IVF News

A fertility clinic in Boston, US, has been ordered to pay 108 thousand dollars in compensation to a man whose frozen embryos were used without his consent to impregnate his estranged wife. The figure represents the cost of child support paid for the man's seven-year-old daughter who, the jury on the case agreed, had been born after the clinic impregnated the child's mother without the man's consent. Part of the payment - ten thousand dollars - was said to be compensation for the emotional distress and depression he has suffered.

Last week, a jury found that Boston IVF had acted in breach of its contract with Richard Gladu. Mr Gladu originally sued the clinic and two doctors in 1998 for three million dollars in damages for breach of contract, negligence and emotional distress. Mr Gladu and his wife, Meredith McLeod, had originally gone together to Boston IVF for help to have a second child. Five embryos were created using his sperm and an anonymously-donated egg. Three were transferred to McLeod, who later gave birth to a son. In court, Mr Gladu testified that at this point he had told his wife that he did not want any more children because their marriage was 'rocky' by this time, and he believed that the remaining embryos would be donated to another couple or destroyed. But Ms McLeod returned to the clinic in December 1995, and the remaining embryos were implanted. Gladu said that he did not know his wife had undergone the procedure until January 1996.

The jury found that the doctors who treated Ms McLeod had not themselves acted negligently. However, it did find that the clinic itself was in breach of the terms of its contract, because it did not seek Mr Gladu's written consent before transferring the embryos to his ex-wife. Lawyers representing the clinic argued that the consent agreement Gladu had signed stipulated that it was his responsibility to notify the clinic that he did not want additional children or that his marital status had changed.

A lawyer acting for Mr Gladu said that it was absurd to believe a consent form that he signed before his wife's first IVF pregnancy would also cover a second one two years later. But a spokeswoman for Boston IVF said that the decision could have negative consequences for the whole fertility industry because, for the first time, a consent form has been found to be a binding contract. 'The patient-physician relationship will become such that you'd better bring your lawyer on every visit', she said, adding that the clinic was 'disappointed' by the court's decision, and will appeal. If the jury's decision is upheld on appeal, she continued, it will mean that fertility clinics will be held to an 'unrealistic standard' to guarantee that both parents consent to every stage of fertility treatment. But George Annas, chairman of Boston University's Department of Health Law, Bioethics and Human Rights, said the jury sent out a 'mixed message'. 'They didn't think the doctors did anything wrong, but that the clinic should have had more explicit procedures to make sure they have the consent of the husband every time they did an embryo transfer', he said.

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Measuring pH inside your incubator is now accurate and easy.

Measuring the pH of culture media accurately is extremely difficult because the pH of media droplets under oil shifts above 7.4 within just 2mins 30 seconds of removal from the incubator. So the likelihood is, if measuring the pH of media outside of the incubator, that you are measuring artefact pH levels.

Why use the RI pH Meter?

The RI pH Meter provides accurate, real-time analysis of media pH within the incubator using its unique custom pH probe. The probe, that is the same size as a 1006 petri dish, fits into all incubators, including the Minc incubator, and allows embryologists to adjust the CO2 concentration to obtain the correct pH in the media. No more guesswork or assumptions when trying to deliver the correct pH for the media being used.

How is it used?

Simply make up a media droplet in the custom pH probe and place in the incubator. Pass the cable out through the sample port at the back, plug it in, and shut the door. Once equilibrated, simply make the reading. The unit will then measure the pH in real-time displaying the value on the digital readout with a resolution of 0.01pH.

Trend Analysis

As an optional extra the meter can have onboard memory for data logging. Test results stored by the pH meter may be easily downloaded to a personal computer for analysis and printing so you can analyse your incubator performance over time and develop procedures for equilibration.

Bill Brown, Managing director of Research Instruments said, ?The pH Meter complements the IVF Thermometer in our range of products for environmental monitoring within IVF labs. This is the first time that pH can be accurately measured inside an incubator.?

More information can be found at

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A twenty-six year old British woman has advertised her eggs for sale on an American website in order to pay off debts. Alexandra Saunders ran up debts of up to ?15,000 on credit cards which she hopes will be cleared if an American couple choose to use her eggs at a fee of around ?20,000.

In the UK payment for egg donation is illegal, unlike the US, where a number of websites link childless couples to women willing to donate eggs in exchange for cash. Miss Saunders read about the money that could be made selling eggs in this way in a magazine article. Despite currently holding three jobs, one full time day job and two evening jobs in pubs, her annual income is only around ?20,000. 'It just sounds like a good idea - easy money really - and it helps someone out', she told the Daily Mail newspaper.

