British Fertility Society Report and recommendations

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British Fertility Society Working Party on Sperm Donation Services in the UK

Report and recommendations Members of the Group Mark Hamilton Allan Pacey Mathew Tomlinson Daniel Brison Lawrence Shaw Cathy Turner Laura Witjens Pip Morris Clare Brown Olivia Montuschi Joanne Adams Brian Lieberman Jennifer Speirs

(Chair, British Fertility Society (BFS): Clinician) (Secretary, BFS: Andrologist) (Chair, Association Biomedical Andrologists: Andrologist) (Scientist Representative BFS Committee: Embryologist) (Clinician, Private Sector) (BFS Nurse Representative, London) (Chair, National Gamete Donation Trust (NGDT)) (Donor Recruitment Manager, (NGDT)) (Chair, Infertility Network UK (INUK)) (Donor Conception Network (DCN)) (Donor Recruitment Manager, Manchester, Andrologist) (Clinician, NHS & Private sector) (BFS Counsellor Representative, Edinburgh)

In attendance Gwen Skinner Peter Mills

(Department of Health) (Human Fertilisation and Embryology Authority (HFEA))

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TERMS OF REFERENCE

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“To determine the national requirements to facilitate

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equity of access to sperm donation services in the UK”

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INTRODUCTION The British Fertility Society has been in dialogue for several years with the HFEA, the Department of Health, and Ministers to highlight the difficulties clinics face in developing and maintaining the necessary infrastructure to recruit sperm donors. We have highlighted the steady loss of skill base in the years leading up to the change in the law on donor anonymity in 2005. Currently, only a minority of clinics have sufficient resources to recruit sperm donors and most find it very difficult to compete effectively for the limited resources within the state sector to address the logistics of donor recruitment. The contribution that removal of donor anonymity has made to this problem is an area of controversy. It is certainly the case that donor numbers were declining before the law change came in to force. However, a recent survey conducted by the BFS of clinics in the country has shown that a substantial majority of clinics are struggling to maintain sperm donation services and in some parts of the country these services have now ceased. A number of clinics in the country have, with appropriate staff, infrastructure and resource managed to maintain donor recruitment to some extent, and some centres have continued to supply sperm to other clinics in the UK. Against a background of declining availability of such services the BFS is of the view that a nationally co-ordinated approach to the organisation of sperm donation services is required. The Society convened a working group in late 2006 to assess the key issues in relation to the national provision of sperm donation services. The members of the group consisted of relevant stakeholders including representation from clinical and laboratory service providers, patients (Infertility Network UK), and key support organisations: the National Gamete Donation Trust (NGDT) and Donor Conception Network (DCN). Representatives from the Department of Health and the Human Fertilisation and Embryology Authority were in attendance. This report provides an analysis of the current situation and makes recommendations to the Dept of Health. It was written by Dr Mark Hamilton, Chair of the Working Group, approved by the members of the BFS executive committee, and will be posted on the BFS web-site for comment by members of the Society.

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CURRENT SERVICES There is evidence from a number of sources of patchy availability of service and a diminution in donor recruitment throughout the country. REGISTERED DONORS HFEA figures on the numbers of newly registered donors at licensed centres have shown a consistent secular trend downwards during the period 1991 – 2005 (Figure 1). In this time the total number of donors registering with the Authority has fallen from 503 to 260 per year. The majority of donors are from a white Caucasian ethnicity. Other ethnic groups recruit much fewer per annum. In 2005 the numbers of Indian (10), Black African (3) and Chinese (5) recruits were very low. Ethnic minorities represent a special group for whom provision needs to be made. Certain groups have special cultural issues re gamete donation and its consequences which require special care.

HFEA Registered Donors (91 - 05) 600

503

500

431 422 418 421 369

400

356 265

300

308

328 330

286

263 247 252

200 100 0

91

95

Year

99

03

85 86

Figure 1: Source HFEA 2006

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Table 1 shows recent published figures from the HFEA.

