Thursday, 10 December 2015

Litter of seven puppies are first born through IVF

Nineteen embryos, seven pregnancies, one female beagle ... scientists say procedure could save endangered species and prevent genetic disorders.

From the paint on their toes and the tips of their tails, the puppies stand out as unusual. But the litter of seven will go down in history for more than the colours that tell them apart. Now five months old and doing well, the dogs are the first to be born through IVF.
The healthy delivery of the dogs by caesarean section on 10 July marks a success that has eluded scientists for 40 years since efforts began in the mid-1970s. The procedure could transform attempts to save endangered dog species, and potentially help prevent the genetic disorders that afflict so many breeds.
Born to the same beagle mother, the puppies included two produced from a different beagle mother and a cocker spaniel father, and five from two other pairings of beagles. The seven pregnancies came after 19 IVF embryos were transferred to the mother, according to a report in Plos One.
“We had people lined up, each with a towel, to grab a puppy and rub them and warm them up,” said Alex Travis, a specialist in reproductive biology at Cornell University, in Ithaca, New York. “When you hear that first cry and they start wriggling a bit, it’s pure happiness. You’re ecstatic that they’re all healthy and alive and doing well.”
The team used small daubs of coloured nail varnish to tell the dogs apart. Since they were born, all but one has been adopted. Their names are Ivy, Cannon, Beaker, Buddy, Nelly, Red and Green. Travis gave a home to Red and Green, and while Red’s name honours the informal name for the Cornell sports teams, Travis says Green has yet to be renamed because his children cannot reach a consensus. Nelly will be homed after she has had her own litter of puppies.
The struggle to make IVF work in dogs is down to the curiosities of the canine reproductive system. Dogs ovulate only once or twice a year and the eggs they release are very immature. They are also unhelpfully dark, thanks to fatty molecules inside them, making them hard to work with under a microscope. The list of problems goes on.
Travis and his colleaues first worked out how to obtain eggs that were mature enough to fertilise. The solution turned out to be leaving the eggs in the dogs’ oviducts – the canine equivalent of human fallopian tubes – for a day longer than usual, allowing them to reach a later stage of natural development.
The next hurdle was mimicking the effect of the female reproductive tract, which prepares incoming sperm for fertilisation. Jennifer Nagashima and Skylar Sylvester, researchers in Travis’s lab, found that adding magnesium to the sperm culture did the job. With those two changes, the scientists achieved fertilisation rates of better than 80%.
The final part of the process was to freeze the embryos, so they can be stored until the surrogate mother is at the right stage in her reproductive cycle. Travis had worked out how to do this before, and in 2013 oversaw the birth of the first dog, named Klondike, from a frozen embryo.
Travis said the breakthrough could help conserve threatened and endangered species of dogs in captivity. “If you are managing a species such as the African painted dog, and a male dies, you can collect sperm. And if a female dies, you can collect ovarian follicles from the ovaries and try to mature oocytes in vitro. But then what? To be able to use these resources, you need IVF to be able to produce an embryo from the sperm and eggs,” he said.
Travis added: “Because dogs share so many genetic traits and diseases with people – over 350, which is vastly more than any other species – this technique also gives us new opportunities both to study genetic disease, and with gene editing, potentially prevent it from happening. This will have important implications for both veterinary and human medicine.”


Monday, 7 December 2015

Should the NHS pay for womb transplants?

The first womb transplants are due to take place in 2016. The experimental programme could allow 10 women with damaged or missing uteruses to give birth. If successful, the procedure is likely to be made available to more women who suffer from this particular type of infertility. But should such operations be made available freely on the NHS?

