Category Archives: Embryology

Is Lost Embryo Litigation The New Asbestos? – Above the Law

Earlier this month, a couple filed suit against a fertility clinic in New York. They claimed negligence, fraud, intentional inflection of emotional distress, and negligent infliction of emotional distress. The complaint tells a story of an especially rough road of fertility treatments. Before their family was complete, the couple, Christopher and Nicole Mooney, went through 13 egg retrievals and 15 embryo transfer procedures. That is a lot!

The couple seeks damages from the clinic and its doctors for, among other things:

The clinic, New York Fertility Institute, denies the couples allegations, stating they were surprised by the lawsuit, never lost the couples embryos, and never transferred the wrong number of embryos.Sounds like some pretty fundamental factual issues in the case!

What Does The Expert Say?

Colleen Quinn is a Virginia attorney with a strong assisted reproductive technology (ART) law practice and litigation practice a unique combination, and one well-fitted for the new rising tide of ART litigation. Quinn explained that embryos are actually pretty easy to lose or mis-identify when clinics do not maintain careful record keeping and accountability. She described how embryos are stored in tiny little straws as small as a sewing needle and each straw has to include identifying information. That does sound tough and open to human error. And clearly those of us who cant find our keys most days should steer clear of a profession in embryology.

Making The Grade

Quinn further explained that embryos are typically graded on their level of viability. However, not all grading is the same, depending on the clinic, or even the person doing the grading. Some may be viable and some may not be viable or some may even be semi-viable. How they are marked in such teeny-tiny space in the cryogenically preserved minuscule straw, versus what is placed on paper, requires attention to detail and meticulous record-keeping. But in this context, attention to detail and meticulous record-keeping should be the bare minimum features of the standard of care, when each and every embryo, and the viability or grading of each, is essential to the patients who have paid so much for the creation of each and every embryo as well as the hope that the patient has for each embryo to be their future child.

Quinn believes that patients should have access to information as to the exact status of each of their embryos and their viability. How it was graded, where and how it was kept, whether it was kept in the same vessel or straw as other embryos and if so, which ones, as well as which ones were thawed and discarded, and ultimately, which ones were transferred to the patients or gestational carriers uterus. As both a litigator and ART attorney, I am seeing more and more of these lost or misplaced or mislabeled embryo cases. This could be avoided with better and more careful record-keeping. I know most reputable clinics and fertility doctors do their absolute best however, we are talking about super tiny, yet mega-valuable material that has been created at both a high financial and emotional cost!

Embryo Transportation

Although the Mooney case does not involve the transportation of embryos from one clinic to the other, Quinn notes that this is a point in the process especially vulnerable and ripe for litigation. When embryos are transported to another clinic, the record-keeping of what got sent and what got received is critical. I have seen so many mishaps in the transportation and accounting process.

Time For (More) Regulation

The Mooneys and their attorney have stated that the purpose of the lawsuit is not just to obtain monetary damages, but also, at least in part, to encourage greater regulation of fertility clinics. Of course, greater regulation often means greater cost, and fertility treatment is already prohibitively expensive for many. But given the devastation and heartbreak caused by missing embryo and mixed-up embryo cases in the United States, it does seem appropriate that there be strict record-keeping requirements.The alternative, for some clinics, will be more lawsuits like the Mooneys. And that just means going to court when tragic losses happens, as opposed to preventing them in the first place.

Ellen Trachman is the Managing Attorney ofTrachman Law Center, LLC, a Denver-based law firm specializing in assisted reproductive technology law, and co-host of the podcastI Want To Put A Baby In You. You can reach her atbabies@abovethelaw.com.

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Is Lost Embryo Litigation The New Asbestos? - Above the Law

Egg freezing rises five-fold in part thanks to ‘revolutionary’ technology, experts say – Telegraph.co.uk

The number of women freezing their eggs has risen five-fold since 2013, official figures show, in part thanks to "revolutionary" technology which has boosted success rates.

Health officials have documented a surge in the number of IVF "storage cycles" where people undergo fertility treatment and store their eggs or embryos until a later date.

Data from the Human Fertilisation and Embryology Authority (HFEA) show that the number of embryo and egg storage cycles increased by 523 per cent between 2013 and 2018 - from 1,500 cycles in 2013 to just under 9,000 in 2018.

There was a 93 per cent rise in frozen embryo transfer cycles between 2013 and 2018 - up from 13,421 to 25,889, and an 11 per cent decrease in the number of fresh embryo transfers - from 48,391 in 2013 to 42,835 in 2018.

Around 54,000 patients had IVF treatment in 2018 and the average birth rate per embryo transferred for all IVF patients was 23 per cent.

Experts say the rise could be attributed to the significant improvements to the method known as vitrification.

First used in the UK around 2010, vitrification freezes the eggs roughly 600 times faster than the old method meaning they are more likely to thaw intact.

A paper due to be released next month in the Reproductive BioMedicine Online journal details how eggs now have more than 80 per cent chance of survival thanks to the method.

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Egg freezing rises five-fold in part thanks to 'revolutionary' technology, experts say - Telegraph.co.uk

Opinion: Kenyans must reject Susan Kihikas Bill that proposes massacre of unborn children – Breaking NEWS in KENYA for Today Right Now & Kenyan…

Kenyans, and Africans in general, are known to fight hard when it comes to defending their precious culture.

We pull out all the stops when it comes to confronting persons pushing us to embrace sick western ideologies that go against values we hold dear.

