Altruistic Sperm Donation in Canada: an Iterative Population-Based Analysis

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Table Of Contents

• Executive Summary
• Introduction
• Literature Review
  • Literature Search Strategy
  • Literature Results
    • Factors affecting sperm supply
    • Donor Behaviour
    • Medical Eligibility
  • Factors affecting demand for donor insemination
    • Demand from same-sex female couples
    • Demand from single females
    • Demand from married or common-law heterosexual couples
• Population-based Model Development
  • Estimation of the Supply of Altruistically Donated Sperm
    • Population Estimate
    • Ethnic Origin
    • Health Policy
    • Donor Behaviour
    • Sperm Donor Medical Eligibility
  • Estimation of the Demand for Altruistically Donated Sperm
    • Population Estimates
    • Donor Insemination demand by women in Canada
    • Number of live births permitted per donor
  • Comparison of supply and demand for donor insemination
    • Evidence based "standard model" analysis
    • Best case analysis
    • Worst case analysis
  • Model Results
    • Evidence-based or standard model analysis
    • Best-case analysis
    • Worst case scenario
• Discussion
• References
• Appendix I
• Appendix II
• Appendix III

ADI Working Group

James M. Bowen, BScPhm, MSc ^{Footnote 1,Footnote 3}
Edward Hughes, MB, ChB, MSc ^{Footnote 2}
Daria J. O'Reilly, PhD ^{Footnote 1,Footnote 3}
Kuhan Perampaladas, BSc ^{Footnote 1,Footnote 3}
Feng Xie, PhD ^{Footnote 1,Footnote 3}

20 May 2010

Report No. TEMMP-X022-2010.REP

Submitted to Assisted Human Reproduction Canada (AHRC)

Departments of Clinical Epidemiology & Biostatistics^{Footnote 1} and Obstetrics & Gynecology^{Footnote 2}, Faculty of Health Sciences, McMaster University, Hamilton, ON.
Programs for Assessment of Technology in Health (PATH) Research Institute^{Footnote 3}, St. Joseph's Healthcare Hamilton, Hamilton, ON

Disclaimer

This report was prepared by the Programs for Assessment of Technology in Health (PATH) Research Institute at St. Joseph's Healthcare Hamilton and Dr. Edward Hughes for Assisted Human Reproduction Canada (AHRC).

PATH and Dr. Hughes take responsibility for the final form and content of this report. The statements and conclusions in this report are those of the writing group and not that of St. Joseph's Healthcare Hamilton or McMaster University and the views and opinions expressed in this article are those of the authors and do not necessarily reflect those of Assisted Human Reproduction Canada.

Please contact PATH at www.path-hta.ca if you are aware of new research findings that should inform the report or would like further information.

Funding

Supported by a contract from Assisted Human Reproduction Canada (AHRC).

Correspondence

Dr. Edward Hughes
Department of Obstetrics and Gynecology
McMaster University, Room 4D14
1200 Main West
Hamilton, Ontario, L8N 3Z5
Email: hughese@mcmaster.ca

Presented to the Board of Directors of AHRC on 27 April 2010 in Alymer, Québec.

Suggested Citation

Bowen JM, Hughes E, O'Reilly DJ, Perampaladas K, Xie F. Altruistic sperm donation in Canada: an iterative population-based analysis. [Report No. TEMMP-X022-2010.REP] Submitted to Assisted Human Reproduction Canada (AHRC). Programs for Assessment of Technology in Health (PATH) Research Institute. Hamilton, ON. [20 May 2010].

Copyright: HER MAJESTY THE QUEEN IN RIGHT OF CANADA (2010)

Executive Summary

In Canada prior to the year 2000, there was relatively easy access to donor insemination (DI) using sperm provided by Canadian donors. However, over the last decade, the supply of donor sperm from Canadian men has largely disappeared. This decline is coincident with the introduction of more stringent regulations for donor screening and sample testing in 2000. Moreover, to prevent the commoditization of reproductive capacities, the federal government included a prohibition on payment to donors for gametes in a criminal law proclaimed in 2004. Reimbursement for receipted expenditures is not prohibited. During this time, the importation of sperm to Canada from paid donors in the US and Europe has taken place. However, since an altruistic DI program can support the goals of the new legislation, the current study was designed to determine how such a program can satisfy the demand for donor sperm in Canada, given this country's relatively small population and ethnic diversity.

Methods

Two population-based, top-down mathematical models were developed to estimate both the supply and demand for donor sperm in Canada. These models were based on Canadian census data, information from the published literature, and expert opinions. A Microsoft Excel-based system was designed, with unique spreadsheets, to examine the population-based requirements of an altruistic DI program. The user is able to alter assumptions at each level for supply and demand. "Supply" factors included: population (age and location), ethnic origin, health policy criteria, donor behaviour, and medical eligibility. "Demand" factors included: estimates of utilization by lesbian couples, single women and heterosexual couples. By manipulating these assumptions at any level, a broad range of sensitivity analyses are available to examine various supply and demand scenarios. The ability to perform these additional analyses recognizes that the evidence-based analysis was developed using the published literature and that "real-world" environment may vary from the available study results.

Results

The evidence-based analysis for the availability of Canadian donor sperm, developed using current best evidence, suggests that approximately 4,633 men would present for screening and a total of 60 donors would pass the current Canadian screening criteria including medical requirements, representing 0.00146% of the male population between 21-40 years of age. Using the most optimistic and pessimistic estimates (best and worst case scenarios), the number of available donors ranges between 3,630 and 1. Estimates are highly dependent on the potential behaviour of Canadian men, and their awareness and willingness to donate. Estimates for demand for donor insemination by women between 20-44 years of age, are for same sex couples 3,029, for single women 1,287 and heterosexual couples 1,201, for a total of 5,517. Assuming a maximum of 25 live births per donor, in order to minimize risk of consanguinity, only under the best case scenario with optimized awareness (55% aware of program, 50% of those aware willing to donate and 25% of the willing actually donating) could a Canadian altruistic sperm donation program meet the projected demand for donor sperm, with a potential donor pool representing 0.088% of the eligible male population.