Another argument is that the NHS shouldn't spend money on treating
 because it isn't a disease. This view is out of line with most official classification systems – but some people remain sceptical. One reason for this is that infertility only harms people who want children. People sometimes think of alleviating infertility as being more a way of satisfying a desire for a certain lifestyle than of treating a disease.There are a number of arguments that people who feel uneasy about this prospect might make. One seemingly obvious objection that can be applied to publicly funding any fertility treatments is that they don't save lives. But this argument simply doesn't work. Some of the most important things the NHS does are quality-of-life interventions such as cataract operations, hip replacements and general pain relief. So the fact that fertility treatments are designed to improve rather than extend lives doesn't make them different from widely accepted NHS procedures and isn't a reason not to fund.
But while infertility is only directly harmful to those people who want children, that doesn't mean that it can't be a disease. Whether something is a disease is partly a matter of whether the person's body is functioning as it normally would at any given stage of their life. So we expect a 25-year-old woman's body to be capable of conception and pregnancy – if it is not, this is a pathological state, regardless of whether she wants children. Unwanted infertility can also have very serious psychological side-effects such as anxiety, depression and stress.
Another approach is to argue  shouldn't be provided because of overpopulation. World population grew from 1.6 to 6.1 billion during the 20th century and, as well as pressures on food and water supplies, increasing global population makes it ever harder to tackle climate change. Therefore (so the argument goes) it would be incoherent for governments to expend resources tackling  while at the same time spending public money on what is, in effect, creating extra people.
But restricting infertility services is unlikely to be a fair or effective means of achieving environmental goals. Treating infertile couples makes a comparatively small contribution to population size. In the UK in 2012, just 2% of births resulted from IVFand the figure for womb transplants would only ever be a tiny fraction of this.
Then there are questions of fairness. People who are biologically infertile are suffering from a medical condition that our health system has the technical ability to treat. Given this, denying them such treatment on environmental grounds seems ethically problematic. It would arbitrarily single out people with a particular disability (infertility) and require them to bear costs others don't face. They would then either have to fund treatment themselves or, if they can't afford it, be deprived of the opportunity to be a parent. Whereas if everyone paid evenly spread environmental taxes instead, no single person would need to bear such a high cost.
Adoption and surrogacy
Another suggestion is that, just as paying for everyone to have gold fillings rather than cheaper alternatives would be a waste of NHS resources, womb transplants are a wasteful solution to infertility when adoption and surrogacy arrangements are possible alternatives. But are these really adequate alternatives? Certainly not for those women who attach great value to the experience and process of pregnancy and childbirth.
In any case, adoption and surrogacy can be problematic. Potential adopters must often be willing and able to parent older children, missing out on the early months and years of development and precluding the chance to have their own "genetic child". Surrogacy arrangements, meanwhile, are not legally enforceable in the UK – the surrogate mother can choose to keep the baby even if they are not genetically related. The ban on payments also makes it harder to find willing surrogates.
As with any medical treatment, womb transplants must first be shown to be cost-effective and safe. But if this can be done, there is no good reason to rule out NHS funding.