READ ALSO: DJ Evolve: DPP asks Judiciary to fast track Babu Owino's case after public uproar

Senator Kihika's bill will erode Kenya's culture and soil our beliefs. Photo: Susan Kihika.Source: Facebook

READ ALSO: Woman cries outside Milimani Law Courts, claims Chief Justice Maraga is a deadbeat father

President Uhuru Kenyatta set the best possible example on this front when he stood up to Barack Obama during the latters first trip to Kenya as US President in 2015. Obama lectured Kenyatta in length on Kenyas insipid gay rights record.

Uhuru, however, unequivocally put it to Obama that gay rights is a non-issue in Kenya. He made it clear that while the two countries shared many common values and goals, gay rights is not one of them as our culture and societies do not accept it.

It was impressive seeing Kenyans from all walks of life recently come out with similar boldness and zeal to protest a bill by Nakuru Senator Susan Kihika that seeks to legalise abortion and greatly promote moral erosion.

Just like Obama, Kihika has been exposed to some western ideologies that are distasteful and unacceptable in Kenya. This is courtesy of her long stay in the US where spent 20 years before returning to Kenya to join politics.

READ ALSO: Woman dies two months after posting about dying during lockdown

Senators should not accept the bill as it promotes the killing of unborn children. Photo: Susan Kihika.Source: Facebook

Likewise, she must not be allowed to erode the morals of our delicate youth in the form of the wicked Reproductive Healthcare Bill.

The bill not only seeks to legalise abortion but is also set to escalate this abominable vice by normalizing underage sex. It seeks the introduction of Comprehensive Sexuality Education that will teach that sexual pleasure is a right.

The church has already loudly warned that teaching children that sexual pleasure is a right will open the floodgates for their involvement in sexual perversion such as same sex relationships, rape, bestiality, incest and teenage sex.

But it is the fact that Kihika is openly supporting abortion that must worry Kenyans. How bizarre it is that a woman who is a mother, a wife and purportedly a champion of womens rights is advocating for our girls and women to be allowed to terminate pregnancies whenever they feel like doing so?

No matter what words the senator uses to conceal her wicked motives, it is unarguable that abortion is murder. Life, which is given by God, begins at conception and only the creator has the right to take it.

READ ALSO: Mbunge ahusika kwenye ajali mbaya ya barabarani

Even scientists concur, with the science of embryology showing that a human being is formed from the moment of conception, complete with DNA that is distinct from that of either parent.

Any person who takes such a defenceless life is a murderer. Anyone who aids a person who engages in abortion or promotes abortion is an accessory to the murder. Kihika and her peers behind the wicked bill are thus not any better than terrorists, the blood-thirsty death merchants whose specialty is taking innocent lives.

Other than killing unborn children, abortion equally harms women mentally, emotionally, and physically, with some dying as a result of the act. Loss of fertility and an increase in miscarriages after an abortion are common results.

Why would a female leader, presumably in her right senses, sponsor such a deadly bill in the name of advocating for womens rights?

All women of dignity, and who value human life, have no option but to join hands with other Kenyans in stopping Kihika before its too late. They must make it clear that abortion is moral depravity that is unacceptable here.

From a religious perspective, our faith teaches us that murder is a grave sin and that one who approves of or promotes murder commits a grave sin. Doesnt this mean that anyone who votes for politicians who support abortion, the murder of defenseless children, also commits a grave sin?

The people of Nakuru must avoid partaking in this sin by voting out Kihika come 2022. Future generations will celebrate you for the decision you took.

The writer is Robert Mungai, a regular commentator on social, economic and political affairs.

The view expressed here are his and do not in any way represent the position of TUKO.co.ke

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We lost five children before our daughter Charisa came - Shinel Wanja | Tuko Talks | Tuko TV

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Opinion: Kenyans must reject Susan Kihikas Bill that proposes massacre of unborn children - Breaking NEWS in KENYA for Today Right Now & Kenyan...

Fourth Baby Born in 14 Months Using the Maternal Spindle Transfer Method as Part of Pilot Trial Conducted by the Institute of Life and Embryotools…

ATHENS, Greece, June 30, 2020 /PRNewswire/ -- Within 14 months from the birth of the first baby, three more babies have been born using the maternal spindle transfer method, as part of the pilot trial conducted by the scientific team of the Institute of Life and Embryotools in Greece.

The fourth baby was born at 10:40 am on June 20, 2020, at IASO Hospital, to a Greek mother with a long history of multiple IVF failures. Both the mother and the infant are in very good health.

Attending obstetrician/gynecology surgeon Dr. Georgios Pistofidis issued the following statement: "The greatest satisfaction for a doctor is to overcome complex medical issues. This woman had undergone six failed IVF cycles and four unsuccessful embryo transfers, while her embryos had never reached the blastocyst stage. In the context of the ongoing maternal spindle transfer pilot trial, she managed to give birth to a baby with her own genetic material during the very first embryo transfer."

In a joint statement, Dr. Nuno Costa-Borges, Co-Founder of Embryotools, and Mr. Eros Nikitos, Director of the IASO Institute of Life Embryology Lab, said: "A total of 25 women are participating in the pilot trial and 4 babies have already been born, which are being closely monitored based on a special pediatric protocol, and they are all well health-wise. Another pregnancy is at an advanced stage. We are very satisfied with the results so far. We keep processing the latest medical data arising from our pilot trial daily and significant scientific publications will follow shortly."

About the Maternal Spindle Transfer Pilot Trial

The maternal spindle transfer pilot trial involves mitochondrial replacement in human oocytes, fully preserving the genetic material of the woman who wants to reproduce. In this way, in the context of the pilot trial being carried out by the Institute of Life and Embryotools, the scientific team is researching the potential of addressing the problems of women with fertility issues and multiple IVF failures caused by cytoplasmic dysfunctions of their oocytes, and the potential of addressing serious mitochondrial diseases.