89 Table 1 Numbers of registered sperm donors in the UK

90 91

1991

1994

1997

2000

2005

2006

503

422

356

328

252

296

Source HFEA 2006 + HFEA 2007 (Facts and figures)

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92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114

In 2006 there were 296 newly registered donors in the UK. This slight rise provides some encouragement, though many of these donors will have been registered with the intention of their donation being for a single recipient. In absolute terms the present number of donors is 40% lower than that of the number of registered donors in 1991. These figures are consistent with the various recent surveys on recruitment patterns throughout the country commissioned independently by the BFS and the BBC where there was a consistent message of clinics struggling to provide services. The BFS survey (July 2006), to which 42 centres in the UK responded, revealed increasing difficulty in recruiting donors (86% of clinics), increased costs (89% of clinics) and longer waiting lists (75% of clinics). In some parts of the country Donor Insemination services had been withdrawn (9% of clinics). (Source BFS 2006) A BBC survey of 84 centres in the UK (Sept 06) revealed that 68% of clinics providing DI treatment services were not themselves recruiting donors and that 90% of UK donors were recruited in 10 clinics. DEMAND FOR TREATMENT An absolutely accurate estimate of the demand for treatment services is difficult. The HFEA have recently published historical data on donor insemination (DI) treatment episodes since 1991. (www.hfea.gov.uk/en/1540.html). Table 2 shows the number of patients who have had treatment with donated sperm in recent years.

Table 2 Numbers of patients using donated sperm in the UK since 2000 Treatment

2000

2005

2006

Natural cycle DI

2213

1710

1214

Stimulated DI

1756

1259

1058

IVF DI (own eggs)

839

873

752

TOTAL

4808

3842

3024

115 116 117 118 119 120 121 122 123

Source HFEA 2007 (Facts and figures)

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124 125 126

Table 3 shows the number of treatment cycles carried out in the same period using donated sperm.

Table 3 Numbers of treatment cycles using donated sperm in the UK since 2000 Treatment

127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154

2000

2005

2006

Natural cycle DI

4926

3578

2325

Stimulated DI

3248

2271

1746

IVF DI (own eggs)

979

1023

878

TOTAL

9153

6872

4949 Source HFEA 2007 (Facts and figures)

Since 2000, the total number of patients treated and the number of DI cycles carried out has markedly reduced. The number of IVF associated DI treatments has remained reasonably constant, between 15 and 18% of the total donor sperm utilisation. The majority of treatment cycles are natural or stimulated cycle DI. A dramatic reduction in natural (47.2% of the 2000 numbers) and stimulated (53.8% of the 2000 numbers) DI cycles has been observed. Such a significant change in the utilisation of DI services in the UK merits examination. The advent of intra-cytoplasmic sperm injection (ICSI) has transformed the treatment of male infertility, and without doubt has accounted for a significant reduction in treatment cycles with donated sperm since the mid 1990’s. Indeed, it would be reasonable to suggest that ICSI has been regarded as a routine treatment since 2000. One would on this basis expect the numbers of patients to require DI to remain similar to the figures of 2000 i.e. the DI core of patients. The information from HFEA however, as shown in Table 3, shows a reduction of over 4000 in the number of treatment cycles from 9153 in 2000 to 4949.

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155 156 157 158

Table 4 shows the numbers of IVF and ICSI patients treated in the UK where their own gametes were used.

Table 4 Numbers of IVF and ICSI patients (own gametes) in the UK Treatment

159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186

2000

2005

2006

IVF

18196

19166

18183

ICSI

10468

14600

16363

TOTAL

28664

33766

34546 Source HFEA 2007 (Facts and figures)

In the past 6 years, the number of ICSI patients treated per year has increased by nearly 6000 (10468 in 2000; 16363 in 2006. It is highly likely that this increase is due to lower thresholds in using ICSI as the insemination technique in moderate male factor infertility in preference to IVF, rather than a switch of core DI patients to ICSI programmes using their own gametes. Furthermore the overall increase in ART cycles seen in the UK in the past 6 years probably reflects greater access to services generally. From the above data, which relates to actual treatments carried out, one can infer that there is a potential unmet demand for treatment using DI. An unknown number in addition to those currently receiving treatment may also wish to access services but cannot do so for reasons which may be linked to availability of treatment services, waiting times, costs, and local rationing decisions relevant to age. Forecasting future trends in demand for service is difficult. The present level of 4000 patients per annum may be a reasonable demand estimate, despite the uncertainty of the unknown number of patients potentially waiting for treatment. There may be an additional unmet need in terms of single women seeking treatment, many of whom take advantage of internet based DI services which have until very recently been out with the regulatory boundaries of the HFEA. Recent HFEA figures suggest that just under 40% of registered DI cycles carried out in the UK in 2006 were for single women and lesbian couples (www.hfea.gov.uk/en/1540.html). In 2000 that figure was just over 20%, and the upward trend in proportions may yet continue as internet based services potentially decline in numbers.

