IVF News

BioNews reporting from ESHRE conference, Berlin:

High protein diets could affect a woman's chances of becoming pregnant, a US study carried out on mice suggests. The research, reported at the European Society of Human Reproduction and Embryology (ESHRE) annual meeting in Berlin, suggest that women trying to conceive should avoid 'low carbohydrate' regimes such as the Atkins diet, which feature high amounts of protein and fats. Study leader, David Gardner, of the Colorado Center for Reproductive Medicine, stresses that the effect of diet on mice may not reflect the situation in humans. However, he said that women adhering strictly to high protein diets may have problems conceiving.

The researchers studied embryos grown in the laboratory, produced by mice fed by a diet containing either 25 or 14 per cent protein for four weeks. They found that the high protein diet appeared to disrupt a process called genomic imprinting: the switching off of certain genes in the early embryo, according to whether they are inherited from the mother or father. The diet also affected the ability of the embryos to implant in the womb and the development of the fetus. 'Although our investigations were conducted in mice, our data may have implications for diet and reproduction in humans', said Gardner.

Previous studies have shown that the amount of protein in the diet affects the levels of ammonia in the reproductive tract in cows and mice, and also that ammonia can harm mouse embryos grown in the laboratory. The latest study focused on an imprinted gene called H19, which is involved in embryo growth. The scientists found that only 36 per cent of the embryos from mated mice fed on a high protein diet showed normal H19 gene activity, compared with 70 per cent of the control group. 'Furthermore, only 65 per cent of the embryos in the high protein group developed into fetuses once they had been transferred, compared to 81 per cent in the control group', said Gardner. And, of the embryos that did implant, only 84 per cent developed further, compared to 99 per cent of the control group.

The researchers conclude that their findings, together with similar work carried out on cows, show that women trying to conceive should make sure their protein intake is 'less than 20 per cent of their total energy intake'. An average US diet apparently contains around 14 per cent protein.
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Two new studies have found that acupuncture does not increase the chances of conception through IVF. The first study was conducted by Prentice Women's Hospital in Chicago, and was presented at the American Society for Reproductive Medicine conference in San Francisco, and the second was published in the journal Human Reproduction. 

For the Prentice Women's Hospital study, led by Irene Moy, 124 women were split into two groups. One group was given real acupuncture, while the other was given 'sham' acupuncture, both before and after embryo implantation. The patients undergoing sham acupuncture had needles inserted into the body, but not at known acupuncture points. Of the women taking part in the study, 43.9% given genuine acupuncture conceived, while 55.2% of those given sham acupuncture conceived. 

The study published in Human Reproduction took place at the Department of Obstetrics and Gynaecology at the University of Hong Kong, where real and sham acupuncture was given to 370 patients. In this study the sham acupuncture used a placebo needle, which gave the appearance and sensation of piercing the skin, but was blunt and retracted into the handle of the needle when pressed on the skin. The ensuing pregnancy rate for sham acupuncture patients was 55.1% versus 43.8% for real acupuncture. 

Dr Ernest Hung Yu Ng, who led the study, commented: 'we found a significantly higher overall pregnancy rate following placebo acupuncture when compared with that of real acupuncture. In addition, there was a trend towards higher rates of clinical pregnancy, ongoing pregnancy, live birth and embryo implantation in the placebo acupuncture group, although the differences did not reach statistical significance.' 

There was also a suggestion that the sham acupuncture was having an effect on pregnancy rates, as both sham and real acupuncture appeared to result in a lowering of stress hormones, conducive to pregnancy. Dr Mark Hamilton, chairman of the British Fertility Society said: 'this study illustrates the uncertainty about the role of acupuncture in the treatment of infertility. The jury is still out and there is not enough evidence to suggest this should be a definitive and resources adjunct to traditional treatment.'

The results of the two studies support earlier work that suggested there was no link between IVF success and acupuncture. In what was said to be one of the most thorough studies into the issue, close to 2,500 women were studied across 13 clinical trials looking into the effect of using acupuncture on implantation success rates at both the time of embryo implantation and egg extraction. The findings of the studies were presented by Dr Sesh Kamal Sunkara, who led the team of scientists from Guy's and St Thomas' NHS Trust, at the European Society of Human Reproduction and Embryology conference in Barcelona last week.