Conclusions

Currently, the number of sperm donors available to Canadian women and couples is approximately 200. Of these, less than 40 are Canadian and the rest, paid donors from the US and Europe. The estimate for potential Canadian donor availability within an altruistic program with 60 donors compares negatively with this already limited status quo, unless a program is developed with concerted recruitment.
The current study provides a user-friendly, population-based model for to determine the supply and demand for donor sperm in Canada. Using the best available evidence reflecting current sperm donor behaviour internationally and in Canada, the Canadian male population may not be sufficient to provide an adequate supply. The assumptions used in these models suggest that for an altruistic program to be sustainable, significant changes must occur in the awareness and societal perception of sperm donation. These analyses suggest that sperm supplied by donors from other countries may still be required, in order to meet Canadian demand.

Introduction

Using sperm from a third party to overcome infertility (donor insemination, DI), is an age-old practice.^{Footnote 1} Despite the extraordinary advances in fertility treatment made over the last 30 years, DI remains an important option for conceiving a baby for specific groups. Abnormal sperm quality is responsible for at least one third of infertility.^{Footnote 2} In vitro fertilization with intracytoplasmic sperm injection (IVF/ICSI) is an effective treatment option for many of these affected couples and as a result, treatment of severe male-factor infertility with IVF/ICSI has increased dramatically over the last decade.^{Footnote 3} However, for some heterosexual couples and for all single and lesbian women seeking to conceive, sperm from a fertile, healthy and carefully screened third party or "donor" male remains the safest choice. Medically managed DI is safer, less expensive and more straightforward than IVF/ICSI. For women without a male partner, DI provided through medical means, is the safest and most effective option available. As a reflection of this, lesbian and single women now generate the largest demand for DI.^{Footnote 4}

Until recently, sperm samples from Canadian donors were widely available for use by Canadian women. However, over the last decade, the recruitment of Canadian donors has dramatically declined.^{Footnote 5;Footnote 6} It is possible that this decline was triggered by the intensification of donor-screening regulations and by the passing into Canadian law of the Assisted Human Reproduction Act in 2004 which prohibited the purchase of gametes from donors.^{Footnote 5;Footnote 7} Whatever the reasons for the trend, currently, only two sperm banks offer sperm from altruistic Canadian donors.^{Footnote 8;Footnote 9} The largest, Repromed, located in Toronto, lists 35 Canadian donors in its catalogue as of January 2010.^{Footnote 9} The other Canadian bank, Procrea, located in Montréal, has a limited number of donors available locally, but does not provide commercial access on a national level.^{Footnote 8} Canadian women currently seeking DI thus have to rely on the importation of sperm from other countries. Health Canada does not limit the importation of "paid donor sperm"; with the United States and Denmark being the two main national sources. Despite this, choice for Canadians remains limited. A relatively small number of donors are available for importation (approximately 160), perhaps because of the additional costs of compliance with the Health Canada Directive on screening of donors and their sperm.^{Footnote 7} The United States Food and Drug Administration (FDA), for example, does not require US banks to screen each ejaculate for Chlamydia, but this level of testing is required in Canada. US sperm banks therefore only make a limited number of their donors available for export and recover their costs from recipients. In total then, only about 200 donors are available to all women seeking DI treatment in Canada. Although information on supply is accessible, the demand for DI is very difficult to quantify, with no centralized collection of data and limited ability to assess whether 200 donors is an adequate number for Canada.

An alternative to the status quo of importing sperm from paid donors into Canada is an effective altruistic sperm donation program. This might service the needs of Canadians, while respecting the legislated ban on for the purchase of gametes from donors. France has such a system, but has approximately twice the population of Canada. With only 4 million men aged between 21 and 40 in Canada, is an altruistic sperm donation program workable here? Could such a system meet the needs of specific ethnic groups? How would Canada's vast geography influence its success? These and many other questions deserve attention.

Although there is no infrastructure in place for donor recruitment and sperm processing, a system is in place for patient care. Canadian women and couples seeking DI currently attend fertility clinics and occasionally, gynecologists' offices and family physicians, where they are assessed, monitored and receive treatment. Much of this care is already funded by provincial health plans, including consultation, infectious disease screening, some counseling, blood testing, ultrasound monitoring and the intrauterine insemination process itself. The cost of sperm, currently imported from cross-border commercial banks, which pay their donors, remains the responsibility of patients.

This project examines the population requirements for an altruistic sperm-donor program to service the needs of all Canadians seeking DI. It has been produced with particular attention to the interests of the "patients" involved. Specifically, the needs of women receiving and the donors that provide sperm, as well as the offspring conceived and born through the process, form the basis of the report. It considers both the supply of and demand for donor sperm, accounting for factors such as Canada's ethnic make-up and the proportions of single women, heterosexual couples and same-sex couples who may wish to conceive in this way. Although the report does not provide a blueprint for a national DI program, it provides information on the population challenges that Canada would need to address in establishing one. A key component of this research is the development of a Canadian population-based iterative mathematical model developed in Microsoft Excel, which permits various assumptions to be tested regarding the possibility of a Canadian population based altruistic sperm donation program to meet the DI demand. The model was developed using information gathered from the published literature, Statistics Canada, industry publications, and consultation with clinical experts. This tool is easy to use and may be updated and modified as more information becomes available.

