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Fertility overview

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Fertility

About

What is covered

This pathway covers assessment and treatment for people with fertility problems.
It is estimated that infertility affects 1 in 7 heterosexual couples in the UK. Since the original NICE guideline on fertility published in 2004, there has been a small increase in the prevalence of fertility problems, and a greater proportion of people now seeking help for such problems.
The main causes of infertility in the UK are 'unexplained infertility' (no identified male or female cause), ovulatory disorders, tubal damage, factors in the man, and uterine or peritoneal disorders. In about 40% of cases, disorders are found in both the man and the woman. Uterine or endometrial factors, gamete or embryo defects, and pelvic conditions such as endometriosis may also play a role.
Given the range of causes of fertility problems, the provision of appropriate investigations is critical. These investigations include semen analysis; assessment of ovulation, tubal damage and uterine abnormalities; and screening for infections such as Chlamydia trachomatis and susceptibility to rubella.
Once a diagnosis has been established, treatment falls into 3 main types: medical or surgical treatment to restore fertility and assisted reproduction techniques.

Updates

Updates to this pathway

16 August 2016 Recommendation in intrauterine insemination amended in line with the update of NICE guideline CG156 on fertility problems: assessment and treatment.
11 November 2015 Link to menopause pathway added to oocyte donation
27 January 2015 Hysteroscopic metroplasty of a uterine septum for primary infertility (IPG509) and hysteroscopic metroplasty of a uterine septum for recurrent miscarriage (IPG510) added to tubal and uterine surgery.
22 October 2014 Quality standard on fertility problems added to the pathway.
26 February 2014 Quality standard on children and young people with cancer added to the pathway.

Professional responsibilities

The recommendations in this pathway represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients or service users. Applying the recommendations in this pathway is at the discretion of health and care professionals and their individual patients or service users and does not override the responsibility of health and care professionals to make decisions appropriate to the circumstances of the individual, in consultation with them and/or their carer or guardian.
Commissioners and/or providers have a responsibility to enable the recommendations to be applied (and to provide funding required for technology appraisal guidance) when individual health and care professionals and their patients or service users wish to use them. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this pathway should be interpreted in a way that would be inconsistent with compliance with those duties.

Patient-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Short Text

Everything NICE has said on assessment and treatment for people with fertility problems in an interactive flowchart.

What is covered

This pathway covers assessment and treatment for people with fertility problems.
It is estimated that infertility affects 1 in 7 heterosexual couples in the UK. Since the original NICE guideline on fertility published in 2004, there has been a small increase in the prevalence of fertility problems, and a greater proportion of people now seeking help for such problems.
The main causes of infertility in the UK are 'unexplained infertility' (no identified male or female cause), ovulatory disorders, tubal damage, factors in the man, and uterine or peritoneal disorders. In about 40% of cases, disorders are found in both the man and the woman. Uterine or endometrial factors, gamete or embryo defects, and pelvic conditions such as endometriosis may also play a role.
Given the range of causes of fertility problems, the provision of appropriate investigations is critical. These investigations include semen analysis; assessment of ovulation, tubal damage and uterine abnormalities; and screening for infections such as Chlamydia trachomatis and susceptibility to rubella.
Once a diagnosis has been established, treatment falls into 3 main types: medical or surgical treatment to restore fertility and assisted reproduction techniques.

Updates

Updates to this pathway

16 August 2016 Recommendation in intrauterine insemination amended in line with the update of NICE guideline CG156 on fertility problems: assessment and treatment.
11 November 2015 Link to menopause pathway added to oocyte donation
27 January 2015 Hysteroscopic metroplasty of a uterine septum for primary infertility (IPG509) and hysteroscopic metroplasty of a uterine septum for recurrent miscarriage (IPG510) added to tubal and uterine surgery.
22 October 2014 Quality standard on fertility problems added to the pathway.
26 February 2014 Quality standard on children and young people with cancer added to the pathway.

Sources

The NICE guidance that was used to create the pathway.
Fertility problems: assessment and treatment (2013 updated 2016) NICE guideline CG156
Hysteroscopic metroplasty of a uterine septum for recurrent miscarriage (2015) NICE interventional procedure guidance 510
Hysteroscopic metroplasty of a uterine septum for primary infertility (2015) NICE interventional procedure guidance 509
Laparoscopic helium plasma coagulation for the treatment of endometriosis (2006) NICE interventional procedure guidance 171
Fallopian tube recanalisation by guidewire (2004) NICE interventional procedure guidance 71
Falloposcopy with coaxial catheter (2004) NICE interventional procedure guidance 62
Fertility problems (2014) NICE quality standard 73
Cancer services for children and young people (2014) NICE quality standard 55

Quality standards

Cancer services for children and young people

These quality statements are taken from the cancer services for children and young people quality standard. The quality standard defines clinical best practice in cancer services for children and young people and should be read in full.

