Position Statements 

The Canadian Fertility and Andrology Society offers the following statement, providing additional perspectives and information to support its Position Statement on Compensation for Third Party Reproduction in Canada issued in May 2017.

Overview:

Legalization of compensation for gamete (egg and sperm) donors and surrogates is an important issue that warrants priority consideration. Current federal legislation, introduced in 2004, has failed in its stated goals of protecting health, safety and rights and has put Canadians at risk. Prohibiting compensation has created a significant roadblock for prospective parents who face fertility challenges as they seek to build their families.

• The Assisted Human Reproduction Act, 2004 (Sections 6 and 7) prohibits payments to gamete donors and surrogates with severe penalties for contravening the Act. Reimbursement for direct expenses related to donation or surrogacy is allowed.
• The legislation has failed to meet its guiding principles: protection of health and well-being of women, and protecting the health, safety and rights of all involved.

Implications for Canadians:

Prospective parents who require donor sperm, donor eggs or a surrogate are forced into difficult and risky situations. They face shortages and long wait times: few individuals are willing to altruistically donate or act as surrogates without payment. Some resort to the unregulated and precarious Canadian underground market with no protection for either party. In some cases, expensive cross border purchases are pursued, forgoing control and ability to safeguard medical information. Canadians need accessible and reliable care in Canada.

• Reproductive services, including donated sperm and egg and surrogacy, can be necessary for infertile men and women, cancer survivors, those who carry severe inherited genetic disorders, same sex couples, and single men and women.
• Members of the LGBTQ community are disproportionately affected by the law, as each member must enlist the help of a third party to build their family.
• Sperm from Canadian sources is limited with only one sperm bank operating in Canada.
• Egg donation is particularly onerous, involving hormonal treatment and medical care, limiting willing donors. Likewise, few are willing to act as surrogates without compensation.
• In Canada, an underground “grey market” for these services has emerged, sometimes operating online, including on social media, involving private financial arrangements without regulation or protection for either party.
• While payment for sperm and eggs is illegal in Canada, gametes are regularly imported from foreign countries where compensation is legal. This route is unnecessarily expensive with lack of control over the process and no safeguarding of information as might be useful for future access to medical history on behalf of the children born through these technologies.

Support for review and reform:

Member of Parliament Anthony Housefather (Liberal Mount Royal), an active proponent of decriminalization, proposes to introduce a Private Member’s Bill to this effect. This important issue warrants full discussion and support by policy makers. Eliminating criminal penalties and making way for appropriate protection of Canadians is in the best interests of everyone, including any children born using third party reproduction. Following decriminalization, an appropriate regulatory framework must be developed through consultation, including registries and protection of all parties.

• The anticipated Private Member’s Bill proposes to amend the Assisted Human Reproduction Act, removing the prohibition on payment for gamete donation and surrogacy.
• Decriminalization of compensation for these types of reproductive services is broadly supported, including among prospective parents, gamete donors, surrogates, patient organizations and the professionals who care for them. Canadians support the fundamental premise that building a family should not carry a criminal penalty.

Right to Family

Canadian Fertility and Andrology Society promotes the development and delivery of reproductive technologies that help Canadians build their families.  Provision of these services should be blind to gender, race, family status and sexual orientation.  As health professionals and experts in the field of reproductive medicine our members have a duty to foster healthy pregnancies and offspring, and to advocate for the availability of safe and effective fertility services for all Canadians.

Although the phrasing reflects the societal values of the time, the United Nations General Assembly Universal Declaration of Human Rights (1948) outlines basic human right to a family:

“Men and women of full age, without any limitation due to race, nationality or religion, have the right to marry and to found a family.”

“The family is the natural and fundamental group unit of society and is entitled to protection by society and the State.”

The Constitution of Canada and section 15 of the Canadian Charter of Rights and Freedoms (1986) guarantees that every individual is equal before and under the law and has the right to equal protection and equal benefit of the law without discrimination.  Equal rights irrespective of sexual orientation were finally established through Civil Marriage Act (2005) and Human Reproduction Act (2004).

Most Canadians have physical access to facilities providing a high level of fertility care; however, public funding for these services is not uniform across Canada.  Unlike most developed countries, we restrict access to care through inadequate funding.  Patients in need of gamete donation and gestational surrogacy are also limited by a lack of individuals willing to provide these services on an altruistic basis, as required by the Assisted Human Reproduction Act (2004).  We strongly believe that an adequate level of funding for fertility treatments and an appropriate system for compensation of individuals willing to provide third party reproduction services, will provide Canadians suffering from infertility the opportunity to start a family.

Canadian Fertility and Andrology Society Endorses C David Naylor Report on Strengthening the Foundations of Canadian Research.

