IVF News

One of the questions facing legislators considering changes to UK legislation regulating the provision of assisted conception procedures is the extent to which formal measures may increase the likelihood of donor-conceived people being informed about their origins.

The background to these considerations includes the 2005 legislative change enabling a donor-conceived person to learn the identity of his or her donor and research evidence indicating that relatively few parents of donor-conceived children (and, in particular, heterosexual parents using donor insemination) inform their children about their conception.

Evidence from Sweden, where donor anonymity was abolished in 1985, suggests that the level of parental disclosure increases over time (1). However, key questions remaining are whether the 'natural' pace of change is quick enough, and whether those parents who left to their own devices remain unlikely to tell their children can be encouraged to do so.

Annotation of the birth certificates of donor-conceived people has been proposed as a possible means of ensuring that more donor-conceived people learn of their status (2-4). The government has indicated its preference for educational rather than legislative measures to promote disclosure (5). However, in response to peers' concerns, it has offered further discussions before the Human Fertilisation and Embryology Bill reaches the Report stage in the House of Lords.

Any measure in this direction seeking serious consideration must ensure that individual privacy is not compromised and that additional bureaucracy and public expense are proportionate. Furthermore it must recognise the involvement of two state agencies when a child is born as a result of a donor procedure: the HFEA (through its register of information) and one of the UK's three General Register Offices (GROs) (England and Wales, Northern Ireland, Scotland). Currently there are no provisions for ensuring co-ordination of information between the HFEA and GROs. Doing so seems to offer a way of achieving, to a large extent, the objective of ensuring that more donor-conceived people become aware of their conception, while recognising that no system can guarantee total compliance (since one thing we can be sure of is that wherever there are rules someone will break them).

A possible model can be suggested, and outlined as follows:

" the HFEA notifies the relevant GRO of all donor-conceived births;

" the GRO records a link between its own birth registration and the HFEA records;

" when an application for a birth record is made to a GRO and it is satisfied that the applicant is either the individual to whom the registration relates or his or her legal parent - and those persons only - the 'full' birth certificate that is provided will indicate that the HFEA Register contains information regarding the individual to whom the certificate relates. (This could be achieved by means of an appendix to the certificate which may be detached if the certificate is subsequently required for purposes such as a passport application). As now, an un-annotated birth certificate will be provided by GRO to any other applicant;

" if the individual chooses to contact the HFEA, existing measures with regard to applications to the HFEA Register of Information will come into operation;

" information and advice concerning birth registration should be provided to people undergoing a donor procedure as part of the information, counselling and other preparation provided by a licensed treatment centre to persons undergoing a donor procedure. This should be mandatory and specified as such in the HFEA Code of Practice. Ongoing information, advice and support should also be made available to the family following the birth of a child.

The registration of a child's birth is likely to precede the formal linking of HFEA and GRO data, and so remains reliant on parental veracity. However, non-compliance should be greatly minimised by the provision of information and advice as outlined above; coupled with the knowledge of the future co-ordination of HFEA and GRO records and the knowledge that if the donor-conceived person requests a birth certificate from GRO, this will indicate his or her status.

This proposal not only safeguards individuals' privacy, so that the donor-conceived person or his or her legal parents only will be able to access information disclosing the donor-conceived person's status, but also would not establish any provisions different from those currently regulating public access to birth records that would alert any other enquirer to the possibility of donor-conception. It also avoids establishing a completely separate registration system for donor-conceived births. The downside is that it would involve additional resources insofar as GROs and the HFEA will have to establish systems for the recording of this information. However, since the state legitimises donor conception, it seems perfectly reasonable that it should accept the responsibility this entails. In any event, the limited numbers of individuals involved indicate that any such resource requirements are proportionate.

A more radical version of this model, but which could ultimately reduce bureaucracy, would transfer responsibility for the HFEA Register to the GROs - a model adopted for New Zealand's Human Assisted Reproductive Technology (HART) Register (6). A persuasive case could probably be made for this also. The GROs' current responsibilities and track record for safeguarding sensitive data relating to the Adopted Children, Parental Order, Stillbirth and Gender Recognition Registers indicate that this information would be in safe hands (a not-insignificant consideration at the present time).

 

References:

 

1. Lalos, A., Gottlieb, C. and Lalos, O. (2007) Legislated right for donor-insemination children to know their genetic origin: a study of parental thinking. Human Reproduction 22(6): 1759-1768.