Quality statements

Lifestyle advice

This quality statement is taken from the fertility problems quality standard. The quality standard defines clinical best practice in fertility problems and should be read in full.

Quality statement

People who are concerned that it is taking longer than expected to conceive are given advice on the impact that lifestyle can have on their chances of getting pregnant.

Rationale

Lifestyle factors, including body weight, smoking, alcohol and recreational drug use can have an impact on people’s chances of getting pregnant. People who are trying to have a baby and are concerned it is taking longer than expected, should be given written and verbal advice about changes that can be made to their lifestyle that can help. This information should be provided for both men and women. Positive outcomes from lifestyle change interventions may reduce the need for onward referrals.

Quality measures

Structure
Evidence of local arrangements to ensure that people who are concerned that it is taking longer than expected to conceive are given written and verbal advice on the impact that lifestyle (including body weight, smoking, alcohol and recreational drug use) can have on their chances of getting pregnant.
Data source: Local data collection.
Process
Proportion of people who are concerned that it is taking longer than expected to conceive who are given written and verbal advice on the impact that lifestyle (including body weight, smoking, alcohol and recreational drug use) can have on their chances of getting pregnant.
Numerator – the number in the denominator given written and verbal advice on the impact that lifestyle (including body weight, smoking, alcohol and recreational drug use) can have on their chances of getting pregnant.
Denominator – the number of people who are concerned that it is taking longer than expected to conceive.
Data source: Local data collection. NICE clinical audit tool for fertility: people concerned about delays in conception: audit standard 1b.
Outcome
People who are concerned that it is taking longer than expected to conceive feel informed about the impact that lifestyle can have on their chances of getting pregnant.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and public health practitioners, and commissioners

Service providers (such as primary care, fertility, pre-conception advice and gynaecology services) ensure that written information about the impact of lifestyle on fertility is available to share with people who are concerned that it is taking longer than expected to conceive.
Healthcare professionals and public health practitioners give written and verbal information about the impact of lifestyle on fertility to people who are concerned that it is taking longer than expected to conceive.
Commissioners (clinical commissioning groups and NHS England area teams) ensure that primary, secondary, community and specialist fertility care providers give written and verbal information about the impact of lifestyle on fertility to people who are concerned that it is taking longer than expected to conceive.

What the quality statement means for patients

People who are concerned that it is taking them longer than expected to become pregnant are given advice (both spoken and in writing) on how their lifestyle can affect their chances of getting pregnant, especially if they smoke, drink alcohol, use recreational drugs or are over or underweight.

Source guidance

  • Fertility (2013) NICE guideline CG156, recommendations 1.2.3.1–3, 1.2.4.1–4, 1.2.6.1–4 and 1.2.10.1.

Equality and diversity considerations

Information given about fertility problems should be culturally appropriate. It should also be accessible to people with additional needs such as physical, sensory or learning disabilities, and to people who do not speak or read English. People with fertility problems should have access to an interpreter or advocate if needed.

Referral for specialist consultation

This quality statement is taken from the fertility problems quality standard. The quality standard defines clinical best practice in fertility problems and should be read in full.

Quality statement

People are referred for specialist consultation if the woman has not conceived after 1 year of intercourse or after 6 cycles of artificial insemination, or earlier in certain circumstances.

Rationale

Over 80% of women aged under 40 years will conceive within 1 year if they have regular unprotected vaginal intercourse at and around the time of ovulation. If they do not conceive after 1 year, or after 6 cycles of artificial insemination, they should be referred to specialist services to decide if more support is needed. Women aged 36 years or over and people with a known clinical cause or history of predisposing infertility factors should be offered an earlier referral (before 1 year) because of the impact of these factors on fertility. Delays in referral to specialist services can have a negative impact on patient care and treatment outcomes.

