National Infertility Group Report January 2013

3. What are we talking about?

3.1 Definition of infertility

11. Infertility is recognised across much of Europe as a disease state which can be treated by appropriate assisted reproductive technology. The World Health Organization (WHO)³ defines infertility as: "Infertility (clinical definition): a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse." The WHO defines health as "… a state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity." Infertility, accordingly, is a source of diminished health and social well-being.

12. NICE advises in its 2012 consultation document⁴ that over 80% of couples in the general population will conceive in the first year of having regular unprotected sexual intercourse, and over 90% will conceive after 2 years of trying. The chances of conceiving naturally in the first 2 years of trying far outweigh the overall likelihood of successful IVF treatment. The table below sets out the pregnancy rate over 2 years, by age.

Table 1. Cumulative probability of conceiving a clinical pregnancy by the number of menstrual cycles attempting to conceive in different age categories (assuming vaginal intercourse occurs twice per week).

Adapted in NICE Fertility Guideline consultation 2012⁴, from Dunson et al, 2004.

Age of mother	% Pregnant after 1 year (12 cycles)	% Pregnant after 2 years (24 cycles)
19-26	92	98
27-29	87	95
30-34	86	94
35-39	82	90

Table 2. Research undertaken in the North East of Scotland⁵, showed that with regular unprotected sexual intercourse, 94% of women aged 35 years, and 77% of those aged 38 years, will conceive after 3 years of trying (2009).

Age of mother	% Pregnant after 3 years
35	94
38	77

3.2 Three levels of care

13. Previous working groups on infertility in Scotland - the Expert Advisory Group on Infertility Services in Scotland⁶ and its predecessor 'Infertility Services in Scotland'⁷ (1993) - used a model of services within a framework of three levels of care that is still generally used. These are:

• Level I: initial investigation and management provided by the primary care team.
• Level II: further investigation and management provided by a special interest team in a general hospital gynaecology department.
• Level III: specialist care provided in one of Scotland's four tertiary referral centres (Aberdeen, Dundee, Edinburgh and Glasgow). These centres will also provide Level II care for those couples living within their own catchment areas.

14. Level I care should be couple-based, cover basic history-taking and clinical examination and include laboratory investigations to evaluate the woman's general health status, to confirm ovulation and to assess the quality of the semen of the man. Appropriate diet and lifestyle advice should be given and timely referral to Level II should be arranged. Level II care involves further management of couples referred following completion of basic assessment in Level I. The main investigation undertaken in Level II is tubal patency testing and Level II treatments include ovulation induction and occasionally intra-uterine insemination (IUI), with timely referral to Level III. Level III care involves the provision of assisted conception techniques requiring a licence from the Human Fertilisation and Embryology Authority (HFEA)⁸, including in vitro fertilisation (IVF) and intra-cytoplasmic sperm injection (ICSI). IUI became an HFEA licensed treatment in 2007 and is now mostly carried out in level III centres.

3.3 The main issue is IVF/ICSI

15. In practice, this report concentrates on Level III treatments; assisted conception techniques involving IVF. The report refers to other levels of care where appropriate.

3.4 How are IVF services arranged in Scotland?

16. For Level III services, each of the 14 territorial NHS Boards in Scotland commissions cycles of IVF/ICSI from one of the four specialist tertiary referral centres in the NHS (Aberdeen, Dundee, Edinburgh and Glasgow).

17. The activity and success rates of each of the units in Scotland are reported to the HFEA¹⁶ and the latest published data are shown in Appendix D.

18. Each NHS Board sets out the criteria which couples must meet to be accepted for treatment and has a contract with the provider unit which agrees the number of cycles of treatment which will be carried out on the Board's patients in any given year. The number of cycles is effectively the supply of treatment provided by a Board. If the demand for treatment is greater than this supply then waiting times increase. Long waiting times are one significant reason why couples choose to fund their own treatment either in an NHS provided service or in the private sector.