A recent change to the law in the UK also removed the anonymity of gamete donors. Under the new rules once a child born from donated gametes reaches 18 years old, they may be told the identity of their biological parents. This, coupled with the fact that eggs cannot be bought or sold, as well as the procedure being invasive and uncomfortable, have contributed to a shortage of egg donors in the UK.

There are concerns that women may be unaware of the risks involved in donating if their motives are purely financial. Josephine Quintavalle of Comment for Reproductive Ethics told the Daily Mail that 'the sort of money on offer in the US to egg donors is extremely tempting to some but I think at the very least women should be well informed about the risks. Egg donation is not like sperm donation. Women's eggs have to be harvested and the procedure can cause infertility, illness and even death. That is why people in the US pay such high prices for eggs because of the dangers involved.' Miss Saunders has reportedly not yet received a response to her advert.

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First baby born using BlueGnome’s 24sure single cell screening technology.

Working in collaboration with the world leading IVF centre, CARE Fertility (Nottingham UK), BlueGnome 24sure microarray technology has been used for the first time to successfully screen polar bodies for all 24 chromosomes and select a euploid (normal chromosome content) egg that resulted in a successful pregnancy.

Professor Simon Fishel, Managing Director of CARE Fertility Group said:

"Chromosomal abnormality plays a major part in the failure to establish a pregnancy. Full chromosome analysis may double the chance of success in couples who have a poor chance of conceiving or a history of failed treatments and miscarriage; and maximise the chance of pregnancy in all couples"

"Up to half of the eggs in younger women and up to 75% in women over 39 are chromosomally abnormal. 24sure technology can be used to screen eggs/or embryos in an IVF cycle, evaluate all the chromosomes and select the most chromosomally normal embryos."

The successful birth followed 13 previous failed IVF cycles and the mother was 41 years of age at the time of treatment. Eight eggs were tested using 24sure as part of a consented study and only two were found to be chromosomally normal. One of these led to the birth.

Dr Nick Haan, CEO BlueGnome said:

"BlueGnome is proud to be part of a process that has led to the birth of a child. 24sure technology has been developed specifically to analyse single cells for chromosomal aneuploidy and we believe that this technology may have a major future in pre-implantation genetic screening. However, it is important to emphasize that clinical data is still limited and carefully designed trials are required to properly assess efficacy of the technique."

24sure technology offers a number of important advantages including:

1. Accurate, reliable and sensitive determination of chromosomal aneuploidy as shown by independent (blinded) testing of cell lines and blastomeres with known abnormalities.

2. Robust analysis of multiple sample types including both haploid (polar body) and diploid (blastomere, trophoblast biopsy, cell lines).

3. Rapid 12hour protocol such that samples can processed within an IVF cycle, removing the requirement for freezing.

For further information, please contact

Tony Gordon, BlueGnome

[email protected]

Mobile Tel: +44 (0)7920269316 Office Tel: +44 (0)1223 844441

www.24suretest.com

Cambridge, 8

th September 2009

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A study has found that exposure to the 'harsh' cool-white fluorescent lighting commonly used in fertility clinics, research labs and most office environments could be particularly damaging to an embryo's healthy development. A joint team of researchers in Hawaii and Japan conducted the study on mouse embryos and found that certain types of light exposure are more damaging to embryo development than others.

The study also indicates that mammalian embryos, which develop in dark wombs, lack a protective mechanism that other animals, such as amphibious frogs or fish which lay external eggs, possess in order to cope with exposure to light. These results were published last week in the Proceedings of the National Academy of Sciences of the United States of America.

Sunlight and cool-white fluorescent office light, which is blue-white in appearance, were the most detrimental to the mice embryo development while warm-white light, which is typically used to illuminate homes and residential environments and has a yellow-white colour, was significantly less damaging, according to Dr. Ryuzo Yanagimachi, a retired reproductive biology specialist involved with the University of Hawaii study in collaboration with Manami Takenaka and Toshitaka Horiuchi of the Prefectural University of Hiroshima. They found that even reducing light-exposure to ten seconds for direct sunlight and to a few minutes for blue-white light, still caused damage to the embryos in the study.

It appears that the light stimulus triggers a stress response in the embryos that hampers their healthy development. When exposed to light, the embryos produced increased levels of radical oxygen which is toxic to cellular development, explained Dr. Yanagimachi. He added that the study has lent support to his belief that light is a neglected environmental factor in embryo development.