Professor Peter Braude, from King's College London, said of acupuncture: 'there isn't a disadvantage to it, to the best of our knowledge, but we mustn't say it will make a difference as there is no evidence to support that. I also can't see a mechanism that would explain any positive effects.'

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A woman who was once the world's oldest mother has died from cancer aged 69. María Carmen del Bousada de Lara, from Spain, gave birth to twins two years ago using IVF. She received fertility treatment in Los Angeles, California, after misleading doctors about her age and gave birth to two boys in Barcelona at the age of 66. It is reported that Ms Bousada paid around £30,000 for treatment at the Pacific Fertility Centre where she told doctors that she was 55 to avoid the clinic's age limit for treatment. Her doctor later said that had she known Ms Bousada's real age she would not have performed the procedure.

There is no legal age limit for fertility treatment in Spain and although in the UK the Human Fertilisation and Embryology Authority (HFEA)does not set an age limit either, clinics must consider the welfare of the child above all other considerations. In practice, clinics in the UK do not provide treatment for the over 60s and, inparticular,the National Health Service (NHS)does not usually offer state-funded IVF to women over 35. Commentators have expressed concern that because of their age older mothers may find it difficult to raise their children, especially during the teenage years. ‘We think a limit of 45 should be established in law. Cases like this not only create physical dangers for the mother but many family complications,' said Nuria Terribas, from the Borja Bioethics Institute based in Barcelona. Joseph Torrence, of the Catholic group Iglesia Plural, said that ‘the most important thing is the children are left unprotected, which should not be allowed', adding: 'What is needed are stricter controls to stop this happening again.'

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Recent figures released by the UK fertility regulator, the Human Fertilisation and Embryology Authority (HFEA), show a tenfold plus increase in women over 40 seeking fertility treatment using their own eggs. The number of women over 40 seeking fertility treatment using donated eggs is not know, but could run into several hundred.

In 1991, 596 treatment cycles were performed on women between the ages of 40-45; by 2006 this figure had risen to 6,174. According to HFEA figures, in 2006 women aged 40-45 accounted for 15.5 per cent of all treatment cycles performed in the UK, compared to just 9.2 per cent in 1991. Despite this massive increase of older women seeking fertility treatment, the live birth rate among women over 40 remains relatively low at just 11.8 per cent, compared to 7.6 per cent in 1991.

The HFEA has not released a social profile of women in their forties seeking IVF. The reasons, however, are thought to be societal rather than medical and concerns have been raised by the massive increase in demand for treatment. Dr Allan Pacey, secretary of the British Fertility Society told the BBC: 'The data from the HFEA register would seem to reflect the general trend of couples in the UK to wait until they are older to have their families. But it is dangerous to think that because IVF is now so widely available that couples can delay their attempts to start a family because IVF is some kind of safety net'.

Later pregnancies represent a much higher risk to both the mother and child, than pregnancy in a woman's 20s and earlier 30s. Women over 40 have a greater chance of miscarriage, and there is an increased likelihood of ectopic pregnancy, premature birth, neonatal death and birth defects.

Angela McNab, Chief Executive of the HFEA told the Times: 'It may well be that one of the messages we need to concentrate on is reminding women about their biological clocks, and the increasing difficulties they will have having a baby after 40, and especially after 45'.
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The European Court of Human Rights (ECHR) has today issued its judgment in the case of Evans v the United Kingdom. Natallie Evans, a British woman seeking the right to be able to use her own frozen IVF embryos, asked the court last September to rule whether UK law preventing her using stored frozen embryos, created using her former partner's sperm, violated her human rights under Articles 8 (right to respect for private and family life) and 14 (freedom from discrimination) of the European Convention on Human Rights. She also asked the ECHR to consider whether the embryos themselves had a right to life under Article 2.

