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- n/a
- Document type
- Clinical policy
- Place
- Hertfordshire and West Essex ICB
- Output type
- Clinical Policies & Evidence-based Interventions
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Fertility treatment and referral criteria for tertiary level assisted conception (IVF/IUI)
November 2023 v5.1
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Section No. |
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Key Terms |
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Policy Overview – Eligibility Criteria |
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1.0 |
Introduction |
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2.0 |
Commissioning Responsibility |
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3.0 |
Review |
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4.0 |
Specialist Fertility Services Criteria |
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4.2 |
IVF |
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4.3 |
Clinical Indications |
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4.4 |
Intra-Uterine Insemination (IUI) (unstimulated) |
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4.5 |
Same sex couples |
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4.6 |
Egg and sperm donation where no other treatment is available |
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4.7 |
Egg and sperm storage for patients undergoing essential treatments which might render them infertile |
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4.8 |
Chronic viral infections |
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4.9 |
Other treatments not funded within this policy |
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5.0 |
Referrals from primary care |
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Appendices |
Appendix 1 – Document Version Control – Change history |
KEY TERMS
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Term |
Definition |
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Abandoned or unsuccessful Cycle of IVF |
An abandoned cycle is defined as one which is abandoned after ovarian stimulation, and usually where an egg collection procedure is not undertaken due to lack of response or excessive response to gonadotrophins. An unsuccessful cycle includes unsuccessful fertilisation, unsuccessful cleavage of embryos, unsuccessful conception following transfer of embryos. An abandoned, or unsuccessful cycle counts towards the number of commissioned cycles. |
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Cancelled Cycle of IVF |
A cancelled IVF cycle is defined as one which is cancelled prior to ovarian stimulation, so an egg collection procedure is not undertaken. If a cycle is cancelled due to low ovarian reserve the patient’s eligibility for another attempt will be subject to this policy access criteria. |
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Frozen embryo transfer |
Where an excess of embryos is available following a fresh cycle, these embryos may be frozen for future use. Once thawed, these embryos can be transferred to the patient as a frozen transfer |
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Full cycle’ of IVF/ICSI:
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A full cycle of IVF treatment, with or without ICSI, will usually comprise of:
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Infertility |
Infertility is defined as: The inability to conceive through regular sexual intercourse for a period of 3 years, in the absence of known reproductive pathology, or less than 3 years if there is a specific reproductive pathology identified. Where attempting to conceive by sexual intercourse is not possible (for example for people with a physical disability, people with psychosexual disorders or transgender and same sex couples), this will be considered as inability to conceive for the purposes of this policy. |
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Intra-cytoplasmic sperm injection (ICSI) |
Involves injecting a single sperm directly into an egg to fertilise it. The fertilised egg (embryo) is then transferred to the woman’s uterus.
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In-vitro fertilisation (IVF) |
An IVF procedure includes the stimulation of the woman’s ovaries to produce eggs which are then placed in a special environment to be fertilised. The fertilised eggs (embryos) are then transferred to the woman’s uterus. |
Policy overview
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Eligibility criteria
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No. |
Criterion |
Description |
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1. |
Severe / absolute infertility |
A couple where one partner has a diagnosed cause of absolute infertility which precludes any possibility of natural conception, and who meet all the other eligibility criteria, will have immediate access to NHS funded assisted reproduction services. See section 4.3.2 |
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2. |
Sub‐fertility / mild infertility
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Couples with unexplained infertility or mild male factor infertility / subfertility must have had infertility (no conception) of at least three years of ovulatory cycles, despite regular unprotected vaginal sexual intercourse. Couples who have had 12 cycles of unsuccessful IUI in line with section 4.4. Where mild male factor infertility has been
diagnosed, evidence should be provided to demonstrate that, where clinically
indicated and appropriate, any underlying cause has been investigated and
treated in line with NICE guidance (CG156, 2017). |
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3. |
Test for ovarian reserve using Anti-Müllerian Hormone (AMH) level |
AMH is the preferred test for ovarian reserve. If AMH is unavailable, follicle-stimulating hormone (FSH) is acceptable. Should both tests be undertaken, only the AMH will be considered. To be eligible, the patient should have had one of the following tests measured in the last 6 months of referral from secondary care to the specialist IVF provider.
