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Response to National Institute for Health and Clinical Excellence Consultation on Draft Scope for Update of Clinical Guideline Fertility: Assessment and Treatment for People with Fertility Problems

15 June 2010
This policy document is a response submitted by the Progress Educational Trust (PET) to the National Institute for Health and Clinical Excellence (NICE)'s Consultation on its Draft Scope (.pdf 60.9KB) for an update of its clinical guideline Fertility: Assessment and Treatment for People with Fertility Problems.
Responses to this consultation were summarised and responded to by NICE (.pdf 438KB) in November 2010. The Final Scope (.pdf 34.9KB) for the update of the clinical guideline was published by NICE in October 2010.
PET is grateful to John Parsons for his contribution to this document.

General At the scoping workshop organised by NICE on 15 April 2010 to discuss the updating of the clinical guideline on fertility, it was indicated that at least one of the developers of the updated guideline would be an ethicist.
An ethicist should not be included in the Fertility (Update) Guideline Development Group, unless this is common practice in developing and updating NICE guidelines. The view that fertility and reproduction are intrinsically ethically problematic, in comparison with other areas of healthcare and biomedicine, is a fallacy that can result in barriers to fertility treatment and impeded reproductive autonomy.
Despite the latter-day emergence of ethics as a specialised discipline with associated qualifications and bureaucracy, there can be no qualification that entitles one human being to know better than another what is fundamentally right and wrong. When assembling the Fertility (Update) Guideline Development Group, ethicists' averred lack of vested interest should not be considered preferable or superior to the clear and coherent interests of patients and those who work in assisted conception.

3.1 (a). This section states that 'it is estimated that infertility affects one in seven couples in the UK'. Section 3.2 (a) states that 'infertility affects approximately 10% of the population'.
Even though these two statements do not necessarily contradict one another, using one figure that relates to a proportion of individuals and one figure that relates to a proportion of couples in the same document is potentially confusing. It is also worth checking that these figures are accurate and recent.

3.2 (a). This section states that 'infertility affects approximately 10% of the population'. Section 3.1 (a) states that 'it is estimated that infertility affects one in seven couples in the UK'.
Even though these two statements do not necessarily contradict one another, using one figure that relates to a proportion of individuals and one figure that relates to a proportion of couples in the same document is potentially misleading. It is also worth checking that these figures are accurate and recent.

3.2 (a). This section states that the 'psychological impact' of infertility 'can be severe in some cases and can lead to social disability'. The use of the term 'social disability' is potentially misleading.
It is true that psychology has an important and underappreciated social component, which means that the debilitating impact of psychological problems involves social dynamics. But the brief reference to 'social disability' here is likely to be interpreted in a more pedestrian sense, of social relationships being impeded by infertility because society stigmatises or excludes the infertile. This does not do justice to the psychological (and therefore partly social) dimensions of infertility.
For these reasons, it would perhaps be clearer to omit the reference to 'social disability' altogether.

3.2 (b). The 'wide variation and often limited access to NHS-funded treatment' referred to in this section is largely attributable to different access criteria used by different primary care trusts. These often include social criteria, which were not referred to in the original NICE clinical guideline on fertility published in 2004, and are not considered in this draft scope for an update of the guideline.
Furthermore, primary care trusts are not clear and consistent as to what investigations for infertility can and should be carried out. Resources could be put to better use if there were more judicious use of tests for infertility. For example, ovulation is often assessed by testing for hormones such as progesterone, when in most cases it could be just as easily assessed by asking the patient whether or not she has regular periods. Laparoscopies and tests of the patency of fallopian tubes are similarly overused.

3.2 (b). This section states that the 'management' of infertility and its treatment 'can be shared, at least in the early stages of investigation, between the GP and hospital-based specialised services'. The notion that the management can be shared, if only in the early stages of investigation, is outdated.
GPs should refer patients to a hospital-based specialised service in order to test for infertility. Basic investigations into the condition, such as semen analysis and follicle-stimulating hormone tests, cannot be correctly interpreted by many GPs.

3.2 (c). This section refers to 'effective and appropriate investigations for men and women' including 'assessing ovulation'.
Assessment ovulation is neither effective nor appropriate when done by testing for hormones such as progesterone, because in most cases it could be just as easily assessed by asking the patient whether or not she has regular periods. 'Assessing ovulation' is an overly formal term for this question, which could perhaps be described in a more straightforward manner in the updated NICE clinical guideline on fertility.

