IVF News

A report has revealed that couples receive varied IVF treatment across UK Primary Care Trusts (PCTs), despite guidelines issued by the National Institute of Health and Clinical Excellence in 2004 that all women between the age of 23 and 39 years old should receive three cycles of IVF on the NHS.

Grant Shapps, Conservative MP for Welwyn Hatfield and father of three children born following IVF treatment, conducted the study that revealed the continuing 'postcode lottery' in NHS treatment.

Mr Shapps received a response to his inquiries from three quarters of England's PCTs. He found that at least two PCTs had stopped offering fertility treatment this year due to lack of funds. Some PCTs had introduced varying age restrictions with disagreements over whether a woman over 35 was too old or too young to receive IVF. Some PCTs also offered free IVF even if either partner had already had a child, but NICE guidelines state that childless couples should be the priority.

Mr Shapps has criticised the widespread variation in treatment as determining who has the right to a child and who has not on the basis of PCT's budgets and deficits. Mr Shapps said that, 'Couples are effectively being told that they cannot have a baby while their friends on the other side of the street, who might have a similar set of circumstances, are able to obtain three cycles of IVF provided for them by the NHS'.

Health Minister Caroline Flint emphasised the importance of access to IVF for childless couples regardless of where they lived, but said that the NICE guidelines were just one of the considerations that the PCT had to take into account when deciding on which services to provide locally. When the NICE guidelines were issued in 2004, John Reid, the then health secretary, said that by April 2005 he wanted 'all PCTs, including those who at present provide no IVF treatment, to offer at least one full cycle of treatment to all those eligible. In the longer term I would expect the NHS to make progress towards full implementation of the NICE guidance'.

Dr Mike Dixon, chairman of the NHS Alliance, which represents PCTs, said that he thought it was better that care provisions were determined locally, but warned that when money was short decisions would have to be made as to what was a crucial priority, such as a life saving operation. Infertility Network UK urged the government to consult with all involved with a view to implementing the full NICE guidelines to overcome the regional inequalities.

Around 1.7 million couples suffer fertility problems, and around 10,000 babies a year are born as a result of IVF.

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The UK woman fighting to use stored frozen embryos against the wishes of her former partner has lost her final appeal. Natallie Evans underwent IVF with Howard Johnston in 2001, before Ms Evans had treatment for ovarian cancer that left her infertile. Mr Johnston later withdrew his consent for the six embryos to be used when the couple split up. The Grand Chamber of the European Court today ruled unanimously that there had been no breach of the right to life (Article 2) of the European Convention on Human Rights. On the right to respect for private and family life (Article 8) and the prohibition of discrimination (Article 14), the judges ruled 13 to four against Ms Evans.

Ms Evans, now aged 35, first took her request to use the embryos without Mr Johnston's permission to the UK's High Court in 2003, but lost both the case and a subsequent appeal. Last year, the European Court of Human Rights (ECHR) also ruled against her, so Ms Evans final appeal to the Grand Chamber represented her last chance to save the embryos from destruction. 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.

Commenting on the ruling, Ms Evans said: 'I am distraught at the court's decision. It is very hard for me to accept the embryos will be destroyed'. But Mr Johnston said: 'I feel common sense has prevailed. Of course I am sympathetic, but I wanted to choose when, if and with whom I would have a child'. Dr Allan Pacey, secretary of the British Fertility Society (BFS) also felt the right decision had been made. 'As in many countries, the UK has clearly established principles of shared responsibility from both the sperm and egg provider concerning the fate of any frozen embryos up until the point that they are transferred back into a woman', he said.

Anna Smajdor, a researcher in medical ethics at Imperial College, London, commented that Britain was 'obsessed with the idea that shared genes are the essence of parenthood'. She said: 'There is something deeply amiss here. Ms Evans is not allowed to have her embryos implanted without her ex's consent, yet he - effectively - is allowed to have them destroyed without hers'. But Dr Tony Calland, chairman of the British Medical Association's medical ethics committee, echoed the sentiments of many fertility experts when he said: 'We welcome the fact that the European court has supported the principle of consent from all parties. Having a child is a lifelong undertaking to which both partners should be fully committed'.

