IVF NewsNews: India to introduce new fertility regulation
Antony Blackburn-Starza 06 October 2008
New laws to regulate assisted reproductive technology in India will be introduced to Parliament later this year. The text of the Assisted Reproductive Technology (Regulation) Bill 2008 was published last week by the Indian Council of Medical Research (ICMR) for public comment. The bill aims to regulate surrogacy arrangements in the country where regulation is lacking, in addition to other technologies including pre-implantation genetic diagnosis (PGD) and research on embryos. The bill will set up a National Advisory Board for Assisted Reproductive Technology to oversee the delivery of the services in the country. A regulatory body, the Registration Authority, will grant licences to fertility clinics to store gametes and offer fertility services. Embryo research must be performed on embryos donated for research and not stored beyond 14 days. Researchers must apply for a licence from the Registration Authority to perform research on embryos. The bill will also make it a criminal offence to perform sex-selection procedures except to prevent or treat a sex-linked disorder or disease. Media reports last August about a baby girl, Manyi Yamada, showed inadequacies in India's regulation of surrogacy, which was legalised in 2002. Manyi was born to an Indian surrogate mother, but the Japanese couple who arranged the surrogacy split up prior to the birth of the child. The child's biological father sought parental rights over the child but Indian laws were not clear on the status of foreign parents involved in surrogacy arrangements within its borders and the matter had to be decided in the courts. The new bill will clarify this area by making a surrogate child the legitimate child of a separated or divorced couple. Foreigners seeking surrogacy arrangements in the country will be required to register with their embassy and will have to state with whom the child should be looked after in the event of one of the parent's death. Following surrogacy, the child's birth certificate will show the names of both genetic parents. The bill also forbids women under 21 from entering into surrogacy arrangements and from having more than three live births in their lifetime. Once a surrogate child attains the age of 18, they may apply for information about their surrogate parent. India's Health Ministry does not keep official statistics on the number of surrogate births in the country but it is believed to be low. Media reports suggest that surrogacy arrangements in India can attract surrogate fees of between $12,000 to $30,000, with the industry being worth around $445m. The bill does not ban offering surrogate mothers compensation for their services. Dr P M Bhargava, a member of the ICMR who helped draft the bill, told the Times of India that, 'considering all the news about surrogacy, including the recent case of the Japanese child, we realised that the new law addresses all the problem areas'. The bill is timetabled to be debated by the Indian Parliament in the winter session. [ Full Article ] News: New law affects sperm donation in the Netherlands
Dr. Kirsty Horsey 04 June 2004
A new law that requires sperm donors to be identifiable has come into force in the Netherlands, resulting in a dramatic drop in the number of men coming forward to donate. Women wanting to obtain sperm from Dutch sperm banks are now apparently facing up to two years on a waiting list, since even before the new rules took effect on 1 June.
The law, which was passed after 10 years of deliberation, says that Dutch fertility centres can no longer take anonymously-donated sperm samples, and stipulates that all donor-conceived children will be able to find out the identity of their biological father at the age of 16. One Dutch clinic, in Barendrecht, says that the number of sperm donors on its books has fallen, in anticipation of the new law, from 135 to only 15. Dr Jan Karbaat, from the Bijdorp clinic, said 'I have just placed an advertisement for donors, but got zero reactions', adding that his clinic is considering offering payments for donations. According to reports, a number of Dutch women who want to use donated sperm in order to have a child are crossing the border to Belgium, where donation can still take place anonymously. Hospitals in the Belgian towns of Antwerp and Ghent are reporting an increase in the number of enquiries from Dutch women: one fertility centre says that Dutch nationals now account for five per cent of its patients. A BBC report suggests that it is also likely that Dutch women are seeking sperm from friends in informal arrangements, or via the Internet. Meanwhile, another clinic in Australia has launched an advertising campaign because of a shortage of both sperm and egg donors. Staff at the IVF clinic in Ballarat say that they have a number of childless couples on their waiting lists, and the need for donors is becoming 'urgent'. Dr Russell Dalton, director of the clinic, said: 'It's very difficult, many of these couples have tried to conceive before coming to us and then go through IVF with their own sperm and then are met with the prospect of needing a donor'. Dr Dalton said the clinic is working with the University of Ballarat to determine how many families could benefit from one donor. National fertility guidelines in Australia suggest that 10 families could use one donor's sperm, but Dr Dalton said the university study was to determine how many couples the clinic would release the sperm of one donor to. He added that the clinic's ethics committee was likely to set a lower number, 'possibly around five'. [ Full Article ] News: New embryo-safe way to disinfect laboratory incubators
W Brown 14 April 2009
The need for disinfection of Embryo Culture Incubators is well established. However there are no disinfection products available that are embryosafe... until now. Fertisafe from Research Instruments has been shown to be highly effective at disinfection of incubators and is also embryosafe. Please contact [email protected] for a copy of the white paper on using Fertisafe for disinfection of incubators. Graham Coull, Laboratory Director, Sims International Fertility Clinic says of Fertisafe "we've been using Fertisafe to clean our incubators for the past 10 months and have passed our biological testing each time without any issues." Ronny Janssens, Quality Manager, Centre for Reproductive Medicine, AZ VUB Brussels "I have been routinely using Fertisafe products in the IVF lab and find them to be VOC free, non-toxic to mouse gametes and pre-implantation embryos and an extremely effective sterilization solution.”