2. Department of Health and Social Security (1984) Report of the Committee of Inquiry into Human Fertilisation and Embryology (The Warnock Report), Cmnd. 9314 London: HMSO: 4.25

3. House of Lords and House of Commons (2007) Joint Committee on the Human Tissue and Embryos (Draft) Bill Vol 1: Report: 276 http://www.publications.parliament.uk/pa/jt200607/jtselect/jtembryos/169/169.pdf

4. House of Lords (2007) Official Debates 10 December: Cols 91-108 http://www.publications.parliament.uk/pa/ld200708/ldhansrd/text/71210-0013.htm

5. Department of Health (2007) Government Response to the Report from the Joint Committee on the Human Tissue and Embryos (Draft) Bill. CM 7209 8 October. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/dh_079127

6. Human Assisted Reproductive Technology (HART) Register. http://www.dia.govt.nz/diawebsite.nsf/wpg_URL/Services-Births-Deaths-and-Marriages-Human-Assisted-Reproductive-Technology-(HART)-Register?OpenDocument

 

Acknowledgements: In accepting full responsibility for the ideas contained in this Commentary, I wish to thank Lucy Frith and Caroline Jones for their invaluable advice in helping me to develop and refine them.

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Over the past 14 years, over half of the total number of embryos created for use in IVF in the UK have not been used, according to government statistics. Between 1991 and 2005, 1.2 million embryos were not used, from a total of more than two million embryos (2,137,924) created by specialists while assisting infertile couples in the UK to have babies.

In 2005, the live birth rate statistics improved to approximately 21.6 per cent, resulting in 11,262 children through IVF but still involving the creation of around 191,000 embryos. Lord Alton of Liverpool, an anti-abortion Independent peer, requested the data provided by the Department of Health's minister whilst challenging the permitted creation and uses of unwanted embryos particularly for research during recent parliamentary debates on the Human Fertilisation and Embryology (HFE) Bill 2007, a bill designed to revise and modernise its 1990 predecessor.

Lord Alton expressed surprise at the 'incredible rate' of unwanted embryos created in order to achieve successful pregnancies. The alarming data stirred evaluation of regulatory measures to reduce the number of extra IVF embryos destroyed. 'This is a rather unexpected aspect of IVF', Lord Alton admitted, and advocated embryonic-adoption programmes as a solution. Infertility organisations, including Infertility Network UK, felt there would be 'more scope for embryo donation' if encouraged. Bob Spink, the Conservative MP, turned to the medical community to address its high levels of embryo destruction.

Lord Winston, a leading UK fertility expert, tempered the debate with a reminder that even nature is highly inefficient and 'pretty well all of us' have created embryos through unprotected intercourse that do not implant and develop. Many experts estimate that only half of naturally-conceived embryos successfully implant and women commonly discard microscopic unviable embryos without detection.

Unused embryos in clinics under UK law may by consent be discarded, frozen, donated to research or donated to other infertile couples. Specialists create multiple embryos to increase the efficacy of IVF, an invasive, emotionally-taxing and expensive procedure. Only approximately 20 per cent of these will be considered viable for implantation. The others are usually discarded within days of production. Generally two embryos are transferred to the mother to increase chances of successful implantation. Viable embryos are often frozen for future use and must be destroyed within ten years. A smaller number are donated to research - 82,955 of the 1.2 million. Embryo donation to infertile couples for adoption is rare and generally unpopular with donating and prospective parents who were initially motivated to endure medical intervention to have a biological child.

Last month the Human Fertilisation and Embryology Authority revised its guidance to recommend that clinicians implant only one embryo. The measure aims to reduce risky multiple-birth pregnancies and thereby encourage scientists to discover IVF methods that require fewer embryos. A December 2007 HFEA report revealed that 64 per cent of embryo research conducted in the UK is dedicated to understanding embryo development to improve fertility treatments. Embryo donation for research significantly contributes to further scientific understanding. Many supporters argue it should be encouraged as a more respectful disposal alternative for embryos than pouring them down a drain without contributing to medical progress.

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Commentators have warned that the UK's new Human Tissue and Embryology Bill, which will become law in 2008, could open the way for the first legal genetically modified babies.