Literature Review

Literature Search Strategy

In October 2009, published articles relating to sperm donation were identified using the OVID search engine to search the electronic databases MEDLINE and EMBASE. The search was completed by selecting terms that broadly identified literature that focused on: reproductive technology, artificial insemination, sperm donation, sperm banks, and sperm preservation (Appendix I). Against this broad group of studies, text word searches were applied to identify publications that described issues related to sperm donation including payment, altruism, demand, supply, behaviour, and health policy. Relevant papers were selected and their bibliographies screened.

Literature Results

The literature search produced 161 citations which were examined further for relevance. A bibliography of identified papers can be found in Appendix II. Selected studies containing information specifically addressing factors affecting sperm supply (e.g. national policy, individual's behaviour toward altruistic sperm donation (awareness, and willingness to donate), medical eligibility criteria) and demand for donor insemination (e.g. infertility rates, same sex couples) were used in the development of the population based model.

Factors affecting sperm supply

Health Policy

The literature review identified publications from three countries (i.e. United States, France, and the United Kingdom) that provided the most useful information on paid and altruistic sperm donation programs. Secondary information was collected from other countries.

United States

The US federal government has jurisdiction over gamete and embryo donation and administers this through the FDA (Table 1). The FDA has an extensive list of requirements, which include: assisted reproductive technology (ART) program registration with the federal government, federal inspections of programs that are performing donation and written protocols regarding: donor screening, testing, selection, rejection, and follow-up.^{Footnote 10} In addition, complete records of all donor gamete cycles are required, including documentation of adherence to FDA regulations. Most sperm banks in the United States preserve confidentiality regarding donors but non-anonymous or known donation is accepted as long as all parties agree. The potential donors must undergo the same testing and screening procedures as anonymous donors.

In the US, sperm donors must be between 18 and 40 years of age. Medical eligibility criteria have been established by the American Society for Reproductive Medicine (ASRM), detailing the minimum standards for genetic and health screens.^{Footnote 11} Regarding donor selection, screening includes psychological and semen testing, genetic screening, medical history, physical examination, and laboratory testing for a variety of communicable disease. Some of the major policy issues surrounding donor insemination are that donor confidentiality is protected; payment to donors is allowed but recommended that clinics only pay for time and expenses accrued, and a limit for the number of live births from an individual donor is recommended but not legislated. The ASRM recommendation however is that no more than 25 births occur per population area of 800,000 square miles, in an effort to avoid any significant risk of inadvertent consanguineous conception. This limit does vary across the country, with California establishing a hard target of only 10 births per donor.

France

Since July 1994, a law called 'bioethical' has governed medically-assisted procreation in France (Table 1). This has adopted the rules of the "Centre d'Etude et de la Conservation du Sperme Humain" (CECOS) concerning the donation of gametes.^{Footnote 12} The central tenets of the law establish that sperm donation must be unpaid and anonymous. Male donors must be between 18 and 45 years of age.^{Footnote 13} It is also mandatory that donors have at least one healthy living child. The minimal screening for donors as established by CECOS includes a personal and family history, specifically oriented to detect hereditary disease or sexually transmitted disease, karyotype and blood testing for syphilis, hepatitis, and HIV. Semen analysis with bacteriological testing is also done. Potential donors are rejected if they have high risks for severe hereditary disease or sexually transmitted diseases. Those with some medical risk factors, such as allergy, diabetes, and hypertension can be accepted, but before using them it is necessary to ensure that the personal history of the recipient does not reveal the same disorder.^{Footnote 13} No more than10 living babies can be conceived by the same donor in different families, in order to minimize risks of consanguinity.^{Footnote 13}

United Kingdom

The Human Fertilization and Embryology Authority (HFEA) is responsible for regulating all fertility clinics in the UK (Table 1).^{Footnote 14} All potential donors must be between 18 and 40 years of age.^{Footnote 14;Footnote 15} Sperm donors may receive £15 per donation, plus direct 'out-of-pocket' expenses. However, HFEA announced that unpaid gamete donation was preferred, and their goal is to eventually phase out payments to donors other than reasonable expenses.^{Footnote 16} HFEA has permitted the importation of donor sperm from commercial sperm banks in the United States and Denmark, where donors receive more generous financial remuneration.

In the past, sperm donors remained anonymous from the parents and offspring. In 2005, the law governing donor anonymity changed, entitling any person who is born from donated sperm after April 1 2005 to apply to the HFEA for information about the identity of the donor, once they have reached 18 years of age.^{Footnote 6} In the UK, there is a current limit of 10 births per donor.^{Footnote 14}

Canada

In Canada, semen used for assisted conception is regulated as if it were a drug. Semen screening, processing, distribution and storage thus are governed under the Food and Drugs Act: Processing and Distribution of Semen for Assisted Conception Regulations.^{Footnote 16;Footnote 17} Globally, Canada is also the first jurisdiction to make the purchase of gametes from a donor a criminal offence. Health Canada does not restrict the importation of donor semen from overseas sperm banks at this time.^{Footnote 6}

Semen donation in Canada is now mandated as altruistic and anonymous under the Assisted Human Reproduction Act.^{Footnote 5} Reimbursement of receiptable expenditures is permitted and a donor can also choose to be identifiable. Sperm donors must be aged between 18 years and 40 years according to the Act and Health Canada directive. However, the Canadian Standards Association recommends a minimum age for donors of 21 years of age.^{Footnote 7;Footnote 17;Footnote 18} There are no regulations in Canada dictating the number of children that can be sired from the donated gametes of a single donor at this time.