Key Point: The demand for DI services in the UK is approximately 4000 patients per year.

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The questions pertinent to commissioners and providers of care are:

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Key Point: A minimum of 500 sperm donors are required per annum in the UK to meet

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How many donors are needed?



How best to achieve that number?



How best to provide equitable service both for donors and recipients?

HOW MANY DONORS ARE REQUIRED? Given that the current Code of Practice limits the number of families which can be created by a single donor to 10 then, with the current uptake of DI cycles, a minimum of 400 maximally successful donors would be required to achieve the requisite number of families. Taking account of the need to afford couples/recipients choice in donor selection, acknowledging that not all donors will achieve 10 families, as well as the fact that a number of donors are recruited for single recipient use, together with the unmet need, it was agreed by the group that at least 500 donors per year would be a reasonable estimate of national recruitment requirements. This figure is in line with the estimate made in a BBC survey of centres in September 2006.

demand.

Present donor registration numbers fall some way short of this target with fewer than 300 donors registered in 2006. The Group considered a number of issues in relation to opportunities to adapt donor deployment in such a way as to reduce the burden on demand. ADDRESSING THE SHORTFALL IN DONOR RECRUITMENT Mechanisms to increase donor availability could include improving efficiency and efficacy of donor recruitment steps including advertising, response, screening etc. Other opportunities might lie in adapting current policy in the clinical, laboratory and regulatory arena. These various issues were examined by the group. I.

POLICY/REGULATORY OPTIONS

A. DONOR CHOICE It was agreed that common practice has in the past been to offer patients choice in the characteristics of the donor to be used in treatment. Opportunities for choice in donor have receded in recent times as donor numbers have declined. It could be argued that if the principle of offering choice were removed it might increase availability of treatment. The group did not consider inter-racial choice as negotiable. It may be suggested that trying to match donor characteristics to an infertile male/putative father amounts to clinical collusion in the deceit of a child in respect of origins. The group agreed that this was not the case and that prospective parents should be encouraged to consider telling the child of its origins. There is some evidence that donor offspring find social and family engagement easier if there is less incongruity in relation to existing familial physical characteristics. Where possible,

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matching of donor to parental characteristics should be made available. In summary the group felt

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Key Point: Choice in matching donors to parental characteristics should be available to

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that current practice in offering choice, where possible, should remain.

patients.

B. THE LIMIT ON FAMILY NUMBERS TO 10. The maximum number of families that may be created with a single donor is variable in different parts of the EU. For example, in Holland the limit on family numbers is 25 while in France the limit is 5. An underlying concern has been that inadvertent consanguinity might increase the hazard of introducing autonomic recessive disease into the community. The evidence base derived from genetics literature suggests that there is a large safety margin with a limit of 10 families, or 25 for that matter, given the UK’s population size and geographical distribution (Janssens, 2003). Other issues relevant to population risk of consanguineous genetic disorders would include the degree of assortative mating within society and the prevalence of genetic disease within the population/donor pool. (Wang et al 2007) The option of raising the maximum families’ number therefore would merit consideration. There were mixed views within the group which are summarised in Table 5.

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Table 5 Arguments re increasing the numbers of families conceived from single donors FOR Low genetic hazard European comparisons Favourable population size and dispersal in the UK Donor can control of numbers of families A hierarchical approach limiting numbers could be facilitated Evidence base for limit of 10 is poor (Social Science/Medical)

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AGAINST Welfare of donor conceived children Societal perceptions of acceptability Welfare of recipients ignored by those providing services AND recipients themselves Uncertainty re welfare of existing children of donors Uncertainties of the views of “silent majority”

The arguments permissive of a change include: -

The low risk of inadvertent consanguinity leading to genetic hazard for offspring of donor conceived adults.

