We have some couples who say, just want a healthy donor. And that's literally all they say. It doesn't matter, ethnicity doesn't matter, height, weight, hair color, eye color, none of that matters. Then we have couples who will come in and say, well, she needs to be five eight and Danish, very musical and should have been a high school athlete. If you have her SAT scores, that would be ideal, but like a grade report would be fine too. And so I stop and I say, okay, tell me why you want that information. What is it that you're imagining? And again, you get into the idea of the woman grieving the loss of the genetic connection and wanting to feel some kind of kinship with the donor who she perceives to be similar to her. We then talk about it's very difficult to be so precise in what you're looking for in a donor. It's usually a trade off of the more characteristics you're looking for the longer it's going to take. And so we have that discussion as well in terms of what their plan is for when they want the treatment to commence and when they want the match to take place. We do also talk about privacy disclosure at that very early stage because one of the predictors of telling the child is how many other people you've told during the course of your treatment process. And so if a couple at this stage when they're meeting with me before anything has happened, if they've already told both sets of parents, all their siblings, three best friends and the milkman, they will have no ability to not tell that child and they need to be aware of that. So we need to plan that disclosure even at that very early stage. So the intended parents are finished with me, they go and try to get a donor. There are many donor agencies in Chicago and in any of the big cities in the United States. Most couples meet with more than one agency because agencies differ in terms of their style and kind of how they do things. They then make a down payment which is held in escrow and then they start reviewing the donors that are available to them from the agency and then make the final selection. This is another $15,000 to $16,000 on top of the price of the IVF. About half of that goes to the donor, half of that goes to the agency and all the screening, the legal and all of the work that the agency is doing. The match is made when the agency faxes our nurse, the matching documents, the nurse sends them on for their legal consultation and then the nurse begins to map out what the cycle timing is going to be. Much to the dismay of many intended parents, that cycle is determined by the donor, not them. So it's when the donor is ready to do this, the treatment begins and the mom is matched to the donor's cycle. The legal consultation takes place with I believe you had Nanette Elster speaking to you last week. Nanette is one of the people we refer to for these contracts to talk with people about their roles as a donor or as an intended parent. The two parties have separate but coordinated legal representation to develop the contracts that clarify the rights and the roles and responsibilities of each party. Intended parents receive the right to have the eggs, the embryos and any resulting children and get to decide what to do with any unused embryos that they don't use. Only if the donor agrees to that. The donor may say after you're done, Mr. and Mrs. Smith, I get to decide what happens with those embryos. I may decide to throw them away but the Smiths may want to donate them on to another couple so the lawyers help them clarify that. They also may say, they are very clear that the children born of the donated eggs are not the legal heirs of the donor. This is one of the areas that's very complex if you're doing known donors and it's often why we frown on using known egg or sperm donors because of the inheritance and the legal complications of that. So as I said, egg donation takes six to nine months for the screening and the matching. Treatment takes place on the donor's availability so we're real busy at winter break and summer break and unused frozen embryos stay frozen and are typically used to create full genetic siblings for the egg donor child. And so around the country, I think one of my colleagues, David Hoffman, years ago did a survey. There are over a million frozen embryos in the freezers of IVF practices around the country. And so it's just one of these things as a practice we always are keeping track of and always trying to talk to couples about what do you want to do with these embryos and when are you going to make a disposition decision. So now you know what I do at work all day and now you have an idea of what we do with egg donation. I want to move now to some of the issues that I find kind of troubling and I think in the field we can agree are somewhat controversial. I am not an ethicist, I am just a person who can kind of highlight maybe some of the concerns that we have with the way egg donation is currently done in the United States. In the early days of egg donation, it was all done on a known donation basis. That first case in Australia in 1983 was a sister to sister donation. As and also women going through tubal ligation would also go through an egg harvest and then those eggs could be used for donation. But very quickly demand outstripped supply and agencies began recruiting and compensating donors. The first agency in Chicago opened in 1996 and many others have followed after that. What we get concerned about are the donors are young and most recipients are older, upper income and there's a big disparity between the need for money on the side of the donors and the supply of money from the intended parents. And so always asking that question is