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On 10 April 2007, Natallie Evans lost the final stage of a four year legal battle for the right to implant embryos created with her eggs and the sperm of her former partner. Ms Evans had been diagnosed with cancer, and treatment necessitated the removal of her ovaries, leaving her sterile. Creating and storing embryos would, it was hoped, keep the possibility of motherhood open to her.

However, Ms Evans' hopes were shattered when her relationship broke down and her partner, Howard Johnston, withdrew his consent for the embryos to be used. Since the consent of both parties is required for fertility treatment or even for ongoing storage of embryos, it seemed that Ms Evans would have to forego her dream of parenthood. But she was unwilling to submit to the loss of her embryos without a fight, hence the protracted legal struggle which culminated in the European Court of Human Rights' rejection of Ms Evans' case.

Many people, while sympathetic to Ms Evans' plight, felt that the court had come to the right conclusion. After all, the consent protocols are clear and were accepted by both parties at the time the embryos were created. But while in the eyes of the law the correct decision may have been reached, the case raises some interesting questions. The implication was that people should not be forced to become parents, all other things being equal. Is this an acceptable conclusion? And is it consistent with other legal and social assumptions?

To answer this question, we need firstly to examine the concept of parenthood. I suggest that parenthood is best understood not as inhering solely in genetic ties. Rather, it is a bundle of concepts which may include some or all of the following: being part of a causal chain that brings about the creation of a child; having the intention to procreate; undergoing gestation and childbirth; acquiring legal rights and responsibilities; sharing genetic links; nurturing and rearing.

We may be justified in believing that some of these types of parenthood should not be forced on unwilling people. Forcing people to undergo gestation and birth against their will seems clearly unacceptable. But perhaps the 'right' not to be a parent in the genetic sense has been mistakenly extrapolated from the idea that enforced gestational parenthood is a moral wrong.

The presumed right to abortion is sometimes construed as stemming from a right not to be a parent. But to whom does this right apply? Men are not allowed to force women to undergo abortions, so does this mean that the right applies only to women? Margaret Brazier has suggested that fundamental human rights 'must be gender-neutral' (1). If this were true, then surely a right not to be a parent ought to apply to both sexes.

However, abortion cannot simply be described as an exercise of the right not to be a parent in the genetic sense. If a woman has been impregnated with an embryo that has no genetic link with her, does this mean she has no choice whether or not to continue with the pregnancy? Surely the important fact is that the embryo is inside her body, not that it does or does not share her genes.

This is a vital fact to remember, since what we are protecting here is people's autonomy over their bodies. It is perfectly coherent for respect for autonomy to be afforded to men and women alike. On the other hand, the right not to be a genetic parent, when it conflicts with physical concerns, seems either to come with so many constraints as to be almost worthless, or to lead to unpalatable conclusions. (E.g. that a pregnant woman can be coerced by those who are the genetic parents of the embryos she is carrying.)

Maintaining autonomy over one's body is of the utmost importance. Women have fought long and hard for the right to do so. We must not conflate this with the altogether separate - and lesser - issue of enforced genetic parenthood.

The harms involved in physical coercion and enforced parenthood are very evident. However, the harms involved in enforced genetic parenthood are far less clear. In fact, men undergo enforced genetic parenthood all the time, and society scarcely registers the fact. A man whose partner is pregnant cannot demand she has an abortion. But we could feasibly allow men to sign a waiver stating that they do not consent to the birth of the child, and that they wish to play no part in the child's life or upkeep (2).

It seems highly discriminatory that the partners of fertile women have no rights whatsoever in this respect. A man whose partner has become pregnant without his desire or knowledge has the legal and financial obligations of parenthood thrust upon him, whereas men whose partners are infertile are accorded the right to veto the entire reproductive enterprise.

This being the case, perhaps we should be more sympathetic to men whose partners are pregnant without their consent. Mr Johnston is simply one of many, many men in the UK who go partway toward parenthood and then get cold feet. There is a degree of moral opprobrium associated with reluctant fathers. We are encouraged to see them as being selfish, feckless and irresponsible. But taking the risk of unprotected sex and then deciding one doesn't want to be a father is arguably no more culpable than creating embryos and then changing one's mind. The latter is perhaps worse, as it involves reneging on an agreement and causing grief to one's partner.

