How to Make a Family: The Blog

I Feel Like I've Always Known You

The recent report from the UK, about a married couple who turned out to be biological twins separated at birth, is being cited as an example of the many "what-if's" in the wide open ethics of reproductive manipulating.

David Alton, a member of Britain's upper House of Lords, brought the anecdote up in discussion about proposed legislation in the UK that could allow the anonymity of sperm donors on birth certificates. Before any American sperm donors or related infertility patients become alarmed, you need to know that current UK rules by the Human Fertilisation and Embrylogy Authority (HFEA) allow for NO anonymity by gamete donors after April 2005.

So while the once-married-now-divorced twins in question were not (as far as I know) the result of IVF, Lord Alton used their sad story to illustrate further potential for heartache and lawsuit among the millions of people being born as the result of donated gametes, cases in which most are thus far not aware of their biological connections.

The folks at BioEdge report "The tragic case highlighted the growing possibility of unwitting incest in the population, now that as many as one child in 25 is born through IVF in some countries."

Never mind the ramifications of not knowing your genetic propensity for certain diseases, and there's the important issue of simply knowing from where you come in every way.

I have truly enjoyed reading about the ART-related ethical dialogues in other countries over the past decade and more. While it may seem to Americans, focused and driven as we tend to proudly be, like so much circular banter, the truth is that we don't engage in enough of the same over on this side of the pond. We just do not, not in wide circles anyway.

Evidence of my claim: if you were to breeze through the headlines (as I tend to do for lack of time) and especially if you stick to the US papers and news websites, you'll get that the most important part of this whole story is "Separated twins marry, forced to break up in UK", as said the Reuters report published in, among other spots, the Boston Globe.  Even the NY Times' own correspondent writes focuses on this titillating moment of "eeww!" in regards to the dilemma at hand. We hear echoes in our reading brains to the tune of "Shocking! Outlandish!" -- the freakish sideshow lives.

But if you want the real story -- the details of the legislation that is being proposed and considered and debated in all earnestness, wherein the deeply felt concerns about the welfare of children and their parents and, indeed, society as a whole are being expressed with persuasive emotion -- you might want to slog through the clay-thick transcripts of Parliamentary proceedings (I've at least narrowed it down a bit for you to this page of the Daily Hansard, but I encourage you to link through to the previous and continuing discussion pages).

Granted, in addition to risking glazed eyes from the convoluted language common to any governmental transcript, you have to wade carefully through the British niceties that are, well, foreign to most of us Americans. But if you manage it, you'll find the story by Lord Alton, true though it is, was only an example used to illustrate a potential area of concern. It is not The Story.

Perhaps The Story is that the American media prefers to present the teasing tawdry tidbits of an incredibly powerful ongoing inquiry that can have lasting impact on the human experience. Oh, but that's just so blase.

Link: Separated twins marry, forced to break up in UK - Boston.com.

Trouble in Egg Donor Paradise

This is how the Book of Rules is built: one stupid incident at a time. Only this time, it's possible that there are a lot of stupid -- and possibly tragic -- incidents to use in building a case for more stringent egg donor guidelines or even regulations.

One of the earliest and biggest egg donor registries (a place where folks who are donating and those who are seeking eggs can meet and greet), Options, is going bankrupt. In its wake, one of their employees is coming out with a story that's not new, but has been kept under relative wraps for awhile. Long story short, it's about how even egg donors who are particularly choosy about who gets their gametes don't have a leg to stand on.

This article in the Orange County Register details the mess, and if you've ever used Options -- based in California but accessible from virtually anywhere via the Web -- you might want to peruse their printed list of contract numbers. The author of the article advises folks who find their contract number listed "request copies of their medical records."

Link: News: Thousands of human eggs may be missing | eggs, options, doctors - OCRegister.com.

For Babies' Sake

Jerome Burne argues in the Daily Mail that not enough is being done to tease out all the future ramifications of ART in IVF: Why we must be told the truth over birth defects.

He highlights how unaccessible the HFEA's data is for the pursuit of research that would shed more light on just how safe things like fertility drugs and techniques such as ICSI are in regards to long-term effects on moms and offspring.

Excerpt:

Can these drugs cause cancer? By boosting oestrogen and stressing the ovaries, they may cause cell abnormalities. The link was described as "controversial" in the journal Nature this August. A study last year failed to find a link; yet the journal points out that those involved were mostly taking an older drug.

Could newer ones be carcinogenic? It is not clear. Who's investigating? Probably not the drug companies.

According to former chief medical officer of the FDA Dr Suzanne Parisian, "drug companies are not required to collect safety data on IVF drugs regarding the risk of cancer or other serious health conditions." Once again, long-term UK studies could help resolve the issue.