Table 1. Comparison of National Sperm Donation Programs and Policies

Country	Male Age limit (years)	Compensation for Sperm Donation	Oversight of Donor Screening process	Donor offspring limits	Anonymity
Canada	21-40	Unpaid (reimbursed for receiptable expenditures)	Health Canada	None	Yes
United Kingdom	18-40	Unpaid* (reimbursed for out of pocket expenses)	Human Fertilization and Embryology Authority (HFEA)	10	No
United States	18-40	Paid	Guidelines by American Society for Reproductive Medicine (ASRM) and oversight by FDA	25/850,000 (ASRM guideline) 10 (California)	Yes
France	18-45	Unpaid	Federation of the Centre d'Etude et de la Conservation du Sperme Humain (CECOS),	5-10	Yes

Donor Behaviour

In the world-wide literature, estimates regarding male awareness of the need for sperm donors ranged from greater than 50% to 98%. In the study by Purdie et al. ^{Footnote 19} awareness of sperm donation programs was estimated to be 55% of the population while in another study conducted by Onah et al.^{Footnote 20} cites 98% awareness. These contradictory findings regarding public awareness of gamete donation have been summarized in a recent review by Hudson.^{Footnote 21}

The estimates regarding male willingness to altruistically donate sperm also varied significantly. A survey of 301 donors applicants completed by Repromed in Toronto found that 36.6% of participants would be willing to donate without reimbursement. However, the survey participants were not from a representative sample of the male population as they had previously responded to an advertising poster regarding semen donation.^{Footnote 22} In a review of the literature related to willingness to donate sperm the general range of male willingness was between 12 and 15 percent.^{Footnote 21} Other studies have suggested a 15 %, 21 % and 50% willingness to donate.^{Footnote 19;Footnote 20;Footnote 23} Another estimate of the willingness to donate sperm was derived from the results of a survey of male blood donors, 51% of whom were willing to donate their semen.^{Footnote 24} With only about 5%-6% of the general population currently acting as blood donors, this translates into a 3% willingness to donate.^{Footnote 24}

Apparently, "willing donors" may actually change their minds prior to donation. In a study published in 2000, up to 75% of willing donors decided against donating sperm once they received information regarding the procedures and time commitment required.^{Footnote 25} Similar donor "drop-out" rates were found in the study by Del Valle et al. where 37/49 (76%) of initially willing donors withdrew their consent.^{Footnote 22} Estimates regarding the proportion of men that actually present to donate sperm are also limited. Only one study was identified that provided information concerning this parameter. This study found that only 1 male out of 20 (5%) who considered donating, actually followed through and donated sperm.^{Footnote 19}

Medical Eligibility

From a Canadian perspective, information regarding how many men actually meet each screening criteria issued by the Health Canada Directive was found from a current study published by Repromed Canada.^{Footnote 22} The information was abstracted and the proportion of men that passed each criterion was incorporated into the model. Applying Canadian criteria in one clinic setting, 1/78 or 1.28% of men of eligible age (21-40 years of age) that presented for screening were eligible to be donors.^{Footnote 22} In this study, 90 men were willing to donate sperm without payment. Of these individuals, 12/90 were not eligible due to age requirements leaving 78 eligible applicants. Further screening excluded 29 individuals based on high risk life-style, medical history, and other reasons.^{Footnote 22} The remaining 49 donor applicants were further screened. Of these 37 (76%) withdrew their application, six (12%) were excluded due to poor sperm quality, three (6%) due to infectious or genetic screening, one (2%) due to genetic and medical history and finally one (2%) applicant was excluded based on Health Canada exclusion criteria. Ultimately, only one donor was accepted into the donor program.^{Footnote 22}

Similar data are available from the United States. Following medical evaluation, 0.90% if potential donors were deemed eligible.^{Footnote 26} In the UK, the published information regarding medical eligibility suggest that a larger percentage of men (3.63%) are able to provide sperm for donor insemination.^{Footnote 27}

Factors affecting demand for donor insemination

Demand from same-sex female couples

Studies exploring the demand for donor sperm are sparse, particularly focusing on demand from same-sex female couples. Internationally, there are many jurisdictions that do not permit donor sperm to be used by lesbian couples.^{Footnote 13;Footnote 28} The lack of social acceptance in some jurisdictions, and the recent legalization of donor sperm use by donor sperm in single women and lesbian couples in others, may explain this deficiency in the literature. However a current study conducted in Belgium looked into the number of request for donor sperm and found that lesbian couples had the highest demand in relation to single women and heterosexual couples.^{Footnote 4}

Demand from single females

Published information regarding the demand for donor insemination by single Canadian women is unavailable. One study however conducted in Belgium, found that the average age of single women seeking sperm donation was 34, with a range between 23-49, and about two thirds of women fell between the ages 31-40.^{Footnote 29}

Demand from married or common-law heterosexual couples

Approximately 10% of heterosexual Canadian couples will experience infertility and of these, a small proportion will seek donor insemination. In 1993, the Canadian Royal Commission on New Reproductive Technologies found that 8.5% of all cohabitating couples experience infertility.^{Footnote 30} This was similar to the findings of another published study, which found the prevalence of infertility to be 9%.^{Footnote 31} Furthermore, in a study conducted by Hull et al. it was estimated that 24% of couple's infertility was due to male infertility.^{Footnote 32} Only a proportion of infertile couples (56%) will seek medical treatment.^{Footnote 31} No estimates of the proportion of infertile couples using DI could be found upon reviewing the literature.

Information on these factors affecting supply of and demand for donor sperm obtained from the literature provide a foundation for the population-based models that follow.