Tests should not be repeated within 6 months, however if out of date at the point of referral, it is the responsibility of the secondary care provider to repeat the test. HWE ICB will only accept AMH or FSH tests which have been arranged through NHS primary, community, or secondary care services for the funding application. |
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4. |
Maternal age, number of cycles and embryo transfers
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For women aged 23 to less than 43 years from the date of referral from secondary care to specialist IVF provider with funding prior approved; Funding will be valid for 12 months or, for women over the age of 42, funding will be valid until their 43rd birthday. The ICB will fund one full cycle of IVF with a maximum of two embryo transfers with or without ICSI (either one fresh and one frozen or two frozen if a fresh embryo transfer was not initially possible). This includes any abandoned / unsuccessful IVF cycles and no further IVF cycles will be funded. All frozen embryos should be used before a new fresh cycle is considered. For the number of embryos placed into the uterus during each embryo transfer See section 4.2.4 |
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5. |
Partner age |
There is no age restriction for a partner who is not undergoing egg harvesting or fertility treatment.
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6. |
Previous specialist fertility treatment |
Previous privately or NHS funded specialist fertility treatment for either partner including IVF and IUI will count towards the IVF or IUI treatment funded by the NHS. Therefore, if either partner has received previous fertility treatment privately but less than they would have been eligible for locally on the NHS, the couple are eligible for NHS funding for the remaining clinically appropriate treatments up to their full local NHS entitlement. If either partner has received the full local NHS entitlement of IVF, IUI or other specialist fertility treatment set out this policy for his or her infertility, whether in the current or any previous relationship, the couple is not eligible for NHS funding. This includes treatment received within or outside of the UK. |
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7. |
Parental status
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Couples are ineligible for treatment if there are any living children from the current or any previous relationships, regardless of whether the child resides with them. This includes any adopted child within their current or previous relationships; this will apply to adoptions either in or out of the current or previous relationships. |
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8. |
Child welfare |
Providers must meet the statutory requirements to ensure the welfare of the child. This includes the HFEA’s Code of Practice which considers the ‘welfare of the child which may be born’ and takes into account the importance of a stable and supportive environment for children as well as the pre‐existing health status of the parents. |
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9. |
Residential status
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Both partners must be registered with a GP in Hertfordshire and West Essex ICB area. If their GP registration is less than 12 months, they can be eligible if they can demonstrate residency of 12+ months in the ICB area they are currently residing. |
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10. |
Smoking status |
Couples who smoke will not be eligible for NHS‐funded specialist assisted reproduction assessment or treatment and should be informed of this criterion at the earliest possible opportunity in their progress through infertility investigations in primary care and secondary care. Couples presenting with fertility problems in primary care should be provided with information about the impact of smoking on their ability to conceive naturally, the impact of smoking on the success rates of IVF the risks of smoking in pregnancy and the adverse health impacts of passive smoking on any children. Smoking cessation support should be provided as necessary e.g., referral to Stop Smoking Service. Both partners must have been non‐smokers for at least 8 weeks at the time of referral to the secondary care provider, and this must be maintained throughout fertility investigations and treatment. This applies equally for partners who are not providing gametes (eggs or sperm) and are not undergoing fertility treatment as passive smoking may affect the fertility of the partner undergoing fertility treatment. Smoking status should be ascertained by carbon monoxide testing from the Stop Smoking Service prior to IVF treatment starting. For the purposes of this policy, use of e-cigarettes or nicotine replacement therapy will be considered equivalent to non-smoking status (NB couples should still have been non-smokers for at least 8 weeks). |
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11. |
Minimum / maximum body mass index (BMI) |
Women undergoing fertility treatment must have a BMI of between 19 and 30 Partners providing gametes (eggs or sperm) must have a BMI of less than 30. Patients outside of this range will not be added to the waiting list and should be referred back to their referring clinician and/or general practitioner for weight management, advice and support if required. There are no BMI criteria for partners who are not undergoing fertility treatment or providing gametes (eggs or sperm). |
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12. |
The minimum investigations required prior to referral from secondary care to the tertiary centre
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Female:
Male:
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13. |
Rubella status |
The woman must be rubella immune. |
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14. |
Previous sterilisation |
Couples are ineligible if previous sterilisation has taken place (either partner), even if it has been reversed. |
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15. |
Medical conditions |
A decision may be made not to provide treatment or funding on other medical grounds not explicitly covered in this document. |
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16. |
Date of eligibility |
Eligibility for treatment commences on the date that the secondary care provider refers the patients to the IVF specialist provider with funding prior approved. |
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17. |
Length of funding variation
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Couples must complete their cycle within 12 months of funding being agreed. An extension of this period will only be considered in exceptional clinical circumstances and with prior agreement from the Individual Funding Request team. For patients receiving fertility treatment that are over the age of 42 years at the point of referral into a specialist fertility provider, funding will only be valid until their 43rd birthday. |
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18. |
Excluded treatments.
