Angelica Cheng
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English translation of the following Chinese article:
Third-generation IVF treatment, an expensive, risky and unnecessary gamble for infertile couples in Singapore?
The incidence of infertility in Singapore is on the rise due to the increasing trend of late marriages and advanced childbearing. A woman's fertility declines drastically after the age of thirty-five, as the number of live eggs in the ovaries rapidly decreases as menopause approaches. In addition, it is well known that the incidence of births with genetic abnormalities, especially Down's Syndrome, continues to rise as maternal age increases.
In Chinese culture, congenital disabilities such as Down's syndrome might be seen as a burden to the family, society and the nation. Therefore, there is a high demand for genetic testing among anxious couples undergoing assisted reproductive treatment to avoid births with genetic abnormalities such as Down syndrome. Non-invasive prenatal testing (NIPT) after conception is not satisfactory as it may require abortion of genetically abnormal fetuses, which entails emotional trauma and medical risks.
As a result, many assisted reproduction clinics around the world offer third-generation IVF treatments that involve genetic testing of embryos prior to transfer to the uterus. This procedure is known as pre-implantation aneuploidy genetic testing (PGT-A) or pre-implantation genetic screening (PGS) of embryos.
A fairly convincing marketing argument is that it may be wiser to make a small additional investment in genetic testing to avoid the potential trauma of terminating a fetus with a genetic abnormality, or worse, to spend more money on meeting the educational and healthcare needs of a child with Down syndrome.
Another clever marketing ploy is the intentional distortion of statistics to exaggerate the risk of birth defects in older women, especially the concept of “relative risk”. For example, the prevalence of Down syndrome is 0.1% among women in their mid-twenties, 1.0% among women in their thirties, and 3.0% among women in their early forties. A common “scare” tactic in healthcare marketing is to claim that the risk of Down syndrome increases tenfold as women approach their thirties and thirtyfold in their early forties. Thus, it is easy for patients with a relatively shallow knowledge of statistics to exaggerate the risk of Down syndrome simply through subtle manipulation of words and numerical data.
To promote this genetic testing technique, foreign assisted reproduction clinics may be careful to tell patients that they can secretly choose the sex of their babies, even though sex selection for social reasons may be prohibited or discouraged in their national jurisdictions.
In Singapore, however, genetic testing of IVF embryos is severely restricted. This is not a routine clinical service but is largely restricted to clinical trials in government hospitals and is not available in private assisted reproduction centers. Currently, the embryo genetic testing procedure is only available to women aged 35 years and above, or those who have undergone more than two failed in vitro fertilization attempts or more than two recurrent miscarriages, regardless of age.
As a result, many infertile Singaporean couples are travelling overseas for third-generation IVF treatment. This is an alarming trend as these patients are unaware of the latest scientific and clinical data proving the numerous flaws and pitfalls of the 3rd generation IVF technique. As the old saying goes, there is no smoke without fire. If the third generation IVF technique is really that good and effective, why is the Singapore Ministry of Health so severely restricting this technique?
In fact, the latest statements and actions of reputable professional organizations and medical regulators in the UK and the US have cast some doubt on the third generation IVF technology. For example, the UK's Human Fertilization and Embryology Authority (HFEA) has given IVF a “red light”, reflecting concerns about misdiagnosis and a lack of conclusive evidence of improved conception rates. Similarly, the American Society for Reproductive Medicine (ASRM), after reviewing 20 years of available clinical data, concluded that IVF III does not improve pregnancy rates and its effectiveness in reducing the risk of clinical miscarriage is unclear.
In addition, Singapore patients must also be wary of ongoing class action lawsuits in the United States against third-generation IVF technology, which has been recognized as the most visible and widespread case of fraud in the field of assisted reproduction. The lawsuits, initiated by various law firms including Berger Montague LLC, Constable Law LLC and Justice Law Collaborative LLC, are targeting a number of genetic testing companies, including CooperGenomics Inc, CooperSurgical Inc, The Cooper Companies Inc, Reproductive Genetic Innovations LLC, Progenesis Inc and Natera Inc.
In a similar lawsuit in Australia, Monash IVF Fertility agreed to pay $56 million to compensate 700 former IVF patients whose viable embryos were destroyed as a result of a misdiagnosis of a third-generation IVF technique that may have robbed many of their lives. These IVF patients had a chance to become parents.