Population-based Model Development

Two population-based models were developed using Microsoft Excel; one to estimate donor supply and the other to estimate the demand for donor insemination in Canada. To examine the potential of the Canadian male population to support an altruistic sperm donation program, factors affecting the supply and demand for DI were varied in the models. These included donor and recipient age, geographic region, ethnicity, health policy, male behaviour, demand for DI and the medical screening criteria used in other jurisdictions (US and UK).^{Footnote 26;Footnote 27} Due to the significant uncertainty surrounding some parameters, extensive sensitivity analyses were conducted to estimate the impact of best and worst case scenarios on both demand and supply models. Close attention was paid to the proportional estimates used for male behaviour towards sperm donation and female/couples' attitudes in seeking donor insemination. The following sections will briefly describe each model.

Estimation of the Supply of Altruistically Donated Sperm

A five-step model was developed to estimate the number of potential altruistic sperm donors in Canada. Each step reflects an element that would affect donor supply. The chosen steps were: population (age and location), ethnic origin, health policy criteria, donor behaviour and medical eligibility. Population and ethnic origin criteria were used to identify all possible donors in Canada. While the health policy, behaviour variables and medical eligibility criteria were used to "filter" the potential pool of donors and reflect a final estimate based on selected criteria. A general schematic of the model is shown in Figure 1.

Figure 1. Model of Sperm Donors in Canada

Population Estimate

Based on Canadian criteria for sperm donation, the Canadian population data for males between the ages of 21 to 40 was obtained from the 2006 Canadian Census of Population.^{Footnote 33} The age of eligible donors was determined according to the Canadian Standards Association Standards for Tissues for Assisted Reproduction.^{Footnote 18} In order to examine both the national and regional feasibility of an altruistic sperm donation program, the 2006 Canadian Census data were obtained for each of the 10 provinces, 3 territories as well as 3 major urban centres: Toronto, Vancouver, and Montreal. The age range was cross referenced with the selected geographic regions to give a precise estimate of the number of eligible males within any region of Canada.

Ethnic Origin

The classification of visible minorities in the 2006 Canadian Census is made according to the Employment Equity Act, and defines visible minorities as 'persons, other than Aboriginal peoples, who are non-Caucasian in race or non-white in colour'. The Canadian visible minority categorization consists of 10 distinct minority groups (Chinese, South Asian, Black, Filipino, Latin American, Southeast Asian, Arab, West Asian, Korean, Japanese), as well as other visible minority groups (census respondents written in a group that was not represented in the census) and non visible minority groups (groups considered non visible minorities and aboriginals).^{Footnote 33} This categorization method was considered to be broad enough to examine the feasibility of providing a DI program to various ethnic populations across the country.^{Footnote 33} From these data, the proportion of men in Canada between the ages of 21-40 that belong to a specific visible minority group was calculated and cross referenced within a specified age range and geographic region.

Health Policy

Various countries have specific criteria dictating who may be eligible to donate. A health policy filter incorporating these factors was therefore added to the model. Thus, this step of the supply model provides the ability to calculate number of men who may be eligible to donate, based on health policy factors used by these countries. For instance, in France, donors must have fathered at least one healthy child. In order to incorporate this element into the model, the proportion of men from the 2006 Canadian Census with at least one child living at home was used as a surrogate, since information regarding the proportion of men with offspring was not available. The Canadian practice regarding sperm donation independent of the fact that the donor having a child or are married or in a common law relationship was used as the default and the impact of employing a policy similar to France can be evaluated, if required.

Donor Behaviour

The impact of Canadian male behavior with respect to awareness of the option of donating sperm, as well as the proportion of men who might present themselves for screening, was incorporated into the sperm supply model. These details were initially estimated based on information extracted from published articles and then verified through consultation with a clinical expert.^{Footnote 34} Most of the literature available regarding this element focused on sperm donors' attitudes towards donation, rather than the general public's perception and willingness to donate. As Canadian male behaviour and sperm donation have not been extensively evaluated, a wide range of estimates were incorporated into the model to reflect this uncertainty. Awareness of an altruistic sperm donation was incorporated into the model with a minimum and maximum value of 5% to 55%, respectively with a mid-range value of 25% being used as the default.^{Footnote 19} Similarly for "willingness to donate" a minimum and maximum value of 3% to 50% was used as model parameters.^{Footnote 19;Footnote 20;Footnote 23} Finally, to estimate the percent of men that actually "present for screening" a minimum and maximum value of 1% to 25% may be chosen.^{Footnote 22;Footnote 25}

Sperm Donor Medical Eligibility

The final step of the supply model was to determine, of those men who presented themselves at a donor clinic, how many of them would be eligible to donate, based on current medical screening criteria. Screening criteria from other jurisdictions were also used in order to examine the impact of modifying the Canadian screening processes The primary value used in the model was set to reflect application of the current Canadian criteria.^{Footnote 22}

Estimation of the Demand for Altruistically Donated Sperm

A five-step model was also used to estimate the demand for donor insemination. The overall demand for donor sperm was identified to be from three distinct groups: same sex female couples; single women; and, heterosexual couples with infertile men. The demand for sperm donors did not include directed donations but considered only the need for undirected sperm donors. For each group, a demand estimate for women/couples seeking sperm was obtained. The proportion of women that would meet medical eligibility criteria was estimated based on expert opinion and applied to all groups. Figure 2 shows the overall structure of the model.

Figure 2. Model of demand for donor insemination in Canada

Population Estimates

As with the supply model, the 2006 Canadian Census data were used to obtain population estimates for each of the three groups that may be seeking donated sperm: same sex female couples; single women; and, heterosexual couples with infertile men.^{Footnote 33} It was assumed that women between the ages of 20-44 were eligible for donor insemination based on current clinical screening criteria.