The new Bill will allow the genetic modification of embryos up to 14 days old, although the law will not permit the modified embryos to be implanted into a woman's womb. Scientists hope that the new regulations will allow them to discover more about congenital disorders such as motor neurone disease, and potentially to develop ways of treating such disorders, or at the very least to reduce the number of babies born with incurable genetic disorders.

However, the Bill has been criticised by some for potentially allowing spurious manipulation of embryos, leading to parents creating designer babies, and turning human life into a commodity. David King, from the campaign group Human Genetics Alert, termed the decision to allow the manipulation of human embryos 'dangerous' and stated that 'traditionally, we see human beings as inviolable and endowed with rights - they must be accepted as they are. Genetic modification degrades human subjects into objects, to be designed according to parents' whim'.

Other experts have denied that the law will lead to any such explosion in designer babies, with Professor Lord Robert Winston accusing Dr King of 'pure scaremongering', and explaining that the technology needed to produce designer babies would be out of reach of scientists for a very long time, let alone being prohibited in a reproductive sense by the new legislation.

Meanwhile, Jackie Ballard, former Liberal Democrat MP and chief executive of the Royal National Institute for Deaf and Hard of Hearing People (RNID), has advocated that deaf couples be allowed to screen their embryos in order to pick a deaf child, rather than one with normal hearing, should they so wish.

The Bill has a clause that prohibits parents choosing an unhealthy embryo, if healthy embryos exist, and so deaf parents would not be allowed to deliberately select a deaf child. However, disability charities have argued that this is discriminatory, because while parents will be able to choose screened embryos that are free of disabilities, a baby could not be deliberately created with a disability. This particularly angers some deaf activists, because they argue that deafness is not a disability, but a cultural identity. Ms Ballard stated 'we would like to retain, as far as possible, parental choice, but it has to be in conjunction with a clinician so that people know exactly what they are choosing'.

Doctors are opposed to allowing parents to select deaf children, claiming that it is an abuse of medical technology. Professor Gedis Grudzinskas, medical director of the Bridge Centre, an embryo screening clinic, said 'deafness is not a normal state, it is a disability. To deliberately create a deaf embryo would be contrary to the ethos of our society'.

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A groundbreaking new device has been launched worldwide that takes the IVF process to a much higher level of safety.

In a move that will reassure patients everywhere, a rapidly growing number of clinics in the UK, the US and elsewhere are adopting IVF Witness – a system which is revolutionising the IVF process by eliminating the possibility of mix ups. 

Developed by Research Instruments Ltd, IVF Witness uses radio frequency identification tags to track IVF samples through the fertilisation process and sets off an alarm if samples from different parents are brought into the same work area. Exhaustive tests have proved the RFID system to be absolutely safe.

Overlake Reproductive Health in Bellevue, Seattle, is the first clinic in America to use IVF Witness.

‘I admit I was sceptical at first but, after using the system for the last four months, I am now a complete convert,’ said Shaun Kelly, Overlake’s Laboratory Director.  ‘We still check everything visually because, if anything, the system makes you even more aware of the importance of vigilance. 

‘The advantages are two-fold.  Firstly, patients feel far more relaxed and confident about the procedure because they have an ID card which puts them in control and secondly embryologists are reassured by having an extra safety net.  It tightens up the whole IVF process and makes it far more secure.’

Hull IVF Unit, a UK-based clinic that was recently given a five star rating in the latest ivfworld.com ratings survey, has also started using the new system.

‘We have chosen to install this system for two reasons,’ said Dr John Robinson, Hull IVF Unit’s Scientific Director.  ‘Firstly, and most importantly, it greatly reduces the possibility of human error.  Secondly, unlike the double witness process, it does not require two members of staff to operate – it allows embryologists to work safely and effectively, without frequent interruptions to witness with other colleagues. 

‘In Hull we see about 350 IVF patients each year and the manual system becomes more difficult to manage, and potentially less reliable, the busier it gets.  IVF Witness minimises human intervention and the system’s workstation won’t allow the wrong eggs and sperm to be used in the same location:  very reassuring for both patients and staff.  In effect, it is providing a continual and very robust safety check, independent, and additional to the many checks embryologists have to carry out while working.’

Bill Brown is the Managing Director of Research Instruments, based in the UK, which developed the device.