19. Provider units hold separate waiting times for each of the Health Boards, so the waiting time of a couple is not necessarily the result of the capacity of the provider unit but is a result of the commissioning arrangements of the Health Board in which they reside.

20. There are wide variations in the provision of infertility services amongst NHS Boards, including waiting times, the number of cycles of IVF offered, the definition of a cycle and eligibility criteria. Table 4 on page 15 sets out some of this variation.

21. Table 3 sets out numbers of NHS and self-funded IVF treatment cycles by NHS Board during 2011/12.

Table 3. Numbers of NHS-funded and self-funded IVF treatment cycles by NHS Board of residence of patient.

NHS Board	Number of fresh cycles in 2011/12 NHS-funded	Number of fresh cycles in 2011/12 Self-funded	Number of fresh cycles in 2011/12 Total
Greater Glasgow & Clyde	388	81	469
Lanarkshire	185	38	223
Ayrshire & Arran	118	24	142
Dumfries & Galloway	33	7	40
Tertiary centre (Glasgow)	724	150	874
Lothian	195	159	354
Borders	33	27	60
Tertiary centre (Edinburgh)	228	186	414
Grampian	120	120	240
Highland	70	69	139
Orkney	12	6	18
Shetland	10	5	15
Tertiary centre (Aberdeen)	212	200	412
Fife	55	57	112
Forth Valley	54	43	97
Tayside	85	65	150
Western Isles	10	2	12
Tertiary centre (Dundee)	204	167	371
Scotland	1368	703	2071

Self-funding is patients paying for treatment in NHS centres (Dundee, Edinburgh, Glasgow), or University centres (Aberdeen). These figures do not include treatment undertaken in the private sector.

3.4.1 The financial arrangements for IVF are different to other NHS services

22. We know that where patients do not meet the access criteria for IVF they can opt to 'self-fund' in an NHS or University managed facility or in the private healthcare sector. Generally, self-funding in an NHS/University facility is cheaper than treatment in a private clinic. Furthermore, a proportion of patients who do meet the NHS access criteria and who want to avoid long NHS waiting times choose to self-fund.

23. Reliance on self-funding is a core element of three of the four NHS centres, where income from patients self-funding has, for many years, helped to subsidise the provision of NHS treatment.

24. Not all the patients included in the activity shown in the four NHS centres are fully funded by the NHS. Indeed, 34% of fresh cycles are paid for by patients treated in NHS units. The reasons behind this lie in the way in which these units were initially developed.

25. In Aberdeen the IVF Unit is administered by the University of Aberdeen, which employs the staff and owns the equipment. The NHS contracts with the University for an agreed number of cycles on an annual basis. The remaining activity within the Unit is funded by patients themselves. Often patients self-fund because of prolonged waiting times but in many instances it is because the patients do not meet NHS eligibility criteria.

26. The Unit in Dundee has been providing IVF treatment since the early 1980s and started offering self-funded treatment in 1994. This was around the time Health Boards started contracts with Units and it was realised that there was a market for those who would not be eligible for NHS-funded treatment and who could not afford or did not wish to access treatment at a private Unit. Since that time, the tariff has been set based on the number of cycles the unit can provide per year and takes into account all expenditure including staffing, overheads, equipment, and consumables. The unit is non profit making; the self-funded income supplements the income from NHS contracts and keeps the Unit viable.

27. NHS Boards have occasionally made contracts with private fertility units to provide cycles of IVF to reduce waiting times.

3.5 Why do we have a problem of inequity and long waits?

28. The National Infertility Group acknowledges that, although the EAGISS report⁶ was a well-evidenced piece of work, the implementation of its recommendations has varied in NHS Boards across Scotland. EAGISS recommended that a Health Board with a population of 250,000 would need to commission 154 cycles of IVF per annum. This would mean a total of 3,080 cycles for a Scottish population of 5 million. Yet today NHS Boards are only commissioning 1368 cycles. The cost per cycle has doubled since EAGISS made its recommendations.

