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Eligability criteria

Assisted Conception Policy
NHS Eligibility Criteria for assisted conception
services (excluding In vitro fertilisation (IVF)
Intracytoplasmic sperm injection (ICSI)
treatment) for people with infertility in
Nottinghamshire County.
February 2011
Although Primary Care Trusts (PCTs) and East Midlands Specialised
Commissioning Group (EMSCG) were abolished at the end of March 2013
with the formation of 5 Nottinghamshire County wide clinical
Commissioning Groups (CCGs) policies that were in place prior to 1 April
2013 remain in place to ensure a consistent approach.

The NHS Nottingham North & East Clinical Commissioning Group have
adopted this policy, in its existing form, at a meeting of its Governing Body
on 20 August 2013.

This policy sets the overall parameters within which care will be delivered.
NHS Nottinghamshire County Assisted Conception Policy - Revised Feb 2011
1. Introduction

This paper sets out the criteria for access to NHS funded specialist fertility services
for patients who are the responsibility of NHS Nottinghamshire County.
In response to the publication of the East Midlands Specialised Commissioning
Group's Commissioning Policy on In Vitro Fertilisation (IVF), Intracytoplasmic Sperm
Injection (ICSI) within Tertiary Infertility Services (1st December 2010, version 2)
NHS Nottinghamshire County have reviewed the existing infertility policy and made
necessary revisions to ensure consistency in eligibility criteria between the
interlinking policies.
This policy covers the provision of Donor Insemination (DI), Intrauterine Insemination
(IUI) and Oocyte Donation (OD) only and should be read in conjunction with the East
Midlands Specialised Commissioning Group Commissioning Policy for IVF / ICSI
within Tertiary Infertility Services, (1st December 2010, version 2).
It sets out the minimum entitlement and service that will be provided for NHS fertility
services across the health community. IVF and ICSI services are commissioned
separately by the East Midlands Specialised Commissioning Group.
Couples requiring Pre-Implantation Genetic Diagnosis will be considered under the
current East Midlands Specialised Commissioning Group Commissioning Policy for
Pre-Implantation Genetic Diagnosis.
Initial investigation of patients is usually carried out by a network of specialist
gynaecologists at NHS Hospital Trusts throughout the Nottinghamshire area. Access
to fertility services for routine tests, investigation and diagnosis is available via GP
referral using the Assisted Conception Assessment Sheet (appendix C).
In any healthcare system there are limits set on what NHS funded care is available
and on what people can expect. Primary Care Trusts (PCTs) are required to achieve
financial balance; they have a complex task in balancing this with an individual's
rights to health care. It is the purpose of the criteria set out here to make the limits
on fertility treatment fair, clear and explicit.
The National Institute for Clinical Excellence (NICE) provides guidance on NHS
fertility services and the same principles have been used to develop the local policy.
This policy should be read in conjunction with the NICE Fertility Guidance available
on their web site at.
The NICE Guidance places NHS assisted fertility services firmly in the mainstream of
NHS provision, and therefore as a result, patients will expect the NHS to provide this.
Abbreviations used in the document are explained in Appendix A.
Definitions of technical terms are contained in Appendix B.
Appendix C is the assisted conception funding assessment sheet. It is a mandatory
requirement that the assessment sheet is completed for NHS funding to be
considered.
NHS Nottinghamshire County Assisted Conception Policy - Revised Feb 2011 Infertility is defined, in accordance with the EMSCG Commissioning Policy for IVF /
ICSI within Tertiary Infertility Services (1st December 2010v2), as failure to conceive
after frequent unprotected sexual intercourse for one to two years in couples in the
reproductive age group or by undertaking 6 cycles of Donor Insemination without
conceiving or by having a defined tubal blockage thereby preventing conception.
Around 84% of couples attempting to conceive as a result of regular sexual
intercourse are successful after trying for one year. After two years this figure rises
to 92%. Female fertility declines with age and for women aged 38 about 77% of
those who have regular unprotected sexual intercourse will get pregnant after 3
years.
At any point in time, the estimated prevalence of infertility is one in seven couples in
the UK. A typical Primary Care Trust can expect about 230 new consultant referrals
(couples) per 250,000 head of population per year (NICE CG11, 2004). Table 1
summarises the expected demand per year for Nottinghamshire County and
Nottingham City PCTs.
The need for such services may increase due to the trend towards later first
pregnancies and an increasing number of remarriages. Demand is also increasing
due to increased public awareness of treatment possibilities. It is likely that there is
unexpressed and/or unmet demand, particularly from women with secondary
infertility (those who have conceived before but do not necessarily have a child).
The following table summarises the expected demand per year of infertile couples
based on new consultant referrals for NHS Nottinghamshire and NHS Nottingham
City.
Table 1: Expected demand for infertility referral for treatment per year
Area
Total population1
Demand estimate per
year (230 couples per
head
population
250,000)
Nottinghamshire County 650,000
PCT
Nottingham City PCT
1 EMPHO: based on 2001 census