‘After looking at several possible alternatives, we chose to develop a Radio Frequency Identification (RFID) system because it is far more effective and reliable than anything else on the market,’ he said. ‘RFID continually monitors the whole work area so no transfer can take place between non-matching samples.  It makes it impossible for a sample to be transferred to a non-matching patient without an alarm going off.’

For more information, visit www.research-instruments.com

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British scientists have created early-stage, human sperm from female stem cells, according to a news report in New Scientist magazine. It is claimed that the research will pave the way for same sex couples to have children that are genetically their own. However, other scientists are sceptical that this procedure would ever be possible.

Professor Karim Nayernia at the University of Newcastle initially fertilised mice with sperm derived from embryonic stem cells (ESCs) in 2006, which gave rise to seven pups, six of which survived. In more recent work, he took human male stem cells from bone marrow and formed 'spermatogonia', primitive sperm cells that can form mature sperm cells by going through a process called meiosis. Nayernia has now apparently done the same using human female stem cells, work that has yet to be published.

The next stage in the process would be to make these primitive sperm cells undergo meiosis, which Nayernia claims he has started to do. The result could be that female eggs are fertilised by 'female' sperm, thereby eradicating the need for male gametes. However, Dr Robin Lovell-Badge, a stem cell expert at the National Institute of Medical Research in London, does not think the approach it will work. He told the Telegraph newspaper that the 'presence of two X chromosomes is incompatible with this. Moreover they need genes from the Y chromosome [from the male sperm] to go through meiosis. So they are at least double damned'. Safety issues have also been raised, since the mice pups in Nayernia's initial study had health problems.

A Brazilian team of scientists lead by Dr Irina Kerkis at the Butantan Institute in Sao Paolo also claim to have made sperm and eggs from male mouse ESCs, and are currently starting to take the work into human cells. The research brings hope to people dealing with infertility, a problem that affects one in six couples, although scientists say the process is still in its infancy and treatments are a long way off.

There is also potential to use 'induced pluripotent stem cells', stem cells derived from human skin cells, as a starting point for the process. This could enable gay men to donate skin cells that would be used to create stem cells from which eggs could be formed. The eggs could then be fertilised using sperm from his partner, and placed in a surrogate mother.

Greg Aharonian, a patent analyst in the US, is trying to patent the technology behind 'female' sperm and 'male' eggs. A self-proclaimed 'troublemaker', he wants to undermine the argument that marriage should remain heterosexual because its main purpose is procreation.

The controversial developments have provoked mixed responses in the UK and US. Mike Judge from the Christian Institute faith group says that 'children need male and a female role models'. Many religious groups still oppose gay marriage. Josephine Quintavalle, from the pro-life lobby group Comment on Reproductive Ethics, says: 'we are looking at absurd solutions to very obscure situations and not addressing the main issue. Nobody is interested in looking at what is causing infertility - social reasons such as obesity, smoking and age'.

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Supplying a comprehensive and hands-on approach to in vitro fertilization (IVF), this source presents established state-of-the-art procedures and techniques, as well as the most current research in the field. Expert contributors explore the history of IVF and progress to future research pathways. Additional coverage includes preimplantation genetic diagnosis, oocyte retrieval, oocyte donation, and micromanipulation procedures such as ICSI, assisted hatching, and embryo biopsy.
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There was a lively audience at this public meeting held at the Centre for Life in Newcastle on 12 February, an evening debate organised by Progress Educational Trust. This is perhaps not surprising given the recent media speculation and the current political debate about the Human Fertilisation and Embryology Bill which proposes to ban the use of artificial gametes for fertility treatment. It was opportune therefore to address the scientific, ethical and political issues.

Professor John Burn provided an overview of the genetic principals of reproduction. The scientific basis of reproduction is the preservation of the genes that we carry in every cell in our body. The gametes are the specialised cells (sperm and egg) that are the means by which the male and female genes are introduced at fertilisation. There is thus no ethical or scientific reason to enshrine special status in the gamete as distinct from any other cell type. It is the consequence of fertilisation, the embryo and its potential to create a new individual, that needs to be given appropriate respect. There is a very high attrition rate following natural fertilisation in humans and even at birth, 2-3 per cent of all naturally conceived children carry severe congenital problems. This illustrates the frequency with which such faults occur naturally in humans. More faults (3-4 per cent) occur after assisted conception, illustrating the care that must be taken when considering the introduction of any new reproductive technology. Questions from the audience raised the issue as to why more research is not done to investigate these causes of infertility. Since most of these problems arise during the development of sperm and eggs and early post-fertilisation development, there are strong arguments to support further research on artificial gametes. Ultimately however, in relation to treatment, the welfare of any child conceived must be our prime concern. The inherent and inevitable risk to the child in conception and during birth must be minimised and must be balanced against the interests of the infertile couple.