Donor Insemination demand by women in Canada

Information regarding the demand for donor insemination in Canada was unavailable in the published literature. A recent retrospective analysis, from Belgium, of a large cohort of women over a 5 year period (2000-2005) that received donor sperm for artificial insemination at a single clinic provides some insight into the demographic of women using donor sperm.^{Footnote 4} The Belgium study characterized the requests for donor sperm from 1654 women from three groups: lesbian couples, single women and heterosexual couples. The ratio of use by each of the three groups was 913:378:363 or approximately 5:2:2 for lesbian couples, single women and heterosexual couples with male infertility, respectively.^{Footnote 4} The model assumed that the demand in Canada will follow a similar ratio of request. The relative number of women from each of the three groups was then estimated using the total number of lesbian couples seeking donor sperm as the reference value.

The proportion currently with children was considered to be a potentially useful starting point to estimate ongoing demand. This proportion was based on the data obtained from the 2006 Canadian Census, which states that about 15% of the approximately 20,000 same-sex female couples across the country currently have children.^{Footnote 33}

Single women were defined as those who were not currently married or in a common law relationship, including those that are currently separated, divorced or widowed within this group.. Relative to the requests for donor sperm from lesbian couples the proportion of single women between the ages of 20-44 was calculated to be 0.06% to provide a 5:2 ratio between the two groups. As this estimate was based on the information from a single clinic, a wide range of possible values were included, to examine the effect of this parameter on the model.

Based on the literature review, it was assumed that 8.5% of married and common-law couples will experience infertility and that 24% of these will be due to male infertility.^{Footnote 30;Footnote 32} Again a similar ratio of 5:2 was used to estimated that donor insemination would be used by only 1.8% of these couples. It should be noted that the vast majority of heterosexual couples with male infertility now choose other options including intrauterine insemination with husband's sperm or most commonly, IVF with ICSI.^{Footnote 34} The model also assumed that of all potential seekers for donor sperm, 98% will meet the eligibility criteria in being a suitable recipient.^{Footnote 34}

Number of live births permitted per donor

To complete the models for supply and demand, the number of live births permitted per donor is required. The range for this parameter was obtained from the studies describing the National programs. The number of live births per donor for the standard model was set at 25, with a range of 10 to 50 live births, to permit further evaluation of this parameter.

A summary of all of the model parameters and estimates with associated ranges are provided below in Table 3. The evidence-based estimate values were used as the initial standard model analysis and various parameters were changed to reflect different scenarios. Any combination of values may be used to examine a wide range of circumstances related to the supply of altruistically donated sperm and the demand by individuals and couples seeking donor insemination. An overview of the Excel-based interface model and tabs is provided in Appendix III.

Table 2. Summary of model parameters and available choices

Model Parameters	Evidence Based Analysis	Available Choices
Geographic location	Canada	Canada, Newfoundland & Labrador, Nova Scotia, Prince Edward Island, New Brunswick, Québec, Ontario, Manitoba, Saskatchewan, Alberta, British Columbia, Yukon, Northwest Territories, Nunavut, Vancouver, Toronto, Montréal
Lower Age Limit for males	21	18-40 in 1 year increments
Upper Age Limit for males	40	18-40 in 1 year increments
Ethnic Origin	All	Nonvisible Minorities, Chinese, South Asian, Black, Filipino, Latin American, Southeast Asian, Arab, West Asian, Korean, Japanese, Visible Minorities
Only married men are eligible to donate	Off	On, Off
Men eligible only if they have offspring	Off	On, Off
Proportion of men aware of program	25%	5%-55% in 1% increments
Proportion of men willing to donate	15%	3%-50% in 1% increments
Proportion of men presenting for screening	3%	1%-25% in 1% increments
Screening criteria Canada, US or UK	Canada	Canada, UK, US
Proportion of men that pass overall medical screening process	1.28%	UK = 3.24%; US = 0.90%
Proportion of female same sex couples wishing to have children	15%	10%-25% in 5% increments
Proportion of single women seeking sperm donated for DI	0.06%	0.05% -, 0.1% in 0.01 increments and 0.1% - 1% in 0.1% increments
Proportion of couples experiencing infertility problems	8.5%	8.0% - 12.0% in 0.5% increments
Proportion of couples affected by male infertility	24%	23% to 30% in 1% increments
Proportion of couples seeking DI using donor sperm	1.8%	0.2% - 3.0% in 0.2% increments
Proportion of women meeting screening criteria	98%	n/a
Number of permitted live births from single sperm donor	25	10, 15, 20, 30, 50

Comparison of supply and demand for donor insemination

Total supply (i.e. the number of total live births possible, based on the supply of donor sperm and the number of allowable live births per donor based on health policy criteria) was calculated as well as the total demand for donor sperm. The difference between donor supply and demand for DI was then determined to estimate the number of male donors required to support an adequate altruistic sperm donation program in Canada. Three analyses were conducted to provide an estimate of the supply and demand for altruistic sperm donation. These analyses consisted of an evidence-based calculation using the best available evidence and estimates, a worst-case scenario which minimizes supply and a best-case scenario for which donor supply is maximized.

Evidence based "standard model" analysis

The evidence-based "standard model" analysis employs the best available data to estimate the number of sperm donors and the demand for donor insemination in Canada. The analysis includes, all men in Canada aged between 21-40 years of age, regardless of ethnicity. Marital status or prior offspring are not included in this model. Based on best evidence, it was assumed that 25% of men would be aware of the need for altruistic sperm donors, and of those 15% of men would be willing to donate their sperm and 3 percent would present themselves for all necessary screening and sample collections. The model also assumed that 1.3% percent of men would pass the medical eligibility criteria based on the best available Canadian evidence (Table 3).^{Footnote 22} The demand for donor insemination from same-sex female couples, single women, and married or common law heterosexual couples was set as follows: it was assumed that 15% of all female same-sex couples would seek DI, 0.06% of all single females between the ages of 20-44 and 1.8% of all heterosexual couples would require donor insemination (Table 3).