when is payment coercive versus an appropriate compensation for the donor's time and effort? This all happens and the backdrop of the National Organ Transplant Act that actually bans payment for human organs and tissue but allows and you can see the quote, reasonable payment for the removal, transport, implantation and processing of that tissue. Reasonable payment has never been defined and to my knowledge there's never been a case saying you can't do this because you're paying donors. Germany, Norway, Sweden and Japan have completely banned egg donation. Canada, the UK, France and some states in Australia allow egg donation but with no compensation. They'll like pay for your parking, maybe they'll buy you lunch but no compensation as we think about it here in the United States. The United States, Turkey, the Czech Republic and South Africa allow payments to donors. The Ethics Committee of the American Society of Reproductive Medicine had a position statement in 2007 saying that financial compensation of donors is justified but the compensation should be structured to reflect the time, effort and discomfort of the donor. So when you have a donor cycle, the money is put in escrow. So for example now a donor makes $7,500 to $8,000 in Chicago for one donation cycle. That money is put in an escrow account. She gets a portion of it when she's completed her medical screening. She gets another portion of it when she begins her medication. She gets another portion of it when she finishes her medication and she gets the last bit when she's done with the egg retrieval. And so that's in keeping with the spirit of the ASRM guidelines. In 2007 they said payments over $5,000 need justification and over $10,000 is not appropriate. In 2007 the national average was $4,200. 85% of programs paid donors the same meaning they didn't pay a premium for donors with proven fertility, certain physical attributes or certain ethnicities. There are certain ethnicities that are very difficult to get for recipient couples. To get a Jewish donor, we send most of our couples to New York. Very, well the agencies in New York have a lot more. It is very difficult to get Japanese donors. It's very difficult to get South Asian donors. And so there's certain groups that are just very difficult to recruit or are not interested in being donors. Higher compensation, not surprisingly, on the coasts, lower in the Midwest and in the South. Everything changed a couple years ago. A very concerted effort by a donor, she organized a group of donors and brought a class action suit against ASRM for price fixing and unfair competitive practices. She felt that donors should have the right to get the amount of compensation that they felt they were worth. And if they had those desired characteristics shouldn't they have the opportunity to get more money for them? According to the Wall Street Journal on February 3rd of last year, ASRM settled. So they've removed language about specific dollar amounts in the compensation. The new Ethics Committee document came out last month and so we all read it hot off the presses. They still said financial compensation to donors is justified because it advances the ethical goal of fairness to donors. Failure to provide compensation would demean their contribution but they took out any specific language about dollar amounts. So they really want us to provide accurate information but not to have undue influence financially for donors. So we should talk to them about the potential risks both medical and psychological and legal. We should always make compensation based on time and burden. Importantly, we should not link it to the number of eggs or the outcome of the cycle. Some practices had talked about splitting batches of donors so that you could have donor A give eggs to couple one and couple two. That really fell out of favor because in the lab eggs are like any other tissue in the human body. Some are really good, some are kind of medium and some are not good at all. And so who's gonna be the one wanting to split that batch of eggs in the lab? I know it wouldn't wanna be me and I don't think it's any of the embryologists I know. So now they're back to one donor, one couple. Egg donors can have up to 40 eggs retrieved at any one given time. But they don't want those donors, those super donors to be compensated more highly than other donors. So here's what I found lately. You can go on any website and Google we need an egg donor and you will find these ads. Genius Asian egg donor needed $35,000. We're looking for an attractive and intelligent egg donor. Compensation is $75,000. So you get the picture of how things are going to go. This concerns me very deeply, but I don't know what the answer is in terms of how you manage this, in terms of managing the donor's needs and the intended parents' needs to engage in this collaborative reproduction. The forces that are pushing compensation higher obviously is the removal of the monetary guidelines. Also, agencies will tell you we need to pay them more because we need to get more donors because we have more intended couples who need eggs. So we have to keep everything going. Also, agencies talk about wanting to retain donors. And so again, they talk about adding a premium to donors who will donate more than once. And all of this is due to the increase in number of recipients who are desirous of this treatment. Some countries ban payments to donors. Donors that do not offer compensation have long wait times and a very short availability of donors. This has really led to the develop of a phenomenon called reproductive tourism. We get couples from all over the world who come to the United States, not just our