The asymmetry of the law with respect to fathers and mothers, whether fertile or not, needs to be straightened out. Even after the ties of gestation and birth are over, mothers are not forced to accept the further legal and financial obligations of parenthood. They can choose to give their children up for adoption. Men do not have this right. They are utterly at the whim of their partners' choices. In this environment, men's rights are very much constrained compared to those of women. And this constraint extends far beyond what is justified by the mother's physical connection with the child.

It is my contention that this injustice should be remedied. Not by respecting men's or women's 'right' not to be parents, but by affording men and women the same rights in terms of choosing not to assume legal, social or financial responsibility for the child.

In the context of this far greater injustice to men in the UK, I have limited sympathy with Mr Johnston. He, along with other men and women, should have the opportunity to state his refusal to fulfill the function of a social parent, and this should be recognisable in law. If this were possible (and we allow it in the case of gamete donors), it would be hard to see what further harm could come to Mr Johnston purely from the knowledge that a child might be born with some of his genes. Certainly any such harm is far harder to identify or quantify than the harms of enforced physical, legal or financial parenthood.

References:

1. Margaret Brazier, 'Reproductive Rights: Feminism or Patriarchy?', John Harris and Soren Holm, eds., The Future of Human Reproduction (Oxford University Press, 1998)

2. This view is forcibly argued by Elizabeth Brake in her paper 'Fatherhood and Child Support: Do Men Have a Right to Choose? Journal of Applied Philosophy, Vol. 22, No. 1, 2005.

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Researchers have found that diabetes may affect sperm quality, after a study comparing the DNA in sperm from diabetic and non-diabetic men found more DNA damage in the sperm cells of the diabetic men.

The study, conducted by the research group at Queen's University Belfast, with findings published in the journal Human Reproduction, found that around 52 per cent of the DNA in the sperm cells of diabetic men was fragmented, compared with only 32 per cent for the non-diabetic men. Fragmentation of the DNA in sperm is one of the main causes of male infertility, because it prevents the sperm from delivering intact genetic information to the egg, which is required for the creation of a viable embryo.

The study compared the sperm from 27 diabetic men with that from 29 non-diabetic men in their early 30s. Dr Ishola Agbaje, who lead the research project, said, 'Our study identifies important evidence of increased DNA fragmentation of nuclear DNA and mitochondrial DNA deletions in sperm from diabetic men'. He stated that these findings would have implications for male fertility, which has already been decreasing over the last 50 years. The increasing global incidence of diabetes could further propel the decline in male fertility.

Professor Sheena Lewis, director of the Reproductive Medicine Research Group, and co-author of the paper, said that the study was very small, and so served to highlight a possible concern. She stated that 'our study shows increased levels of sperm DNA damage in diabetic men. From a clinical perspective this is important, particularly given the overwhelming evidence that sperm DNA damage impairs male fertility and reproductive health'.

Professor Lewis said that further research would be needed to quantify the exact nature of the DNA damage caused by diabetes, and whether there were additional health effects for the children of diabetic fathers. Dr Allan Pacey, senior lecturer in andrology at the University of Sheffield, stressed the importance of the quality of sperm DNA, and further said that 'it would be important to understand the mechanism by which this damage occurs so that if it can be avoided we can work out how to do this'.

Matt Hunt, science information office at Diabetes UK, called for further research, after labelling the findings alarming. He said 'this is the first research to suggest DNA damage may be occurring at a cellular level and that it is a cause for great concern'.

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Hopes aroused by a controversial study suggesting that women may be able to produce new egg cells have been seemingly dashed. The 2005 paper, published in the journal Cell by researchers at Massachusetts General Hospital, fleetingly gave hope to infertile women when it suggested that egg production may be restarted in sterile mice.

This work, however, was challenged last year in a Nature paper published by Harvard researchers, who could find no evidence of egg regeneration. And now a new study, published in the latest issue of the journal Developmental Biology, further entrenches this viewpoint.