3.2 (c). This section refers to 'effective and appropriate investigations for men and women' including 'assessing tubal damage'. But assessing tubal damage is rarely an effective or appropriate investigation.
It has long been the case that in vitro fertilisation can be used to treat infertility without recourse to either investigative procedures assessing tubal damage, or the corrective surgery that might be required to repair tubal damage.

3.2 (d). This section divides 'fertility treatment' into three categories, the second of which is 'surgical treatment'. It is worth noting that some surgical procedures are commonly offered under the auspices of fertility treatment, despite the fact that they do not result in any significant improvement of fertility.
For example, although removal of fibroids from the uterus may improve fertility in specific instances (depending on which parts of the uterus are affected), there is no evidence that fibroid removal automatically improves fertility. Nonetheless, the misapprehension that fibroid removal automatically improves fertility has been allowed to develop, and unnecessary fibroid removal procedures are conducted as a consequence.

3.2 (e). This section lists examples of 'treatments that deal with means of conception other than normal coitus'.
It is worth noting that three of the examples listed – ' gamete intrafallopian transfer (GIFT)', 'zygote intrafallopian transfer (ZIFT)' and 'pronucleate stage tubal transfer (PROST)' – are principally of historical interest, as they are now rarely used and all but obsolete. There is no longer any compelling case for NHS funding of these treatments.

3.2 (f). This section states that 'the existing NICE clinical guideline on fertility, published in 2004, provided a comprehensive coverage of the subject and allowed for a more evidence-based approach to investigation and management of infertility'.
It is worth noting that while the existing NICE clinical guideline on fertility was much needed, the unfortunate fact is that as of 2010, there are many parts of the UK where it has yet to be implemented.

4.1.1 (c). This section refers to 'men whose sperm has not achieved conception after being used for 3-6 cycles of donor or partner insemination'. This is an overly broad category of the population which requires clarification, as it is not clear what is being inferred from the fact that 3-6 cycles of insemination have not resulted in conception.
For one thing, there are relatively accurate methods for testing the viability and motility of sperm before insemination takes place. Another source of confusion is the conflation between 'donor' and 'partner' insemination.

4.1.1 (d). This section refers to 'women with predisposing factors that affect fertility', but omits any mention of men with predisposing factors that affect fertility. Nor does any other section in this part of the draft scope address this category.
One example of a predisposing factor that can affect fertility in men is cystic fibrosis, which can involve congenital absence of the vas deferens connecting the testicles to the penis. Therefore even if the testicles are able to create viable sperm, there is no means of transporting them appropriately. Other examples include undescended testicles and (applicable to both men and women) the consequences of untreated or repeatedly contracted gonorrhea.

4.1.1 (e). This section specifies that 'people with conditions that require specific consideration in relation to methods of conception, such as...cancer' will be covered by the updated NICE clinical guideline on fertility.
This contradicts section 4.3.2 (r), which specifies that 'applications of cryopreservation in cancer treatment' will be excluded from the updated NICE clinical guideline on fertility.
In our opinion, the updated NICE clinical guideline on fertility should address applications of cryopreservation in cancer treatment. So section 4.3.2 (r) should be omitted, and section 4.1.1 (e) should be retained.

4.1.2 (a). This section specifies that 'women who have reached the natural menopause (natural cessation of periods between 45-55 years with mean age of 51 years)' will not be addressed by the updated NICE clinical guideline on fertility.
Age is indeed a criterion used to determine who is entitled to NHS-funded fertility treatment, but the specified ages are not consistent between different primary care trusts. Indeed, many primary care trusts deny NHS-funded fertility treatment to women who fall well below the 45-55 age range specified here. It needs to be made clear that women under 45 years of age should be able to access treatment.
It is worth noting that age criteria for entitlement to NHS-funded fertility treatment pose a problem not only in terms of upper age limits (above which patients are denied treatment), but also in terms of lower age limits (below which patients are denied treatment). The latter can jeopardise fertile women's chances of successful fertility treatment (required if their partner is infertile), by causing a delay before treatment during which their natural fertility deteriorates.
Figures recently published by the Office for National Statistics show that the typical age for a first-time mother has risen to 29.4 in 2009, compared with 29.3 in 2008 and 28.4 in 1999. This social trend needs to be taken into consideration, when considering the most clinically effective age to receive fertility treatment.