-

European comparisons reveal countries where there are higher numbers of families permitted per donor e.g. Holland (25).

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254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274

-

The observation that the UK population size and geographical dispersal is greater than in Holland and a nationally organised donor distribution scheme could take advantage of this in managing the risk.

-

Donors themselves have a say in the numbers of families that might be created through their donations. This might allow a hierarchical approach to family numbers in to which both donors and recipients could “buy” according to their own personal preferences.

-

The present limit of 10 has been set entirely arbitrarily without a medical or social science evidence base.

The arguments against a change include: -

Concerns that the welfare of donor conceived people may be prejudiced through the genesis of increased numbers of half siblings, potentially unknown to the donor conceived child.

-

Uncertainties exist as to societal perceptions of a change in the limit and the views of the silent majority.

-

Concerns that in the drive to provide and receive treatment to achieve pregnancy and parenthood, the welfare of recipients is ignored by those providing services and the recipients themselves.

-

There are concerns that the welfare of existing and future children of donors may be ignored.

The issues raised through this analysis were debated within the group. It was felt useful to look at the concerns from the perspective of the relevant stakeholders: The recipient Anxious to receive treatment. Current provision of services inadequate. Counselling needs important. With information and implications issues covered empowered to make decisions. Evidence suggests that many do not tell offspring of origins despite current thinking in favour of openness. The donor Little evidence to suggest that donors have articulated a view specific to family numbers. Opportunities within consent process to allow individual preferences on circumstances of donation to be addressed within defined boundaries. Donor conceived people, particularly as adults Unable to protect their own interests and thus of particular concern. Knowledge that there may be substantial numbers of genetically related individuals in the community may be emotionally taxing. No research evidence at present that this is an issue. Other offspring Existing and future offspring of donors may also find the knowledge that there may be substantial numbers of genetically related individuals in the community disturbing. No research evidence at present that this is an issue.

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Society The views of Society were not sought when the present limit of 10 families was set. At the time the limit was set the numbers of donors available was quite different from the present situation. The lack of availability of donors currently has to be acknowledged, and recruitment strategies and distribution of donated samples requires re-evaluation. Within society there are many who oppose de facto the use of gamete donation in the treatment of infertility. Those individuals will not change their views. However treatment services will continue to be available within the confines of legislation and strict regulation. Given the dearth of knowledge within the social science arena with respect to harm specific to family numbers, and the reassurance that current outcome data with respect to family functioning is favourable, any change in regulatory recommendations must be evaluated prospectively.

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While persuaded of the low genetic risk it was suggested that with non-anonymous donation the donor group might wish to limit the number of families with whom they might in time have association. Public sensitivities also might prevail in what might be considered acceptable family numbers, although it is quite possible that some donors would have few anxieties about the issue and be unconcerned about an imposition of a ceiling on family numbers. Donors in existing legislation are entirely at liberty to stipulate how many families they may want to be associated with. Perhaps there is an opportunity to increase donor availability through a change in this element of current legislation. This complex issue was also examined in the SEED report issued by the HFEA in 2004. Extract from the Seed report (www.hfea.gov.uk) 3.4

Whilst some people worry that the widespread use of gametes from a few donors could lead to consanguinity (genetically related people having children together) our research found no evidence that this risk would be significant given the relatively small numbers involved and given the large and mobile populations typically served by UK clinics. Nor did respondents to the consultation produce any such evidence although some, with consanguinity in mind, proposed complicated approaches to controlling the use of each donor’s gametes, such as limiting the number of offspring according to the catchment area of the clinic and accounting for mobility of the population or, alternatively, ensuring that each donor’s gametes were widely distributed geographically. Others returned to the approach of appealing to a notion of how many genetic offspring it was reasonable for one person (donor) to produce.