clinic, but all IVF clinics, come to the United States, do a cycle of egg donation or sperm donation that they can't do in their home country, get pregnant and fly home. The other issue that I should just note for you is if you look at the National Health Service in the United Kingdom, they now have nine donors on their pool of donors. And so people come to the United States to get donors. Just a little summary, the pros and cons. People who are pro payment for donors say it's fair to donors. It maintains a high number of donors and creates more children in our very pro child society. People who argue against donations say it's a commodification of life. It undermines the altruism of a donor. Children are seen then as products. And this is the one of all these that stick with me that also is concerning to me that this is only available to really wealthy people. We have to acknowledge this. This is not something that's available to people across the board and particularly in this day and age of concerns about healthcare spending. It's a real concern. There's a very unequal distribution. So now we're gonna turn to something a little bit less contentious but equally important in my view. Second issue I wanna talk about is post donation wellbeing of egg donors. So you have this lovely young woman come to be a donor. She undergoes a medical procedure for which she will obtain no health benefit. Other examples of individuals like this are kidney donors or research subjects that are exposed to medical procedures. A thorough discussion of the procedures and its risks are necessary for the process of informed consent. And in the world of egg donation we get concerned about this because in the need to get more donors oftentimes the discussion of the risks and benefits can be short changed or not even covered at all. But then we have to ask ourself the question what are the risks? What is it that we need to inform these young women about in terms of what the consequences might be for their decision to become a donor? In 2006 the Institute of Medicine convened a panel looking at the risks of oversight donation for stem cell research because they were interested in beginning stem cell research at an institute in California. So they gathered a group of us together and stuck us in a room for a couple of days to review all the literature on the medical risks and the psychosocial risks of egg donation and it resulted in this report. All of the data that we had to review was obviously from egg donors who donated for clinical purposes because at the time they were not donating for stem cell research purposes. The IOM report just to summarize it identified three short term medical risks to donors. Ovarian hyperstimulation syndrome or OHSS. This is when the ovaries respond really robustly to the medicine and a woman gets very bloated, she gains weight, she can have nausea, she can have shortness of breath and in very serious cases she can have ovarian torsion where the ovaries twist inside the pelvis and that is a very serious problem. It's estimated that one to 11% of donors experience some level of OHSS. The next risk is the surgical risk of bleeding or infection related to the retrieval process. That risk is estimated to be at about 1%. The next risk is the risk of anesthesia, of the sedation that the donor goes through during the time of the egg retrieval. That risk is also estimated to be about 1% or less but there was one study that actually followed up with donors and about 4% of them said they had nausea or vomiting after the anesthetic. Psychological risks include mood swings from the medication, about half the women report transient depression, anxiety and irritability while on these medications. Regret is a more difficult risk to define but you find about 15% of donors who will say, I really regret having been a donor and it's not the week or two after they donate, it's a few years after they donate and they say, you know, I'm not sure I really wanted to do this. The other thing they are very concerned about is future contact with the child. Very much concerned that someday they will receive a knock on the door to say, hey mom, here I am. And so these are the kinds of things that stick with them psychologically and can cause them some distress in years to come. The long term medical risks, not surprisingly is impaired fertility for our population of donors. About 12% of donors who subsequently tried to get pregnant had infertility. 5% of them actually had to go get infertility treatments themselves. The last risk that we get concerned about is the risk of cancer. We have, I wanna be very clear, we have no data but the IOM concluded that it's a plausible concern that there would be an increase in breast, ovarian and or endometrial cancers in women exposed to these medications over several cycles. It is unknown though whether a healthy young woman would experience this because they're not, they don't have any underlying infertility causes that might make infertile women more susceptible to those types of cancers. So it is unknown whether there is a cancer risk for donors. There are two papers though that I think really opened up the conversation about this. And I will draw your attention to the one by Schneider in 2008 and Schneider is a physician and she was the mom of the donor who died. And she wrote very poignantly and very meaningfully about watching her donor go through the donation process three times, four years later she developed colon cancer and she died at the age of 31. Now we all know that a couple of cases does not causality make and I'm not implying that. Why Schneider's paper was important though is it was very much a call to we've