Today, the ECHR unanimously ruled that there had been no violation of Article 2 concerning the actual embryos; unanimously that there had been no violation of Article 14 concerning the way Ms Evans was treated by the law; and, by five votes to two, that there had been no violation of Article 8. The ECHR found that the UK was not obliged to take positive legislative steps to ensure that a woman who begins IVF treatment in order to have a genetically-related child should be permitted to implant embryos after the withdrawal of consent by her former partner. It said that the UK's legislation had 'struck a fair balance' between the competing interests at stake, including those of the community as a whole, which is entitled to have laws giving 'certainty' in what is often a contentious area of medicine. It said that because there is little consensus across EU member states as to how this area should be regulated, the UK government enjoys a 'wide margin of appreciation' when deciding what its own laws should be. The court pointed out that having a clear or 'bright line' approach - that helps to create certainty and maintain public confidence in the law - is desirable. However, it did point out that this 'bright line' did not necessarily have to be drawn at the point of continued storage or use of frozen embryos, but could be drawn elsewhere, such as at the point of creation of the embryo. Or, said the court, it would be possible to legislate to say that such consent should become irrevocable - in any case, it said, 'a fairer balance' could arguably be struck.

The court went on to conclude that because there had been no violation of the right granted under article 8, it was unnecessary to consider whether - as a result of the breach of her Article 8 rights - she had in fact been discriminated against, contrary to Article 14.

Two of the seven judges - Judges Traja and Mijovic - dissented on the Article 8 point, saying that the majority decision 'gave excessive weight to public policy considerations and to the State's margin of appreciation without paying due attention to the nature of the individual rights in conflict'. They said that the right to IVF procreation had a 'higher ranking value' and therefore deserved 'a fairer balancing than that struck by the 1990 Act' and that the exceptional nature of Ms Evans' case - the fact it affects 'the very core' of her right - should have warranted a 'deeper consideration', as not to do so is 'unacceptable under the Convention'. In short, they argued that 'the dilemma between Natallie's right to have a child and her former partner's right not to become a father should not be resolved on the basis of such a rigid scheme and the blanket enforcement by the UK law of one party's withdrawal of consent'. They said that the withdrawal of one party's consent should generally be taken to prevail, except in situations where the other party has no other means to have a genetically-related child and has no existing children.

The embryos in question were created in 2001 using Ms Evans' own eggs and sperm from her then partner, Howard Johnston, who later withdrew his consent to their use. The UK's law, in the form of the Human Fertilisation and Embryology (HFE) Act 1990, requires continued consent from both parties in order for embryos to be used or remain in storage. A withdrawal of consent means that the embryos should be destroyed. The embryos represent Ms Evans' last chance to have her own biologically related child, as her ovaries were removed when they were found to be cancerous. It was at this point that she also agreed to store embryos created with her partner's sperm - rather than frezzing her eggs or using donor sperm to create embryos. At a hearing last year, permission was granted to keep the embryos in storage while the human rights case was heard and until an outcome was finalised, a legal process that normally takes several years. However, the ECHR expedited Ms Evans' claim because of the exceptional nature of the case.

The ECHR ended its judgment by saying that parties had the ability to ask that the case be heard by the Grand Chamber of the European Court of Human Rights. In a statement to the press, Muiris Lyons, the solicitor acting for Ms Evans, said that this, along with the fact that the five majority judges expressed their 'great sympathy for the plight of Natallie', and the strength of the dissenting judgment, had convinced her to request that the case be referred to the Grand Chamber. 'This will involve us applying on her behalf for the case to be referred', he said, adding 'her application will then be considered by a panel of 5 new judges who will decide whether or not to refer the case to the Grand Chamber. If Natallie is successful then her case will be considered by the Grand Chamber which consists of 17 judges'. In its ruling, the ECHR also reminded the UK Government that it must take appropriate measures to ensure that Natallie Evans' embryos are not destroyed until the judgment became final or pending any further order.

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 Amsterdam, The Netherlands: Women with cystic fibrosis can have fertility treatment to help them have babies without any long-term adverse effects on either themselves or their children, according to new research presented at the 25th annual meeting of the European Society of Human Reproduction and Embryology in Amsterdam today (Tuesday).