Causes of infertility
Review of clinical studies of couples seeking treatment, provide the following
approximated proportions for the principal causes of infertility. A significant proportion
of couples will have more than one cause and the distribution varies between primary
and secondary infertility.
Ovulatory failure Low sperm count or quality There is evidence that infertility causes considerable emotional stress and distress, which may affect many areas of couples' lives and can result in social handicap. NHS Nottinghamshire County Assisted Conception Policy - Revised Feb 2011
Types of fertility treatment
There are three main types of fertility treatment: medical treatment (such as drugs for
ovulation induction); surgical treatment (e.g. laparoscopy for ablation of
endometriosis); and assisted reproduction.
Assisted reproduction techniques include:
Intrauterine insemination (IUI) In vitro fertilisation (IVF) Intra-cytoplasmic sperm injection (ICSI) Donor insemination (DI), oocyte (egg) donation (OD) and cryo-preservation (oocytes and/or embryos)
NB: Provision for IVF/ICSI is not covered by this policy. Refer to the East Midlands
Specialised Commissioning Group Commissioning Policy for IVF / ICSI within
Tertiary Infertility Services (1 December 2010v2)
NICE does not recommend assisted reproduction procedures like gamete
intrafallopian transfer (GIFT) or zygote intrafallopian transfer (ZIFT) and these will not
be funded by the NHS.

All couples are eligible to receive treatment of Clomifene Citrate. Medication should
only be prescribed following clinical investigation in line with the NICE Clinical
Practice Algorithm, Fertility - Assessment and treatment for people with fertility
problems. February 2004
2. Eligibility Criteria
Establishing eligibility under this Policy
All couples are eligible for consultation and advice in primary care.
Guidance for referral of infertile patients is included in the assisted conception
assessment sheet (See Appendix C.)
A couple in the reproductive age group who fail to conceive after frequent
unprotected sexual intercourse for one to two years (or by undertaking 6 cycles of
Donor Insemination without conceiving or by having a defined tubal blockage thereby
preventing conception) should be offered further clinical investigation including
semen analysis and assessment of ovulation as appropriate.
Where there is clear reproductive pathology, infertility of any duration will be
considered. This will include couples who cannot achieve full sexual intercourse due
to disability. Eligibility for NHS funded treatment will be assessed against the
treatment referral criteria and this may, in turn, affect the decision to investigate.
Priority for treatment
Agreed eligibility criteria have been set so that couples with the best chance of
success are given priority over others in order to produce the best outcomes.
Following referral, couples should have a prognostic estimate that the successful
outcome of a cycle will be greater the 10%.

Criteria for referral
In order to achieve the maximum benefit for the resources available the following
referral criteria should be used by referring physicians.
NHS Nottinghamshire County Assisted Conception Policy - Revised Feb 2011 The establishment of these access criteria should be undertaken by the
patients' GP to ensure that only appropriate couples who meet the terms of the
policy are referred.


Table 2: Eligibility Criteria
23 – 39 years
Patient should be referred by the age of 39 years.

NB: Patient should be informed that any stimulation
treatment must take place before the patient's 40th
birthday. This applies to stimulation treatment both for
fertility procedures under this policy and IVF / ICSI.