Important Note:

Births of children using the maternal spindle transfer method are performed in the context of an ongoing research protocol concerning a pilot trial that leads to pregnancy, which is conducted in accordance with the terms and conditions of Law 3305/2005. Based on current scientific findings, the maternal spindle transfer method is not an established infertility treatment, nor a recognized method of medically assisted reproduction.

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Fourth Baby Born in 14 Months Using the Maternal Spindle Transfer Method as Part of Pilot Trial Conducted by the Institute of Life and Embryotools...

How to safely deliver fertility treatments in the COVID-19 era: the controversy of guidelines – BioNews

29 June 2020

The Health Secretary's announcement on 1 May 2020 that fertility services in the UK could apply to reopen (see BioNews 1045) was a message of hope for all those who depend on fertility treatment for having a baby. Around the same time, various national and international scientific fertility societies published guidance on the 'safe' restart of the services during the coronavirus pandemic.

Fertility clinics in the UK had therefore the rather straightforward task of re-designing their practice protocols according to this COVID-19 guidance. Or perhaps this was not so straightforward?

As the medical director of a group of fertility clinics in the UK, I was assigned to design the new coronavirus-proof practice for my group. However, after starting to read the published guidelines, I soon realised that their recommendations were not as aligned as anticipated.

True, some of the recommended practice points were similar - mainly the use of social distancing and the use of personal protective equipment (PPE) by clinical staff. On the other hand, the guidelines approached the topic of testing for COVID-19 in their own different ways. For example, the European Society for Human Reproduction and Embryology (ESHRE) guidance recommended testing only for individuals who have symptoms or have had contact with someone with symptoms of COVID-19 infection, while the British Fertility Society and Association of Reproductive and Clinical Scientists (BFS-ARCS) advised to routinely test IVF patients for COVID-19, if a test is available.

When I investigated the availability of testing, I found out that indeed testing is available, but one had to research which tests are more reliable before deciding which one to go for. Moreover, the logistics of ordering the test, sending the sample to the laboratory and retrieving the result in time for the treatment had to be worked out.

I was so intrigued by the different approaches of the fertility guidelines, which prompted me to author an opinion paper about it, which has now been accepted in a reputable reproductive medicine journal.

Why is there such controversy among the guideline recommendations?

The inconsistencies in guidelines cannot be simply explained by geography. After all, these guidelines come from Europe (including the UK) and North America (USA and Canada), which have been experiencing similar challenges with coronavirus.

The answer is obvious; we simply do not know enough about the virus and we are still developing the relevant tests. More importantly, there is no experience how to best apply these tests in the fertility setting.

Guidance is, therefore, based mostly on expert opinion rather than scientific evidence.

It has to be acknowledged that fertility treatment is unique, in the sense that it lasts for a few weeks, during which one's good health needs to be continually re-affirmed. This is different to elective surgery, where a COVID-19 test can be scheduled just before admission.

One could hope to repeat the COVID-19 test every few days or before every visit to the fertility clinic. However, this is not practical for many reasons. The test often has to be outsourced to an external laboratory and inevitably takes at least a couple of days for the result to be available.

Testing introduces a substantial burden on the fertility services and staff resources, as well as an obvious financial burden for the paying party - whether this is the patient or the health authority.

Another concern has to do with the reliability of the test. No currently available test will pick up 100 percent of COVID-19 cases (current tests have approximately 70 percent sensitivity). This implies that, even if we performed the test repeatedly, we could still 'miss' some of the patients who carry the virus.

The absolute benefit of testing also has to do with how widespread the virus is in the community at any given point in time. At times of low infection rates, the chance of a COVID-19 test being positive is expected to be quite low.

Finally, there are other readily applicable measures, which help to reduce transmission (such as the social distancing and use of PPE); so, even if a patient carries the virus and doesn't know it, this does not mean they will definitely transmit it to others.

So, how should fertility clinics design their COVID-19 protocols for safety?

Until such time when enough experience has accumulated in the fertility sector, each clinic has to make its own decision how to go about it. Since there is no single full-proof test or intervention against coronavirus at the moment, combined measures are warranted. These measures should include social distancing when possible, PPE use, remote appointments, strict sanitation etc. Whether opportunistic COVID-19 testing should be part of the 'artillery' remains up to the individual clinic.

In my opinion, there are reasons for opting to apply more, rather than fewer, anti-COVID-19 measures at the restart.

Firstly, it is presumed to be safer to test, as doing a COVID-19 test can only detect more positive cases than not doing one. This will allow prompt cancellation of the treatment, thereby minimising the risk to others.

Secondly, testing allows the clinic to obtain important feedback on the usefulness of this approach, which could inform future policies. For example, if the test detects positive cases, it is obviously useful and should be continued (or even expanded). If, on the other hand, no positives are detected over a considerable number of sampled patients, this could make an evidence-based argument for discontinuing the test.

If a clinic chooses not to test, they can only learn the hard way, through trial and error; if they experience COVID-19 'clusters', their measures obviously allow enough COVID-19 cases to slip through (a 'cluster' is at least two positive individuals, patients or staff, who have had contact during the fertility treatment).

Other important metrics should also be internally monitored by clinics. The regional trends in infection rates as published by authoritative bodies - need to be regularly monitored. If the rates increase, it makes sense to tighten the anti-COVID-19 measures, which could include introducing - or re-introducing - a COVID-19 test.

Another important outcome to monitor is for the presence of clusters of positive cases within the same clinic. Clinics should be encouraged to report COVID-19 clusters that occur in their practice to the regulator - the Human Fertilisation and Embryology Authority (HFEA) - together with an action plan how they aim to minimise recurrence by strengthening their COVID-19 protocols.