The Canadian Fertility and Andrology Society (CFAS), the voice of researchers in the field of reproductive medicine in Canada, strongly supports the findings of Canada’s Fundamental Science Review released by C David Naylor in April 2017. The Report is a much-needed declaration of the importance of fundamental research in Canada given the current flat-lining of research funds and widespread loss of confidence in the Canadian scientific funding mechanism. The CFAS agrees that the recommendations laid out in the report are vital for the future of Canada’s place in global health care.

Developments at the Canadian Institutes of Health Research (CIHR), Canada’s principal source of funds for medically-related science research, have increasingly placed an overwhelming focus on commercialization, with far too little emphasis on the value of fundamental scientific enquiry. However, clinical advances are often dependent on achievements in basic research and there is a long history of fundamental research leading to critical advances in reproductive medicine and assisted reproduction. One of many examples is the culture media used in today’s clinical IVF treatments that was developed as a result of many years of empirical basic research performed using oocytes and embryos from animal models. The CFAS thus strongly agrees with Dr Naylor that, “neglecting basic science owing to impatience or uncertainty contradicts much of the historical evidence.”

Canada is at the forefront of fundamental research in the area of reproductive medicine, with world leading laboratories publishing cutting-edge research in the areas of gametogenesis, fertilisation, and embryo development and differentiation, to name but a few. By following through on the recommendations of the Naylor Report, we will have the opportunity to maintain our leadership in this field of science and medicine. The CFAS membership comprises both basic scientists and clinicians focused on reproductive biology. AS such, we have a long track-record of fostering collaboration at scientists and clinicians, thus maximising the likelihood of frontline discoveries being translated into clinical progress. CFAS does not position itself to ‘compete’ with other fields of research, but rather wholeheartedly supports an increase in basic science funding across all biomedical disciplines.

CFAS strongly endorses the sentiment of the Naylor Report finding that investigator-led operating grants be given the highest priority, as important discoveries arise when talented scientists are trusted to form and test their hypotheses. Moreover, CFAS welcomes the observation that further aid for early career researchers is essential. Canada has a rich vein of talented young scientists with focus on basic and applied reproduction, and whose ability to flourish is currently under threat at the hands of low grant success rates. By re-investing in fundamental research, we mitigate the risk of losing some of the smartest minds in our field.

We conclude that the report is well considered, timely, and has the potential to leave a lasting positive impact of Canadian scientific research. This, in turn, will have far-reaching impact upon health care and the broader economy. Canada must bring investments in front-line research back in line with other G7 countries so that it can be competitive and at the forefront of science and innovation. We applaud Minister Duncan for launching this enquiry, and now encourage the Federal Government to adopt the findings of the Naylor Report. The Canadian Fertility and Andrology Society would be honoured to participate in any way that might aid its implementation.

Compensation for Third Party Reproduction in Canada

Current federal law in Canada, as described under Sections 6 and 7 of the Assisted Human Reproduction Act, 2004 (AHRA), prohibits the purchase of eggs and sperm, from donors or anyone acting on behalf of donors, the purchase or sale of embryos, and payment of a fee to a surrogate. In all cases, reimbursement of expenses is permitted with receipts. However, exactly what expenses are allowed is still under consideration by Health Canada. In the meantime, penalties for contravening the Act are severe, amounting to a maximum fine of $500,000 or imprisonment for up to 10 years.

The prohibitions and associated criminal penalties of the AHRA have severely limited the number of donors and gestational surrogates available to Canadians in need. Those in need include infertile men and women, cancer survivors, individuals who carry severe or even fatal genetic disorders who wish to break the chain of inheritance, same sex couples and single men and women. As a consequence of the law, many Canadians either wait indefinitely for an opportunity that may never come or resort to other means such as cross border reproductive tourism, sometimes incurring risks that are out of the control of Canadians and the Canadian healthcare system. Many pay for and import donor gametes from foreign countries where compensation is legal.

The Canadian Fertility and Andrology Society believes that maintaining the status quo is simply not an option. In the thirteen (13) years since the Act came into law many advances in assisted reproductive technologies (ART) have occurred and society has become more comfortable with third party reproduction along with non-traditional family building. As a leading liberal democracy, our laws must keep pace with advances in science and society. Today, the medicine and technology exist to safely offer the opportunity for these Canadians to found a family – a basic human right as articulated in the 1948 United Nations General Assembly Universal Declaration of Human Rights.