Best case analysis

The best case scenario regarding donor supply and demand was examined by setting the variables associated with donor behaviour to their most liberal estimates, while the estimates for demand were set at the most conservative levels. The only variables that changed from the standard model estimate were variables relating to male behaviour in the supply model: for the best case scenario, 55% of males would be aware of the need for altruistic sperm donors, of those, 50% would be willing to donate, and 25% of those would present themselves for all screenings and sample collections. From a donor demand perspective, none of the variables changed from the standard model analysis (Table 3).

Worst case analysis

The worst-case scenario was based on conservative estimates for donor variables; (i.e. awareness, willingness to donate, and number of men presenting to be screened). Male awareness of sperm donors and willingness to donate were both set at 5%, while it was assumed that only 1% of males would present for all screening and sample collection procedures. At the same time, the demand for donor insemination (i.e. same-sex female couples, single women, and married or common law heterosexual couples) was set at their highest levels. It was assumed that 25% of all female same-sex couples, 1% of all single females between the ages of 20-44 and 3% of all heterosexual couples were seeking children through donor insemination (Table 3).

Table 3. Model Parameters used for each supply and demand donor insemination scenario

Model Parameters	Evidence-based analysis	Best-case analysis	Worst-case analysis
Supply Of Sperm
Geographical area selected	Canada	Canada	Canada
Age Category	21 to 40	21 to 40	21 to 40
Ethnic Origin (Men & Women)	All	All	All
Health Policy
Only married men are eligible	Off	Off	Off
Men eligible only if they have offspring	Off	Off	Off
Male Donation Behaviour
Proportion aware of program	25%	55%	5%
Proportion willing to donate	15%	50%	3%
Proportion presenting for screening	3%	25%	1%
Medical Eligibility
Screening Criteria	Canada	Canada	Canada
Proportion of men that pass overall medical screening process	1.3%	1.3%	1.3%
Number of allowable live births	25	25	25
Demand For Donor Sperm
Geographical area selected	Canada	Canada	Canada
Age Category	20 to 44	20 to 44	20 to 44
Ethnic Origin	All	All	All
Proportion of female same-sex couples	15%	15%	25%
Proportion of single women	0.06%	0.06%	1%
Proportion of heterosexual couples	1.8%	1.8%	3%

Model Results

Evidence-based or standard model analysis

The standard model predicts a total of 60 available sperm donors (0.0014% of the eligible Canadian male population) with demand for donor insemination will come from 5,517 women or 0.1% of eligible Canadian women seeking donor sperm (Table 4). Demand is greatest from single women, followed by same sex couples, and finally from married/common law couples. To balance this model, an additional 161 Canadian donors would be required, assuming a maximum of 25 births from each donor.

Best-case analysis

The best-case analysis, predicts a total of 3,630 Canadian sperm donors representing 0.0881% of the eligible male population. In this analysis the demand for donor insemination remained the same as the evidence-based analysis (Table 4). If the total number of pregnancies per donor was again set at 25, the supply of donor sperm would exceed the demand, with the possibility of having a potential for 90,750 possible live births from the estimated donor pool.

Worst case scenario

The worst case scenario, where the availability of sperm donors is minimized and the DI demand maximized, a single Canadian donor would be available. Maximizing the demand estimates indicates that the total demand by women seeking donor insemination would come from 28,496 women or 0.5158% of the eligible population. Under these conditions there would be a short-fall in the number of donors, requiring an additional 1,139 donors would be required in order to meet the demand for donor insemination assuming that 25 pregnancies are permitted per sperm donor (Table 4).

Table 4. Comparison of estimates of supply & demand for a hypothetical altruistic sperm donor program in Canada for the evidence-based, best-case and worst-case scenarios

Scenarios	Evidence-based analysis	Best-case analysis	Worst-case analysis
Male population base (21-40 years of age)	4,117,935	4,117,935	4,117,935
Number of men presenting for screening	4,633	283,108	62
Total number of men eligible to donate sperm	60	3,630	1
Proportion of selected population base	0.0014%	0.0881%	0.00002%
Female population base (20-44 years of age)	5,524,270	5,524,270	5,524,270
Number of female same-sex couples	3,029	3,029	5,048
Number of single women	1,287	1,287	21,447
Number of heterosexual couples	1,201	1,201	2,001
Total demand for donor sperm	5,517	5,517	28,496
Proportion of selected population base	0.1%	0.1%	0.5158%
Total supply or number of live births (eligible donors permitted 25 live births)	1,500	90,750	25
Difference between donor insemination requests (demand) and donated sperm (supply)	4,017	-85,233	28,471
Number of additional donors required to meet donor insemination demand	161	-3,409	1,139

Discussion

This is the first Canadian population based analysis to examine the possibility of implementing an altruistic sperm donation program and to determine whether a sufficient pool of altruistic male sperm donors exists to meet the demand for artificial insemination by donor. By estimating the potential number of altruistic sperm donors in Canada and the possible demand for donor sperm, it is possible to set future recruitment goals that will satisfy demand.