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How to safely deliver fertility treatments in the COVID-19 era: the controversy of guidelines - BioNews

In the NGSS, a Dogmatic Standard on Evolution – Discovery Institute

Inaccurate teaching about evolution is widespread, as Jonathan Wellss review of textbooks shows. The 2013 Next Generation Science Standards (NGSS, which most states have adopted verbatim or used to inform their science standards, are one sided on the issue as well.

Ive recently been perusing Proficiency Scales for the New Science Standards: A Framework for Science Instruction and Assessment, by Robert J. Marzano and David C. Yanoski. Marzano is a big name in education. The Marzano Framework and the Danielson Framework are the two most prominent teacher evaluation models. Proficiency scales are frameworks that help teachers grade students according to a state standard, to measure their progress of learning.

This book provides proficiency scales for each of the NGSS. Proficiency scales are generally on a 4-point scale, with a score of 3 meaning meets standard. 2. A score of 4 means a student demonstrates in-depth inferences and applications that go beyond what was taught according to Marzano. Scores lower than 2 demonstrate partial success at 2, with or without teacher help.

Id like to examine the proficiency scale for one of the most dogmatic standards on evolution in the NGSS:

Communicate scientific information that common ancestry and biological evolution are supported by multiple lines of empirical evidence (for example, communicate orally, graphically, or textually to give evidence for common ancestry and biological evolution such as similarities in DNA sequences, anatomical structures, and the order of appearance of structures in embryological development and to explain how each line of evidence relates to common ancestry and biological evolution).

What does Marzano list for score 2.0 criteria? The student will:

(a) Recognize or recall specific vocabulary (for example, anatomical structure, biochemical characteristic, biological evolution, common ancestry, degree of kinship, development, DNA sequence, embryological, evidence for unity of life, order of appearance, origin of life, phylogenetics, shared characteristic, similarity, structure).

(b) Describe similarities in DNA sequences, anatomical structures, and order of appearance of structures in embryological development of various organisms.

(c) Describe the process of biological evolution.

Lets analyze each of these in turn. For (a) some of these vocabulary terms are a great choice, but some are somewhat complex to define (origin of life or biological evolution, for example). More importantly, there are issues with using phylogenetics and embryological development as evidence for common ancestry and biological evolution. Okay, (b). Jonathan Wells (Icons of Evolution, Zombie Science both address this) and others have written extensively on homology and embryology in the past and how they fail to support evolution. And (c). Well, scientists are still trying to figure out how to describe the process of biological evolution. A student performing below standard is supposed to be able to do this? And what specifically is the student to describe neo-Darwinian theory? Genetic drift? Evo-devo?

The Marzano proficiency scales are undoubtedly used by a myriad of science teachers. At least on evolution, thats contributing to inaccurate education.

Photo credit:Yustinus Tjiuwanda viaUnsplash.

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In the NGSS, a Dogmatic Standard on Evolution - Discovery Institute

Surrogacy and human rights – Anna Dannreuther – UK Human Rights Blog

26 June 2020 by Guest Contributor

In Re X (Parental Order: Death of Intended Parent Prior to Birth) [2020] EWFC 39 the Family Court read down section 54 of the Human Fertilisation and Embryology Act 2008 to enable a parental order to be granted where an intending parent died shortly before the childs birth. This ensured the childs Article 8 and 14 rights were protected, and prevented much emotional hardship for this family.

The case has already been cited in Re A (Surrogacy: s.54 Criteria) M [2020] EWHC 1426 (Fam) as comprehensively setting out when a court may read down the statutory criteria in section 54.

Parental orders an introduction

Section 54 of the Human Fertilisation and Embryology Act 2008 enables two people to apply for a parental order over a child who has been born as the result of a surrogacy arrangement. A parental order transfers legal parenthood from the legal parents at the time of the childs birth (usually the surrogate and if applicable her husband or civil partner) to the intended parents.

Parental orders are recognised as having a transformative effect on the legal relationship between the child and the [intended parents]. The effect of the order is that the child is treated as though born to the applicants. It has a clear implication as regards the right to respect for family life under Article 8. A v P [2011] EWHC 1738 (Family), per Munby J [24].

The Facts

In this case, Mr and Mrs Y had struggled to conceive their own children, having undergone several unsuccessful IVF treatments, including using eggs donated from a friend. They then considered surrogacy and eventually met Mr and Mrs Z with whom they entered into a surrogacy agreement. The agreement set out the intentions of the parties, including that Mr and Mrs Y would apply for a parental order after the birth of the child. The resulting embryo consisted of Mr Ys sperm and Mrs Zs egg. Mr and Mrs Y and Mr and Mrs Z became closer during the pregnancy and it remained all four of the parties intentions that Mr and Mrs Y become the legal parents of the child.

Tragically, five months into Mrs Zs pregnancy, Mr Y died of heart failure. This left open the question of whether and how Mr and Mrs Ys status as legal parents of the child could be recognised, given the requirements of the statute that two applicants make the application, amongst other things. The child, X, was born four months later. Mrs Y brought an application for a parental order on behalf of herself and her late husband.[1] In her supporting statement, she said:

It is incredibly important to me to apply for a parental order. It is not just for myself or for [Mr and Mrs Z] (who have never intended to be her legal parents), but because I want her to have the surname [Y] and to have her father recognised. It will break my heart for her, and him, if it is not possible for [Mr Y] to be put on her birth certificate The way [X] was conceived was all about love, and [Mr Y] is and always will be her daddy. I know, had he been here, that he would never have stopped talking about her, and she would have made him so proud. She deserves to have a parental order which recognises him as her father, and I hope that the court will find a way to make it possible.