[ Full Article ] News: Ethics of PGD: should embryos affected with a hereditary disorder be transferred if no unaffected embryos are available?
ESHRE 11 July 2008
Barcelona, Spain: The numbers of cycles of preimplantation genetic diagnosis or screening are rising steadily in Europe with over 2,700 reported in 2004 (the most recent year for which data are available). Fertility centres are able to screen for a growing number of genetically related conditions, but what should doctors do if no embryos without the targeted condition are available for transfer and the parents request that affected embryos should be transferred instead? Ethicist Dr Wybo Dondorp told the 24th annual meeting of the European Society of Human Reproduction and Embryology in Barcelona today (Monday): "Parental requests for transferring affected embryos should not be dismissed beforehand as a sign of irresponsible capriciousness. As the couple's primary wish may be for a child, they may reason that if a non-affected, healthy child is not what they can get, they will also be happy with, and good parents for, a child with a condition they at first intended to avoid. Respect for autonomy at least requires taking such requests seriously, even if, in view of all other considerations, doctors decide not agree to the requests." Dr Dondorp, who is a senior research fellow at the faculty of Health, Medicine and Life Sciences, department of Health, Ethics and Society at Maastricht University (The Netherlands), said that before couples have preimplantation genetic diagnosis (PGD), fertility clinics should discuss the decision-making process and the particular clinic's policy in their pre-test counselling sessions with prospective parents, so that everyone was clear about what the options were in cases where no unaffected embryos could be obtained. He said the most important consideration was the welfare of the child, particularly taking into account doctors' professional responsibility "to do no harm". "A high risk of serious harm is a contraindication for transferring affected embryos. The present consensus is that where the classical indications for PGD are concerned, doctors should, as a general rule, not transfer affected embryos where no non-affected ones are available. In pre-test counselling it should be explained that if no non-affected embryos are available, the only options are trying a new cycle or being advised to reconsider one's reproductive plans such as refraining from reproduction, using donor eggs or sperm, or adoption. "The welfare of the child is closely connected to the classical indication for PGD: a serious disease caused by a single gene mutation for which there are no, or limited, treatments, and, in most cases, presenting early in life. An example is an embryo that is homozygous for cystic fibrosis, where the child will definitely have the disease. In such cases it is inconceivable that doctors would agree to transfer these embryos as it would be at odds with their professional responsibilities." However, as the use of PGD is being extended increasingly to conditions outside the classical range of indications, transferring affected embryos need not always involve a high risk of serious harm. This is obvious where treatable diseases are concerned, such as MCAD deficiency (where people with a faulty medium-chain acyl-CoA dehydrogenase gene are unable to metabolise fat, but can lead a healthy life by observing a strict diet). "Things are less clear where PGD for hereditary cancer syndromes is concerned. Debate about this is urgent, as centres are already confronted with parental requests to transfer embryos found to have the targeted mutation (e.g. BRCA1 or BRCA2 genes for hereditary breast cancer) in cases where no non-affected ones turned out to be available. How should they respond? That there seems to be more room here to at least discuss the issue has everything to do with the nature of the conditions in question: serious but later onset, incomplete genetic penetrance (not all individuals with the mutation will also have the disease) and availability of some therapeutic options," said Dr Dondorp. "In the case of PGD for hereditary cancer, room for manoeuvre will depend on a case-sensitive evaluation of aspects relevant to the 'high risk of serious harm' criterion, also in view of the family history. If this approach is acceptable and if further debate leads centres to decide that they would not categorically rule this out, pre-test information about centre policy should be adapted accordingly. It must be made clear that there may be, with conditions, room for shared decision-making about transferring affected embryos. But that does not amount to leaving it to the parents, as doctors cannot avoid their professional responsibility for the welfare of the future child." He concluded: "However, professionals may still find it difficult to respond to such requests that lead not only to the deliberate conception of a child in need of special care, but also to the very outcome they set out to prevent when offering PGD to a couple. Is it acceptable to use PGD just for trying to have a better result than one is eventually prepared to accept? This fits in with a wider debate about the morally charged nature of PGD and the proportionality of its uses: is it acceptable to use PGD for avoiding treatable disease, such as MCAD, in the first place?" Together with Professor Guido de Wert, also from Maastricht University, Dr Dondorp is writing a paper to be published in Europe's leading reproductive medicine journal, Human Reproduction, on these issues. This is the first time ethicists have considered the questions that arise as a result of extending the use of PGD to hereditary symptoms such as cancer and MCAD. [ Full Article ] News: UK's oldest IVF mother has baby