Until relatively recently, cystic fibrosis (CF) was a death sentence and most people with the disease died by the time they reached their teenage years. Now, this is no longer the case, and, thanks to better treatment of the condition, people live far longer and want to start their own families. But women with CF face a problem in addition to the effects of pregnancy on their health: CF itself can make them infertile.

In the first, long-running study to investigate and evaluate systematically the use of assisted reproductive technology (ART) in a group of infertile women with CF, researchers based at the Hôpital Cochin Saint Vincent de Paul in Paris (France) looked at 24 women between 1998 and 2008. After assessing their health, three women were discouraged from undergoing fertility treatment for medical reasons and six are still being assessed. However, the remaining 15 women all received fertility treatment.

Dr Sylvie Epelboin, a gynaecologist, obstetrician and co-ordinator of the Paris-based ART-CF disease network, who led the research, said: “Women with cystic fibrosis often have thick cervical mucus preventing them from becoming pregnant naturally. However, a pregnancy can be achieved by the use of intrauterine insemination (IUI) or in vitro fertilisation (IVF). Fertility treatment has to depend on the woman’s pulmonary and nutritional status, and there are ethical concerns about the welfare of the child whose mother might become severely ill, have to receive a lung transplant or die.”

All 15 women had partners without the CF gene mutation and, apart from failing to conceive, other indicators of fertility were normal. The women were aged between 24 and 36.

The doctors tried IUI first with the patients and 15 successful pregnancies were achieved using this method. One woman had IVF after IUI failed and she became pregnant after frozen embryo transfer. Another woman became pregnant after egg donation because her ovaries had failed. In total, there were 17 pregnancies in 13 of the 15 women, resulting in 12 live births, two ongoing pregnancies and three miscarriages.

All the women, apart from one, were able to give birth without a caesarean section, and although 50% of them had diabetes during pregnancy and there was a slight decline in lung function during the year of pregnancy, all the mothers have remained healthy. The babies were born on average at around 37 weeks, with only four babies having a low birth weight of less than 2500g (birth weights ranged from 1910-3500g). There were no babies with very low birth weights (less than 1500g). Five babies were breastfed. All children (seven girls and five boys), aged 10 years to one month, are healthy.

Dr Epelboin said: “The results of our study are good news for women with cystic fibrosis because they show that ART is a hopeful option for them and does not increase the risk of medical problems or death for either themselves or their children. Furthermore, the possibility of ART for this growing population of young adults with cystic fibrosis has a positive impact on their quality of life by satisfying their wish to become parents. These women had given mature consideration to their desire for a child and were fully supported by their families. All these considerations are equally true for infertile men with CF, who also require ART, usually via ICSI, to have children.”

However, she warned that it was important that a network of dedicated CF, ART and obstetrical teams should look after women with CF before, during and after pregnancy. The women’s general health should be carefully assessed and they should receive medical, genetic and ethical counselling before embarking on fertility treatment.

“Treatments inducing ovulation must be conducted with the goal of achieving a moderate response and a single pregnancy, and close monitoring for prenatal care is needed throughout the pregnancy. It is important for CF women to have singleton pregnancies because of the extra strain that a multiple pregnancy would place on the lungs and heart, for nutritional balance, and because of the additional risks of premature birth, which could be linked to abdominal efforts caused by coughing. In addition, a single birth is easier for these women to manage for post-natal care and medical follow-up.”

Diabetes and glucose intolerance occur frequently in people with CF, due to the worsening of their pancreatic disease. Some CF women have diabetes before pregnancy and so it needs to be under perfect control with insulin before they become pregnant. Other CF women can develop diabetes as a result of their pregnancy (gestational diabetes), and this also needs to be carefully controlled and monitored although it frequently disappears once the woman has given birth.