Summary of the Law

Section 54 HFEA contains several requirements that must be fulfilled before a parental order can be granted. Those at issue were:

While the applicants would easily have satisfied the statutory requirements if Mr Y were alive, his untimely death frustrated the courts ability to find these criteria clearly fulfilled.

Both the lawyers for the applicants, Natalie Gamble, and for the court-appointed guardian for the child, Ruth Cabeza, argued that the court should read down section 54 to ensure Xs human rights were protected. They referred to section 3 of the Human Rights Act 1998, which obligates courts to read primary legislation in a way that is compatible with Convention rights so far as it is possible to do so.

Theis J acknowledged that in certain circumstances section 3 required courts to read in words which change the meaning of the enacted legislation, so as to make it Convention-compliant, per Lord Nicholls in Ghaidan v Godin-Mendoza [2004] All ER (D) 210 at [32].

The question in this case was whether reading section 54 to enable a parental order to be made in respect of an intending parent who died before the child was born went with the grain of the legislation, or whether the scale of what is proposed would go beyond any implication that could possibly be derived from reading the existing legislation (per Lord Nicolls and Lord Roger in Ghaidan v Godin-Mendoza [33],[115]).

Section 54 human rights read downs

Section 54 has been subject to numerous human rights read downs. In A v P [2011] EWHC 1738 (Fam), Theis J had previously found that section 54 could be read down to allow an application where an intended father had died after the application had been issued, but before the order was made. In so deciding, Theis J focused on the transformative nature of a parental order, recognising that no other order can give recognition to [the childs] status in the same transformative way as a parental order can, and that a parental order would protect the identity of [the child] and the family unit in accordance with Article 8.

Non-compliance with the six-month time limit for making an application was also held not to prevent a parental order being made in Re X (A Child) (Surrogacy: Time Limit) [2014] EWHC 3135 (Fam).

While in the 2015 case of Re Z [2015] EWFC 73, the court found it could not read down the two applicant requirement to allow a single applicant to apply, that was because Parliament has expressly contemplated and rejected the idea that single applicants could apply. A declaration of incompatibility was therefore made, and Parliament subsequently enacted the Human Fertilisation and Embryology Act 2008 (Remedial) Order 2018, permitting single applicants to apply.

Submissions

The advocates submitted that, unlike in Re Z, there was no evidence that Parliament has ever considered the possibility of an intended parent dying during a surrogacy pregnancy, or that such a person should be excluded from obtaining a parental order. They further relied on the Joint Committee on Human Rights (JCHR) June 2018 report on the draft remedial order responding to Re Z, allowing single applicants to apply for parental orders, which had emphasised:

It is difficult to see the policy justification for seeking to distinguish between these different situations, or for placing such difficult emotional decisions on people with such significant potential impacts.

The two-applicant rule, the JCHR found, seems to introduce a new version of discrimination based on a new category without any justification. The advocates submitted this clearly signalled that the will of Parliament now seeks to ensure the law does not discriminate against different categories of applicants for parental orders on the grounds of relationship status. Further submissions were made drawing on provisions in the Human Fertilisation and Embryology Act 2008, whereupon legal parenthood status is acquired from the date of transfer of the embryo or artificial insemination.

It was submitted that these considerations supported the notion that it would go with the grain of the legislation to enable X to have Mr Y registered on her birth certificate.

Judgment

Theis J found that Articles 8 and 14 of the ECHR were clearly engaged in this case. While X was not able to establish a family life with her biological father prior to his premature death, the court was required to protect her Article 8 right to recognition of her identity as the child of her deceased father. Theis J relied on Munby Ps comments on section 54 in Re X, where he said:

Section 54 goes to the most fundamental aspects of status and, transcending even status, to the very identity of the child as a human being: who he is and who his parents are. It is central to his being, whether as an individual or as a member of his family. [] This case is fundamentally about Xs identity and his relationship with the commissioning parents. Fundamental as these matters must be to commissioning parents they are, if anything, even more fundamental to the child. [] A parental order, like an adoption order, has an effect extending far beyond the merely legal. It has the most profound personal, emotional, psychological, social and, it may be in some cases, cultural and religious consequences. [] any application for a parental order implicates both the childs right to family life and also the childs right to private life.

Theis J also reiterated that Article 8 rights include the right to adequate legal recognition of biological and social ties (citing D, G v ED, DD, A, B [2015] EWHC 911 (Fam)). She noted that Xs birth certificate currently names an individual (Mr Z) with whom she has no connection as her father.

Article 14 was found to be engaged on the grounds that Xs Convention rights should be secured without discrimination of any ground, including birth or other status. Without a parental order, X is unable to have a birth certificate that reflects the relationship and connection she has with Mr and Mrs Y as her parents, solely because of the circumstances of her birth through surrogacy.

Theis J found that reading down the legislation does not go against the grain of the legislation. To the contrary it provides the order that best meets a child born as a result of this type of arrangement.

Furthermore, no other order can accurately and properly reflect Xs identity. A child arrangements order or special guardianship order would grant Mrs Y parental responsibility limited to Xs minority, but it would not negate Xs legal relationship with Mr and Mrs Z and would result in her biological father being a legal stranger to her. An adoption order could only be applied for by Mrs Y acting alone. A failure of the law to recognise Xs connection with her biological father (by not granting a parental order) would amount to a breach of her Article 8 and Article 14 rights.

Theis J therefore read down the statute to enable the section 54 requirements to be met where an applicant dies after the childs conception but prior to its birth, where they would have been met immediately prior to the death. The court also determined, in line with section 1 of the Adoption and Children Act 2002, that the order met Xs lifelong welfare needs.