Pioneering work by Solly Zuckerman in the 1950's showed that female mammals are born with all of their eggs, a viewpoint that remained unchallenged until reproductive endocrinologist Jonathan Tilly's work on mice 2004-5. His research seemed to provide evidence for 'ovarian stem cells' present in the mouse bone marrow, which had the ability to migrate and repopulate mice ovaries rendered infertile by chemotherapeutic agents, following a transplant.

The latest research, led by University of South Florida scientists Lin Liu and David Keefe looked at gene expression profiles (which reveal gene activity) in the ovaries of 12 women aged between 28 and 53. They found no evidence of any expression pattern signatures consistent with egg cell production and subsequent ovulation.

'Despite using the most sensitive methods available, we found no evidence of any egg stem cells in human ovaries, demonstrating that Dr Tilly's findings in mice do not apply to women', Dr Keefe said. 'Dr. Tilly likely was seeing non-egg cells which resemble eggs'.

Tilly countered in the most recent issue of Cell Cycle, 'It is disappointing to see arguments against the possibility of postnatal oogenesis [new egg cell production] in mammals still being drawn using solely an 'absence of evidence' approach'.

Some hope remains though, as the cells Tilly has visualised in mice may prove to be eggs, albeit immature non dividing ones, which could prove central to some form of future treatment.

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The first Canadian clinic to offer long-term egg storage services for healthy young women has opened, aimed at those who wish to delay childbearing until a later age, when their eggs would be less likely to be successfully fertilised. Previously, this option has only been available to cancer patients before treatment as a last hope against ensuing infertility. The clinic's director, Dr Essam Michael, feels that egg freezing should be available to healthy women as 'insurance' against the risk of infertility resulting from attempting motherhood too late in life.

Many fertility experts caution that such insurance might provide a false sense of security in encouraging women to postpone pregnancy, when recent data shows the success rate of fertility treatment using frozen-thawed eggs is only three to four per cent. Scientifically, the long-term health and safety risks are unknown, with international studies just embarking to collate and study the data from this new technology.

Although success is not guaranteed, Dr Michael believes that it provides a meaningful chance which can help many women avoid potential heartache later in life. He recommends it should be available to women older than 27 years, when a woman's fertility begins to decline. Age is the most determinative factor leading to failed pregnancies and infertility which affects 17 per cent of healthy Canadian couples. After the age of 35, women's fertility rate dramatically decreases yet increasing numbers of women for personal and professional reasons are seeking to become mothers after 35.

Prospective clients must first meet with a psychologist. Prior to the procedure, patients must inject follicle stimulating hormones daily for ten to twelve days. The eggs are then harvested by keyhole surgery and 'frozen' through cryopreservation until later 'thawed' for use in assisted reproduction when the woman desires.

Others are sceptical about an unregulated consumer market pandering to this new technology. But while this is true in the US, in Canada egg freezing is a 'controlled activity' under the 2004 Assisted Human Reproduction Act. Health Canada currently launched a review into the health and safety risks for egg freezing. If it concludes the practice is too risky then clinic licenses will be appropriately restricted.

Issues of older parenting are outweighed for many women who will eagerly pay for a chance to preserve their fertility in an unknown future. The procedure costs $5,000 and $300 per year thereafter for storage. National healthcare provision for assisted reproduction depends upon the province. So far, three women have undergone the procedure at the clinic without paying privately.

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US Sociologist Rene Almeling has discovered that the dramatic disparity between the value of egg donors over sperm donors goes much deeper than compensation fees. Her research reveals that sperm donors are undervalued fiscally, and are also treated with less appreciation, and are less prepared for the emotional consequences of being genetic donors.

The comparative study, carried out at the University of California, Los Angeles, indicates that striking inequalities are perpetuated by gender-stereotyped social attitudes to motherhood and the female role in the procreative process, over counterpart concepts of men and fatherhood. Ms Almeling's findings will be published in the June issue of the American Sociological Review. It is thought to be the first comprehensive study comparing US gender compensation rates for gamete donation.

In the US women in major cities on average are paid upwards of ?2,500 for their egg donation, regardless of the resulting quality or egg extraction success. Male donors in contrast receive an average ?25 to ?38, and only if the sample meets the high sperm count quality-control standard.