The Canadian Fertility and Andrology Society proposes that the Government of Canada amends the AHR Act to permit reasonable compensation for gamete donors and surrogates. Allowing reasonable compensation helps prevent abuses, ensures fairness and transparency, and improves access to care for those seeking third party reproduction. If conducted under clear, evidence based Canadian standards of care with the health and safety of the donors, surrogates, and intended parents in mind, a viable system of compensation for third party reproduction can be developed in Canada. Canadians have waited far too long for the government to act while thousands of Canadians suffer the consequences of a law that limits their ability to create a family.

Use of Letrozole for the Management of Infertility

Clomiphene citrate (Clomid™ and Serophene™) is a trusted medication for the management of ovulatory disorders such as polycystic ovarian syndrome (PCOS). Clomiphene citrate is presently the only oral fertility medication approved by Health Canada, and is the main medical fertility treatment prescribed by family physicians and obstetricians/gynaecologists. Recently, the only manufacturer of clomiphene citrate discontinued its production and unless other suppliers emerge the world-wide supply will be exhausted later this year.

Letrozole (Femara™) is an effective oral ovulation induction agent and appears to be more effective than clomiphene citrate for achieving live birth in patients with ovulatory disorders[1] . For many fertility specialists, letrozole is the first-line treatment for the management of ovulatory infertility. For the management of unexplained infertility both clomiphene citrate and letrozole appear to be equally effective, but less effective than gonadotropin-based treatments[2,3]. However, as a low risk, low cost, oral medication, we expect that the demand for letrozole will increase dramatically as the supply of clomiphene citrate depletes.

Letrozole has been used as an ovulation induction agent since 2000 with a growing body of evidence for its use. However many physicians are reluctant to prescribe it due to a statement issued by the manufacturer Novartis on November 17th, 2005, warning against its use in premenopausal women due to the potential for fetal toxicity and malformation (Femara_DHCP_E_2005_Nov.pdf). This formal statement was prompted by a single abstract presented at the CFAS-ASRM annual meeting in 2005[4]. One hundred fifty babies resulting from the use of letrozole born from couples with unexplained infertility or PCOS were compared to a database of over 36,000 normal deliveries. The abstract reported no difference in the overall rate of all malformations, but reported an increase in locomotor and cardiac malformations in the babies born after letrozole treatment. Beyond the small size of the study group, this comparison is limited because infertility itself is a significant risk factor for fetal malformations and the controls were babies born to normally fertile couples. This study was never published, and larger published cohort studies have since demonstrated no increased risk of malformations after letrozole use[5-7].

Over a decade of clinical use and scientific observations demonstrate the safety and efficacy of letrozole in the management of infertility. Therefore, the CFAS supports the use of letrozole for the treatment of ovulatory dysfunction and unexplained infertility, after an appropriate infertility work-up and under the care of a physician educated in its use.

References

1. Legro et al. Letrozole versus clomiphene for infertility in the polycystic ovary syndrome. N Engl J Med 2014;371:119-29.
2. Diamond et al. Letrozole, Gonadotropin, or Clomiphene for Unexplained Infertility. N Engl J Med 2015;373:1230-1240.
3. Liu et al. Letrozole versus clomiphene citrate for unexplained infertility: a systematic review and meta-analysis. J Obstet Gynaecol Res 2014;40:1205-16.
4. Biljan et al. The outcome of 150 babies following the treatment with letrozole or letrozole and gonadotropins. Fertil Steril 2005;84(Supp 1):S95.
5. Sharma et al. Congenital malformations among babies born following letrozole or clomiphene for infertility treatment. PLoS One 2014;9(10):e108219.
6. Tatsumi et al. No increased risk of major congenital anomalies or adverse pregnancy or neonatal outcomes following letrozole use in assisted reproductive technology. Hum Reprod. 2017 Jan;32(1):125-132.
7. Tulandi et al. Congenital malformations among 911 newborns conceived after infertility treatment with letrazole or clomiphene citrate. Fertil Steril 2006;85:1761-5.

New and Experimental Treatments for Assisted Reproductive Technology (ART)

A new procedure or technology to be introduced into ART treatment shall be considered experimental if:

1. it is not already in common clinical use and part of established medical practice, and
2. it is more than an incremental modification of current procedures, and
3. there is insufficient published evidence in the peer-reviewed literature to demonstrate that the procedure is both safe and effective.

It is the CFAS position that:

an experimental procedure should not be offered or advertised as a treatment outside of a research protocol,

and

research involving experimental procedures in clinical ART settings must be part of a well-designed study that aims to gain knowledge about the procedure’s efficacy or safety or to answer other valid research questions.

In addition, counselling that specifies that the procedure is experimental should be provided, and informed consent must be obtained using a form that specifies clearly that the procedure is experimental.

Finally, the introduction of experimental procedures or technologies must be carried out with appropriate protections for research participants in accordance with the policies in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans” (TCPS2, 2014, http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2- eptc2/Default/, as updated) and in accordance with a duly constituted Research Ethics Board (REB).