3.5

Given that only relatively small numbers of offspring per donor are contemplated, the principal concern seems to be on the effect on donor-conceived people (and their parents) of knowing that there might be a large number of people who are genetically related to them. (As donors are free to set upper limits themselves, we assume that their concerns can be addressed in this way.) These concerns were raised both by stakeholders at the meeting in July 2004, and by many respondents to the consultation.

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3.7

Among consultation respondents, many clinics and recipients (particularly recipients who had waited, or were waiting, a long time for treatment) argued for a higher limit to increase the availability of treatment. It was notable that the interests of some recipients appeared to be at odds with some of the views expressed by donor-conceived people. The difference of perspectives was reflected by the average value suggested by the different groups: medical and scientific respondents, gamete donors and recipients tended to favour a higher number (10 or more) whereas donor-conceived people and counsellors/social workers and those with an ethical or religious interest favoured a lower limit (the average being 4-5 families).

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In summary, it was the view of the Authority at that time that while the risk of unwitting consanguinity was very small there may be other arguments on the side of leaving donation associated families limited to 10 for reasons linked to the welfare of the parents of donor conceived families and their children. UK Donor Link recommended a limit of 3 families per donor and BICA/Progar suggested the limit should be 6. It was agreed by the group that there was no real evidence base to underpin the concerns that increased numbers of families per donor would constitute a risk sufficient to prevent consideration of a change in policy. The group concluded that an increase in the numbers of families should be considered. The majority view was that this should be raised to 20 families, though a minority suggested that 15 would be more acceptable and some suggested no change. The Group strongly recommended that social science based research should be initiated on outcomes for donors, existing children of donors, and donor conceived families. Research on societal opinion should be facilitated both with respect to current regulatory constraints as well as any possible changes. It was also the view of the group that it was essential for recipients to be made aware of the wishes of the donor in determining family numbers during the consent process for treatment. Such knowledge would allow for choice in the selection of a donor relevant to potential family numbers which may be important for the individual seeking treatment.

Key point: The number of families created through a single donor should be re-evaluated and flexibility in approach encouraged.

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Key point: Social science based research should be initiated on outcomes for donors, existing children of donors, donor conceived children and societal opinion with respect to current circumstances and any change in policy.

C. SHARING AND EXCHANGE SCHEMES Other clinic schemes for increasing donor availability are in existence (Ferraretti et al 2006). These include sperm sharing schemes where male partners of infertile females requiring IVF can donate

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samples for storage to a DI clinic where the IVF treatment is taking place, allowing part funding for

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Key point: Research on sperm sharing schemes should be facilitated to permit further

that treatment. There is experience of this in the UK for a clinic’s in house DI programme as well as export to other clinics. Mirror exchange programmes such as have been reported in Italy where the male partners of females undergoing egg donation treatment can undertake to provide sperm for the DI programme which allows quicker access to the IVF programme than would be usual (8 months rather than 2 years). This has proved acceptable to as many as 60% of patients in egg donation programmes. Both forms of “sharing” entail additional counselling needs. There is a paucity of data around the emotional fall-out through such schemes and significant questions of risks of coercion exist.

evaluation of this option

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D. KNOWN DONATION The National Gamete Donation Trust commissioned a survey in 2007 of clinic practice in the UK in providing for known donation. Of 29 clinics surveyed, 28 agreed to give comment to questions about practice in handling requests for known donation. 22 (75%) provided the service but 6 indicated that the practice was rare and was confined principally to patients from the Asian sub-continent. A minority of clinics providing the service indicated in routine information for patients that the possibility was available. There was inconsistency in approach to the development of clinic policy in this area. Clinic staff perceived that there was an increased need for counselling for these patients and that additional costs were a significant consideration in supplying these services. The group discussed these findings and were of the view that the British Infertility Counselling Association should be asked to provide guidance to clinics in this area of practice. One donor per family will present particular cost implications for clinics providing substantial amounts of such services, particularly relevant to screening and counselling.

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Key point: Guidance is sought on the particular counselling needs of known donors and recipients.

II.

IMPROVING DONOR RECRUITMENT METHODOLOGY WITHIN CLINICS A.