Despite commonly held views that an egg donor scarcity and sperm donor abundance exist, the current situation is actually the reverse. Potential US egg donors outnumber recipients but only a fraction of the male population have a reliably high enough sperm count to meet donation standards and 90 per cent of potential sperm donors are rejected. Supply-demand economics would therefore predict the large number of potential egg donors to reduce their payment, and the sperm donor scarcity to increase their rates, but the market for gametes has defied basic economics. Almeling suggests that American, middle-class cultural norms and the devalued male role in reproduction and parenthood warps standard market trends to reflect these social views.

Egg donation is more invasive and bears statistically low but serious risks that sperm donation lacks. However, Almeling argues that these medical differences alone are insufficient to account for the 'pronounced double-standard', saying 'Men donors are paid less for a much longer time commitment and a great deal of personal inconvenience'. Sperm donors often sign a year contract to donate weekly and are asked to abstain from intercourse for two days before donating to avoid their sperm count being too low for payment. Egg donors also abstain from intercourse but only for the six weeks of daily hormone therapy before their commitment ends.

Almeling's interviews revealed that reproductive health workers treat male and female donors differently, creating very different donation experiences. Women are reminded and thanked for their generous 'gift of life'. Sperm donors are appreciated but with a more perfunctory attitude that they are getting paid for something they would do anyway. They are not made to feel as though they have done something special for others. Recipient couples are often encouraged to write cards or give cash bonuses and gifts of gratitude to egg donors but not to sperm donors. Almeling appears to have uncovered an unexpected bias in the fertility industry.

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This study by Elliott et al (2007) opens a new debate about the removal of lysed material from frozen thawed embryos. The first such experiment which showed benefits of removing lysed cells was also done on mouse model back in 1993 (Alikani et al, 1993). Many other studies have been performed (Rienzi et al, 2002 and Nagy et al, 2005) with encouraging results. This has led to the regular use of the technique in many clinics around the world on human embryos. It is known as Lysed Cell Removal (LCR), and involves removing lysed cells that get damaged as a result of freezing at the time of thawing from human embryos. Scientists believe that these damaged cells secrete toxins and sometimes their accumulation at the site may negatively impact the growth of the embryos. Studies have reported highly improved implantation rates using the above technique in their IVF labs (Nagy et al, 2005, Rienzi et al, 2002&2005).

This experiment is a step towards finding the cause of this increased success rate when lysed cells are removed. The lack of consistency in condition to human embryo culture makes the selection of mouse embryos most apt for this study. Murine embryos were thawed at the two-cell stage. The study then looked into the effect of LCR after mechanical lysis (as opposed to natural lysis caused by the detrimental effects of freezing) of the murine embryos. Mechanical lysis was used to control the degree of damaged cells. The mouse embryos were distributed in three groups Control group (n=37) with no lysis, Group-1- (n=40) consisting of cell lysis and removal and finally Group-2- (n=40) consisting of cell lysis only.

The results of the experiment show that there was no significant difference between the three groups on day two in the mean number of blastomeres both before and after mechanical cell lysis. There was significant difference between group 1 and 2 when embryo development rate was calculated (the number nuclei cell at the blastocyst stage divided by intact blastomere number on day two). There was hardly any difference in the development stage on day three. However day four showed a higher number of embryos had reached the later embryonic development stages of blastocyst and hatching blastocyst. There was highly significant at p value of <0.005 lower growth when control group when compared with group 2 and also a significant difference with a p value of < 0.05 when group one was compared with group 2.