55 years or younger >19 BMI <30 BMI <35
Welfare of Child The welfare of any resulting children is paramount. In order to take into account the welfare of the child, the centre should consider factors which are likely to cause serious physical psychological or medical harm, either to the child to be born or to any existing children of the family. This is a requirement of the licensing body, Human Fertilization and Embryology Authority. Family Structure No living children from current or previous relationship(s), including adopted children, but excluding foster children. There needs to be an explicit and recorded assessment that the social circumstances of the family unit have been considered within the context of the assessment of the welfare of the child. Both partners must not be a current smoker The couple are registered with a NHS Nottinghamshire County GP practice. Written consent to treatment is required from both partners Any cycle of infertility treatment already undertaken (whether self or NHS funded) will be taken into account when determining NHS funding entitlement. NHS Nottinghamshire County Assisted Conception Policy - Revised Feb 2011 3. Treatment Protocol

The treatment protocol recommended by NICE (NICE CG11, 2004) should be
followed. Lifestyle, medical and non-invasive surgical treatments for infertility should
be attempted before considering options like IUI, IVF and ICSI.
Treatment provision
NHS funding will provide a maximum of 6 cycles of donor insemination (DI) or a
maximum of 3 cycles of intrauterine insemination (IUI) treatment.
Treatment should be started no later than 12 months from the decision to offer
assisted conception.
Suitable couples should undertake DI (subject to availability and/or patient choice) or
IUI before being considered for IVF/ICSI under the East Midlands Specialised
Commissioning Group Commissioning Policy for Tertiary Infertility Services.
Availability of Intrauterine Insemination (IUI)
Couples who fail to conceive after 1-2 years unprotected sexual intercourse or 6
cycles of DI and fulfill the eligibility criteria may be offered intrauterine insemination
(IUI) if clinically appropriate.
Couples will normally be offered no more than a maximum of 3 IUI treatments.
Couples who do not conceive after IUI will have a full entitlement to IVF in line with
the stated eligibility criteria in the East Midlands Specialised Commissioning Group
Commissioning Policy for IVF / ICSI within Tertiary Infertility Services 1st December
2010v2)
Couples who choose not to have IUI and progress straight to IVF, will not be
permitted to be offered IUI if IVF fails.
Donor Sperm
This will be funded only where azoospermia or severe oligospermia is present or to
avoid transmission of inherited disorders to a child where the couple meet the other
eligibility criteria.
This would mean up to 6 cycles of donor insemination, or a maximum of 3 cycles of
IUI if required, and in addition to IVF entitlement if required.
Donor Egg
One attempt at donor egg treatment will be available only to those women who have
undergone premature ovarian failure due to an identifiable pathological or iatrogenic
cause or to avoid transmission of inherited disorders to a child where the couple
meet the other eligibility criteria. NHS funding will cover the cost of the Donor Egg
Register.

Surrogacy
NHS Nottinghamshire County will not provide routine funding for the medical
treatment required to give effect to a surrogacy arrangement because:
(a) this treatment is not considered by NHS Nottinghamshire County to be a priority
for NHS investment,
NHS Nottinghamshire County Assisted Conception Policy - Revised Feb 2011 (b) NHS Nottinghamshire County is unlikely to be in a position to be able to reach an
assessment as to whether the parties have concluded a lawful surrogacy
arrangement, and
(c) NHS Nottinghamshire County is concerned that the funding of such treatment
raises substantial risks that NHS bodies and doctors providing care connected to
surrogacy arrangements would be exposed to unknown medico-legal risks.

Surrogacy, or any assisted conceptions involving surrogacy do not form part of this
policy. Refer to NHS Nottinghamshire County Policy for Surrogacy for further
information.

Embryo Ovarian or Testicular Tissue, Egg and Sperm Storage
Embryo freezing and storage is available to couples meeting the eligibility criteria for
IVF / ICSI. Refer to the East Midlands Specialised Commissioning Group
Commissioning Policy for IVF / ICSI within Tertiary Infertility Services (1st December
2010 v2) for details.
Ovarian or testicular tissue storage will not be carried out outside a clinical trial.
These are currently experimental.
Where clinically appropriate Pre-Treatment Sperm Freezing and storage will be
offered as part of the core treatment for IVF / ICSI for those couples meeting the
eligibility criteria for assisted conception. Sperm will be stored for three years
according to HFEA Guidance.

Sterilisation
Couples where one partner has been sterilised will not be eligible for treatment, even
if a successful reversal has been achieved. Reversal of sterilisation is not routinely
available as an NHS funded treatment.


4. Exceptional circumstances
In the rare or exceptional circumstances where a couple or clinician feel that the
couple represent a special case then an application can be made to the PCT's
Individual Funding Request Panel for consideration of exceptional funding. For
couples to be considered for exceptional funding, an Individual Funding Request
Form must be completed in full and submitted to the Individual Funding Request
Team for consideration.
5. Review
These treatment criteria will be reviewed in February 2012 or in the light of any new
guidance, whichever is the earliest.