It is therefore necessary to understand the various drawbacks and pitfalls of the third generation IVF technique and why it is so strictly regulated by the Singapore Ministry of Health.
First and foremost, patients must be aware that genetic screening may damage their embryos. The technique is highly invasive and requires biopsy of some of the cells in the embryo. This can cause some damage to the embryo and can impair its developmental potential.
Experts point out that studies claiming that genetic testing of embryos has no adverse effects are often based on testing good, high-quality embryos rather than more “fragile”, low-quality embryos that may suffer more. Since older women tend to have weaker, lower quality embryos, these embryos may be more susceptible to damage during testing.
Second, genetic testing is prone to misdiagnosis, which can lead to patients discarding viable embryos capable of producing healthy babies. This is because the test only takes cells from the ectodermal layer that produces the placenta and umbilical cord, which does not represent the endodermal layer that produces the baby itself.
“Mosaic embryos” (mosaic embryos), which contain a mixture of genetically normal and abnormal cells, have been shown to have the ability to self-correct and produce healthy babies. This “self-correcting” mechanism involves pushing genetically abnormal cells out of the ectodermal layer to form the placenta and umbilical cord.
Women of advanced age have a limited number of embryos during assisted reproduction therapy. Therefore, excluding or discarding mosaic embryos, which have the potential to produce normal babies, will greatly reduce the chances of successful in vitro fertilization. Some advanced assisted reproduction therapy patients may have no embryos remaining for transfer after genetic testing.
Finally, several large-scale clinical trials have shown that embryo genetic testing does not improve pregnancy rates. in 2019, a large multicenter randomized clinical trial involving 34 assisted reproduction clinics in the U.S., Canada, the U.K., and Australia, including 661 patients between the ages of 24 and 40 years old, found no significant difference in the overall improvement in pregnancy rates with embryo genetics. in 2021 , another large clinical trial in China involving 14 assisted reproduction clinics with a total of 1,212 patients between the ages of 20 and 37 reported similar unfavorable results, which were published in the prestigious New England Journal of Medicine.
As a result, serious doubts have been cast on the medical benefits of the third generation IVF technique based on the latest scientific and clinical data. Singaporean patients should therefore be cautious about using this technology, which is severely restricted in their home country, when traveling abroad.
The incidence of infertility in Singapore is on the rise due to the increasing trend of late marriages and advanced childbearing. A woman's fertility declines drastically after the age of thirty-five, as the number of live eggs in the ovaries rapidly decreases as menopause approaches. In addition, it is well known that the incidence of births with genetic abnormalities, especially Down's Syndrome, continues to rise as maternal age increases.
In Chinese culture, congenital disabilities such as Down's syndrome might be seen as a burden to the family, society and the nation. Therefore, there is a high demand for genetic testing among anxious couples undergoing assisted reproductive treatment to avoid births with genetic abnormalities such as Down syndrome. Non-invasive prenatal testing (NIPT) after conception is not satisfactory as it may require abortion of genetically abnormal fetuses, which entails emotional trauma and medical risks.
As a result, many assisted reproduction clinics around the world offer third-generation IVF treatments that involve genetic testing of embryos prior to transfer to the uterus. This procedure is known as pre-implantation aneuploidy genetic testing (PGT-A) or pre-implantation genetic screening (PGS) of embryos.
A fairly convincing marketing argument is that it may be wiser to make a small additional investment in genetic testing to avoid the potential trauma of terminating a fetus with a genetic abnormality, or worse, to spend more money on meeting the educational and healthcare needs of a child with Down syndrome.
Another clever marketing ploy is the intentional distortion of statistics to exaggerate the risk of birth defects in older women, especially the concept of “relative risk”. For example, the prevalence of Down syndrome is 0.1% among women in their mid-twenties, 1.0% among women in their thirties, and 3.0% among women in their early forties. A common “scare” tactic in healthcare marketing is to claim that the risk of Down syndrome increases tenfold as women approach their thirties and thirtyfold in their early forties. Thus, it is easy for patients with a relatively shallow knowledge of statistics to exaggerate the risk of Down syndrome simply through subtle manipulation of words and numerical data.
To promote this genetic testing technique, foreign assisted reproduction clinics may be careful to tell patients that they can secretly choose the sex of their babies, even though sex selection for social reasons may be prohibited or discouraged in their national jurisdictions.