Unheard story of surrogate mothers

29-year-old Lakshmi hails from a remote village in Anantapur and is a victim of the ills that any woman born into a poor family in India can suffer. She had rented her womb once for the money to clear her weaver husband’s loans. Despite knowing that the process is fraught with dangers, she is ready to do it yet again, this time to get her step daughter married
Only her eyes and nose were visible. The scarf that she wrapped around her head concealed most of her features. Her moistened eyes revealed her helplessness and pain.  “The physical and mental trauma that one goes through during childbirth has repercussions beyond money. I wouldn’t want any woman driven by poverty renting her womb, if she can help it,” her simple words were conveyed in a voice choked with emotion at a panel discussion on commercial surrogacy. 
29-year-old Lakshmi hails from a remote village in Anantapur and is a victim of the ills that any woman born into a poor family in India can suffer. She has never been to school, was married off before she was a major to a maternal uncle twice her age, and is mother to two young boys of her own as well as a teenage daughter of her husband from his previous marriage.
Her husband, a weaver, is partially blind and has no steady income. “Reddy Anna”, the agent who looks for women in need of money promised to get her a princely sum of three-and-half lakh rupees, an offer that would enable her to clear her husband’s loans if she rented her womb. After the required tests were conducted at a Hyderabad clinic, she was under medical supervision.
“I was surprised to see so many women like me and was told that it was one of many centres. I was anaemic but was provided good care till the baby boy was delivered. I cried uncontrollably after giving away the child that had grown inside me. To everyone else it was just a commercial transaction almost like renting a car park,” says Lakshmi. 
All deliveries of this nature as a rule are conducted through the C-section. The surrogate mother receives no post- operative care with the entire paraphernalia disappearing as quickly as they came once the baby is delivered and bundled away to distant lands.
Like clinical trials, surrogacy is a lucrative option for most foreigners who view India as the ideal place for “reproductive tourism”.  The low cost of in-vitro fertilisation and the lack of a stringent regulatory framework to protect the rights of surrogate mothers and babies is being viewed as a serious flaw in India, one of the few countries where commercial surrogacy is legal. 
Lakshmi has seen cases where surrogates have died as a result of complications during pregnancy or inadequate post-natal care. There are also horror stories of multiple embryos being implanted in the womb for higher chances of success. The worst case scenario is where babies born with disabilities are abandoned by the biological parents.
The estimated 9 billion dollar industry is at present a boon for the tourism and hotel industry, fertility clinics and brokers like “Reddy Anna” who make enough commission to have them permanently scouting for “rented wombs”.
The Indian government is in the process of finalising the draft of the Assisted Reproductive Techniques (regulation) Bill with greater attention to the rights of surrogate mothers. The government’s decision to prevent foreigners using India as a cheap “baby market” and importing embryos is however coming under fire.
Driving the lucrative foreign market underground is fraught with risks, say experts. While the rights of “needy infertile married couples” for surrogacy termed as “altruistic surrogacy” are being accepted unquestioningly, fertility experts and women’s organisations feel commercial surrogacy definitely needs a proper legal framework and regulation.
A total ban may not be the answer, they feel. With no health insurance care or policy for children born with disabilities, poor lives are being compromised in the present state of affairs. “There is no exploitation. This is a voluntary business contract between human beings involving exchange of money,” says a fertility expert, whose practise revolves around women like Lakshmi.
The cost of having a surrogate baby for foreign couples is a round 18,000 to 25,000 dollars, a third of what it costs in a developed country like the United States and poor women are paid for their services she reasons.
The question is, do we “ban commercial surrogacy”, which is a billion dollar business and risk black market operations or ensure greater regulation and protection for our poor women? Even as the debate goes on, Lakshmi has rejected her own advice and agreed to rent her womb yet again. This time to get her step-daughter married. “I know my life is at risk. Show me an alternative way of earning this money and I won’t do this again,” she says. I have no answer at least for now and neither does the government.


New Delhi: Government for commercial surrogacy ban to guard surrogate mothers

Government has proposed to ban commercial surrogacy to prevent exploitation of surrogate mothers through a legislation, Lok Sabha was informed today.

New Delhi: Government has proposed to ban commercial surrogacy to prevent exploitation of surrogate mothers through a legislation which is under inter-ministerial consultation, Lok Sabha was informed today.

"Department of Health Research (DHR) has drafted a comprehensive legislation, Surrogacy (Regulation) Bill) which is under ministerial consultation to prevent exploitation of surrogate mothers," Health Minister JP Nadda said.

He said that government had issued notices to DHR conveying ban on import of human embryos except for research purposes and Ministry of Home Affairs asking them to not grant visa to foreign national (including Oversees Citizen of India) intending to visit India for commissioning surrogacy.

"The state governments have been asked to constitute regulatory authorities to regulate surrogacy as per the National Guidelines for Accreditation Supervision and Regulation of ART clinics issued by government in 2005," he said.

Provisions will also be made in the draft Surrogacy (Regulation) Bill to ensure medical, nutrition and overall health care of surrogate mothers in consultation with the Ministry of Women and Child Development.


Wednesday, 2 December 2015

Needed, an Assisted Reproduction Law that Doesn’t Discriminate Against Single Women

Throughout the draft ART (Regulation) Bill, the role and importance of the husband has been over-emphasised. It debars single women from availing ART services, violating their fundamental right to procreation