This study suggests that an altruistic sperm donor program in Canada may not be sustainable, based on population data and reasonable estimates of other factors affecting supply and demand, without a concerted awareness and recruitment campaign. The evidence-based standard model analysis suggests that there is a large gap between the numbers of altruistic sperm donors available and the demand for donor insemination. Del Valle et al. found recruitment rate for altruistic donors to be less than 1% of those presenting for consideration and similarly, Paul et al found that there exists a high level of attrition between presentation and donation, emphasizing the need to maintain a large pool of potential donors.^{22 ;Footnote 27}

Five main factors have been considered in the supply model: population, ethnic origin, health policy, behaviour variables, and medical eligibility. The analysis evaluates the impact of each on sperm donation in Canada. Only three factors: health policy, behaviour variables, and medical eligibility, can be modified through changes in health policy or recruitment strategies. The current guidelines regarding health policy put very few social restrictions on the type of men who are eligible to donate sperm, with the only major exceptions being age and not from a high-risk of HIV population (e.g. intravenous drug users). If Canada were to adopt a policy similar to that of France and require donors to be married and have at least one offspring, it would significantly exacerbate the shortage of potential sperm donors. Male behaviour also appears to be a key factor that affects supply: even with the best-case estimates, the potential pool of sperm donors was 0.0881% of the eligible population. Therefore, looking into strategies that increase male awareness and willingness to donate will most likely ease the shortage of sperm donors. There were a variety of methods used in other jurisdictions that attempted to increase the number of sperm donors, they including: 1) asking couples seeking DI to recommend to family and friends the need for sperm donors 2) asking patients that are about to undergo a vasectomy if they would consider donating sperm 3) mirror gamete donation, where the partner lacking the usable gamete donates in exchange for the gametes they need i.e. a man donates sperm in exchange for oocytes and vice versa 4) looking at the impact of a media campaign on increasing awareness for altruistic sperm donation or appeal to their self esteem.^{Footnote 13;Footnote 35} Finally, one of the largest barriers to sperm donation is the inconvenience of donating.^{Footnote 36} Whether any of these strategies will work in a Canadian context is yet to be determined and should be investigated in future studies.

Several limitations of this study should be considered. Firstly, the model assumes that estimates obtained from the literature are reflective of Canadian values and attitudes. Some of the parameters in the models were actually based on studies conducted abroad. In addition, several parameters such as Canadian male behaviour towards altruistic sperm donation require further study, perhaps through the use of focused surveys. Due to the limited amount of primary research on this topic, all studies that helped identify appropriate variable estimates were used. Secondly, it was assumed that estimates used for behavior variables were independent of ethnicity and geography. This may also be inaccurate since there is evidence in the literature that indicating that certain ethnic groups are more willing to donate than others and that there are shortages of donor sperm from specific ethnic groups. In addition, there may be differences between people's propensity to donate from a rural rather than urban regions.^{Footnote 25;Footnote 37;Footnote 38} Thirdly, most parameter estimates were mostly obtained from studies that using survey responses. The reliability of these methods to determine actually behaviour may be limited; responses to surveys, especially in regards to organ/tissue donations, may differ from actions. Fourthly, estimates surrounding demand for donor insemination were based on clinic experience rather than evidence.^{Footnote 34} There were no available data informing the demand for DI from single women, or same sex couples.

A further consideration not taken into account in these models is the effect of payment on male behavior towards sperm donation. However, evidence suggests that payment does change male willingness to donate, especially among younger donors.^{Footnote 39-Footnote 43} Studies conducted when payment was permitted, found that 32 % of donors donated purely for financial reasons.^{Footnote 41} Similarly, Ernst et al. found that 95% of donors were motivated by financial remuneration.^{Footnote 40} When considering donating based on purely altruistic reasons, this number was lower and ranged between 5-8% in the above studies.^{Footnote 40;Footnote 41} Some donors' motivation for donating were based on a combination of both altruistic and financial reasons (60% and 77%).^{Footnote 40;Footnote 41} A study by Sauer found that 69% of donors were motivated by money and were unwilling to participate if payment was removed.^{Footnote 42} Although this model does not take into account the effect of payment because of the legal parameters in place in Canada, it should be noted that payment does have an effect on male behaviour.

In conclusion, the evidence-based standard model indicates that the demand for DI exceeds the potential supply available from eligible and willing Canadian men providing a donor pool of only 60 men. Further evaluation using a worst case scenario in the analysis indicates a significant shortfall in the number of donors and the inability for the Canadian population to support an altruistic sperm donation program, at this time and without concerted awareness and recruitment activity. Under ideal conditions used in the best-case analysis, an altruistic sperm donation program could be achieved; however considerable effort would have to be made to create a significant increase in the awareness of the program and change in societal behaviour towards sperm donation.

References

Appendix I

Targeted literature search of the electronic databases to identify altruistic sperm donation

1. Humans
2. Altruism
3. altruis$.ti,ab
4. 2 or 3
5. exp insemination, artificial/ or exp reproductive techniques, assisted/
6. Sperm Banks/
7. Semen/
8. Semen Preservation/
9. sperm$.ti,ab.
10. dona$.ti,ab.
11. 10 and 9
12. 8 or 6 or 11 or 7
13. 12 and 5
14. 4 and 13
15. from 14 keep 1-18 (18)
16. paid.ti,ab.
17. 16 and 13
18. national.ti,ab.
19. 18 and 13
20. from 19 keep 19,25-26,29,31-32 (6)
21. health.ti,ab.
22. poli$.ti,ab.
23. 22 and 21
24. 23 and 13
25. supply.ti,ab.
26. 25 and 13
27. from 26 keep 1-3
28. demand.ti,ab.
29. 28 and 13
30. 24 or 26 or 19 or 29 or 17 or 14

Appendix II

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Appendix III

Model Interface Overview

The Microsoft Excel-based model is designed to be user-friendly, with 5 unique tabs (Title, Instructions, Estimate of Altruistic Sperm Donors, Estimate of Demand for Donor Sperm and Scenario Summary) to guide through the various steps in examining the possibility of a population based altruistic sperm donation program in Canada.

Tab 1. Model Title

Tab 2. Instructions for estimating donor sperm supply and demand

Tab 3. Estimate of supply of altruistically donated sperm in Canada interface

Tab 4. Demand for donor insemination interface

Tab 5. Scenario Summary Interface