Reporting of IVF Outcomes

In vitro fertilization (IVF) is an effective treatment for many causes of infertility. While high quality IVF services are provided by clinics across Canada, there are many different ways to present IVF success rates. To assist patients as they make informed decisions about their care and in the interest of transparency, the Canadian Fertility and Andrology Society (CFAS) believes that each centre should present outcome data to the public in a form that is clear and easy to understand.

For more than a decade, almost all Canadian IVF centres have voluntarily reported their IVF outcomes to a national registry. Initially, this was called CARTR (the Canadian Assisted Reproductive Technology Registry). CARTR has recently agreed that BORN (the Better Outcomes Registry and Network) Ontario would administer the registry as the CARTR-BORN collaboration.

The CARTR-BORN collaboration produces a national report that is presented each year at the CFAS annual meeting[1]. That report organizes the data by patient age (<35, 35-39, 40+), the type of treatment performed (fresh cycles, frozen-thaw cycles, donor egg cycles, etc.), and the denominator used (cycles started or embryo transfer). Only aggregate data, not data for individual centres, is publicly presented in CARTR-BORN[1].

To allow patients to make well-informed decisions, it is the CFAS position that all Canadian IVF centres should adopt the CARTR-BORN framework for presentation of any IVF outcome data that they wish to share with their patients and the public:

• Use the internationally-accepted definitions specified by the International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO)[2]
• Explicitly state the definition of pregnancy used
• Report the exact time period to which the data refers and the number of cycles involved
• Present both fresh and frozen-thaw cycles separately and present the results per cycle start
• Divide patients into the CARTR-BORN age groups (<35, 35-39, 40+) and report the number of cycles in each group
• Separate reports on patients using their own eggs from those using donor eggs
• If CARTR-BORN national averages are used then include the most recent CARTR data.

1 Gunby (2014) Assisted reproductive technologies in Canada: 2012 results from the Canadian ART register.

http://www.cfas.ca/index.php?option=com_content&view=article&id=1076&Itemid=668

2 Zegers-Hochshild et al. (2009) The International Committee for Monitoring Assisted Reproductive Technology (ICMART) and World Health Organization (WHO) revised glossary on ART terminology. Hum. Reprod. 24: 2683-2687.

United Kingdom Decision Regarding Mitochondrial Donation

The CFAS Board of Directors supports the UK decision to allow mitochondrial donation for women with inherited, incurable mitochondrial DNA mutations. The CFAS recognizes that the UK plans to introduce this experimental protocol in a few carefully selected centers with strict eligibility criteria and careful follow-up of patients and their offspring. The CFAS applauds the responsible manner in which the UK has sought expert advice and public consultation before proceeding with this initiative.

The Case for Public Funding of In Vitro Fertilization (IVF) with Elective Single Embryo Transfer (eSET) in Canada

According to the World Health Organization (WHO) infertility is a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse.

In Canada, infertility impacts the lives of 10 to 15 per cent of reproductive age couples, and results in considerable psychological distress including low self-esteem, depression, diminished well-being, and feelings of sexual inadequacy and isolation.

Provincial and territorial health plans currently cover the cost of the investigation of infertility, confirming that they recognize infertility as a legitimate medical condition. However, too many jurisdictions do not pay for even the most basic fertility treatments. The Canadian Fertility and Andrology Society (CFAS) believes that the treatment of infertility is as important as many other services currently funded publically.

In Vitro Fertilization (IVF) is the most effective treatment for most causes of infertility, and when combined with elective single-embryo transfer (eSET) minimizes the risk of multiple pregnancy. However, the high cost of IVF limits access for many who would otherwise benefit from this treatment. As a result, many patients resort to alternative treatments that have a lower chance of success and/or a higher risk of multiple pregnancies.

Public funding of IVF with eSET has been shown to reduce the risk of twins and highorder multiples that may result from fertility treatments dramatically. The risks associated with multiple pregnancies include prematurity, prolonged admission to neonatal intensive care units, a greater risk of neonatal death and long-term disabilities such as cerebral palsy and blindness.

Public funding for fertility treatment has a direct influence on access to care and treatment utilization. In the absence of public funding for fertility treatment, individuals with greater financial resources are better able to overcome their condition and build their family than those with a lesser means, in opposition to the principal of universality which is the foundation of Canada’s healthcare system.

Worldwide, an increasing number of countries fund IVF. The vast majority of European countries cover three or more treatment cycles. In the United States, a country that has long resisted the public funding of health care, an increasing number of states require private insurance policies to cover IVF treatment.