Quality measures

Structure
Evidence of local arrangements to ensure that referral pathways are in place for specialist consultation when women have not conceived after 1 year of intercourse or after 6 cycles of artificial insemination, or earlier in certain circumstances.
Data source: Local data collection.
Process
a) Proportion of people (women aged 35 years or under and men) who are referred for specialist consultation if the woman has not conceived after 1 year of intercourse or after 6 cycles of artificial insemination, when there is no known clinical cause or history of predisposing factors for infertility in the woman or man.
Numerator – the number in the denominator who are referred for specialist consultation.
Denominator – the number of people (women aged 35 years or under and men) who have not conceived after 1 year of intercourse or after 6 cycles of artificial insemination and there is no known clinical cause or history of predisposing factors for infertility in the woman or man.
Data source: Local data collection. Data can be collected using the NICE clinical audit tool for fertility: people concerned about delays in conception: audit standard 3.
b) Proportion of people who are referred for specialist consultation within 1 year of identification of fertility problems when there is a known clinical cause in the woman or man, a history of predisposing factors for infertility or the woman is aged 36 years or older.
Numerator – the number in the denominator who are referred for specialist consultation within 1 year of identification of fertility problems.
Denominator – the number of people who have not conceived and have a known clinical cause, a history of predisposing factors for infertility or the woman is aged 36 years or older.
Data source: Local data collection. Data can be collected using the NICE clinical audit tool for fertility: people concerned about delays in conception: audit standard 4.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (primary care, secondary care and specialist fertility services) ensure that referral pathways are in place so that people who have not conceived are referred for specialist consultation after 1 year of intercourse or 6 cycles of artificial insemination, or earlier depending on the presence of known infertility factors and the age of the woman.
Healthcare professionals refer people for specialist consultation if they have not conceived after 1 year of intercourse or 6 cycles of artificial insemination, or earlier depending on the presence of known infertility factors and the age of the woman.
Commissioners (clinical commissioning groups and NHS England area teams) ensure that there is sufficient capacity within specialist services and that agreed pathways and referral criteria are in place for people who have not conceived to be referred for specialist consultation after 1 year of intercourse or 6 cycles of artificial insemination, or earlier depending on the presence of known infertility factors and the age of the woman.

What the quality statement means for patients

People finding it difficult to get pregnant are referred for specialist advice and tests if they have been trying for a year or longer or have had 6 cycles of artificial insemination (which is the direct insertion of sperm into a woman's womb or the neck of the womb). If they have a known problem that might affect their fertility or the woman is aged 36 years or older, they should be referred earlier.

Source guidance

  • Fertility (2013) NICE guideline CG156, recommendations 1.2.13.5, 1.2.13.6 and 1.2.13.7 (key priorities for implementation).

Definitions of terms used in this quality statement

Circumstances for earlier referral
An earlier referral should be offered if there is a known clinical cause of infertility in the woman or man, a history of predisposing factors for infertility (such as amenorrhoea, oligomenorrhoea, pelvic inflammatory disease or undescended testes) or the woman is aged 36 years or over. [Fertility (NICE guideline CG156), recommendation 1.2.13.7]
Specialist consultation
Assessment, investigation or treatment in secondary or tertiary care services (for example, urology departments, gynaecology departments or fertility clinics). [Expert opinion]

Counselling

This quality statement is taken from the fertility problems quality standard. The quality standard defines clinical best practice in fertility problems and should be read in full.

Quality statement

People who are having problems conceiving are offered counselling before, during and after investigation and treatment for their fertility problems.

Rationale

People experiencing fertility problems should be offered counselling because fertility problems themselves, and the investigation and treatment for fertility problems, can cause emotional stress.

Quality measures

Structure
Evidence of local arrangements to ensure that people who are having problems conceiving are offered counselling before, during and after investigation and treatment for their fertility problems in secondary or tertiary care.
Data source: Local data collection.
Process
a) Proportion of people who are having problems conceiving and who are having investigations for fertility problems in secondary or tertiary care who receive counselling.
Numerator – the number in the denominator who receive counselling.
Denominator – the number of people who are having problems conceiving and who are having investigations for their fertility problems in secondary or tertiary care.
Data source: Local data collection.
b) Proportion of people who are having problems conceiving and who are having treatment for fertility problems in secondary or tertiary care who receive counselling.
Numerator – the number in the denominator who receive counselling.
Denominator – the number of people who are having problems conceiving and who are having treatment for their fertility problems in secondary or tertiary care.
Data source: Local data collection.
c) Proportion of people who are having problems conceiving and who have received treatment for fertility problems in secondary and tertiary care who receive counselling.
Numerator – the number in the denominator who receive counselling.
Denominator – the number of people who are having problems conceiving and who have received treatment for fertility problems in secondary or tertiary care.
Data source: Local data collection.
Outcome
People who are having problems conceiving feel supported throughout and after investigation and treatment for their fertility problems.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (secondary and tertiary care services) ensure that counselling services are available for people who are having problems conceiving before, during and after investigation and treatment for their fertility problems.
Healthcare professionals refer people who are having problems conceiving for counselling before, during and after investigations and treatment for their fertility problems.
Commissioners (clinical commissioning groups and NHS England area teams) ensure that counselling services are available before, during and after investigation and treatment for people with fertility problems, and that pathways and referral criteria are in place.