Dr Donald Bruce presented ethical concerns about artificial gametes. These centre primarily on the creation and use of embryos to derive embryonic stem cell lines from which sperm could be derived. Thus, those who have ethical or religious objections to in vitro fertilisation are unhappy about the creation of artificial gametes. Since it is possible that sperm may also be made from other stem cells, this objection to the use of embryos may not be relevant. Sympathy was expressed for infertile men who may benefit from such scientific developments including those who have been left infertile after successful cancer treatment.

Media and political discussions have raised concerns that artificial gametes may be used to create children for lesbian couples using both their DNA by creating a sperm from one partner to fertilise the egg of the other. The use of donated sperm to allow lesbian women to be parents is now accepted practice. Artificial gametes might give lesbian couples the possibility of a child who would have a complete knowledge of their genetic origin. This must surely be in the best interest of the child. Scientists and clinicians do not define the meaning of parenting; they respond to the clinical needs of individuals. Reproductive choices are made by individuals framed by the values of the society in which they live. A progressive society protects these choices.

Realistically, this is still only theoretical. Much research is still needed to develop the necessary technology and address the safety issues related to the use of laboratory grown sperm. The prospect of growing functioning eggs is many years away. Artificial gametes are not yet ready for clinical use. But Professor Burn also illustrated the remarkable speed at which scientific developments can occur. The ability to read individual genomes as a routine procedure would never have been thought possible just a few years ago and now it is a feasible option. Sperm is likely to be ready to test in clinical studies within the lifetime of the Human Fertilisation and Embryology Bill currently being considered in Parliament. The UK is internationally recognised as having provided legislation that allows science to progress within a regulated framework. This has kept the UK at the forefront in this field. A clause in the current Bill intends to prohibit the use of laboratory derived sperm from ever being used for fertility treatment in the UK. An amendment has been tabled that would permit Parliament to reconsider the issue whenever appropriate. Regulations could be made to permit their use to treat infertile couples if new developments had successfully addressed the safety issues.

The meeting was open to the public and widely advertised. The attendees were non-selected and came from throughout the UK. After hearing the scientific and ethical discussion, a vote was taken by the 86 attendees on this clause in the HFE Bill. Six per cent voted for the government's proposed complete ban in primary legislation on the use of artificial gametes for fertility treatment. 53 per cent preferred that it be banned now but that Parliament be given regulatory making powers to reconsider the issue at any appropriate time in the future. The remaining 41 per cent felt that there should be no specific ban and that the current regulations provided by the HFEA licensing procedure were sufficient. The proposed government ban on the use of artificial sperm for fertility treatment may not reflect the wishes of society, since 94 per cent of those at the meeting who took part in the vote reflected a desire for a more progressive approach. Professor John Burn provided an overview of the genetic principals of reproduction. The scientific basis of reproduction is the preservation of the genes that we carry in every cell in our body. The gametes are the specialised cells (sperm and egg) that are the means by which the male and female genes are introduced at fertilisation. There is thus no ethical or scientific reason to enshrine special status in the gamete as distinct from any other cell type. It is the consequence of fertilisation, the embryo and its potential to create a new individual, that needs to be given appropriate respect. There is a very high attrition rate following natural fertilisation in humans and even at birth, 2-3 per cent of all naturally conceived children carry severe congenital problems. This illustrates the frequency with which such faults occur naturally in humans. More faults (3-4 per cent) occur after assisted conception, illustrating the care that must be taken when considering the introduction of any new reproductive technology. Questions from the audience raised the issue as to why more research is not done to investigate these causes of infertility. Since most of these problems arise during the development of sperm and eggs and early post-fertilisation development, there are strong arguments to support further research on artificial gametes. Ultimately however, in relation to treatment, the welfare of any child conceived must be our prime concern. The inherent and inevitable risk to the child in conception and during birth must be minimised and must be balanced against the interests of the infertile couple.