The CFAS recognizes that public funding of IVF in Canada is an investment in our future that would reduce inequity in access to fertility care, and improve the health of patients and their children alike. By not funding IVF, provincial and territorial governments invite continued suffering from a disease for which effective treatments exist. If Canadian governments wish fully to support their citizens suffering from infertility, then the CFAS believes that they should fund IVF with eSET.

Egg Freezing

Current Status of Oocyte Freezing:

Recent advances in oocyte cryopreservation (“egg freezing”) techniques have greatly improved the survival when thawing frozen eggs and the subsequent effectiveness when used to achieve pregnancies. As a result, women can now bank their eggs with a reasonable expectation that those eggs may provide a future pregnancy after storage and thawing.

Women face the reality that their ovaries age more rapidly than other organs and tissues. As a result, fertility declines at an increasing rate, particularly after age 35. For this reason, some women may consider banking their eggs if they expect to delay starting a family. In such cases oocyte cryopreservation provides more options in the future if spontaneous conception is not possible.

CFAS Position on Egg Freezing:

The Canadian Fertility and Andrology Society considers oocyte cryopreservation to be a well-established technique that is no longer considered experimental. It has become an option for women wishing to preserve their fertility in the face of anticipated decline, as with radiation therapy or chemotherapy, or through the natural aging process.

The CFAS recommends education for young women regarding the effects of aging on fertility and natural conception, as part of routine well-woman care. Such discussions are a medical necessity and a societal responsibility. Prior to oocyte cryopreservation, women are encouraged to consider all aspects of this process including the risks of ovarian stimulation and oocyte retrieval, and the risks associated with pregnancy with both assisted reproductive technologies and conception at advanced ages.

Physicians offering oocyte banking should provide suitable resources and counselling including information regarding risks, expected outcomes including pregnancy rates, and alternatives to egg freezing that will enable women to make informed choices.

Minimum Qualifications for Physicians Offering Assisted Reproductive Care

The provision of tertiary infertility care including IVF and the use of gonadotropins requires specialized expertise and training. The Canadian Fertility and Andrology Society (CFAS) is concerned that there are physicians offering to care for couples with infertility who do not have sufficient training.

Fellowship training in reproductive endocrinology and infertility (REI) has existed for over 20 years. These fellowships equip physicians with the knowledge, understanding and skills to safely and appropriately manage patients with infertility. Furthermore, they provide training with regard to the potential pitfalls and complications that may result from controlled ovarian hyperstimulation, oocyte retrieval and embryo transfer.

These complications may include severe ovarian hyperstimulation syndrome, high order multiple pregnancy, injury to internal organs, massive hemorrhage and even death.

The concept of a subspecialty in reproductive endocrinology and infertility (REI) was introduced by the Royal College of Physicians and Surgeons of Canada (RCPSC) in 1989, and existed even earlier than that in the United States. There are now numerous RCPSC accredited REI fellowship training programs in Canada and many equivalent accredited programs in other countries.

The CFAS recognizes that there are some physicians without formal REI fellowship training who have been offering high quality and safe fertility services including IVF based on continuous practice in the specialty dating back to at least 2004. In some cases, these individuals are pioneers in the field and have helped mold the profession as we practice it today. The CFAS recognizes these physicians as fertility specialists who are competent and capable of providing assisted reproductive care.

However, aside from these cases, the CFAS believes that any physician wishing to provide assisted reproductive care should be fellowship trained, and that the minimum standard for offering such care in Canada should be completion of an accredited two to three year fellowship training program in REI.

Accreditation of Assisted Human Reproduction Centres

The Canadian Fertility and Andrology Society (CFAS) endorses the accreditation of organizations engaged in providing assisted human reproduction services. Accreditation sets standards of excellence and promotes a culture of continuous quality improvement. Achieving excellence through continuous quality improvement is central to the goals and philosophy of the Society. Through accreditation, organizations can establish a standard of care so that no matter where patients are treated within Canada, they can be assured of receiving safe, high quality reproductive care. Accreditation, therefore, is an essential element of ensuring a standard excellence within the industry and in enabling public trust in assisted reproductive technologies.

Gamete Donor Anonymity

Individuals who are the product of fertility treatment using donor gametes (sperm or oocytes) often seek information about or contact with their donor “parent”. While the Canadian Fertility and Andrology Society (CFAS) acknowledges the compelling rights and needs of the offspring of gamete donors, the Society believes the rights of the donors cannot be ignored. Regardless of individual or majority positions of CFAS members, the Society and its members must obey the law. The CFAS Board of Directors encourages members involved in both recruiting gamete donors and in offering donor gamete services to their patients to counsel these individuals that they could lose their anonymity and suggest they consider the impact of this loss. The Board is unable to offer an opinion on the potential loss of donor anonymity for cases where offspring already exist.