References
NICE Clinical Guideline 11, Fertility: assessment and treatment for people with
fertility problems (2004)
EMSCG P006v2 Commissioning Policy for In Vitro Fertilisation (IVF) /
Intracytoplasmic Sperm Injection (ICSI) within Tertiary Infertility Services (1st
December 2010 v2)
Van der Spuy, Z. M., Steer, P.J., McKusker, M., et al. (1988) Outcome of pregnancy
in underweight women after spontaneous and induced ovulation. BMJ 296, 962-967.
NHS Nottinghamshire County Assisted Conception Policy - Revised Feb 2011 Appendix A

Abbreviations used
Body Mass Index
Donor Insemination
General Practitioner
Human Fertilisation and Embryology
Authority
Intracytoplasmic sperm injection
Intra-uterine insemination
In vitro fertilisation
National Institute of Clinical Excellence
Oocyte (Egg) Donation
Primary Care Trust
NHS Nottinghamshire County Assisted Conception Policy - Revised Feb 2011 Appendix B
Definitions

Term
Definition
Further information
The healthy weight range is based Patient. Uk on a measurement known as the Body Mass Index (BMI). This can
be determined if you know your NHS Direct weight and your height. This calculated kilograms divided by the square of BBC Healthy Living your height in metres. In England, people with a body mass index between 25 and 30 are categorised as overweight, and those with an index above 30 are categorised as obese. Intra Cytoplasmic Sperm Injection Glossary, HFEA
(ICSI): In conjunction with IVF,
where a single sperm is directly injected, by a recognised practitioner, into the egg. A clinic may also use donor sperm or eggs. Intra Uterine Insemination (IUI):
Insemination of sperm into the uterus of a woman. In Vitro Fertilisation (IVF): Patient's As above
eggs and her partner's sperm are
collected and mixed together in a
laboratory to achieve fertilisation
outside the body. The embryos
produced may then be transferred
into the female patient.
Donor Insemination (DI): The
introduction of donor sperm into the vagina, the cervix or womb itself. Oocyte (Egg) Donation: The
process by which a fertile women donates her eggs to be used in the treatment of others or for research NHS Nottinghamshire County Assisted Conception Policy - Revised Feb 2011 Appendix C
Assisted Conception Assessment Sheet
Patient NHS Number: Partner NHS Number: Patient Address: Patient GP Details: Partner GP Details:
Please refer to the EMSCG IVF & ICSI Policy December 2010 & PCT Assisted Conception Policy Feb 2011 for guidance
Criteria
True 'T' or False 'F'
Couple has failed to conceive after frequent unprotected sexual intercourse for 1- 2 years in those of reproductive age, or have a defined tubal blockage thereby preventing conception. Female partner is aged 23 to 39 at the start of the treatment cycle. The Female partner to have a body mass index (BMI) greater than 19 and less than 30 The male partner to be aged 55 years or younger The male partner to have a body mass index (BMI) less than 35 Neither partner has previously been sterilised Both partners must be a non-smokersa. Patients who wish to quit smoking should be referred to New Leaf Nottinghamshire, on 0800 3897712 orBoth partners have no living children from a current or previous relationship(s) including adopted children, but excluding foster children The couples health and social circumstances would pose no significant risk to conception, pregnancy or the resultant child The couple are to be registered with a Nottinghamshire County GP Overall Result (for use by PCT only)

Completed By:……………………………………………………… Designation………………………………………………….
Signed………………………………………………………………. Date………………………………………………………….

Please complete and attach this form to your patient's chosen secondary care provider via the Choose & Book System.
If the couple meet the eligibility criteria please specify couple's preferred provider: CARE Nottingham, NURTURE Nottingham, Burton Hospital, Burton,
Bourn Hall Cambridge, University Hospitals of Coventry & Warwickshire Coventry, University Hospitals of Leicester Leicester, Jessops Hospital Sheffield, CARE
Sheffield.

Source: http://www.nottinghamnortheastccg.nhs.uk/wp-content/uploads/2014/04/7.-Policy-for-Assisted-Conception-Prior-to-IVF-Feb-2011-NNE.pdf