The researchers suggest that labs which deal with human and animal embryos would improve their success in embryo development if they (1) replace 'harsh' office lighting with 'softer' warm-white light bulbs for illumination, thereby reducing damage to reproductive materials when they are unavoidably exposed to light in the lab, and (2) generally attempt to minimise light exposure as much as possible during each stage of embryo development that is manipulated outside of the uterus including during egg extraction, sperm insemination and fertilisation.
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An embryo screening test could significantly increase IVF success rates, US researchers have found. The test allows doctors to quickly select the most likely embryos for successful implantation into the womb, helping reduce the risks of genetic birth defects, miscarriage and failed pregnancy.

Researchers compared screened with non-screened embryos and found 87 percent of patients who underwent screening had a healthy baby. This fell to 68 percent for patients whose embryos were transferred without the test. 'In this particular test we can get an answer in four hours, we do not have to cryopreserve (freeze) the embryos and we can implant them the next day', explained study leader Dr Richard Scott, a specialist in 24-chromosome aneuploidy screening.

During the test, a biopsy is taken from a five-day old embryo to examine whether it has two copies of all 23 chromosomes. Almost half the embryos resulting from IVF are aneuploid, meaning they have too many or too few chromosomes. Implantation of such embryos could lead to the development of various genetic conditions or spontaneous abortion. Only those with the exact set of 46 chromosomes are selected for use in IVF after the test.

Presenting his research at the American Society for Reproductive Medicine (ASRM), Dr Scott also explained how the improved success rate also meant only one embryo needed to be transferred at a time, reducing the risk to mother and baby from a multiple pregnancy. 

Currently genetic screening is available in the UK to test for inherited diseases including cystic fibrosis and muscular dystrophy, but some fertility doctors believe such tests should be routinely offered. The study involved 80 patients of an average age of 34 and the researchers now propose to continue with a three-month trial involving up to 500 patients.

It is thought the screening test will cost an additional £1,000 to £2,000 in addition to standard IVF costs. Tony Rutherford, chair of the British Fertility Society, expects the test will take two to three years to develop.

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In this week's BioNews, we report on a paper published in the Journal of the American Medical Association which shows that postmenopausal women having egg donation are just as likely to conceive as younger women. Although we've known it for some time, the study confirms that it is the age of the donor eggs, rather than the age of the recipient womb, which is the important factor in conception. As long as a younger woman's eggs can be used, their postmenopausal sisters can be mothers too.

Following the publication of the findings, many American newspapers have reviewed the ethics of postmenopausal mothers. Roberta Springer Loewy of the University of California at Davis, disapproves of such uses of reproductive technology. 'Simply because we find we can and want to do something doesn't mean we ought to do it,' Loewy said. Meanwhile, Ruth Faden, a bioethicist at Johns Hopkins University, observed: 'We're trying to improve people's quality of life as they age on every dimension. Why should the reproductive arena be different?'.

Of course, one thing that this study does not do is to resolve the ethical disagreements. But it does clarify some of the issues for older women thinking about using IVF and egg donation to become a mother. As the study shows, conception rates in younger and older American women using egg donation may be comparable, but the associated risks of pregnancy in women over 50 are considerably higher. The incidence of caesarean sections, pre-eclampsia and gestational diabetes are all higher in postmenopausal women.

This information is useful for older women thinking about whether or not to proceed with postmenopausal egg donation. But British women may wish to consider one further thing: the women in the American study had, on average, three to four embryos transferred to their wombs in order to achieve a pregnancy. The maximum number of embryos which can, by law, be transferred to a women receiving treatment in the UK is three - and one or two is becoming the norm. As a result of the higher numbers of embryos transferred, a third of the births in the American study were of multiple babies. In a country like the UK, where clinicians more often seek to avoid multiple births, the success rate of postmenopausal egg donation is likely to be lower.
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The Australian federal government is planning to cut back on funding for IVF in its budget next month. It is considering placing a cap on the number of Medicare-funded IVF treatments to a maximum of three for women over 42 and three per year for women below that age. The average cost of a cycle of IVF in Australia is about $8000, of which about half is usually Government-funded. At the moment, there is no limit to the number of IVF cycles that a woman can receive.



Health Minister Tony Abbot has justified the proposals, saying that the Government could not afford to fund so many 'elective procedures'. He said that after Medicare's share of the costs of IVF rose by 25 per cent in 2004, there was a concern that some fertility doctors might be 'profiteering'.