The results showed that more LCR embryos reach blastocyst stage compared to non-LCR embryos. These frozen thawed embryos after LCR showed faster cleavage than even the control group however this was not so significant unlike that reported in human embryos (Rienzi et al, 2002). This is the only study published that looks into the impact of mechanical cell lysis. The use of nuclear staining to check nuclear growth rate gives a better verification of the cell growth after LCR. This study confirms that Assisted hatching with LCR technique used for human embryos certainly increases quality of embryos and that accumulation of dead cells is a hindrance in the development of the growing embryos. However, the implantation potential of the embryos after mechanical LCR was not verified due to lack of mouse host. This is a drawback in the study and leaves a void that should be looked in future studies. However, it is certainly a step forward towards finding the reason for this increased implantation.
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Raids carried out earlier this year by the UK's Human Fertilisation and Embryology Authority (HFEA), on IVF clinics run by the pioneering fertility expert Mohamed Taranissi, have been ruled unlawful by the High Court of Justice. The case was expected to go to a full hearing, but was concluded when the HFEA conceded that the evidence presented to magistrates under oath in the application for warrants was insufficient. The High Court rejected a further claim that the HFEA had acted out of improper purpose.

On 15 January this year, police-assisted HFEA teams conducted simultaneous, unannounced inspections of Taranissi's two London clinics - the Assisted Reproductive and Gynaecology Centre and the Reproductive Genetics Institute - investigating claims that patients had been treated without a valid license. That same evening saw the transmission of 'IVF Undercover', a special investigative report by the BBC current affairs series 'Panorama', in which undercover journalists posed as infertile women and allegedly received inappropriate advice at the same clinics. The HFEA claimed that the timing of its raid in relation to the BBC programme was coincidental, but the resulting impression of collusion with the BBC attracted widespread criticism.

The HFEA has agreed to pay most of Taranissi's court costs, which have been estimated at £1.2million - more than a tenth of the HFEA's current annual expenditure. Taranissi expressed regret that 'money, estimated to be in excess of £1m, which could have been spent on research or genuine issues of patient safety has instead ended up in the pockets of the lawyers'. The HFEA, for its part, claimed that it had 'acted in good faith and on advice'. Taranissi later told the Guardian newspaper that the episode had been demoralising: 'If I have to be a solicitor because I have to look at all these legal things, then maybe I should just call it a day because I don't want to be like this. If I'm not going to be able to do what I like to do and what I'm good at, then what's the point of continuing?'

In light of the HFEA raids being ruled unlawful, medical practitioners and commentators have called for resignations at the HFEA and for a full investigation by the Department of Health. In a separate case, Taranissi is suing the BBC for libel, on the grounds that the allegations made in 'IVF Undercover' were inaccurate and defamatory. An HFEA hearing scheduled for 13 July will consider the original allegations against Taranissi.
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The Roman Catholic Bishops of England (RCBE) have told the UK parliament that inter-species embryos - those containing genetic information from both human and animals - should not be treated any differently from 'normal' embryos, and that women should be given the chance to carry their genetic offspring to term.

There is currently a real shortage of human eggs for use in embryonic stem (ES) cell research. It is hoped the problem can be overcome through creating embryos by transferring human genetic material into 'hollowed out' animal eggs. The resulting entity - a 'cybrid' - would be over 99 per cent genetically human and less than one per cent animal. As it stands, the new draft Human Tissue and Embryos Bill will ban the creation of embryos that contain genetic material from both animals and humans, but will make an exception for certain types of research, including cybrid embryos. The draft Bill imposes a strict 14 day time limit on the use of these entities in research, at which point they must be destroyed.

The RCBE and the Linacre Centre for Healthcare Ethics told the parliamentary committee who are scrutinising the draft Bill: 'At the very least, embryos with a preponderance of human genes should be assumed to be embryonic human beings, and should be treated accordingly. In particular, it should not be a crime to transfer them, or other human embryos, to the body of the women providing the ovum, in cases where a human ovum has been used to create them'.

The RCBE have been accused of misunderstanding the science involved in creating such embryos. Cybrid embryos will have no 'mother'; rather, an animal ovum will be stripped of its genetic identity and used as an empty vessel to cultivate hES cells from cloned human cells. It is hoped that such research will lead to advances in treatment for devastating diseases such as Parkinson's and Alzheimer's.

Liberal Democrat MP, Dr Evan Harris, has described the RCBE's position as 'absurd' and 'inconsistent', adding: 'Most of these embryos will be created using animal eggs, but even if they were created using human eggs, they would be created by cloning and the Catholic Church has previously opposed reproductive cloning of even fully human embryos'.
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