This meant that the court did not need to consider the childrens guardians arguments about the applicability of section 1 of the Law Reform (Miscellaneous Provisions) Act 1934, and about whether that provision needed to be read down.

Comment

This is another instance of the Human Rights Act 1998 remedying a potentially large injustice for the family involved. As Theis J recognised, these were compelling facts. X had been living with Mrs Y since birth, who had provided her with a loving home, and her birth had been planned long ago by Mr and Mrs Y who intended to be her lifelong, loving parents. The surrogate parents, Mr and Mrs Z fully supported Mr and Mrs Y in becoming Xs parents.

The fact that Mr Z died shortly before Xs birth frustrated the applicants ability to comply with the technical requirements of section 54. However, their case clearly fell within the intended ambit of section 54 applicants, not least because they so clearly fulfilled the section 54 criteria prior to Mr Ys death. The court rightly had no problem finding that reading down in this context went with rather than against the grain of the legislation, which was to protect commissioning parents against the unfairness of not having their legal parenthood and the familys origins recognised in the form of a parental order.

Although this is a narrow development of the law, it is a nonetheless welcome one for those who find themselves in such tragic circumstances.

Anna Dannreuther is a pupil barrister at Field Court Chambers. She assisted Ruth Cabeza who acted for the childrens guardian in this case. This article represents the views of the author only.

[1] There was a legal question as to the method by which this could be achieved, which was ultimately resolved by the courts reading down of the legislation. See paragraphs [58], [97].

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Surrogacy and human rights - Anna Dannreuther - UK Human Rights Blog

Global In Vitro Fertilization Market Next Big Thing | Major Giants Groupe Clinique Ambroise Par, amedes MVZ Cologne GmbH, AMP Center St Roch, AVA…

Data Bridge Market Research has recently added a concise research on the Global In Vitro Fertilization Market to depict valuable insights related to significant market trends driving the industry. The report features analysis based on key opportunities and challenges confronted by market leaders while highlighting their competitive setting and corporate strategies for the estimated timeline. The development plans, market risks, opportunities and development threats are explained in detail. The CAGR value, technological development, new product launches and Industry competitive structure is elaborated.

Global In Vitro Fertilization Marketis expected to reach USD 847.8 billion by 2025, from USD 465.2 billion in 2017 growing at a CAGR of 10.0 % during the forecast period of 2018 to 2025. The upcoming market report contains data for the historic year 2016, the base year of calculation is 2017 and the forecast period is 2018 to 2025.

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Major Market Competitors/Players:Global In Vitro Fertilization Market

Some of the major players operating in global in- vitro fertilization market are Groupe Clinique Ambroise Par, amedes MVZ Cologne GmbH, AMP Center St Roch, AVA International Clinic Scanfert, Bangkok IVF center, Betamedics, Biofertility Center, Bloom Healthcare, Bourn Hall Fertility Center, , Cardone & Associates Reproductive Medicine & Infertility, The Center for Advanced Reproductive Services, Chelsea and Westminster Hospital NHS Foundation Trust, Cloudnine Fertility, Conceptions Reproductive Associates of Colorado, Cyprus IVF Centre, Dansk Fertilitetsklinik, EUVITRO S.L.U., , Lieff Cabraser Heimann & Bernstein, LLP, Fertility First, IVF Centers Prof. Zech, Flinders Reproductive Medicine Pty Ltd, Genea Oxford Fertility Limited, IVF Spain, IVI Panama, KL Fertility & Gynaecology Centre, Lifesure Fertility and Gynaecology centre, Manipal Fertility, , Medfem Fertility Clinic, Monash IVF, OVA IVF Clinic Zurich, Procrea, RAPRUI S.r.l., SAFE FERTILITY CENTER, SANNO HOSPITAL, SIRM Fertility Clinics, Stork IVF Klinik, ARC-STER S.r.l., The Montreal Fertility Center, Thomson Medical Centre, TRIO Fertility, Virtus Health, VivaNeo, Die Kinderwunsch and among others.

Global In Vitro Fertilization Market,By Product (Reagents, Equipment),Type of Cycle (Fresh Non-Donor IVF Cycles, Frozen Non-Donor IVF Cycles, Frozen Donor IVF Cycles, Fresh Donor IVF Cycles), End User (Hospitals & Research Laboratories, Cryobanks ),Geography (North America, South America, Europe, Asia-Pacific, Middle East and Africa) Industry Trends and Forecast to 2025

Competitive Analysis:

The global In- Vitro Fertilization market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of In- Vitro Fertilization market for global, Europe, North America, Asia Pacific and South America.

Key Developments in the Market:

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Market Definition:

In vitro fertilization is a procedure in which egg from women ovary are removed and after that the egg is fertilized with a sperm in a laboratory procedure, and then the fertilized egg is transfered into the women uterus. In vitro fertilization is used in the management of female infertility. In 2018, the Cooper Companies was announce that the Cooper Surgical acquired the assets of The Life Global Group and its affiliates which is a leading provider of invitrofertilization devices. In July 2018, Merck launched new product Geri Assess 2.0.This product is useful in automatic detection of embryo and blastocyst development, improving efficiency in assessment.

According to the Centre for Disease Control and Prevention in 2016, approximately 263,577 ART (Assisted Reproductive Technology) cycle was performed in US. As per the Human Fertilization and Embryology Authority in 2016, more than 68,000 IVF treatments were provided in U.K. In 2016 Birth rate from IVF has been increased to 85.0% in U.K. In 2016 around 20000 childrens were born by IVF. As per the published news IVF Success Rates For Fertility Clinics in the United States in 2016 and around 263,577 ART cycle was performed in U.S. Due to the increasing rate of infertility amongst the population, patients are opting the IVF Fertilization which is fuelling the growth of market.