Payment to Gamete Donors

Some people seeking fertility treatment identify extremely poor or absent gamete (male or female reproductive cell) production as the root cause of their infertility. Whether this is attributed to the sperm-providing intended parent, the oocyteproviding intended parent or both, these couples require access to “donor” gametes (gametes from an individual not intending to raise any resulting offspring) in order to have a reasonable opportunity of achieving a successful pregnancy.

Couples may have friends or relatives willing to donate gametes to assist them in their effort to become pregnant However, many couples are unable to identify a suitable and willing gamete donor whom they know and must, therefore, find an anonymous source. Using either known or anonymous gamete (sperm or oocyte) donors is relatively common throughout the world and is an accepted practice in Canada.

The Canadian Fertility and Andrology Society (CFAS) Board of Directors recognizes that this is an acceptable practice and asks its members to make themselves aware of relevant Canadian regulations regarding donor testing and compensation. At this time, Canada has strict rules for donor screening and quarantine of gametes during the screening phase. In addition, it is not legal to compensate a gamete donor in excess of expenses incurred as a result of the donation process. The Board is unable to offer an opinion on the risk of using gamete donors where treatment occurs outside Canada.

Selective Reduction

Infertility affects approximately one in six Canadian couples and those who seek treatment often use medications intended to promote maturation of more than a single egg per cycle. This ovarian stimulation may precede timed intercourse, intrauterine insemination (IUI) or in vitro fertilization with embryo transfer (IVFET) and each of these cycle types carries a risk of multiple pregnancy. With timed intercourse and IUI, every egg released has an opportunity to be fertilized and to develop into an embryo with subsequent implantation. Although IVF-ET offers the opportunity to return only one embryo to the uterus, the significant expense of the treatment and the varying success rate often motivates couples to have more than one embryo transferred. In addition, the occasional incidence of one embryo splitting into two embryos (monozygotic twins) means that even single embryo transfers can lead to multiple pregnancy.

The relatively common use of these fertility treatments by Canadian couples has greatly increased the incidence of multiple pregnancy in our country. With this increased incidence, there has been a disturbing increase in complicated pregnancies and poor outcomes. Selective reduction has become an option which may be used to decrease the risk of poor outcome. This treatment involves eliminating one or more implanting embryo(s) to preserve the viability of the remaining embryo(s). This procedure is offered to help ensure maintenance of an ongoing pregnancy as well as the health of the mother. Patients, physicians and members of society have varying views on the ethics and morality of this procedure as it does involve aborting a fetus.

The Canadian Fertility and Andrology Society (CFAS) Board of Directors advises its members to accept what patients request in this situation. However, the Board also encourages medical practitioners involved in fertility treatment to counsel their patients prior to treatment regarding the risks of high order multiple pregnancy (triplets or higher) and the potential need to seriously consider selective reduction should their treatment result in such a high order multiple pregnancy.

The use of Assisted Reproductive Technologies (ART) has increased dramatically over the past few decades. The array and power of available technologies has increased to an even greater extent.

In recent years, it has become possible to perform numerous genetic tests on gametes and embryos prior to returning selected embryos to a recipient uterus. Such an approach has been used to save couples from the painful experience of losing a pregnancy or having a child born with a debilitating disease. These testing approaches may also be used to determine the sex of an embryo or sperm cell allowing this information to impact on decisions regarding embryos selected for transfer.

Aside from sex-linked genetic diseases, Canadian law prohibits the use of genetic testing for sex selection for social reasons. The Canadian Fertility and Andrology Society (CFAS) Board of Directors expects its members to respect and to work within our laws.

Reduction of Multiple Pregnancy Risk Associated with IVF/ICSI IVF Medical Directors of Canada 

Introduction For many couples undergoing IVF/ICSI, a multiple pregnancy (twins) is the preferred and often requested outcome. This, unfortunately, is a very different goal than that of the fertility specialists who provide their treatment and who aim to achieve a healthy singleton pregnancy and live birth. Multiple pregnancies are considered by many physicians and health care providers to be a complication of IVF/ICSI.

In 2006, Canada had the highest rate of multiple pregnancy (along with the USA) associated with IVF treatment among 21 countries surveyed. This, by the majority in the field, is a non‐enviable position since multiple pregnancies are associated with numerous adverse events and outcomes for parents, mothers and babies.    The medical literature is replete with data in these areas.