Over the past few years, Assisted Reproductive Technologies (ARTs) –  a group of technologies that assist in conception – have led to the phenomenal growth in the Indian ‘fertility industry’. The ART business is an integral part of India’s booming medical market and medical tourism industry. However, there is no law so far to regulate and monitor the functioning of the ever increasing number of ART clinics. In 2005, the Indian Council of Medical Research (ICMR) issued guidelines for the accreditation, supervision, and regulation of ART clinics. However, these guidelines are not legally binding on ART clinics. Several studies and media reports have highlighted the rampant unethical and illegal practices of ART clinics where they exploit desperate infertile couples and vulnerable surrogate mothers for commercial gain.
The ART (Regulation) Bill, 2014 – now placed in the public domain by the Ministry of Health and Family Welfare for comments and suggestions – proposes to establish a National Advisory Board, State Advisory Boards and a National Registry for the accreditation, regulation and supervision of ART clinics and ART banks. The core responsibility of these regulatory bodies, according to the draft Bill, is to prevent the misuse of ARTs and ensure safe and ethical ART services. The scope is ambitious and a mammoth infrastructure with matching human resources will be needed to operationalise the proposed regulatory bodies.
In a significant move, the proposed law has placed the onus on ART clinics to prove their innocence in case of the death or disability of either the oocyte donor or surrogate mother. It has also proposed a system of graded penalties/ compensation depending on the degree of negligence. Currently, there is no system in place to address the issue of medical risks including deaths occurring during oocyte donation or surrogacy. There have been instances of deaths of oocyte donors during the procedure. In 2014, Yuma Sherpa, an egg donor for s surrogate, died just after she went through an oocyte retrieval procedure at a fertility clinic in Delhi. The proposed legislation promises to address the rampant malpractices prevalent in the ART industry.
Notwithstanding the urgent need to regulate and monitor the ART industry, the draft Bill, which embodies several problematic clauses, requires certain fundamental changes, corrections and improvements before it is made into a law. One of the major problems is that the draft Bill is premised on patriarchal values and identifies women based on the narrow definition of their marital status.
Single women shut out
Throughout the draft Bill, the role and importance of the husband has been over-emphasised. It debars single women from availing ART services, violating their fundamental right to procreation. In fact, this clause is in contradiction to the existing law which allows a single woman to adopt a child.
Similarly, the draft Bill prohibits unmarried women from becoming oocyte donors or surrogate mothers. Only married women with proven fertility can become surrogate mothers or donate their eggs. On the other hand, when it comes to semen donation there are no such restrictions on men.
In similar vein, mandatory consent of the oocyte donor’s spouse should be deleted from the Bill. A woman has her own individuality and can take decisions for herself and consent to it too. In any event, it would be discriminatory to require the woman to get consent of her spouse for donating her oocytes, when a man is not required to get the consent of his spouse for donating sperms. Further, single women – who may have never married, or be ‘ever married’ (including divorcees, widows, separated women, etc.) should also be allowed to donate under the Bill. How can such women get consent from their spouse, and why should they? These restrictive clauses, which reflect the dominant patriarchal values of our society, need to be reconsidered in favor of respecting the autonomy and freedom of women’s reproductive choices. In addition, one of the clauses of the draft Bill which prohibits a surrogate mother and her husband from having an extramarital relationship during the gestation period violates the rights of the surrogate and their family
Taint of eugenics
Certain clauses of the ART (Regulation) Bill are reflective of eugenic thinking, which has the potential to further reinforce and propagate prejudices and discriminations based on class, caste, gender and ethnicity.
Although the proposed law prohibits ART banks from disclosing the names, identities and addresses of gamete donors and surrogate mothers, it allows the commissioning couples to seek information regarding height, weight, ethnicity, skin color, educational qualification, medical history of the donor, etc. Parliamentarians need to seriously reflect on these clauses, as they have the potential to promote eugenic practices.
ARTs, including in the context of surrogacy, are highly invasive procedures which pose serious health risks to oocyte donors and surrogate mothers. It is, therefore, extremely necessary that the proposed law makes it mandatory for ART clinics and banks to inform oocyte donors and surrogate mothers about the potential health risks associated with the ART procedures. Currently the draft Bill only talks about seeking consent – which is qualitatively different from a comprehensive informed consent procedure.
The draft Bill has proposed to make the Aadhar card the primary identification document for gamete donors and surrogate mothers. The law makers should revisit this clause as it may lead to exclusion and discrimination. Making Aadhar mandatory under this law is in any case violative of the directives of the Supreme CourtThere are many identity proofs used officially, and any of them may be used as a proof. This clause should be deleted or amended appropriately,
Given the exponential growth of the ART industry in the last one decade, its regulation and monitoring has become the need of the hour. Past experiences teach us that the creation of parallel administrative and regulatory structures and bodies do not necessarily lead to better results. We have seen how the PC&PNDT Act created separate bodies and institutions to curb the menace of sex selection, whose satisfactory implementation continues to pose a huge challenge. Making a law is one thing but implementing it has always posed a serious challenge. While it is important to enact a law and create and implement regulatory mechanisms to monitor ART clinics and surrogacy arrangements, the understanding and emphasis on upholding the rights of women and children located in this industry – including egg donors and surrogates – will make the real difference.