Major Market Drivers and Restraints:

Market Segmentation:

The global In vitro fertilization market is segmented based on product, type of cycle, end user and geographical segments.

Based on product, the market is segmented into reagents, equipment.

Based on reagents, the market is further segmented into embryo culture media, cryopreservation media, sperm processing media, OVUM processing media.

Based on equipment, the market is further segmented into imaging systems, sperm separation systems, cabinets, OVUM aspiration pumps, incubators, micromanipulator systems, gas analysers, laser systems, accessories, cryo systems, anti-vibration tables, witness systems.

Based on type of cycle, the market is segmented into fresh non-donor IVF cycles, frozen non-donor IVF cycles, frozen donor IVF cycles, fresh donor IVF cycles.

Based on end user, the market is segmented into fertility clinics & surgical centers, hospitals & research laboratories, cryobanks.

Based on geography, the market report covers data points for 28 countries across multiple geographies namely North America & South America, Europe, Asia-Pacific and, Middle East & Africa. Some of the major countries covered in this report are U.S., Canada, Germany, France, U.K., Netherlands, Switzerland, Turkey, Russia, China, India, South Korea, Japan, Australia, Singapore, Saudi Arabia, South Africa and, Brazil among others

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Global In Vitro Fertilization Market Next Big Thing | Major Giants Groupe Clinique Ambroise Par, amedes MVZ Cologne GmbH, AMP Center St Roch, AVA...

Transgender women ‘should be allowed womb transplants so they can have own babies’ – Mirror Online

Transgender women should be entitled to womb transplant to enable them to have their own babies, according to a leading British surgeon.

Two years ago a woman in Brazil became the first mother to give birth to her child using a womb transplanted from a deceased donor to a woman.

It was a major breakthrough in fertility medicine when the little girl was born healthy and weighing 5.6lbs.

It comes just four years after the worlds first womb transplant baby from a live donor was born in Sweden in 2014.

Surgeon Christopher Inglefield, founder of the London Transgender Clinic, says a successful uterus implant into a trans-female is now achievable.

He says the procedure essentially identical to that of cis-women - aka females born in that gender.

Mr Inglefield, a specialist in gender confirmation surgery as well as facial and body feminisation, said: This pioneering birth is extremely important for any trans female who would like to carry her own child.

Because once the medical community accept this as a treatment for cis-women with uterine infertility, such as congenital absence of a womb, then it would be illegal to deny a trans-female who has completed her transition.

"There are clearly anatomical boundaries when it comes to trans women but these are problems that I believe can be surmounted and the transplant into a trans-female is essentially identical to that of a cis-female.

The Human Fertilisation and Embryology Authority (HFEA) confirm there are no regulations in place to prevent a trans woman who has received a uterus transplant from having IVF treatment.

And Mr Inglefield describes how a transplant would work.

He explained: "The most important step is the harvesting from the donor as great care is required to avoid damage to the arteries and veins supplying the uterus.

"The actual plumbing in is straight forward.

"The donor vessels are connected to the pelvic artery and veins which are the same in both males and females.

"With a uterus transplant in a trans-female, the neovaginal would be opened at the pelvic end to accept the donor womb.

"And the same procedure is used in a cis-female transplant with the donor uterus being attached to the native vagina.

Trans females have a much narrower pelvis than cis-women of the same height, but there would still be room for them to carry a child.

Supplemental hormones could be taken to replicate the changes that occur in the body when a woman is pregnant.

Meanwhile its highly unlikely that a trans female would give birth naturally, but would be delivered via Caesarian section in order to safeguard the child.

Other experts have also endorsed Mr Inglefields claims.

In November last year, Dr Richard Paulson, former president of the American Society for Reproductive Medicine, said there was no anatomical reason why a womb could not be successfully implanted into a transgender woman.

He added: "You could do it tomorrow. There would be additional challenges, but I dont see any obvious problem that would preclude it.

"I personally suspect there are going to be trans women who are going to want to have a uterus and will likely get the transplant.

Womb transplant surgery is being seen as a major cause for hope for those who suffer from Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome.

This is when a woman fails to develop a proper uterus and vagina yet has normal ovarian functions and normal external genitalia.

Women who have MRKH will still go on to develop breasts and pubic hair, but they will not have a menstrual cycle.

The syndrome is thought to affect around 1 in every 4,500 women.

But Mr Inglefield, who appeared in ITV's fly-on-the wall documentary Transformation Street, says the demand among trans women could be far greater.

He added: According to some estimates, the prevalence of transgender females in the UK could be as high as 1,000 per 100,000 persons, around 1 per cent of the population.

Just looking at the potential number of trans females who might seek uterine transplantation surgery and its abundantly clear it could become a vital medical service.

As it stands, trans women face a tricky pathway to motherhood, which is often achieved through surrogacy, adoption or fostering.

But those pathways are not without their own pitfalls and many would-be mothers simply long to carry their child, to be pregnant in the very real sense.

As womb transplant surgery is further improved and perfected, its vital trans women are not excluded from the conversation, at it could immeasurably improve a great many lives.

The Gender Recognition Act 2004 says that a trans female can apply for a Gender Recognition Certificate if they wish for their acquired gender to be legally recognised in the UK.

Applicants must go before a panel, documenting any treatments theyve had to change their sexual characteristics, such as hormone treatment or surgery.

They must have lived in their acquired gender for at least two years if single, or six years if married or in a civil partnership.

A spokesperson for the HFEA said: "I can confirm that to our knowledge there are currently no regulations in place which would prevent a person who has received a uterus transplant from having IVF treatment.