Dr Kirsty Horsey 11 July 2006
A 62-year old woman has become the UK's oldest woman to give birth to a child. Dr Patricia Rashbrook, who already has three children aged 18, 22 and 26, underwent IVF treatment using donor eggs in order to conceive her son, who was born by Caesarean section last week. [ Full Article ] Article: Clinical concerns with the new Finnish fertility law
Merja Tuomi-Nikula, specialist in Obstetrics and Gynaecology 08 March 2006
It has taken almost two decades to establish a legal basis for fertility treatment in Finland. Two years ago, most of the Parliamentary Legal Affairs Committee wanted to limit treatments to heterosexual couples. However, there was no agreement on the rights of egg and sperm donors to choose anonymity. So the government withdrew the proposal, and it went back to the Ministry of Justice for review. Now, a new version of the Fertility Law is before the Legal Affairs Committee of the Parliament. [ Full Article ] News: Chimera embryos spark controversy
Dr Kirsty Horsey 04 July 2003
Experiments in which cells from one early human embryo were mixed with those from another triggered a heated debate last week. The studies of mixed, or chimera embryos (dubbed 'she-males' by the media as they contained cells from one male and one female embryo), were presented at the annual conference of the European Society of Human Reproduction and Embryology in Madrid.
Scientists from the Centers for Human Reproduction in New York and Chicago say they created the chimeras to investigate the possibility that cells from a healthy embryo could be used to treat a genetically defective one. They stressed that their work was not ready for clinical application and that the embryos were destroyed after a few days. But other fertility experts at the meeting called the experiments 'completely flawed', and potentially damaging for the reputation of other fertility researchers around the world. Norbert Gleicher and his team took 21 three-day old female embryos, and injected them with cells taken from early male embryos. Twelve of the embryos continued to develop normally, and these were then grown in the laboratory for three further days. The researchers then studied the make-up of the chimeras, using the Y-chromosome as a 'marker' to track the male cells, and found that the male cells had spread evenly throughout the embryos. Gleicher said the work was carried out with the approval of an in-house ethical committee, and was not done with the intention of implanting embryos into a womb, but to investigate possible treatments for genetic disease. 'If you had an afflicted embryo and if you are able to introduce just 15 per cent healthy cells, you may be able to treat single gene disorders' he told the conference. However, other scientists at the meeting thought that the experiments were flawed, since there is no way of ensuring that the healthy cells would go on to form the organs or tissues affected by the gene defect. For example, to treat the genetic condition cystic fibrosis, the researchers would need to get the healthy cells into the parts of the early embryo destined to form the lungs and the pancreas. 'It is essentially trivial science that shouldn't be done' said Australian fertility researcher Alan Trounson, adding that 'it is difficult to argue why it should be done, to the public'. UK scientist Lyn Fraser, chair of ESHRE's scientific committee, also criticised the study, calling it a 'non-starter'. She added that the production of chimeric embryos to make babies was 'expressly forbidden' in the UK, and that it was unlikely that the Human Fertilisation and Embryology Authority would permit any research on human chimeric embryos. [ Full Article ] Announcement: Free Webinar: Benefits of Using Lasers in Clinical Applications and an In-depth Discussion on Vitrification in Assisted Reproduction
Cynthia Rodzen 01 November 2012
Webinar Summary The Webinar discussion will highlight what infrared laser technology is and how it can benefit clinical applications such as assisted hatching, embryo vitrification, and blastomere/trophectoderm biopsy for pre-implantation Genetic Diagnosis (PGD). A special focus of the Webinar discussion will be dedicated to the work and research of Dr. Juergen Liebermann, who will share his laboratory's results on how Hamilton Thorne lasers can be successfully used to improve the vitrification process. Featured in the Webinar will be a comprehensive demonstration of Hamilton Thorne's cutting-edge and LYKOS® and ZILOS-tk® laser systems that provide the highest level of flexibility, compatibility, and ease-of-use for performing clinical applications. Guest Speaker: Juergen Liebermann, PhD, HCLD (ABB) Dr. Liebermann has authored many papers in the area of reproductive science, and with Dr. Michael Tucker co-edited a book entitled "Vitrification in Human Assisted Reproduction." By getting world-recognized scientists in the field of cryobiology as contributors for this book, it presents the State-of-the-Art on vitrification, a new cryopreservation technique. Dr. Liebermann obtained his PhD in Agricultural Science at the Technical University of Munich-Weihenstephan, Germany in 1995. With his postdoctoral thesis in 2004 he qualified as a university lecturer in Experimental Reproductive Medicine at the Bavarian University of Wuerzburg, Germany. He is a member of SSR, ASRM, ESHRE, ASA, and ABB. He serves as an ad Hoc reviewer for Fertility and Sterility, Human Reproduction, Reproductive Biomedicine Online, Reproduction, European Journal of Obstetrics & Gynecology and Reproductive Biology His interests are developing new techniques for culturing human embryos and protocols for oocyte and blastocyst cryopreservation.
