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

May 2017

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.

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.

Accreditation of Assisted Human Reproduction Centres - 2012

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.

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.

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.