The HFEA is confident the drugs are safe. "There is not sufficient evidence to suggest IVF practice should be altered," says a spokesman.

But perhaps we are missing something important by concentrating on the risks of IVF. Could the problems have more to do with whatever is causing the infertility?

Online Egg Boom Dehumanizes Participants

Harvard author Debora Spar is quoted in this piece that reports on the rapid growth of the egg-find industry through the Internet.

Shelley Smith, director of Los Angeles-based The Egg Donor Program, is quoted:

"...the bad news is that it objectifies the donors and takes away the human contact people should feel when they are building their families. It's not like buying a car from a catalog."

Link: Fertility industry booms online - Yahoo! News.

Gay Men Redefining Family

Following in the heels of ASRM's recently published stance that gay and single people should have equal access to fertility treatment, John Bowe does a nice job illuminating some of the challenges, pitfalls, and beauty of life when gay men want or get to be biological dads.

Link: Gay Donor or Gay Dad? - New York Times.

Susan Estrich: WHAT WOULD YOU DO FOR $80,000? - Yahoo! News

The reality is that baby-making exists in a sort of vacuum between law and no law, where the only ones who are certain of protection are the lawyers, not the mothers or the babies. What counts as protection is far from clear. Does protection mean not getting paid too much, or being paid fair market value? Does protection mean allowing profit to enter a woman's equation, or pretending it is simply a labor of love? Who are we protecting, and against whom?

~Writer and professor Susan Estrich with her take on the pay-for-eggs conundrum.

Link: WHAT WOULD YOU DO FOR $80,000? - Yahoo! News.

ASRM Catches Up: All Kinda Folks Deserve Access

Bearing in mind that ethics aren't regulated, the American Society for Reproductive Medicine has just published their stance on fertility treatment for gays, lesbians, and unmarried people.

Like the American Psychological Association before them (in addition to other groups of pros in the fields of mental health, family issues, and child development,) the ASRM says that there's no sufficient reason to try and bar whole groups of people from entering the Parenthood. Specifically, the ASRM's Ethics Committee has written that disallowing fertility patients access to treatment solely based on their marital status or sexual orientation is simply not justifiable.

Think about it: the guys and gals who put sex-free procreation on the map are finally saying that, well, yeah -- even heterosexual "marital reproduction no longer is solely coital" and might even involve a third-party. So how could clinics possibly still be saying that there's something wrong with helping two men or two women or single people become parents? If their argument is based on old ideas about The Way Things Are Supposed To Be, how do practitioners justify their own profession?

Thing is, they're out there. Remember, in America, medical practitioners aren't bound by much in the way of ethical/moral regulations. If they're uncomfortable with providing services to someone, they simply have a legal right to refuse (beyond life-saving measures...) The ASRM guidelines provide a framework that they encourage practitioners to heed. There are no consequences, so far, for a physician's denying treatment based on things like lifestyle, save for lawsuit threats.

Still, it's relieving to see another example of how this important organization is stepping up to the plate, even if cautiously. In fact, I would venture that among groups of docs, repro med specialists, by virtue of the avant garde realm of creating life in which their profession lies, do a better job of keeping pace with societal changes than do other physicians.

Just So Everyone Gets Their Due

The UK reels from the backlash from donor regulations that remove anonymity from the process. In the U.S., we're still trying to figure out how much a gamete is worth.

The British and others have seen a serious downturn in the number of willing donors, now that they know that resulting kids can look them up in 18 years. In addition, the going rate for egg donor (ED) compensation is around $500 U.S. dollars, paltry in comparison to our American rates of $5k and upwards.

A couple of poster presentations from ASRM 2006 looked at some related numbers.

Dr. Sigal Klipstein from Karrande & Associates of Hoffman Estates wanted to answer the question "What do donors actually do with the money they receive?" in her questionnaire study, "Coercion in the Recruitment of Anonymous Egg Donors."

Noting that the number of ED cycles in the U.S. has tripled in the past eight years, Klipstein described the average U.S. compensation to donors as ranging around $5,000. with some being paid as much as $10,000 for a cycle.

Based on the following numbers, Klipstein concluded that there was no evidence of coercion among the ten (10) respondents, who reported using their $5k compensation for ED in the following ways:

40% pay back loans / decrease debt

20% pay for schooling

20% down payment on property purchase

20% savings

Klipstein partly based her conclusion on the judgement that none of the above expenditures are "luxury items" (defined in the abstract as "vacations or self improvement".) The questionnaire also inquired about the donors' opinion on the amount of compensation and whether more or less would impact their desire to donate again. From their responses, the researcher surmised that while raising reimbursement to $7,000 may increase supply, going down to $3,000 would result in dwindling participation. Still, Klipstein believes there is a threshhold and that paying "a lot more probably will not bring in more donors."