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Some of the treatments not funded by the ICB are (see section 4.9):
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1. Introduction
1.1 This Commissioning Policy sets out the criteria for access to NHS funded specialist fertility services for the population of Hertfordshire and West Essex Integrated Care Board (ICB). The paper specifically sets out the entitlement and service that will be provided by the NHS for IVF and other specialist fertility treatments. These services are commissioned by Hertfordshire and West Essex ICB and provided via contracted tertiary care providers.
1.2 Although the terms 'male' and 'female' are used
throughout this policy, Hertfordshire and West Essex ICB recognise that some
people may be defined as male or female at birth but go on to identify as a
different gender or as non-binary. The terminology throughout this policy is
used to clinically define the reproductive capacity of the individual and
identify the appropriate mechanism of assisted conception for their needs.
2. Commissioning responsibility
2.1 Specialist fertility services are considered as level 3 services (or tertiary services). Preliminary levels 1 & 2 are provided and commissioned within primary care and secondary care services such as acute trusts. To access level 3 services the preliminary investigations should be completed at levels 1 & 2.
2.2 Specialist fertility treatments within the scope of this policy are:
- In‐vitro fertilisation and intra‐cytoplasmic sperm injection (IVF & ICSI)
- Donor insemination (DI)
- Intra-uterine insemination (IUI) unstimulated
- Egg and sperm donation where no other treatment is available (this must be self-funded and self-sourced by the patient)
- Blood borne viruses (ICSI + sperm washing)
- Surrogacy (this is not currently funded)
2.3 Formal IVF commissioning arrangements will support the implementation of this policy including a contract between Hertfordshire and west Essex ICBs and each tertiary centre. Quality standards and clinical governance arrangements will be put in place with these centres, and outcomes will be monitored, and performance managed, in accordance with the Human Fertilisation & Embryology Authority (HFEA) Licensing requirements or any successor organisations.
2.4 This policy is specifically for those couples who do not have a living child from their current or any previous relationships, regardless of whether the child resides with them. This includes any adopted child within their current or previous relationships; this will apply to adoptions either in or out of the current or previous relationships.
2.5 Where couples do not meet the criteria however, their clinician feels they have exceptional clinical circumstances, the clinician can make an application for exceptional funding to the relevant ICB’s Individual Funding Request (IFR) Team. All applications will be assessed in line with the relevant ICB’s IFR policy and funding of any exceptional cases is the responsibility of the ICB.
2.6 Couples eligible for funding in line with this policy will be
offered a choice of providers that have been commissioned by Hertfordshire and
west Essex ICB.
3. Review
The
next revision to the policy will be undertaken within 12 months following a
change in national policy or after three years of its ratification.
4. Specialist fertility services criteria
4.1 The ICB only commissions the following fertility techniques recommended by NICE and regulated by the Human Fertilisation & Embryology Authority (HFEA)
4.2 IVF
4.2.1 An IVF procedure includes the stimulation of the women’s ovaries to
produce eggs which are then placed in a special environment to be fertilised.
The fertilised eggs are then transferred to the woman’s uterus.
4.2.2 Ovarian reserve: to be eligible for IVF the patient should have an AMH level of more than 5.4pmol/l or, if AMH is not available, a FSH level lower than 8.9 IU/l measured on day 1-3 of any menstrual cycle. Tests should be measured within the last 6 months of referral from secondary care to the specialist IVF provider. AMH is the preferred test for ovarian reserve. Where both results are obtained, only the AMH will be considered. Only tests arranged through NHS primary, community, or secondary care services will be accepted for the funding application.
