IVF News

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.

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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'.
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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.

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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.

Dr Rashbrook, who travelled to Eastern Europe for the fertility treatment with her second husband, 60-year old John Farrant, paid ?7000 for the IVF with a donated egg. The treatment was carried out by 'maverick' Italian fertility doctor Severino Antinori, most famous for vowing to clone humans.

Describing her new-born son, Dr Rashbrook, a child psychiatrist, said 'he is adorable', adding that 'having been through so much to have him we are overjoyed. His birth was absolutely wonderful and deeply moving for both of us'. Her husband, 61 year old John Farrant, said that he was 'awestruck' upon seeing his son. 'I felt transformed, as if fatherhood had fulfilled a need in me that I hadn't acknowledged before I met Patti', he added.

The oldest woman to have given birth following fertility treatment is Adriana Iliescu, a Romanian woman, who gave birth aged 66 in 2005. Clinics in the UK are not likely to treat women in their sixties - even though it is not illegal to do so, most clinics have an upper age limit and few would treat women over the age of 45. One thing clinics in the UK have to take into account is the welfare of the prospective child - and many fertility doctors would not consider it to be in a child's best interests to be born to parents who are less likely to survive until it is an adult. Dr Rashbrook defends critics who say the couple have put their needs above those of the child: 'We would not have gone ahead if we felt we would not be good parents', she said, She added: 'I have always looked and felt very young, but nevertheless we have younger friends with children who have agreed to act as surrogate parents should anything happen to us'.

However, some fertility specialists have said they oppose the treatment of older women with IVF. Sam Abdalla, medical director of the infertility clinic at London's Lister hospital, said that although 'it is true we can easily get a 70 year old pregnant, or even someone older', he believes that 'it is much better to have the rules and framework that apply in Britain'. 'I hope this remains an individual case', he added. Patricia Hewitt, the Health Secretary, has however defended Dr Rashbrook, accusing critics of 'gender hypocrisy'. She said that the choice to undergo IVF should be a choice for individual couples and their doctors. But others have called this attitude 'irresponsible'. Ann Widdecombe MP said that it was not the right analogy, as men could conceive children naturally into old age and women could not. Josephine Quintavalle, from the pro-life campaign group Comment on Reproductive Ethics (Core), asked where Hewitt would draw the line: 'at 70, at 80, 100?'

Last week, the oldest woman to give birth to IVF twins did so in New York, aged 59, also following treatment using donated eggs. Mrs Cohen and her husband Frank Garcia, from Paramus, New Jersey, already have a daughter, Raquel, who was conceived in the same way.

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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.

The key features of the proposed new legislation are:

1) Fertility treatment will be provided for single women and to lesbian couples, as well as to heterosexual couples.

2) There will be no age limit for treating women or men. The law says that it will be down to a patient's doctor to evaluate the medical risks or benefits of the possible treatment and/or the pregnancy for the woman, before starting treatment.

3) All egg and sperm donors will be identifiable and registered. At the age of 18, a donor-conceived child will be able to apply to the registry for information concerning their donor's identity.

6) Any embryos already created using anonymous egg or sperm donations, currently in frozen storage, will have to be used or destroyed within six months of Parliament enacting the new law.

5) Surrogacy will not be allowed.

6) Only fertility clinics authorised by the Ministry of Health will be allowed to perform fertility treatments.

FERTILITY TREATMENTS IN FINLAND: CURRENT PRACTICE

To date, fertility treatments in Finland have been carried out to a high ethical and medical standard, despite the absence of legislation. We are one of the leading countries for single embryo transfer in IVF treatment, and we have successfully minimised the rate of multiple pregnancies. We transfer one, or at most two embryos, and still obtain high pregnancy rates. The accepted highest age for treating women is about 45 years in all private clinics, and up to 40 years in publicly-funded clinics.

Up until now, egg and sperm donors have been able to choose between anonymous or known donation, with most opting to remain anonymous. In our clinic, Felicitas, only healthy women under 35 can donate eggs, and all recipient couples must see a consultant before starting the treatment. The waiting time for fertility treatment with donated eggs is approximately one year, and there is constant need for more egg donors. Last year there were approximately 800 treatment cycles using donated eggs in Finland, with the numbers rising every year.

The practice of surrogacy in Finland is currently only permitted using the commissioning mother's own egg [full surrogacy]. A few single women and lesbian couples have used surrogacy, treatment that is always provided with help of a consultant.

CONCERNS WITH THE PROPOSED NEW LAW

Clinicians have raised concerns about some aspects of the new Finnish law. First, with respect to the proposed surrogacy ban, we think it is unfair that women without a uterus will be denied access to infertility treatment. If the woman's ovaries are functioning, we do not see why she should be penalised, as this is a medical condition. This also seems inconsistent with the proposal to treat single women and lesbian couples.

Secondly, we are afraid that if only known egg or sperm donors are permitted, we might lose many donors, making such treatments even more difficult to carry out. It will mean that many couples will travel abroad, and we feel that so-called 'fertility tourism' is not the proper way of helping couples who need treatment with donated gametes. In the original law proposed two years ago, this problem was elegantly solved, in my opinion. Donors could have chosen to be known or not, and in the case of anonymity, the donor would have given a description of themselves to be given to the child after the donor's death (should the parents have informed the child about the circumstances of their conception). This could be a useful compromise for the present law proposal as well, and a solution for this very difficult problem.

Thirdly, we are concerned about the fate of existing frozen embryos belonging to couples who have been treated using anonymously donated gametes. There are currently many ongoing donor assisted treatments and pregnancies in various clinics, and hundreds of embryos stored in Finland. Those embryos belong to the treated couples and I believe nobody else should have the right to decide what to do with them. Many of the couples want to have genetic siblings for their children, a possibility that will be destroyed by the new law.

However, as a clinician working at the biggest private fertility clinic in Finland, I also feel there are positive aspects to the proposed new law - for example, the fact that all clinics will have to meet certain standards set by the authorities. This will help us, as well as the patients. The final decision on the law will be made by Parliament this spring, after MPs have heard from infertility specialists. About half of all MPs are still against the new law, mainly because it advocates the treatment of single women and lesbian couples. It seems likely that this issue will trigger a lively discussion in Parliament, as well as amongst Finnish citizens.

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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.
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Guest Speaker: Juergen Liebermann, PhD, HCLD (ABB)
Director of the Embryology, Andrology and Endocrinology LaboratoriesFertility Centers of Illinois, Chicago/River North IVF Lab

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.

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Vice President of Engineering, Hamilton Thorne

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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'.

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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.

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