Together with Dr Dominique Hubert, a lung specialist and co-ordinator of the network, Dr Epelboin is setting up a long-term survey that follows the CF mothers, couples and children and compares them to women who require ART but who do not have a severe genetic disease. “We want to see how they fare with regards to ethical concerns about the welfare of the child growing up in a family where the mother has CF, and how the mother’s prospects or need for a transplant and her limited life expectancy affect the child and the family. It is only through such long-term monitoring that we can confirm our preliminary optimistic conclusions,” she said.

 

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A new UK study of peoples' attitudes towards social sex selection has found that 80 per cent believe that parents should not be allowed to choose their baby's sex, even for 'family balancing' reasons. The researchers, based at the Policy, Ethics and Life Sciences Unit at Newcastle University, questioned 48 members of the public and ten medical professionals. Study leader Tom Shakespeare said he was 'surprised' that those questioned were so vehemently against sex selection, the BBC News website reports.

The participants were asked their opinions after a discussion about the issues surrounding sex selection for non-medical reasons, also known as 'social' sex selection. The majority did not support this use of reproductive technology, even for couples who already have children of one sex, and want to have a child of the opposite gender. 'I was surprised by the results, but these were not 'off-the-cuff remarks', said Shakespeare, adding 'these were the results of considered views after an hour or two of discussion'.

Among the concerns raised by the group were that sex selection could send out the message that it is morally acceptable to have a strong preference for one sex over the other. Other participants felt that allowing couples to choose their babies' sex could turn children into 'consumer items' - one person said: 'Where does it actually stop? Do you stop at boys, girls, blonde hair, blue eyes, superior race?'.

Josephine Quintavalle, of the pro-life pressure group Comment on Reproductive Ethics (CORE), said that she was delighted by the findings, adding 'the public know where the limits should be and it gladdens my heart'. A spokesman for the Human Fertilisation and Embryology Authority (HFEA) said that the study reinforced the authority's own research that the UK public is not in favour of sex selection for social reasons.

All forms of sex selection for non-medical reasons are currently banned in the UK, following a 2003 ruling by the HFEA. Permitting sex selection for family balancing reasons was cautiously approved in a recent report by the UK House of Commons Science and Technology Committee. Commenting on the Newcastle study, committee member and Liberal Democrat MP Evan Harris said that opinion polls should not be allowed to affect policy making for others, adding 'the point about reproductive autonomy is not whether people think it is a good idea, but whether people themselves think it is such a bad idea that it would do harm'.

The UK Department of Health (DH) is seeking views on whether social sex selection (for family balancing reasons only) should be permitted, as part of its current review of the HFE Act. The public are invited to respond formally to the DH. BioNews readers and any other interested individuals are also invited to informally debate their views on family balancing now, on a DH-funded online discussion forum run by Progress Educational Trust the charity which publishes BioNews. Family balancing is being discussed in the 'Open Forum' area. Feedback from this time-limited website will be submitted to the DH after the public consultation closes on 25 November 2005. Your views are much valued and all are welcome to contribute.

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Claims have been made that a new technique, available in the UK, is being used in other countries to select the sex of embryos for social reasons. According to a report published in the Mail on Sunday, blastocyst transfer results in more male embryos than female being transferred to the womb during IVF treatment.

The technique, which involves the transfer of an embryo five or six days after fertilisation, as opposed to two, is already used because it allows clinicians to choose the healthiest embryos. But Spanish scientists have shown that the technique produces more boys because at that age the male embryos generally appear healthier than the females. Research showed that if an embryo was transferred after six days, there was a 65 per cent likelihood that the baby would be a boy. At two days, there is a 50:50 chance of it being a boy or a girl.

Concerns have been expressed that the technique will be used to introduce sex selection for non-medical reasons in the UK. Nuala Scarisbrick, representing the charity Life, said that 'there are some people who only want boys and, therefore, some people will offer this procedure to create boys'.

But it has been pointed out that the procedure would not guarantee a child of a particular sex, and neither would it guarantee a baby at all, as not all embryos would survive until the later stage. Keeping an embryo in a laboratory might also cause it to develop abnormally, Dr Dave Morroll of Nurture was reported as saying. The Human Fertilisation and Embryology Authority said that blastocyst transfer for non-medical sex selection would not be allowed in the UK.
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Read more by clicking on the links shown here, or visit http://www.hfea.gov.uk/areyouready.html

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New arrangements for the storage of gametes & embryos
The amendments to the Human Fertilisation and Embryology Act 1990, which come into force on 1 October 2009, will change the statutory storage period for embryos from 5 to 10 years. The maximum storage period will also be extended to 55 years.