4.2.3 For women aged 23 to less than 43 years at the start of treatment, the ICB will fund one cycle of IVF with a maximum of two embryo transfers with or without ICSI (either one fresh and one frozen or two frozen if a fresh embryo transfer was not initially possible). This includes any abandoned or unsuccessful IVF cycles.
For women aged 40 to less than 43 years, there must be a discussion of the additional implications of IVF and pregnancy at this age.
Funding is valid for 12 months or, for women over the age of
42, until their 43rd birthday.
4.2.4 Embryo transfer strategies - Number of embryos to be transferred.
Women under 37 years - a single embryo will be placed into the uterus during each embryo transfer.
Women aged 37 to 39 years – A single embryo will be placed into the uterus during each embryo transfer if there are 1 or more top-quality embryos. If there are no top-quality embryos, then a double embryo transfer can be considered.
Women aged 40 to less than 43 years – Consider a double embryo transfer.
4.2.5 Hertfordshire and West Essex ICB will fund storage of frozen embryos for 1 year following egg collection. Following this period, continued storage will need to be funded by the couple.
4.2.6 If any fertility treatment results in a
living child, then the couple will no longer be considered childless and will
not be eligible for further NHS funded fertility treatments, including the
implantation of any stored embryos. Any costs relating to the continued storage
of the embryos beyond the first calendar year of the retrieval date is the
responsibility of the couple.
4.3 Clinical indications
4.3.1 Unexplained Infertility - To be eligible for IVF treatment, couples should have experienced:
- Unexplained or mild male factor infertility/subfertility for at least three years of ovulatory cycles, despite regular unprotected vaginal intercourse (2-3 times per week) or
- 12 cycles of intrauterine insemination.
A
couple who has conceived within the last 3 years or last 12 cycles of IUI (including
chemical pregnancies), but subsequently experienced miscarriage will not be
considered as having sub-fertility.
4.3.2 Mild
male factor infertility or subfertility can be defined in line with NICE CG156
as; when 2 or more semen analyses have 1 or more variables below the 5th
centile (as defined by the World Health Organization [WHO], 2010). The effect
on the chance of pregnancy occurring naturally through vaginal intercourse
would then be similar to people with unexplained infertility.
4.3.3 Severe / Absolute infertility - Eligible couples with a diagnosed cause of infertility as below will have direct access NHS funded IVF.
(a) Tubal damage, which includes:
- Bilateral salpingectomy
- Moderate or severe distortion not amenable to tubal surgery.
Evidence
shows that for women with moderate or severe tubal damage, tubal surgery solely
for the purpose of fertility is not recommended, although tubal surgery itself
may be part of the management plan for the condition causing the tubal damage.
(b) Premature menopause (defined as amenorrhoea for a period of more than 6 months together with a raised FSH >25 and occurring before the age of 40 years).
(c) Severe / absolute male factor infertility (i.e., azoospermia) which, where clinically indicated and appropriate, has been investigated to rule out any underlying treatable cause and precludes any possibility of natural conception.
Results of semen analysis conducted as part of an initial assessment should be compared with the following World Health Organization reference values*:
- Semen volume: 1.5 ml or more
- pH: 7.2 or more
- Sperm concentration: 15 million spermatozoa per ml or more
- Total sperm number: 39 million spermatozoa per ejaculate or more
- Total motility (percentage of progressive motility and non‐progressive motility): 40% or more motile or 32% or more with progressive motility
- Vitality: 58% or more live spermatozoa
- Sperm
morphology (percentage of normal forms): 4% or more
(d) Polycystic ovary syndrome (PCOS) and other ovulation problems adequately treated (in line with NICE guidance) but no successful pregnancy achieved.
(e) Severe endometriosis where secondary care/community fertility consultant opinion is that IVF is the appropriate treatment (eligibility criteria still apply).
(f) Essential medical treatment causing
infertility as a side effect necessitating IVF/ICSI e.g., chemotherapy for
cancer. (Relevant eligibility criteria still apply).
4.4 Intra-uterine Insemination (unstimulated) (IUI)
4.4.1 NICE guidelines state that unstimulated IUI is a treatment option as an alternative to vaginal sexual intercourse in the following groups:
- People who are unable to or would find it very difficult to have vaginal intercourse because of a clinically diagnosed physical disability or psychosexual problem who are using partner or self-funded donor sperm.