"The law, as it currently stands, does not require the person who is carrying a child to have obtained a GRC stating that they are female before having their fertility treatment.

And as stated in the Act the person who carries or has carried a child as a result of an embryo transfer, or artificial insemination, is considered as the mother of the child at birth."

The new test case, which has made headlines across the world, saw a 32-year-old woman born without a uterus given one taken from a 45-year-old donor who died from a brain haemorrhage.

The donor womb was implanted in a 10 hour surgery, which saw veins, arteries, ligaments and vaginal canals being connected.

And she then received fertilised eggs produced by IVF.

The birth took place in December 2017, but has only now been reported in journal The Lancet.

There have been 39 womb transplants across the world and of these, 11 babies born.

Until the Brazil transplant the surgery had failed 10 times.

The womb donor was a mum-of-three, who was in her mid-40s and died from bleeding on the brain.

Just six weeks after the surgery, the woman who received the womb started having periods.

Then, seven months later the eggs, which had been fertilised via IVF, were implanted in her womb.

Her baby was born by caesarean secion on December 15, 2017, and weighed 6lb.

Dr Dani Ejzenbery, from Hospital das Clicas in Sao Paulo, where the surgery was carried out, said: "The first uterus transplants from live donors were a medical milestone, creating the possibilty of childbirth for many infertile women with access to suitable donors and the needed medical facilities.

"However, the need for a live donor is a major limitation as donors are rare, typically being willing and eligible family members or close friends."

Imprial College London's Dr Srdjan Saso described the surgery as "extremely exciting".

The government equalities office estimates there are between 200,000 to 500,000 trans people in the UK.

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Transgender women 'should be allowed womb transplants so they can have own babies' - Mirror Online

A ‘quick and easy’ COVID-19 test developed for population-scale screening – News-Medical.Net

Reviewed by Emily Henderson, B.Sc.Jun 24 2020

Global endeavors to fight the Covid-19 pandemic heavily rely on accurate, fast and frequent tests for the coronavirus SARS-CoV-2 - "test, test, test", as the World Health Organization (WHO) has bluntly put it. Around the globe, the prevailing approach to diagnose acute infections is based on real-time qPCR, a method that amplifies and detects viral nucleic acid molecules in samples obtained from nose and throat swabs. However, qPCR requires sophisticated and expensive equipment and specialist staff to operate it - crucial drawbacks for example in remote or low-resource settings.

Scientists from the Vienna BioCenter and collaborators have now pushed an established nucleic acid detection assay to a new level. The so-called "Loop-mediated isothermal amplification (RT-LAMP)", first developed twenty years ago, is cheap, simple and quick - features that make it in principle an ideal alternative for routine SARS-CoV-2 detection. However, limited sensitivity and robustness have so far held back RT-LAMP-based assays from entering the center stage for SARS-CoV-2 diagnostics. The improvements introduced by the Viennese team overcome these challenges and make RT-LAMP a potential game-changer for population-scale screening approaches, especially in economically disadvantaged countries.

Starting with a 5-minute lysis step that "breaks open" cells and virus particles, RT-LAMP employs a simple reaction in which the viral RNA is converted into DNA and amplified billionfold within less than 30 minutes. The generation of such tremendous amounts of DNA can be directly observed with the naked eye by a visual colour change from purple to sky-blue in the reaction tube. Combining this method with a simple RNA enrichment step is at the heart of the newly developed method as it boosts sensitivity by orders of magnitude. Neither specialist laboratory equipment nor expert skills are needed - the most challenging step is to keep the sample at a stable temperature of approximately 63C during the 30 minutes of the reaction, a task that can - if necessary - be fulfilled by re-purposed kitchen devices.

Our method builds on existing protocols developed for pathogen detection. For SARS-CoV-2-detection, we managed to improve it to a level that matches qPCR-like sensitivity on crude patient samples. We are extremely excited and can barely wait to see it applied. We expect that these improvements, including the ability to perform pooled screening, will make a real difference not only in developing countries, but in low-resource environments anywhere in the World. Sensitive, affordable and rapid SARS-CoV-2 screening and diagnostics approaches are much needed now."

Julius Brennecke of the Institute of Molecular Biotechnology (IMBA) of the Austrian Academy of Sciences

"The way this whole project unfolded is rather exceptional," says Andrea Pauli of the Research Institute of Molecular Pathology (IMP). "It started off as a crazy idea, triggered by our believe that as scientists we must act to help in the current pandemic. Through a remarkable coincidence, Max Kellner, an Austrian PhD student at the institute LMB in Cambridge who had prior experience with isothermal amplification methods, got stranded in his hometown Vienna during the lockdown. When we found out, we teamed him up with Vienna BioCenter PhD students Julian Ross and Jakob Schnabl. And so, two groups, normally working on Drosophila oogenesis and zebrafish embryology, came together and set foot in a new field. An exceptional level of team spirit and enthusiasm allowed us to push this project much further than we had ever envisioned and made it a once in a life-time experience for everyone involved."

IMP and IMBA are members of the Vienna BioCenter, and the breakthrough is testimony to the fruitful and collaborative spirit this campus is known for. The lockdown period boosted these synergistic activities in an unprecedented manner across labs and institutes. While normal research activities have returned to the labs by now, scientists across campus continue to contribute their time and expertise to combat the outbreak of the Covid-19 pandemic. As part of the VCDI (Vienna Covid-19 Diagnostics Initiative) they work jointly on questions that open the door for applications which could benefit millions of people around the world.

The study underlying this news item will be uploaded to the preprint service bioRxiv, where it is expected to become available soon.

Link:
A 'quick and easy' COVID-19 test developed for population-scale screening - News-Medical.Net