China struggles with IVF demand as one-child policy ends

The Nanfang clinic in China's southern Guangdong province says it offers Chinese patients seeking in-vitro fertilization (IVF) the chance to choose the gender of their child, avoid stringent approval checks and snarling queues.
It has to advertise this with caution. China's strict regulation of its IVF market forbids gender selection, requires birth licenses and proof of marriage, and prohibits some more advanced procedures - rules that have pushed patients to go overseas or seek treatment in unregulated clinics at home.
Demand for IVF in China is expected to rise after Beijing scrapped its controversial one-child policy in October, which will strain already-crowded state-run hospitals but create opportunities for overseas health centers, firms helping train local doctors - and underground clinics.
"Here we can do IVF with gender selection and you don't need lots of documentation," a doctor at the Guangdong clinic surnamed Hao told Reuters, adding there had been a 50 percent jump in consultations since the one-child policy announcement.
She said many of her patients were younger women opting for IVF so they could choose a boy, a traditional preference. The doctor did not give her full name and "Nanfang" is a common name for businesses in southern China.
Beijing's tight control makes it hard for private firms to operate IVF clinics in the country, but growing demand for doctors and specialists has created other gaps in the market.
"Training to help up-skill clinicians and embryologists to treat the patients is definitely a big growth area," said Jason Spittle, global director of training at U.S. medical device maker Cook Medical, which has a reproductive health unit.
"China is set to be the biggest IVF market in the world, probably within the next couple of years."
Looking overseas
Chinese couples who have the financial means often go abroad to the United States, Australia, Thailand and Vietnam for IVF.
"The biggest driver is that there are so many hoops to jump through to get IVF treatment here," said Mr Lei, a China-based intermediary who helps patients go to Thailand, who like many Chinese was reluctant to give his full name to a reporter.
Rising Chinese demand for fertility treatments is therefore good news for overseas clinics such as Australia-based Monash IVF Group and Virtus Health or Superior A.R.T. in Thailand, where 30-40 percent of patients come from China.
"Our clinic has prepared Chinese-speaking staff to coordinate with rising number of Chinese patients," said Superior A.R.T. deputy manager Arnon Sinsawasdi, adding the end of the one-child policy should give business a boost.
IVF Australia, part of Virtus Health, plays on Chinese demand for the latest procedures with a Chinese-language website advertising its "cutting-edge technology" to help parents "achieve their dream of having a child".
"Lots of patients go to these places just because they have unique demands. For example domestically they can't do things like surrogacy or gender selection," said Li Yuan, director of reproductive medicine center at Beijing Chaoyang Hospital.
Non-commercial surrogacy is allowed in Australia, while the United States permits gender selection. Thailand, though, has been cracking down on both practices to close loopholes that have lured patients from overseas.
Overloaded clinics
Patients and doctors in China said state IVF centers were often over-stretched - little surprise given each clinic serves around 3.8 million people, compared with 700,000 people per clinic in the United States, health ministry data show.
"Clinics are so busy it's unbearable. Whichever hospital you go to it's always rammed with people," said a junior doctor at an IVF clinic in Shanghai, who asked not to be named.
This creates a market for unregulated providers, who advertise their offerings online and on social media platforms, while avoiding detection by overworked watchdogs despite a recent crackdown on the market.
"In the past few years our checks in some areas haven't been strict enough, routine oversight has been lax, and strikes against illegal behavior have fallen short," China's health ministry said in a statement in July.
"That's led to chaos in the assisted reproduction market."
Patient numbers are still climbing too. There were nearly half a million treatment "cycles" in 2013 at 356 approved clinics, compared with just under 200,000 cycles that year in the higher-value U.S. market.
Despite the growth, though, many still struggle to get access to IVF at all: poorer provinces have few clinics and many can't afford a pricetag that starts at 30,000 yuan ($4,697).
"You can't use state insurance, it's all paid out-of-pocket," said Ms Cui, 37, a financial worker in Dalian who underwent successful IVF treatment in 2013.
"I was lucky that it worked in one go, but many people try a number of times which mean it's even more expensive."