In Nov. 2009, at a multiple births roundtable meeting, the IVF Medical Directors of all 28 clinics in Canada voted unanimously to work towards the following goals:

1. reducing the multiple pregnancy rate associated with IVF to 25% by 2012 and to 15% by 2015,
2. performing elective single embryo transfer (eSET) in 50% or more of cycles in “good prognosis patients” by 2012,
3. virtually eliminating treatment – related higher order multiple pregnancies by 2015,
4. developing and implementing country‐wide educational tools for patients,
5. developing and implementing training workshops and innovative practice updates among Canadian ART professionals,
6. redefining AHR success as a “healthy singleton live birth.

These goals were felt to be realistic and achievable. This unanimous agreement was reaffirmed at the subsequent annual Medical Directors meeting held in conjunction with the CFAS 2010 Annual Meeting.

Promotion of eSET and a reduction in the overall number of embryos transferred   were considered to be the two obvious areas for immediate attention. It has been shown   that eSET employed  in a fresh embryo transfer cycle combined with replacement of another single embryo in a cryopreserved embryo transfer cycle (when the fresh eSET fails) can result in a significant decrease in the multiple pregnancy rate without, or at most, minimally affecting the clinical pregnancy rate. In Sweden, the reduction in the multiple pregnancy rate was achieved through mandated eSET with the multiple pregnancy rate dropping from 22.6% to 6.2%. In 2009 eSET cycles were uncommon (1.9% of fresh embryo transfers) in Canada.

According to the 2010 CARTR report the number of eSET transfers in IVF cycles rose to 12.1% and the multiple pregnancy rate has dropped to 24.2%. However, this does not reflect a true national perspective since at least half of this reduction is due to the high uptake of eSET in Quebec where almost half of the cycles are associated with eSET.    Lack of government funding of IVF has been cited frequently as the major impediment to patient acceptance of eSET.  Patients often state that they wish to maximize the success of a single IVF cycle whereas others will state that they can only afford to pay for one cycle of treatment. By having a twin pregnancy they can complete their desired family with one treatment, one pregnancy, one cost and two babies. Others actually believe that twins are glamorous and that their children will grow up having a playmate and best friend from the outset.

In jurisdictions where IVF is funded, liberal use of eSET in addition to   minimization of the number of embryos replaced in non‐eSET cycles has either been legislated (for specific patient groups) or promoted by the medical providers. Countries such as Sweden, Belgium and the UK are examples of how funding has been used to minimize the number of embryos replaced with a resultant decrease in multiple pregnancies. Conversely, the IVF program at the University of Iowa has demonstrated that a successful eSET program can also be established in a non‐funded environment. Justification for such “risk reduction programs” in IVF in Canada has been demonstrated in a recent publication which concludes that “A mandatory policy of single embryo transfer would be of substantial benefit to the health of Canadian babies while still benefiting infertile couples”.

The Quebec experience is an ideal example of the impact that funding can have on the establishment of a successful eSET program and concomitant reduction in the multiple pregnancy rate. Funding of 3 IVF cycles became a reality in Quebec in August 2010. Although the regulations related to funding provide some flexibility in the number of embryos replaced, the physicians have gone beyond and self‐imposed even more restrictive rules with respect to the number of embryos replaced. By the end of 2010 the number of SET cycles increased from 1.6 % to 48.6% and the multiple pregnancy rate in contrast dropped precipitously from 27.2% to 5.2 %.

It is also widely accepted that in order to have a successful eSET program, a clinic must also have a successful embryo cryopreservation program. However, whether eSET is performed on day 3 or day 5 often depends on the choice of the physicians and, in some cases, the ability of the laboratory to culture embryos to the blastocyst stage.

The IVF Medical Directors Position Statement ‐ 2012

The IVF Medical Directors

1. Unanimously support the goals of each clinic reducing their respective multiple pregnancy rate associated with IVF to 25% by 2012 and to 15% by 2015.
2. Support each clinic promoting eSET for good prognosis patients including oocyte donor cycles where the donor is less than 35 years of age and classified as a good prognosis donor.
3. Support a reduction in the number of embryos replaced in cycles where more than one embryo is replaced (especially in women over age 35).
4. Support the development and distribution of educational material for physicians and the public relating to the facts associated with multiple pregnancies including not only the medical risks to mothers/ fetuses/newborns/children but also the social, emotional and financial implications.
5. Support the development of novel, improved, integrated counselling methods for patients in order to assist them in making an appropriate informed choice regarding the number of embryos to be replaced.
6. Propose establishing a clinic‐specific multiple pregnancy risk minimization strategy.