PROCESSING OF DONORS

There are a number of stages in the processing of donors in recruitment centres. These typically follow a progression through: •

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Handling initial contact



Genetic and Medical History

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352 353 354 355 356 357



Screening semen analysis



Blood borne virus screening



Other screening tests



Counselling



Storage



Repeat testing



Release of specimens for treatment

Some centres carry out screening tests and counselling arrangements in slightly different ways. Figures published from Newcastle (Paul et al 2006 (Table 6)) are typical of many DI centres in the country.

Table 6 Attrition of Donors Numbers (%) of potential donors Applicants Rejected at initial phone call

1101 (100.0) 87 (7.9)

92.1

Defaulted semen analysis

308 (28.0)

64.1

Rejected at semen analysis

595 (54.5)

10.1

40 (3.6)

3.6

Released donors

358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375

Attrition (% of total applicants still in programme)

Paul et al (2006) While some donors may be rejected at the first contact (7.9%) during telephone discussion around process and initial medical history, a significant proportion (28.0%) are lost between the point of first contact and submission of the first semen sample. It is not clear why many default at this stage, though it is clearly important that donor enquiries are dealt with promptly and phone calls returned. The issue of lab time for sample provision at times in the day/week which are convenient for donors is a possible area for improvement. This would entail increased service provision costs but these may be supportable if attrition rates were to fall. The timing of Blood Borne Virus (BBV) screening was also discussed. There is variability in approach to this with some centres not freezing specimens until BBV negativity is confirmed. This may slow the process and contribute to donor attrition. Safety issues in relation to unscreened samples being frozen were aired. The risks, while not absent, are probably very low. This has been considered by a separate working group on screening guidelines for sperm, egg and embryo donation, their report will be published in the next few months.

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376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407 408

Variability in sperm quality in individual donors was also discussed which influences the time

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Key point: While in IVF programmes consideration could be given to lowering the quality

(donations) it may take to obtain a suitable number of straws/vials for use. This is a matter which is out with laboratory control. Numbers of donations required to achieve a satisfactory store thus varies and may range form as few as 8-10 separate donations to as many as 40. This information will be important for potential donors at first screening telephone contact and possible high number of attendances may put some men off. In the Newcastle series the average number of straws obtained per donation was 12.6 with 566 straws stored per donor i.e. 44 donations. An occasional frustration for laboratories is the top quality donor who stores several hundred straws and achieves pregnancies very quickly and the lab is left with several hundred straws which cannot be used. This issue is linked to the family number limit currently in place. The data from Newcastle, again mirrored by the Group’s experience, is that few individuals default from post quarantine serological testing (3.6%). It has been suggested that newer techniques of screening donors using PCR technology might speed up the time to release specimens. However, the 2008 updated screening guidelines have found there is insufficient current evidence and validated testing methods to recommend this approach. Whilst ultimately this situation may change, it was the view of the group that such approaches are unlikely to result in greater numbers of donors completing quarantine requirements. B. CHANGING THRESHOLDS FOR ACCEPTANCE OF DONATIONS In the Newcastle series, a high number of donors were rejected at the time of semen analysis (54.5%) on the grounds that sperm quality is below the laboratory standard, both in terms of fresh quality but also in terms of post-thaw survival. There is a lack of clarity around what is the minimum standard of sperm quality (fresh/frozen) suitable for donation. BAS guidelines (1999) indicate that local laboratory standards should be used. Lowering the threshold for sperm suitability could be considered. Quality standards required for semen parameters in DI are not only determined by concerns around effectiveness of treatment but importantly also with safety issues for offspring. While lower quality sperm parameters might be able, through IVF, to generate embryos suitable for transfer, there are concerns that perturbations of DNA are more likely where there is suboptimal sperm. It was felt by the group that it would be undesirable to lower sperm quality standards even for IVF patients though it was noted that individuals who require IVF with donor sperm comprise 15 - 18% of national demand in the last 2 years.

threshold for acceptance of samples on to DI programmes, anxieties exist with respect to safety. Existing sperm quality parameters for acceptance should remain.