4.3.1 (d). This section specifies that clinical issues covered by the updated NICE clinical guideline on fertility will include 'clinical effectiveness, cost effectiveness and referral for IVF treatment'. One corollary of this is that the update of the clinical guideline must address the question of who should receive fertility treatment.
Criteria used by primary care trusts to determine who is entitled to NHS-funded fertility treatment include age and also lifestyle factors such as body weight (usually measured by body mass index) and smoking. These criteria are inconsistent between different primary care trusts, resulting in inequity.
Aside from the inequity of inconsistent criteria, there are two fundamental problems with using lifestyle factors to determine entitlement to NHS-funded fertility treatment. First, there is a need to establish clearer evidence about the effect of body weight, smoking and related factors upon the outcome of fertility treatment. Second, there is a compelling argument that it wrong in principle to deny fertility treatment on the basis of a patient's lifestyle. To do so is effectively to divide patients into the categories of the deserving and the undeserving.
Implicit in the fact that IVF is (supposed to be) freely available is a good-faith assumption that the state should provide assistance to those who wish to have children. Although there is a case for placing some conditions upon this provision in order to manage public expense, these conditions should not involve a concomitant bad-faith assumption about the fecklessness of patients with unhealthy lifestyles.
It is also worth noting that age criteria for entitlement to NHS-funded fertility treatment pose a problem not only in terms of upper age limits (above which patients are denied treatment), but also in terms of lower age limits (below which patients are denied treatment). The latter can jeopardise fertile women's chances of successful fertility treatment (required if their partner is infertile) by causing a delay before treatment in which their natural fertility deteriorates.
Figures recently published by the Office for National Statistics show that the typical age for a first-time mother has risen to 29.4 in 2009, compared with 29.3 in 2008 and 28.4 in 1999. This social trend needs to be taken into consideration, when considering the most clinically effective age to receive fertility treatment.

4.3.1. This section begins a list of 'key clinical issues that will be covered', but the list omits an item that was present in an earlier iteration of this draft scope, namely 'effectiveness of natural cycle and mild treatment IVF'.
It is not clear why the item was removed. We request that it be reinstated.

4.3.2. This section begins a list of 'issues' that 'were excluded from the original guideline and will remain excluded from the update'. It is obvious from this list that NICE has failed to grasp the fact that non-traditional families are increasingly commonplace, and cannot be easily partitioned from traditional families.
The list appears to reflect a desire on the part of NICE to distinguish infertility attributable to biological factors affecting a traditional couple from infertility attributable to unconventional lifestyle or family arrangements. Such a distinction is no longer tenable. NICE needs to acknowledge that same-sex couples and single people access fertility treatment. Equality and non-discrimination are principles firmly enshrined in law. Same-sex couples can register as civil partners, can adopt children, and cannot legally be discriminated against in providing goods and services.
It is almost certainly unlawful, under the Equality Act (Sexual Orientation) Regulations promulgated through the Equality Act 2006, to single out same-sex couples for special consideration or to continue to ignore the difficulty experienced by same-sex couples in accessing NHS-funded fertility treatment. NICE should not encourage such discrimination. Nor should NICE countenance a situation where a lack of clarity regarding entitlement to treatment makes clinicians targets for possible litigation brought by patients denied treatment.
This update of the NICE clinical guideline on fertility is an excellent opportunity for NICE to make the guideline consistent regardless of sexual orientation.

4.3.2 (c). This section specifies that 'surrogacy in the absence of reproductive pathology' will be excluded from the updated NICE clinical guideline on fertility.
This discriminates against same-sex male couples, who may require surrogacy in the absence of reproductive pathology.

4.3.2 (r). This section specifies that 'applications of cryopreservation in cancer treatment' will be excluded from the updated NICE clinical guideline on fertility.
This contradicts section 4.1.1 (e), which specifies that 'people with conditions that require specific consideration in relation to methods of conception, such as...cancer' will be covered by the updated NICE clinical guideline on fertility.
In our opinion, the updated NICE clinical guideline on fertility should address applications of cryopreservation in cancer treatment. So section 4.1.1 (e) should be retained, and section 4.3.2 (r) should be omitted.

4.5. This section concludes with the following sentence: 'It is important that the developers are mindful of the effective use of NHS resources as well as the value placed on the benefits of assisted reproduction by people seeking fertility treatment.'
This sentence should be omitted. For one thing, it is superfluous in light of the first sentence of this section – 'developers will take into account both clinical and cost effectiveness when making recommendations involving a choice between alternative interventions' – and in light of people's broader familiarity with the fact that NHS resources are circumscribed.
Furthermore, there is a risk that by emphasising the effective use of resources at the outset of the development process, this will foreclose prematurely the options considered by the Fertility (Update) Guideline Development Group. Developers require the latitude to explore ideas thoroughly, before going on to consider the resource implications of those ideas.