The move has sparked opposition from liberals. Rhondda Vanzella, vice president of the New South Wales (NSW) Liberal Party said that the Government should not impose limits on fertility treatments. Nearly 100 members of the NSW Liberal Women's Council have voted unanimously to tell the federal government that the budget should not include limits on IVF funding. Decisions about IVF should 'be between a woman and her doctor, and the Government should not interfere', they said. In addition, Julia Gillard, the federal Shadow Health Minister, has launched a petition to protest about the proposed limits.



Peter Costello, Australia's chancellor, said that 'nobody's going to stop IVF treatment where it has a reasonable chance of success', but added, 'there's no point in.giving treatments where there is a very very low chance of success'.

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Mammals may continue to produce new eggs throughout their lives, a study carried out on mice suggests. The findings challenge the long-held belief that female humans, mice and other mammals are born with a finite supply of eggs, which lasts until the menopause. A team of researchers at the Massachusetts General Hospital in Boston, US, say that if their results are confirmed in humans, all current theories about the aging of the female reproductive system will have to be revisited. And the potential existence of 'ovary stem cells' could pave the way for new treatments into treating infertility, say the scientists, who published their results in the journal Nature.

For decades, scientists have believed that all of a woman's immature egg cells are all produced before she is born. Between puberty and the menopause, a few hundred of these are released as mature eggs, while the rest gradually die off. But the new study shows that in mice, there is evidence of ovary 'stem cells', which are capable of producing fresh eggs throughout the animal's reproductive life. At first, the researchers were shocked by their results: 'We had a six-month period of disbelief, when we had trouble digesting the whole thing,' said team leader Jonathon Tilly.

Tilly's team had been studying the process by which ovarian follicles (containing immature egg cells) die off in adult mice. To their surprise, they found although there was a high level of dying follicles in adult female mice, the animals still had a plentiful supply of healthy follicles. 'That's when all the whistles and bells went off,' said Tilly. The only likely explanation was that new eggs were being continuously made to replace the lost ones. To test their theory, the researchers then looked for evidence of germ cells, the stem cells that give rise to oocytes in the developing fetus. They found potential 'ovary stem cells', which appear to share many of the features of male germ cells, on the outer surface of the ovary.

Reproductive biologist Roger Gosden, of the East Virginia Medical School in Norfolk, US, said that the ability to make more eggs would be a revolution in womens' health. 'In theory, it would allow you to have better control over the timing of the menopause, to grow more eggs for one's own fertility treatment, to prevent premature menopause, to recover fertility after chemotherapy, and on and on,' he said. However, he also cautioned that it is not yet clear whether stem cells exist in human ovaries, or how prolific they might be.
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Yves Bolduc, the Minister for Health in Quebec, Canada, has announced plans to introduce free fertility treatment through the extension of Medicare coverage. This move will fulfil Premier Jean Charest's 2008 campaign promise and will make Quebec the first jurisdiction in North America to offer fertility treatments free of charge.

The programme is expected to cost Quebec $32 million in its first year of implementation, rising to $80 million by 2014. However, the new system is expected to make savings in other areas. Under the current private-sector treatments, cost effectiveness means that more than one embryo are usually implanted at a time. This often leads to multiple births and increases the risk of premature deliveries. Under the new Medicare system, single embryo transfer will be preferred and the number of premature births is anticipated to decrease from 30 per cent to under 10 per cent for assisted pregnancies. Bolduc emphasised that this decline is expected to save the medical system a significant amount.

Dr Hananel Holzer of the McGill University Reproductive Centre expressed his approval for the plans to provide free treatment. The Centre currently performs 1,000 cycles of embryo implantation a year at the cost of $10,000 per cycle. With the introduction of free fertility treatment that number is now expected to rise to 3,000 to 4,000 cycles by 2014. Holzer commented that 'it's the most frustrating thing to hear from a couple: 'We can't have child, we want to have a child, but we can't afford it''. The announcement made on Thursday moved towards combating this problem.

While such an expansion of medicare coverage has generally been welcomed, the feeling amongst independent experts is that they have not yet been given the opportunity to digest the proposals. Abby Lippman, an expert on reproductive genetics from McGill University said that the press release has not really provided more information and that she had not yet seen the proposed regulations to govern the programme. Nine pages of legal text were distributed just before Bolduc began the news conference giving little time for analysis and reflection. There will now be a 45-day window for independent experts to comment. As Lippman said, 'the devil is in the details - and we don't have a single detail.'

However, while comments are being formulated by the fertility community, the overall response has been that of excitement. Beverly Hanck, executive director of the Infertility Awareness Association of Canada in Montreal stated: 'This is wonderful news'.

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