Thomas Kenny is a New England leader in the engineering and electronic fields, with multiple important products to his credit, including the ZILOS-tk® and XYClone®. Mr. Kenny has been with the Company since its inception and is a central figure in Hamilton Thorne's technical capabilities. In addition to his development duties, Mr. Kenny speaks at product symposia around the world, and is a graduate of Wentworth Institute of Technology. [ Full Article ] News: World Health Organisation recognises infertility as a disease
Dr Vivienne Raper 30 November 2009
The World Health Organisation (WHO), in conjuntion with the International Committee for Monitoring Assisted Reproductive Technologies (ICMART), has formally recognised infertility as a disease in its new international glossary of Assistive Reproductive Technologies (ART) terminology. The jointly-prepared glossary appeared simultaneously in journals Fertility and Sterility and Human Reproduction. According to the glossary, infertility is 'a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse'. The move was described as 'a significant milestone for the condition' by the American Society of Reproductive Medicine (ASRM). 'We applaud the WHO for leading this important effort and for being so clear about the disease status of infertility', said Dr William Gibbons, ASRM President. He added: 'For too long those suffering from infertility have had their condition slighted or even ignored. Insurance companies don't pay to treat it, governments don't put adequate resources to study it and consequently patients suffer. We hope that this international recognition that infertility is, in fact, a disease will allow it to be treated like other diseases'. [ Full Article ] News: Accurate editing of human DNA now possible, say scientists
Anna Cauldwell 14 November 2013
A molecular technique that enables any part of the human genome to be altered with extreme precision has been hailed by scientists as a breakthrough in genetics. It is the first time researchers have been able to engineer any part of the genome without introducing mutations, reports The Independent. 'This is really a triumph of basic science', Professor Craig Mello, University of Massachusetts Medical School professor and joint recipient of a Nobel Prize in 2006 for a previous genetic discovery, told The Independent. 'It's a tremendous breakthrough with huge implications for molecular genetics'. Crispr was originally discovered in bacteria by Japanese researchers in 1987. However, it was largely dismissed by scientists as 'junk DNA' until 2012 when Professor Jennifer Doudna, University of California, Berkeley, uncovered its potential. Crispr uses an RNA guide molecule that can be programmed to match any unique DNA sequence. This guide is attached to a special enzyme that finds the target sequence of DNA and cuts both DNA strands in the double helix. This then allows copied DNA to be inserted into the genome and defective DNA to be deleted. Previous gene therapy techniques have made use of less accurate methods that often require the use of a modified virus that inserts DNA at random in the genome, leading to safety concerns. The Independent reports that some experts have predicted Crispr may soon be used in human gene therapy trials to treat incurable viruses such as HIV or untreatable genetic disorders such as Huntington's disease. Crispr could also be used to potentially correct gene defects in human embryos in IVF, Professor Mello added, although the use of an embryo that has been genetically altered in IVF remains illegal in the UK. While the development has been widely welcomed by the scientific community, some experts have emphasised that it may be too soon to call its benefits. Professor Dagan Wells, University of Oxford, said: 'I think it's important to stress that the therapeutic potential of this sort of genetic microsurgery is yet to be proven. Additionally, a significant amount of work will need to be done to assess the safety of the method before it can be used clinically'. Professor Robin Lovell-Badge, MRC National Institute for Medical Research, said while there was much deserved excitement surrounding the technique, 'hype needs to be tempered with a little caution'. 'Although remarkably efficient compared to other techniques, the genetic changes introduced by the Crispr technique are not always as perfect as designed and on occasion it could introduce problems that are just as worse as the one being corrected', he said. On its potential application to IVF, Professor Peter Braude, Emeritus Professor of Obstetrics and Gynaecology at King's College London, said although the news was 'fascinating', the technique still had a long way to go in relation to IVF. 'For almost all known genetic diseases there is always a proportion of embryos that do not contain the mutation and thus can be selected for by preimplantation genetic diagnosis, a relatively modest modification of the IVF technique without the need for genetic manipulation'. 'Germ line therapy still has a long way to go before it is more widely accepted, both in terms of safety evaluation, and ethics of appropriateness of use', he said. [ Full Article ] |