When some of the UK reporters asked her opinion on their country's present conundrum, Klipstein said she believes the removal of anonymity has a far greater impact on donors coming forward than any amount of money could adequately compensate. "[Donors] aren't doing it because they want to have a child out there who may contact them later..."

In a simply interesting look at compliance with ASRM guidelines, J. Luk, MD, PhD of Harvard University School of Medicine reviewed the websites of all agencies that have signed an agreement with SART to abide by the ASRM Ethics Committee Guidelines governing egg donor payment.

After writing off the agencies with non-working websites, Luk reviewed the contents of sites for 51 agencies and found the following:

The national average egg donor (ED) compensation fee is $5,313.

The national average agency fee (paid by the recipient parents for agency services) is $3,631.

Three (3) centers listed ED compensation at more than $10,000.

Ten (10) centers offer compensation variances based on personal characteristics.

Both paying donors more than $10k and offering varied compensation based on personal characteristics of the donor are discouraged by the ASRM guidelines. When reporters inquired about any available consequences (there are none), Luk recommended that ASRM consider removing non-compliant agencies from their online list, in addition to the creation of a related oversight committee. Moderator of this briefing, Dr. Robert Visscher, suggested that entities that do not meet guidelines are in fact at greater theoretical risk for lawsuit should any client dealings go awry.

The Cost of A Strike o' Lightning

As far as anyone knows, there's never been an incidence of disease transmission by way of the single oocyte cell. Still, the FDA saw fit to include these cells and their use in tissue regulations that went into effect in May 2005.

Coming from a previous career in social work, I'm too familiar with the overload of busy work that bureaucracy breeds. I recall my own struggle with the cascade of regulatory duties back in the 90's when government entities were just starting to come forth with funding for HIV services. It was from that perspective that I understood the presentation by Drs. Valerie Baker and David Adamson of Fertility Physicians of Northern California at ASRM 2006. Their poster demonstrated the cost of compliance with the FDA regulations.

The cost to their clinic at one year post implementation of the FDA regulations for 40 egg donor cycles performed from May 2005 through May 2006: $228,180.

Neither physician grumbled about any of the data, gleaned through staff surveys and calculation of costs incurred, or the conclusions. They matter of factly described the new regulatory experience as making the process more rigorous, requiring behavioral changes, and resulting in greater reassurance -- at great cost. Grumbling wasn't necessary to get their point across. Dollar signs and numbers speak loudly.

Upon interview, Dr. Adamson remarked that while he and other experts look forward to continued collaboration with the FDA on future revisions and other regulations as they come, there are a host of entities to which he and his colleagues are required to report, including the FDA, the ASRM, California's own state agencies, and the CDC. He emphasized, "To say that IVF is unregulated in this country is incorrect. The only thing that is truly unregulated in the U.S. [fertility treatment industry] is reproductive choice."

How Many Embies Are Too Many?

More research highlights from ASRM 2006:

Additional delving into the pros and cons of transferring fewer embryos from IVF, as Cornell researchers explored their own database of ICSI cycles from 1993 to 2005. They compared outcomes among those patients who'd had single embryo transfer (SET), two embryos (2ET), and three or more (3ET).

From the total of 11,237 cycles analyzed, some of their findings, as reported from "Consequences of an Eventual Restrictive Embryo Transfer Policy of ICSI Outcomes" by Peter C. Klatsky, MD:

The more embryos transferred, the higher the overall pregnancy rate.

Most of the SET patients were such because they had only 1 good embryo to transfer anyway. They tended to be poor responders with poor prognoses.

Use of SET decreased the pregnancy rate, but that was accounted for by the fact that it also decreased the multiple gestation rate.

2ET increased the risk of having twins to 27 percent.

When asked, Dr. Klatsky said there's been a measurable decrease in patient desire for twins since 1995. At present, approximately 56 percent of infertility patients interviewed want twins and even fewer like the idea of triplets. In contrast, 16 percent of patients in 1995 thought triplets "would be fine."

Another study using Cornell's wealth of data, "Consequences of a Restrictive ART Law on Clinical Outcome," aimed to simulate the consequences of restrictive Italian and German laws if similar laws were in place in the United States. Italy and Germany have notoriously strict requirements on the use of ART. For example, in any given IVF cycle, only three eggs can be inseminated, and any resulting embryos must be transferred immediately rather than being frozen.

To simulate such a climate of restrictions, the researchers compared cycles based on number of mature eggs inseminated. They found a direct correlation between number of oocytes inseminated and the incidence of multiples. Fewer eggs undergoing ICSI leads to fewer pregnancies. Importantly, they also found an inverse relationship between number of oocytes injected per cycle and pregnancy loss.

Related: see the newest embryo transfer guidelines put forth by SART/ASRM at the 2006 meeting.