got to do a better job and inform consent process with donors. It's not just a question of here girls, we want your eggs, sign this form. We really need to talk to them about the risks and benefits for themselves. It may seem like an obvious point to many of you. It is not in the day-to-day practice maybe as thorough as we might want. Certainly maybe not as thorough as research subjects undergoing the informed consent process for a medical study. Post donation well-being and informed consent are important because we really want to make sure we know what the risks and benefits are from what the donor has experienced. The few studies that are there do recommend detailed counseling for donors including numerical estimates of risks included in the consent forms. The long-term follow-up of donors, physical and psychological health I believe is an imperative and I'm not aware of any initiative to do that. And certainly with the number of donors increasing this can be a concern in the decades going forward. And specifically we also want to think about saying something to a donor like there are no significant long-term risks is very different than saying we don't know of any significant risks and we have to say we don't know because we haven't looked. I think people are hesitant to look at this because what if there are risks? What is this going to do to this whole model of how all of this is happening? That doesn't mean it's not a good idea and it doesn't mean it's not necessary in my view. Last, let's talk about privacy and disclosure and this is the topic that is very near and dear to me because it takes up a lot of my time in my counseling with my couples. Because I've been at Northwestern for 22 years I've had the privilege of couples coming back to me. They may have an eight-year-old child and the father is dying of cancer and the child was born of sperm, donor sperm and now the mom is saying what do I do? Do I tell, do I not tell? He's on his deathbed, he's not gonna be here. Do I add that into the mix? Or a lesbian couple who has a five-year-old daughter and kind of goes to school one day and says oh, I have two moms. Other people have moms and dads and some people have one mom, I have two moms. How did I get in the family? And then we talk about the narrative for how you tell the child about their donor origin. Kurt Vonnegut has a very good quote that I like to think about when I think about privacy and disclosure. Keeping big secrets is difficult even for really smart people. It is the most controversial aspect of gamut donation. Then there are numerous medical personality and cultural factors that affect disclosure. You'll remember that the first case of donor sperm use was in 1906 at Jefferson Medical Hospital in Pennsylvania and that was a live donation. The husband didn't know, the woman didn't know and only was it known after the fact that a donor had been used. Sperm donation has had a very long history of privacy because people were concerned about disclosing male infertility and the effect that that might have on the man and his sense of self-esteem and his sense of virility. That has carried over into the practice of egg donation even in current times. In the past 25 years though, there's several factors that have been pushing us to more disclosure and more openness. The first is the open adoption model where we know that adoptees are getting more and more access to information about their biological parents. The second is the use of donor sperm and donor eggs by lesbian couples and single women who want to have information particularly about their sperm donor so that the child can have a sense of a male person in their life. Ethics statements from ASRM and the Human Fertilization and Embryo Authority also have come down to say disclosure is the way to go. You need to tell your child, the child has a right to know. And in both Denmark and the United Kingdom, there is legislation to that effect. When you're a donor in those countries, you're registered and you agree to become known to the offspring when the offspring is 18 years old. The last thing that's changing the landscape here in the United States is the donor sibling registry. The donor sibling registry was started by Wendy Kramer who is a single mom by choice who had a child with banked donor sperm. Her son was really interested in knowing do I have any siblings? So she started this website where women who've had kids with donor sperm can register. They say what year their child was born, what bank they used and what their donor number was and then you can search the data set and see if there's any other offspring from that donor. One of my former patients has twin 18 year olds. Her daughter spent a week in Cape Cod with her 18 half siblings. And that was a really, really interesting thing to hear about. What do patients actually do? So we can all say, oh, you gotta tell, you gotta tell, you gotta tell. But what do couples actually do? Tallendini did a summary of the world's literature, which is 16 studies, to find out what couples do in terms of disclosure. And I'll draw your attention to the top line for sperm donor families, about 21% of them have told their child, 36% plan to tell, 30% are not gonna tell and 13% don't know. The numbers are a little bit different with egg donor families in that most, about half, plan to tell and only 16% plan not to tell. Many donor moms will say to you, yeah, I'm gonna for sure tell. I'm the mom because I carried the baby. I've got that gestational connection to the baby and that gives me that feeling of security and attachment with the child. So I'm not really threatened by the notion of informing my child that we used a donor