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C. CHANGING THRESHOLDS FOR ACCEPTANCE OF DONORS

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Key point: Current recommendations on the maximum age limits of male donors should be

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The group considered the link between increased paternal age and genetic hazard for offspring. The present age limit recommended in the HFEA Code of Practice for sperm donors is 45 years. The British Andrology Society (1999) guidelines proposed a limit of 40 years. The 2008 updated guidelines, shortly to be published, are supportive of maintaining the recommendation at 40 years on the strength of an observed association with increasing paternal age and risks of congenital abnormality in offspring. While it is attractive, against a background of sperm donor shortages to consider re-evaluation of age limits of donors it was felt that it would be inappropriate to recommend change in the current regulatory requirements.

supported.

D. OTHER FACTORS INFLUENCING RECRUITMENT Other issues influencing recruiting process may be of importance. These include public awareness of the problem, local availability of donation centres, anonymity concerns, concerns re inadvertent incest, concerns that matters of a personal nature in relation to medical history, sexual orientation, and any history of sexually transmitted disease might be exposed. These are areas which can be influenced in the construct of models of service provision and process and improved public information services. III.

SERVICE MODELLING Possibilities to consider in improving numbers of donors as outlined above could be summarised in to two streams: that of increasing the pool (improved advertising, public awareness, targeting specific groups e.g. vasectomy patients, sperm sharing, increasing numbers of families, lowering quality thresholds for IVF patients, encouraging donors to “bring a friend”) and decreasing attrition rates (improved efficiency of first response to enquiries, local availability of donor centres, widening lab availability times, adjustment of sperm quality criteria). Fundamental to achieving these twin aims is the focussed deployment of the current limited resources in national efforts to improve recruitment and service availability. The best model to achieve this aim was discussed by the group. Table 7 shows the distribution of patients receiving DI services in 2003-4 within the UK. While a concentration of service not surprisingly exists within London, throughout the rest of the country there is a reasonably even level of delivery of care.

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Table 7 Distribution of patients receiving DI services in UK AREA

% OF UK PATIENTS TREATED

456 457 458 459 460 461 462 463 464 465 466 467 468 469 470 471 472 473 474

London

28

NW

10

South/East

10

SW

10

E. Midlands

6

W. Midlands

9

Yorkshire

7

Scotland

10

Wales

2.7

N. Ireland

1.3

Such information suggests that a model of service delivery needs to be spread throughout the country with perhaps extra availability within the capital. The service needs relate to donor management including the organisation and co-ordination of advertising campaigns, the response to response to enquiries, and the counselling and screening of donors, sample collection and storage of donations. Re-screening of donors at the conclusion of quarantine requires co-ordination as does subsequent distribution of cleared samples. Recipient services include counselling, medical assessment and treatment. The group considered a number of options in respect of a national service framework and felt that a principal of regional (hub) centres providing the bulk of donor management and both regional and local (spoke) centres providing services for recipients was the best proposal. In such a way there would be economies of scale in relation to the costs and energy required in the initial management of donors, an area of substantial attrition in donors (>35%). Hub centres would also be the focus for the co-ordination of distribution of samples through the country and would have responsibility for the monitoring of outcomes and family numbers per donor. The model is summarised in Table 8.

475 476 477 478

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479 REGIONAL/NATIONAL ADVERTISEMENT CO-ORDINATION REGIONAL HUB CENTRES

LOCAL SPOKE CENTRES

Handling initial contact Genetic and Medical History

DONORS

Screening semen analysis Blood borne virus screening Other screening tests Counselling Storage Repeat testing

Repeat testing

RECIPIENTS

Release of specimens for treatment

Counselling

Counselling

Medical Assessment

Medical Assessment

Treatment

Treatment

480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 499 500

Table 8 This concept of hub and spoke services can be considered in pragmatic detail. The HFEA figures (2003-4) on the national distribution of patients (Table 7) provide a useful guide in determining the best deployment of such resource. On the basis of continued distribution of activity in a similar pattern there is potentially a need for 13 regional centres with responsibilities as outlined above. Local centres wishing or needing to provide service for local patients are more difficult to predict though it is possible that all current licensed centres might consider offering service to recipients. It would however not be cost efficient to have all centres expending energy and resource in donor recruitment. It would also be important to capitalise on current national approaches to donor recruitment and the involvement of the National Gamete Donation Trust would be essential.