In Singapore, however, genetic testing of IVF embryos is severely restricted. This is not a routine clinical service but is largely restricted to clinical trials in government hospitals and is not available in private assisted reproduction centers. Currently, the embryo genetic testing procedure is only available to women aged 35 years and above, or those who have undergone more than two failed in vitro fertilization attempts or more than two recurrent miscarriages, regardless of age.
As a result, many infertile Singaporean couples are travelling overseas for third-generation IVF treatment. This is an alarming trend as these patients are unaware of the latest scientific and clinical data proving the numerous flaws and pitfalls of the 3rd generation IVF technique. As the old saying goes, there is no smoke without fire. If the third generation IVF technique is really that good and effective, why is the Singapore Ministry of Health so severely restricting this technique?
In fact, the latest statements and actions of reputable professional organizations and medical regulators in the UK and the US have cast some doubt on the third generation IVF technology. For example, the UK's Human Fertilization and Embryology Authority (HFEA) has given IVF a “red light”, reflecting concerns about misdiagnosis and a lack of conclusive evidence of improved conception rates. Similarly, the American Society for Reproductive Medicine (ASRM), after reviewing 20 years of available clinical data, concluded that IVF III does not improve pregnancy rates and its effectiveness in reducing the risk of clinical miscarriage is unclear.
In addition, Singapore patients must also be wary of ongoing class action lawsuits in the United States against third-generation IVF technology, which has been recognized as the most visible and widespread case of fraud in the field of assisted reproduction. The lawsuits, initiated by various law firms including Berger Montague LLC, Constable Law LLC and Justice Law Collaborative LLC, are targeting a number of genetic testing companies, including CooperGenomics Inc, CooperSurgical Inc, The Cooper Companies Inc, Reproductive Genetic Innovations LLC, Progenesis Inc and Natera Inc.
In a similar lawsuit in Australia, Monash IVF Fertility agreed to pay $56 million to compensate 700 former IVF patients whose viable embryos were destroyed as a result of a misdiagnosis of a third-generation IVF technique that may have robbed many of their lives. These IVF patients had a chance to become parents.
It is therefore necessary to understand the various drawbacks and pitfalls of the third generation IVF technique and why it is so strictly regulated by the Singapore Ministry of Health.
First and foremost, patients must be aware that genetic screening may damage their embryos. The technique is highly invasive and requires biopsy of some of the cells in the embryo. This can cause some damage to the embryo and can impair its developmental potential.
Experts point out that studies claiming that genetic testing of embryos has no adverse effects are often based on testing good, high-quality embryos rather than more “fragile”, low-quality embryos that may suffer more. Since older women tend to have weaker, lower quality embryos, these embryos may be more susceptible to damage during testing.
Second, genetic testing is prone to misdiagnosis, which can lead to patients discarding viable embryos capable of producing healthy babies. This is because the test only takes cells from the ectodermal layer that produces the placenta and umbilical cord, which does not represent the endodermal layer that produces the baby itself.
“Mosaic embryos” (mosaic embryos), which contain a mixture of genetically normal and abnormal cells, have been shown to have the ability to self-correct and produce healthy babies. This “self-correcting” mechanism involves pushing genetically abnormal cells out of the ectodermal layer to form the placenta and umbilical cord.
Women of advanced age have a limited number of embryos during assisted reproduction therapy. Therefore, excluding or discarding mosaic embryos, which have the potential to produce normal babies, will greatly reduce the chances of successful in vitro fertilization. Some advanced assisted reproduction therapy patients may have no embryos remaining for transfer after genetic testing.
Finally, several large-scale clinical trials have shown that embryo genetic testing does not improve pregnancy rates. in 2019, a large multicenter randomized clinical trial involving 34 assisted reproduction clinics in the U.S., Canada, the U.K., and Australia, including 661 patients between the ages of 24 and 40 years old, found no significant difference in the overall improvement in pregnancy rates with embryo genetics. in 2021 , another large clinical trial in China involving 14 assisted reproduction clinics with a total of 1,212 patients between the ages of 20 and 37 reported similar unfavorable results, which were published in the prestigious New England Journal of Medicine.
As a result, serious doubts have been cast on the medical benefits of the third generation IVF technique based on the latest scientific and clinical data. Singaporean patients should therefore be cautious about using this technology, which is severely restricted in their home country, when traveling abroad.
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