egg. Most parents tell others during the fertility treatment about using donor gametes to conceive. We first documented this in 2004 in a study of five different clinics where couples were using donor gametes to conceive. Most people regret telling others. If you ask them after the fact, if there was one thing that they would do differently in the treatment process, that's what they say. They would say if we had it to do over again, we would maintain privacy. It was interesting when we were doing long-term follow-up studies. This is years ago when I was at University of Connecticut, we were studying families of donor sperm and we always had a plan to call around the time of the child's birthday just to check in with the families and see how they were doing and seeing how the child was and what their disclosure plan was. So I called up the study subject on a Saturday. He's like, hi, how are you? It's Susan, yeah, how are you? Fine, fine. How are you doing? How often do you think about using donor to conceive? I'm going through the questions in the study. And he goes, Susan, I only think about it when you call. I said, oh, really? Okay. So I go back to the group and I said, you know, we really need to rethink this methodology because we are now influencing the process and that is not okay. So we stopped. But it really, it taught me something very important in the process of doing clinical research in something like this, which is, in many respects, a very large social experiment in human reproduction. You don't know where you're influencing the process. Why do parents tell their children? First and foremost, parents will tell you the child has a right to know and that their kind of central belief about parenting is honesty is the best policy and that then informs their decision. The other reason they say is that we've told so many other people now we have to tell the child. We have no degrees of freedom around this. And the other is that the child should have access to their genetic information. Reasons why parents don't tell, they'll say to you, oh, there's no reason to tell. It's nothing important about this. They will also say the rearing parent is the real parent. They also talk about their community or their culture would be very negative about the use of donor gametes. And then the last is they think that their child would be somehow harmed or stigmatized in school, with friends, if it became known publicly that they were a child of a donated sperm or egg. Arguments to tell are often based on the belief that children who are told will have better psychological and social adjustment than children who are not told. Interestingly, there is no support from this position and this is work done by Susan Golembach and her colleagues at Cambridge. They're really the only people in the world who are doing these wonderful longitudinal studies of certain samples of donor gamete children. But they don't find any differences in psychological and social adjustment between children who are told and children who are not told. What do donor conceived individuals want? Nobody knows because you can't study them because half of them don't know who they are. So it becomes a very tricky thing to think about. When you set out internet ads, doing subject recruitment for people who are born via donor sperm or donor egg, by definition, those are children who've already been told. So you've got a systematic bias already in your sample. When we think about counseling couples in this treatment process, we always talk about the respect for an individual to know genetic information about themselves. In my role as a mental health professional, I have to stay neutral. I know what I would do, but I know that being dogmatic is rarely helpful. And so instead what I wanna do is help them consider what are the pros and cons of disclosure? What are the pros and cons of privacy? Specific to their family, specific to their beliefs, specific to their community. We also want to explore what are the basic values in parenting? What are we trying to do when we've raised our child? What kind of values are we trying to instill in them? The other thing we talk about, and this is the simplest thing in the world, but it sometimes feels like a great hurdle, is what is the narrative for how the child came into the family? And the couple be like, I don't know how to tell them they were born of donor sperm. Well, okay, mom and dad wanted you very much. You need an egg, you need a seed. We didn't have a seed for daddy, so a very nice man gave us a seed. We put them together and that made you. Oh, and they're like, oh, well, the child's gonna have so many questions. They're gonna get so worked up about it. I said, maybe, but more times than not, they'll just say, oh, what's for dinner tonight? And they're gonna move on. Because the easier you are with that information, the easier it's going to be for the child to assimilate that information. They'll come back and ask questions. They'll find out what they need to find out, but they will take their lead from you in terms of how you're talking to them as the parent. The other thing that's really changing the landscape in this line of work is the huge amount of genetic information that we have access to. People may have genetic tests in a medical setting that gives them information that they previously didn't know. And also over-the-counter gene testing with 23andMe and other things, you can start to see who you're related to and who you're not. And that will change this field very dramatically. In conclusion, gamete donation has led to the creation of tens of thousands of children. Genetically unrelated to one or both parents. The ethical