Dr Donald Bruce presented ethical concerns about artificial gametes. These centre primarily on the creation and use of embryos to derive embryonic stem cell lines from which sperm could be derived. Thus, those who have ethical or religious objections to in vitro fertilisation are unhappy about the creation of artificial gametes. Since it is possible that sperm may also be made from other stem cells, this objection to the use of embryos may not be relevant. Sympathy was expressed for infertile men who may benefit from such scientific developments including those who have been left infertile after successful cancer treatment.

Media and political discussions have raised concerns that artificial gametes may be used to create children for lesbian couples using both their DNA by creating a sperm from one partner to fertilise the egg of the other. The use of donated sperm to allow lesbian women to be parents is now accepted practice. Artificial gametes might give lesbian couples the possibility of a child who would have a complete knowledge of their genetic origin. This must surely be in the best interest of the child. Scientists and clinicians do not define the meaning of parenting; they respond to the clinical needs of individuals. Reproductive choices are made by individuals framed by the values of the society in which they live. A progressive society protects these choices.

Realistically, this is still only theoretical. Much research is still needed to develop the necessary technology and address the safety issues related to the use of laboratory grown sperm. The prospect of growing functioning eggs is many years away. Artificial gametes are not yet ready for clinical use. But Professor Burn also illustrated the remarkable speed at which scientific developments can occur. The ability to read individual genomes as a routine procedure would never have been thought possible just a few years ago and now it is a feasible option. Sperm is likely to be ready to test in clinical studies within the lifetime of the Human Fertilisation and Embryology Bill currently being considered in Parliament. The UK is internationally recognised as having provided legislation that allows science to progress within a regulated framework. This has kept the UK at the forefront in this field. A clause in the current Bill intends to prohibit the use of laboratory derived sperm from ever being used for fertility treatment in the UK. An amendment has been tabled that would permit Parliament to reconsider the issue whenever appropriate. Regulations could be made to permit their use to treat infertile couples if new developments had successfully addressed the safety issues.

The meeting was open to the public and widely advertised. The attendees were non-selected and came from throughout the UK. After hearing the scientific and ethical discussion, a vote was taken by the 86 attendees on this clause in the HFE Bill. Six per cent voted for the government's proposed complete ban in primary legislation on the use of artificial gametes for fertility treatment. 53 per cent preferred that it be banned now but that Parliament be given regulatory making powers to reconsider the issue at any appropriate time in the future. The remaining 41 per cent felt that there should be no specific ban and that the current regulations provided by the HFEA licensing procedure were sufficient. The proposed government ban on the use of artificial sperm for fertility treatment may not reflect the wishes of society, since 94 per cent of those at the meeting who took part in the vote reflected a desire for a more progressive approach.

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We are delighted to announce that the University of Oxford�s new MSc in Clinical Embryology is now inviting applications for entry in October 2008. Students wishing to apply should follow the instructions given at www.admin.ox.ac.uk/postgraduate/apply/. Please note that the University recruits students into postgraduate courses by way of �gathered fields� (see www.admin.ox.ac.uk/postgraduate/apply/gathered.shtml). This allows the University to recruit students throughout the academic year (via a maximum of six gathered fields). Student applications now being accepted for the fifth gathered field (Deadline 16th May 2008). Students may apply using a written application form or online. Students wishing to apply for this course should note that the tuition fees are �25,000 and that the following three Colleges are willing to accept our students: Jesus College (www.jesus.ox.ac.uk/), Oriel College (www.oriel.ox.ac.uk/) and Worcester College (www.worc.ox.ac.uk). Student funding details and information for overseas students are available at www.admin.ox.ac.uk/io/. Please note that in addition to the normal application process, which requires a completed application form and curriculum vitae, we would like each of applicants to write a short (no more than 500 words) statement explaining why the student wishes to take the course and how the student thinks the course will influence their future career.

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A research team at Cornell University in New York has created what is believed to be the first genetically engineered human embryo. A gene that acts as a 'tracer' was inserted into the embryo, to determine whether its activity could be followed over time. The researchers from the Center for Reproductive Medicine and Infertility at Cornell Medical Center were successful in tracing the gene, and said that the purpose of their work was to study how diseases such as cystic fibrosis, hemophilia and cancer develop. The procedure has been technically feasible for many years, however this is believed to be the first instance where a foreign gene has been introduced into a human embryo. The embryo was destroyed after five days. 