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Get ready - 8th Code of Practice, consent forms and Directions
The 8th Code has been updated to reflect changes in the Human Fertilisation and Embryology Act 2008 and in HFEA policy. The consent forms and Directions have also been updated in line with the amended Act. 

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New parenthood laws
The law around legal parenthood following fertility treatment changed in April 2009. The change affects both fertility treatment patients and clinics. The HFEA reviewed its policies to reflect the law change.

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Compliance cycle
With the introduction of the new Act, we’ve looked at how we can improve what we do as part of the Government’s Better Regulation initiatives. This, and discussions we’ve had with you, have prompted us to look at how we inspect the fertility sector.

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Donor information access review
Due to recent amendments to the HFE Act, the HFEA is required to make changes to the type of information it provides to those affected by donation.

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Use of embryos for training
The HFEA’s Licence Committee has agreed to vary all IVF treatment licences to include training. Centres will only be able to use embryos for training for activities authorised by the HFEA. The HFE Act 1990 (as amended) prohibits the creation of embryos for use in training. The Authority cannot, therefore, lawfully authorise the training of persons to perform intra-cytoplasmic sperm injection (ICSI).

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Embryo testing
The HFE Act 2008 has brought the regulation of preimplantation genetic diagnosis (PGD) and preimplantation genetic screening (PGS) onto a statutory footing for the first time. This required HFEA to revise how it licensed embryo testing.

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Using patient data to help improve fertility treatment
From October 2009 new legislation will allow the HFEA to release identifying information about a patients’ treatment to researchers.

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Choose a Fertility Clinic
Our new ‘Choose a Fertility Clinic’ will present clinic data in a more meaningful way.

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Clinic staff portal
HFEA is introducing an online clinic portal which centres will use to provide information on their licensed activities and provide statutory and non-statutory information.

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New licences for clinics
The Human Fertilisation and Embryology Act 2008 introduced new conditions which are applicable to all centre licences. Read about the new arrangements

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A group of researchers at the Bourn Hall Clinic, Queensland University of Technology and the Weill Medical College of Cornell University, New York, have concluded that IVF treatment does not hasten the onset of the menopause or the severity of symptoms, having investigated the first generation of IVF patients. 

Senior research scientist Dr Kay Elder and her team examined women who were treated at Bourn Hall Clinic in the UK between 1981 and 1994. When IVF treatment was first used there were worries that the hormones used to stimulate the ovaries to generate the eggs required might trigger an early menopause, by 'using up' a woman's eggs too quickly. 

However, through theory and biological observations on 700 women, the age of onset of menopause was found to be more linked to maternal history than IVF treatment, and there was no increase in perimenopausal symptoms. Dr Elder said of the concerns that 'it was unknown territory in those days. Although all the studies showed that the treatment was safe, it was ground-breaking and we couldn't predict the potential long-term impacts'. 

Lawrence Shaw of the British Fertility Society welcomed the findings, which he said were unsurprising, but nevertheless helpful. 'This is a question patients often ask - and it's very useful to finally have a scientific study to point to which offers them reassurance that IVF will not affect timing or severity of the menopause,' he said. 

Meanwhile, a group of researchers publishing in JCEM, a publication of The Endocrine Society, claims to have discovered a way to product a woman's age at menopause more accurately. The study shows that anti-Mullerian hormone (AMH) levels in the blood can reflect how many follicles are present in a woman's ovaries. The stock of follicles ensures monthly ovulations, and depletion of the stock leads to menopause. Dr Jeroen van Disseldorp and Dr Frank Broekmans of the University Medical Centre Utrecht in the Netherlands said that 'knowing when menopause may occur could greatly impact childbearing decisions and our findings show that such knowledge may now be available from AMH levels'.

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