concerns persist about payment to donors, informed consent and the well-being of donors, and information sharing to offspring and others. Large long-term studies are needed to understand this complex form of family building to better guide parents and to better guide children. Fundamentally, we're always asking, what is it that makes us a parent? This is the thing that always keeps me coming back to this line of research. Is it nature or is it nurture? And as this t-shirt says, either way, it's your parent's fault. I thank you very much. I'll be happy to answer any questions. Thank you so much. That was a great talk. Thanks, William. What responsibility is there, if any, to those women who are being screened to be donors, especially those who have a positive finding on the MMPI or other psychological screening? Is there some kind of track for future care? What is the responsibility to those? What we do is we bring them back in and we have another separate appointment with them. You typically don't show people the actual profile of the MMPI, but you absolutely interpret the results back to them and say, the tests indicated you might be having difficulty with depression or it looks like there's a problem, maybe with some rapid thoughts and maybe some hypomania. Have you thought about talking to someone? We can get you connected to where you need to get connected to take care of this. You wanna be very, very diligent with that, both on the psychological side and on the medical side. Many donors do not have access to regular medical care and very commonly if we see it like a positive pap screen, the intended parent's like, oh, well wait, when is she gonna be back? And it's like, you know, she's done. She's gotta go get her own health needs taken care of. So yeah, there's definitely follow-up steps when we find something on the screening. And that was gonna be my kind of follow-up question. So I presume that some, if not a good number of these women are uninsured, underinsured in terms of complications from the procedure, et cetera. Whose responsibility is it? Should there be such an issue? So what happens is there's an insurance company that provides specific insurance for egg donors and the agencies purchase that for the donors at the expense of the intended parents. So the intended parents pay for that. So if there's any hospitalization, anything at all, they have that policy covering the donors. So comparable to what we heard last week in terms of surrogacy. Yes. You got me thinking about the parallels between egg donation and organ donation. And it strikes me that two differences are that organ donors, I don't think, get paid. And the second is that organ recipients, but not egg recipients, get ranked and there's a list. I'm sorry, I missed that last part. People waiting for an organ go into a list and get ranked, whereas it doesn't sound like egg recipients do. No, it's really just a matter of when the timing is right for them to find the donor that they're gonna get matched to. There's definitely a supply and demand component to it, but I think it's not like the list with recipients. Could you just to follow up on this? I was quite surprised to see how quickly the American Society of Reproductive Medicine settled that lawsuit. The matter of a year or two, conceding that free market system had, they must have sensed that they were not gonna prevail in court, and two years is a very quick decision. You wonder if something like that might not apply going forward to solid organs also. I mean, claims like that. But the two year, when the AMA was fighting questions about advertising, they fought it for 12 years before they lost. But this was a two year fight. This was quick. They gave it up. Oh yeah, Matt, yeah, we'll get up there. Matt. Yeah. It's called in terms of the social test experience, and now with our new president, we're gonna be done to stay with it. So, how do they call the inequality directly? I don't think, I don't know is the answer to that. I think it is really plausible that insurance coverage for this is gonna go away if I had to guess, and that is gonna change the market really dramatically, particularly in the states like Illinois where they do mandate at least some form of coverage, but I don't know. The inequality is very unsettling. It has that very coercive feeling to it of donors doing this for the money. Most of them will tell you though they do have an altruistic motivation as well, but they wouldn't do it if they weren't getting compensated. So it happens all the time that women who are, who might smoke and might drink and might be depressed and might have some other imperfection of that sort, get pregnant deliberately or otherwise and have babies. Yep. Given that, how do you justify these severe restrictions and goals of perfection essentially that apparently are used in the agencies to screen out anybody who isn't perfect from being an egg donor? It is a very good question, absolutely. I think the agencies are responding to the intended parents. They will accept more donors. Like the criteria we had listed there, when you get to that point, you're not excluding that many because there's not that many you're gonna have a substance abuse issue or a mental health issue. Many intended parents are not gonna select those donors and that's why they make the justification for it, that they're gonna have a donor there that doesn't get selected. It's really interesting when you talk to those women who want to donate and don't get picked, talk about a long-term psychological consequence. And I've talked with some of them and it's very sad because they really want to be helpful and they really want to participate