Table 9 shows a possible distribution of hub centres based on current delivery of treatment in the UK.

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501 502

Table 9 Possible numbers of centres Area

Proposed number Numbers of local of hub centres centres London 3 North West 1 South/East 1 South West 1 East Midlands 1 West Midlands 1 Yorkshire 1 Scotland 2 Wales 1 Northern Ireland 1 TOTAL 13 Let market forces prevail over the number of local centres (85 licensed clinics at present).

503 504 505 506 507 508

Reviewing the distribution of current centres offering DI as per the HFEA Guide to Clinics (2005/6) specific clinics that might be considered as hub centres could comprise facilities in the following locations: 1 2 3 4 5 6 7 8 9 10 11/12 13 14

509 510 511 512 513 514 515 516 517 518 519

% of UK patients treated 28 10 10 10 6 9 7 10 2.7 1.3

AREA London South London West London North/East North West South South West East Midlands West Midlands Yorkshire Scotland West Scotland East/North Wales Northern Ireland

LOCATION OF HUB CENTRE London South London West London North Manchester Southampton Bristol Nottingham Birmingham Leeds Glasgow Aberdeen Cardiff Belfast

No formal approaches have been made to centres in these cities as yet, though potential service leads in most centres have already indicated willingness in principle to participate in such a scheme. IV.

COSTS Detailed costs of the proposed model have yet to be determined but examples of centre budgets are available from Nottingham, Sheffield and Manchester. There are common groupings in those budgets linked to laboratory equipment and consumables, personnel, advertising and clinical treatment costs. Taking account of the staged approach to donor recruitment outlined above, estimates of the cost per donor (initial set up to release of samples) can be as much as £2500 per donor. It would be expected

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520 521 522 523 524 525 526 527 528 529 530 531 532 533 534 535 536 537 538 539 540 541 542 543 544 545 546 547 548 549 550 551 552 553 554 555

that a nationally co-ordinated budget would allow for improved efficiency and economies of scale that would bring this figure substantially down. SUMMARY The task of the working group was to provide an analysis of the current situation of donor insemination services in the UK and make recommendations to the Department of Health on service planning. Against a background of a significant national shortage of donors to meet current and potential need for services, it is the view of the Group that a National Service Framework as modelled above, together with consideration of policy change in relation to family numbers would have a substantial and beneficial effect on donor management and supply as well as improving availability of and access to services for patients. REFERENCES 1. British Fertility society. BFS Donor Survey 2005/6. British Fertility Society http://www.fertility.org.uk/news/pressrelease/06_09-ResultsofDonorSurvey.html (2007) 2. BBC News. Clinics in 'crisis' and having 'great difficulty' getting sperm donors. http://www.bbc.co.uk/pressoffice/pressreleases/stories/2006/09_september/14/sperm.shtml (2006) 3. Human Fertilisation and Embryology Authority: Facts and figures www.hfea.gov.uk/en/1540.html (2007) 4. Human Fertilisation and Embryology Authority. The SEED report. http://www.hfea.gov.uk/en/492.html (2006) 5. Joint UK Fertility Professional Organisations (ABA/ACE/BAS/BFS/RCOG) UK Guidelines for the medical and laboratory screening of sperm, egg and embryo donors Human Fertility In press (2008) 6. National Gamete Donation Trust. Known donation in the UK: a survey of clinic practice. Personal communication (2007) 7. Janssens PMW. No reason for a reduction in the number of offspring per sperm donor because of possible transmission of autosomal dominant diseases Human Reproduction 18 669-671 (2003) 8. Wang C, Tsai MY, Lee MH, Huang SY, Kao CH, Ho HN & Hsiao CK. Maximum number of live births per donor in artificial insemination. Human Reproduction 22 1363 -1372 (2007) 9. Ferraretti AP, Pennings G, Gianaroli L & Magli MC. Semen donor recruitment in an oocyte donation programme. Human Reproduction 21 2482 - 2485 (2006) 10. Paul S, Harbottle S & Stewart JA. Recruitment of sperm donors: the Newcastle-upon-Tyne experience 1994 – 2003. Human Reproduction 21 150-158 (2006)

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