Prion

CFAS position statement on the possible clinical significance of prion proteins in urinary-derived human menopausal gonadotropins and human chorionic gonadotropin:

Recent data published by van Dorsselaer et al indicate that urinary gonadotropins including, urinary-derived human chorionic gonadotropin, may contain normal prion proteins. Such proteins are often found in the urine of most healthy individuals. Abnormal prion proteins, in contrast, are not usually found in the urine of otherwise healthy individuals. The abnormal prion proteins have been implicated in certain neurological disorders, specifically Creutzfeldt-Jakob Disease (CJD). This is the human equivalent of “mad cow disease”. It is important to note that van Dorsselaer et al did not find any abnormal prion proteins in the urinary gonadotropins. The concern raised by the authors is that they suggest that the abnormal prion proteins could at some time contaminate urinary gonadotropins. Based upon the authors’ research as well as that of others, this has never occurred. Moreover van Dorsselaer et al acknowledge that there are no known cases of CJD associated with the use of urinary-derived human gonadotropins including FSH/LH or chorionic gonadotropins preparations. The authors conclude that with the availability of recombinant gonadotropins, the risk of prion contamination might be reduced even further. The study considers an important issue since the use of urinary gonadotropins is global.

The CFAS has reviewed the study published by van Dorsselaer et al and find the data intriguing. However, the concern raised by the authors is not substantiated by clinical evidence as no cause and effect relationship has ever been demonstrated. The question of the clinical significance of these observations remains unanswered. Regardless, the CFAS is continuing to review this data and as well as other literature pertaining to this issue. Over the next few weeks we hope to offer more extensive comments on the safety of urinary hMG.

At this point in time, the CFAS can conclude:

1. Urinary gonadotropins may contain normal prion proteins. Presently, there appears to be no clinical consequence to this observation.
2. Urinary hMGs have been available for over 50 years and used by millions of women worldwide. To date and to the best of our knowledge, there has never been a case of a prion-associated disease such as CJD reported in a woman previously exposed to urinary gonadotropins.
3. Prions may be easily transmitted via an intra-muscular injection. The current urinary gonadotropin preparations however, are most often injected by the subcutaneous route. We are unaware of any risk of prion transmission following a subcutaneous injection.

Based upon current knowledge and literature, there appears to be no confirmed clinical differences in the safety or efficacy among the currently available urinary gonadotropins compared to the newer recombinant gonadotropin products. The CFAS remains committed to protecting the safety and welfare of our patients. With that in mind, we shall continue to monitor the medical literature and await further evaluation by world experts in this field as the data are further scrutinized.

Publicly – Funded IVF Treatment in Canada

The Canadian Fertility and Andrology Society (CFAS) supports fully the provision of publicly funded in-vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) treatment across Canada. Infertility has been defined by the World Health Organization as a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse [1]. Since infertility has been defined as a disease, and its associated diagnostic and surgical management deemed “medically necessary” by provincial medical insurance plans, full infertility treatment including IVF and ICSI must also be made available as a funded service, and easily accessible to all Canadians.

Canada is one of few developed countries that do not fund all infertility treatments. In order to ensure that provincial medical insurance programs are in compliance with the Canada Health Act (Section 9 – Comprehensiveness), CFAS believes that fully-funded infertility treatment must be provided to all insured persons, as defined by the Act. In addition, funding must be adequate to ensure sustainability of services, regardless of where the services are delivered.

A randomized controlled study has shown IVF/ICSI to be an extremely effective treatment for infertility [2]. Economic studies in many jurisdictions have established the overall positive financial returns and benefits to society of fully-funded IVF. In 2009 the CFAS commissioned a panCanadian study to analyse the costs associated with IVF treatment and its delivery within qualitymanaged clinic environments [3]. The CFAS fully endorses this study as a primary guiding factor in the development of any publicly-funded system providing IVF treatment. That report should be used in conjunction with sound multiple pregnancy prevention initiatives, especially single embryo transfer [4], as the model to best serve the needs of subfertile Canadians.

[1] Zegers-Hochschild F, Adamson GD, de Mouzon J, Ishihara O, Mansour R, Nygren K, Sullivan E, Vanderpoel S; International Committee for Monitoring Assisted Reproductive Technology; World Health Organization. The International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) Revised Glossary on ART Terminology. Hum Reprod, 24: 2683-7, 2009.

[2] Hughes EG, Beecroft ML, Wilkie V, Burville L, Claman P, Tummon I, Greenblatt E, Fluker M, Thorpe K. A multicentre randomized controlled trial of expectant management versus IVF in women with Fallopian tube patency. Hum Reprod, 19: 1105- 9, 2004.

[3] La fécondation in vitro au Canada: Analyse de la structure des coûts. La Société canadienne de fertilité et d’andrologie, 2009. www.cfas.ca/images/stories/pdf/fiv_structure_des_couts.pdf

[4] La Société canadienne de fertilité et d’andrologie. Incidence and complications of multiple gestation in Canada: Proceedings of an expert meeting. Reprod. Biomed. Online, 14: 773-90, 2007.