The research was originally presented in the autumn of 2007 at the annual meeting of the American Society of Reproductive Medicine. The UK Human Fertilisation and Embryology Authority (HFEA) included the study in a review of stem cell technology, and warned that such research would raise 'large ethical and public interest issues'. The study did not receive widespread media attention until recently, when it was reported in the Sunday Times newspaper last week. 

The research did not violate any federal restrictions on human embryo research, and was approved by a review board at Cornell University. The National Institutes of Health (NIH) did not regard the research as gene therapy because the embryo is not considered a person under federal regulations. The embryo used in the study was non-viable because it contained extra chromosomes, and it could never have become an infant. 

The inserted gene was one that makes green fluorescent protein (GFP), which is a common tool in life sciences research. It is typically used to understand the underlying biology of diseases by following the developmental trajectory or fate of cells labelled with the GFP gene in disease models. Cells that have successfully incorporated the gene into their DNA appear fluorescent green. The scientists used a modified virus, commonly used in gene therapy treatments, to deliver the GFP gene to the embryo. 

Gene therapy involves introducing foreign genes into humans to treat diseases in a particular organ or tissue. Genetic alterations from such 'somatic gene therapy' are not passed onto future generations because they are not present in the gametes - the sperm or egg. In this study, because all the cells of the embryo were fluorescent, the gametes that would develop from the embryo would also be fluorescent, and in theory would be passed on in the germ line. The researchers stressed that the embryo was destroyed after five days and was non-viable. 

However, critics have argued that this research represents the first step towards 'designer babies', demonstrating that the technology exists to genetically manipulate human embryos and insert genes with desired traits such as intelligence or fitness, or to correct genes which cause disease. Dr Zev Rosenwaks, who conducted the research, stated 'none of us wants to make designer babies', and said that the purpose of the work was stem cell research. Marcy Darnovsky, associate director at the Center for Genetics and Society, cautioned that the researchers crossed an 'important ethical boundary' without any public consultation or discussion, a concern that was also raised by the HFEA. Under the new UK Human Fertilisation and Embryology Bill, such genetic modification of embryos for stem cell research would be legalised, but implantation into the womb would remain banned.

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A legal fight by a UK woman to have a child using sperm taken from her husband after his death is underway. The case highlights the need for regulatory clarity on the issue, which first came to prominence in 1995 when Diane Blood won the right to conceive using sperm from her comatose spouse. 

Doctors were allowed to harvest the sperm as the unnamed 42-year old woman and her husband, from Twickenham. London, had just begun fertility treatment, a judge ruled. However, the Human Fertilisation and Embryology Authority (HFEA) are questioning the legality of the sperm extraction process. The law currently requires the man's written consent, although a gynaecologist has confirmed that the couple were seeking fertility treatment before the man's death. 'Had the husband had the opportunity to give consent in writing, it is clear from the overwhelming evidence that he would have done so', said David Josiah-Lake, the solicitor representing the woman.   

In Diane Blood's case, she was eventually permitted to undergo treatment abroad when the HFEA lifted its ban on the export of human gametes. She now has two children. She supports the current applicant, saying: 'If the couple were engaged on a joint venture to have a child and there is evidence from a conversation that the deceased would have wished the surviving partner to continue with that notwithstanding his death, then I see no need for that consent to be in writing. I cannot imagine life without my children. They bring joy to a great many people including my late husband's family'.    

Vincent Cable, the widow's local Liberal Democrat MP, submitted an amendment to the Human Fertilisation and Embryology Bill, currently passing through parliament, which would allow the use of sperm in such cases in the UK, removing complications surrounding cross-border fertility treatments. He additionally proposed that a consultant's confirmation of the deceased's intention to have children should be sufficient evidence of consent.   

'This amendment is quite narrowly drawn but would deal with a small number of specific cases where it is a woman's right to have a child by her partner. In this case the couple were already embarking on fertility treatment and it was clear her husband had it in mind to support her having a child in this way, so she could have a stronger case than Mrs Blood', said Cable.  

The widow hopes that the HFEA will allow her to use her late husband's sperm to conceive a brother or sister for their only daughter. The HFEA said that they could not comment on the case as it was before court.

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