29. There are several reasons why the EAGISS guidelines have not been uniformly implemented:

• NHS Boards have a responsibility to spend the funds they receive from the government in a way that maximises the health of their population. The benefit of infertility treatment, in spite of the emotional stress associated with it, is seen as a low priority compared with the treatment of other conditions with more evident consequences in terms of premature death, disease and disability.
• The improvement of effective and efficient treatment services has been the major focus of the NHS in Scotland in the last decade. Targets have been put in place for a wide range of healthcare activities, yet none of these has required NHS Boards to improve access to IVF treatment.
• Targets for treatment waiting times have been put in place nationally. The exclusion of IVF from these has meant that large differences between NHS Boards have been able to persist and develop.
• Although the incidence of infertility has not changed, the demand for treatment has grown due to other factors such as the choice couples make to delay starting a family.
• IVF and ICSI have become increasingly the treatment of first choice for infertility - particularly male factor infertility - in preference to other modes of treatment.

30. The Group recognises that the Scottish Government and NHS Boards will be faced with many difficult choices around healthcare priorities, but sees no good reason why infertility services across Scotland cannot be better aligned and provided more equitably in future.

3.6 What has been done in the past to manage the problem?

31. The Expert Advisory Group on Infertility Services in Scotland (EAGISS) recorded in its report⁶, published in 2000, that: "The NHS Executive and its Scottish counterpart have acknowledged that infertility management represents a healthcare need." The report noted the wide variations in provision among Scottish Health Boards. The National Infertility Group notes that, 11 years after the publication of EAGISS, equity of access has yet to be achieved across Scotland.

32. The Scottish Executive published the EAGISS report in February 2000 to inform NHS Boards' planning and provision of infertility services in Scotland. These guidelines, which remain extant, recommend that those who are eligible for NHS funded in vitro fertilisation (IVF) treatment should be entitled to a maximum of three NHS funded cycles of assisted conception. This includes a minimum of two transfers of fresh embryos obtained following a full cycle of down-regulation, ovarian stimulation and egg recovery. Where frozen embryos are available, the third NHS-funded cycle should involve transfer of stored embryos.

33. EAGISS further recommends that once accepted onto an assisted conception programme, eligible couples should be permitted to undergo successive cycles within a time frame of their own choosing. They should not return to the end of a waiting list following an unsuccessful cycle of treatment.

34. EAGISS also recommends that NHS-funded assisted conception should be offered to couples who meet the following eligibility criteria:

• Infertility with an appropriate diagnosed cause, of any duration

or

• Unexplained infertility of at least 3 years duration
• Female partner aged <38 years at the time of treatment
• Neither partner previously sterilised
• No child living with the couple in their home
• Less than three previous embryo transfers funded from any source

35. In 2007, the Government conducted a stakeholder consultation on views about access to Level III infertility services, with the aim of producing recommendations on access for NHS Boards across Scotland. The report of the review was published¹⁰ in March 2007, and recommendations for access to services were sent to NHS Board Chief Executives.

36. The 2007 recommendations were:

• The upper age limit for access to NHS-funded Level III assisted conception treatments (ACT) should be 39 years inclusive, i.e. the woman should be before her 40th birthday at the time of treatment.
• In addition, the upper age limit should not apply for replacement of frozen embryos which were created from previous treatments occurring before the patient's 40th birthday, i.e. if a woman is in the middle of eligible cycles of treatment, then the frozen embryo can still be used after the 40th birthday.
• Timing - once accepted onto an ACT programme patients should be allowed to undergo successive cycles of Level III ACT within a reasonable timescale agreed between themselves and the clinicians providing the treatment.

37. The NICE Guideline on Fertility was first published in 2004¹¹ and is currently undergoing a partial review. A consultation was launched in 2012⁴, and publication of the updated guideline is planned for 20 February 2013. The NICE Guideline on Fertility is being developed for use in England, Wales and Northern Ireland. The guideline is not mandatory.