- People with conditions that require specific consideration in relation to methods of conception (for example, after sperm washing where the male is HIV positive)
- People in a same‐sex relationship. See section 4.5.
4.4.2 A
maximum of 6 cycles of unstimulated IUI will only be offered if prior approval
for funding is obtained from the ICB and the couple have previously self-funded
6 cycles.
4.5 Same-sex couples
Female same‐sex couples are entitled to IVF treatment on the NHS following 6 cycles of self-funded IUI and a maximum of 6 cycles of NHS funded unstimulated IUI (which will only be offered if prior approval for funding is obtained from the ICB).
Surrogacy is not funded for male same-sex couples under this policy.
4.6 Egg and Sperm donation where no other treatment is available.
4.6.1 The couple are expected to self-fund an egg or sperm donor. This would include donors which are self-sourced or altruistic donors. Couples may choose to be placed on a waiting list until an altruistic donor becomes available. When funding has been approved it is valid for 12 months only, this should be taken into consideration when sourcing a donor. HWE ICB do not hold any responsibility for the quality and genetics of donor eggs and sperm.
4.6.2 IVF
using a self-funded donor egg will be available to women who have undergone premature
ovarian failure (defined as amenorrhoea >6 months and a raised FSH >25) due
to an identifiable pathological or iatrogenic cause before the age of 40 years
or to avoid transmission of inherited disorders to a child where the couple
meet all the other eligibility criteria.
4.7 Egg and sperm storage for patients undergoing essential treatments which might render them infertile.
This is covered in separate ICB policies. See Gamete Storage at https://hertsandwestessex.icb.nhs.uk/information-clinicians/evidence-based-intervention-policies-prior-approval-applications
4.8 Chronic viral infections
4.8.1 Patients with chronic viral infections who are eligible for IVF treatment should be referred to one of Hertfordshire or west Essex ICB commissioned IVF specialist providers who have the appropriate processing facilities to accommodate these patients.
4.8.2 Sperm washing without IVF can be offered to couples with chronic viral infection (hepatitis C and HIV) in line with NICE guidance as a risk reduction measure to prevent further transmission of infection to the partner and unborn child.
4.8.3 As per NICE guidance, the ICB do not offer sperm washing as part of
fertility treatment for men with hepatitis B.
4.9 Other treatments not funded within this policy.
4.9.1 Surgical sperm retrieval for male infertility is the commissioning responsibility of NHS England and is excluded from the ICB commissioned service.
4.9.2 Pre‐implantation
genetic diagnosis (PGD)This policy does not include pre‐implantation genetic screening as it is not considered
to be within the scope of fertility treatment. This service is commissioned by
NHS England. Providers should seek approval from the Specialist Commissioning
team at NHS England.
4.9.3 Privately
funded care. This
policy covers NHS funded fertility treatment only. For clarity, other than for
egg and sperm donation, patients will not be able to pay for any treatment
which cannot be separated from what is included in the NHS funded package.
Patients who meet the eligibility criteria but agree to commence treatment on a privately funded basis cannot retrospectively apply for NHS funding for any associated costs relating to the private treatment.
4.9.4 Surrogacy and any associated treatment is not commissioned by Hertfordshire and west Essex ICB. This includes part funding during a surrogacy cycle.
4.9.5 Specialist fertility services for members of the Armed Forces. These are commissioned separately by NHS England.
4.9.6 Specialist fertility services for single females are not funded.
5. Referrals from Primary Care
5.1 Couples who experience problems with their fertility must attend their GP practice to discuss their concerns and options. The patients will be assessed within primary care in the first instance. Support to improve lifestyle choices which influence fertility such as smoking, and obesity should be initiated. Couples with unexplained infertility should be referred from primary care after 12 months expectant management and when other lifestyle factors have been optimised. i.e., weight loss and smoke cessation for at least 8 weeks. Referrals are made to the community or secondary care provider using the primary care referral form.
5.2 After assessment in the community or secondary care provider, the decision to refer a couple for IVF or other specialised fertility services will be based on an assessment against the eligibility criteria in this policy. A request for funding must be made using the Prior Approval application form.
5.3 After funding has been approved, referral to the tertiary centre must be via a consultant gynaecologist or an accredited GP with Special Interest (GPwSI) in gynaecology.
Appendix 1. Change History