in this process and then they end up going, you know, what is it about me that nobody wants to take my genes? So yeah, it's a concern. Please. I was a little late so we'd be able to cover this but I'm wondering now that they're frozen egg banks. Yes. They do this process because it's a different relationship like just buying eggs from a bank versus like choosing a donor who's going through this process just for you. People do worry about that. I think the thing that is going to keep this process, the live match donors around for a little while longer is the frozen egg technology just became non-experimental in 2013 and you need 10 eggs to create one potential viable pregnancy. So you have a six to 10% chance per egg. So you could have all those banked eggs that you want but you're never gonna have as many as you're gonna need to meet the market demand if that makes sense to you. Once the technology for freezing eggs becomes more robust and more mature, I think it will actually change and it'll be much more like the model of frozen sperm. I was fascinated if I heard you correctly when you said that donors might negotiate with the agencies or with the potential recipients that they had control over the additional eggs that were not used. The disposition, yes. And now in a free market system can they sell those eggs to the highest bidder? Well, what's interesting is usually embryo donation doesn't get compensated. And I don't know why that is but typically embryo donation is not compensated and because the embryos exist in banks and they get matched to recipient couples, there's not that money that is changing hands. Darren. Yeah, just a mundane question. Did the recipients get to see pictures of the potential donors? 37% of recipients want to or have seen a photograph of their donor. And I know that because it was one of the things we studied in a paper that we did. Some of them want to, some of them don't. The ones who do very much have this feeling of I wanna make sure she looks nice. The ones who don't say, I don't wanna be feeding my baby at two in the morning when I'm really, really tired and have this image of this other person in my head or I don't wanna be walking down Michigan Avenue and say, oh my gosh, are you my donor? So it's about 37% to see a photograph. Can they see one if they want to? It depends, it depends. Some agencies will have photographs of the donors as children. Some of them have photographs in current time. It really just depends on what the parties want and what the agency typically will do. Yeah, I'm wondering about cases where you have an egg donor and a surrogate carrier. Does that come up often and create a lot of complications? Comes up all the time and it does. It's very complex to organize because you're screening the donor, you're screening the surrogate and then you're coordinating all those legal contracts. Some of the biggest issues that come up there are prenatal testing and termination of pregnancy if any medical, health issues are found in the fetus. And so you have to make sure you've counseled all parties ahead of time about what's going to happen because ultimately the surrogate's gonna be the one who's gonna get to decide. But you have to make sure the egg donor knows that and you have to make sure the intended father knows that or the partner of the intended mother if it's a same-sex couple. Did you follow that? I hope I didn't confuse you. And just for that example that you talked about, sir, that's very common among gay male couples. They have a surrogate, they have their egg donor and then the partners typically will alternate in terms of whose sperm is used to create the embryos. What is the position of the religious hospital regarding the procedure? I'm sorry. What is the position of the religious hospital? Religious hospitals. Oh, yeah. What is the position of religious hospitals? Religious hospitals don't do this. Yeah. Is the position. Many religious traditions are not enthusiastic about what we do. And I think that's putting it diplomatically. So interesting story. I actually started the process of applying to donate an egg in the past because I thought it was so fascinating. And you keep saying you screen the candidates and eventually I didn't get selected because I had far too much family history issues. But I thought it was interesting. I could have easily lied with any of the questions. Like, do you have depression? Do you have family history of depression? Do you have history of substance abuse? I mean, on the application, I could have said no, no, no, no, right? And like, how would you have actually screened me officially to find out if. All of this is based on self-report. And so it would start with the questionnaire and then it would be follow-up questions on the questionnaire. And during the psychological consultation, but it's a very, very good point. You are relying on the fact that women are being truthful on their questionnaire. Recipients do ask when they're gonna start doing genetic testing of donors. And that's coming down the pike. Some practices in New York will routinely screen donors just to look at their karyotypes, I believe is the correct term. And people ask us all the time, well, are you backing up this information? Are you talking to their other family members? Are you doing all the medical tests that need to be done? And that's not the current state of the practice at this point. It's not like you could go find my mother or my father and you don't know what I mean. Exactly. Okay, exactly. Thank you. Well, I want to thank you for the group that Dr. Clark, that was a fabulous talk. Well, thank you very much. Thanks so much. Thank you so much for having me.