What the quality statement means for patients

People finding it difficult to get pregnant have the opportunity to see a counsellor before, during and after any tests or treatment for fertility problems.

Source guidance

  • Fertility (2013) NICE guideline CG156, recommendation 1.1.2.4.

Equality and diversity considerations

Good communication between healthcare professionals and people with fertility problems is essential. Care and support, and the information given about it, should be culturally appropriate. It should also be accessible to people with additional needs such as physical, sensory or learning disabilities, and to people who do not speak or read English. People with fertility problems should have access to an interpreter or advocate if needed.

Semen analysis

This quality statement is taken from the fertility problems quality standard. The quality standard defines clinical best practice in fertility problems and should be read in full.

Quality statement

Services analysing semen samples use methods and reference values in accordance with the most recent World Health Organization laboratory manual.

Rationale

Semen analysis is the primary assessment tool for male fertility potential. The accuracy of the result is dependent on following accredited methods of analysis that are regularly audited and subject to quality control. Variations in laboratory techniques significantly influence the reliability of the results of semen analysis. This may lead to a longer process for investigating male infertility, and possibly to inappropriate treatment.

Quality measures

Structure
Evidence of a quality assurance programme to ensure that services analysing semen samples use methods and reference values in accordance with the most recent World Health Organization laboratory manual.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (laboratory services) ensure that there is a quality assurance programme in place so that services analysing semen samples use methods and reference values in accordance with the most recent World Health Organization laboratory manual.
Healthcare professionals (such as scientists and laboratory technicians) analysing semen samples use methods and reference values in accordance with the most recent World Health Organization laboratory manual.
Commissioners (clinical commissioning groups) ensure that the laboratory services they use comply with the most recent World Health Organization laboratory manual.

What the quality statement means for patients

Men having their semen checked to measure the quantity and quality of their sperm have it tested by a laboratory that uses recommended methods to provide an accurate result.

Source guidance

  • Fertility (2013) NICE guideline CG156, recommendation 1.3.1.1.

Definitions of terms used in this quality statement

Reference values
The results of the 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.
The reference ranges are only valid for the semen analysis tests outlined by the World Health Organization.
[Fertility (NICE guideline CG156), recommendation 1.3.1.1]

IVF for women under 40 years

This quality statement is taken from the fertility problems quality standard. The quality standard defines clinical best practice in fertility problems and should be read in full.

Quality statement

Women aged under 40 years who meet the criteria for in vitro fertilisation (IVF) are offered 3 full cycles of IVF.

Rationale

Access to the appropriate number of full cycles of IVF for women who meet the criteria for IVF will increase the likelihood of those women becoming pregnant. IVF should be considered as an option only if expectant management and first-line treatments for women have not led to a pregnancy. This staged approach to treatment supports the efficient and equitable use of healthcare resources.

Quality measures

Structure
Evidence of local arrangements to provide 3 full cycles of IVF for women aged under 40 years who meet the criteria for IVF.
Data source: Local data collection. National data on provision of IVF are available from the Human Fertilisation and Embryology Authority.
Process
Proportion of women aged under 40 years who meet the criteria for IVF who are offered 3 full cycles of IVF.
Numerator – the number in the denominator who receive 3 full cycles of IVF.
Denominator – the number of women aged under 40 years who meet the criteria for IVF.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (specialist fertility services) ensure that policies are in place on provision of 3 full cycles of IVF for women aged under 40 years who meet the criteria for IVF.
Healthcare professionals (in specialist fertility services) adhere to policies on provision of 3 full cycles of IVF for women aged under 40 years who meet the criteria for IVF.
Commissioners (clinical commissioning groups) should commission sufficient capacity within specialist fertility services to provide 3 full cycles of IVF for women aged under 40 years who meet the criteria for IVF.

What the quality statement means for patients

Women under 40 finding it difficult to get pregnant who have been trying for 2 years or longer or have had 12 cycles of artificial insemination (which is the direct insertion of sperm into a woman's womb or the neck of the womb) are offered 3 full cycles of IVF. A full cycle of IVF involves collecting eggs and sperm, fertilising the eggs outside the woman's body, and placing 1 or 2 fertilised eggs (embryos) into the womb to start a pregnancy.

Source guidance

  • Fertility (2013) NICE guideline CG156, recommendation 1.11.1.3 (key priority for implementation).

Definitions of terms used in this quality statement

Criteria for IVF for women aged under 40 years
Women aged under 40 years should be offered 3 full cycles of IVF if they have not conceived after 2 years of regular unprotected vaginal intercourse or 12 cycles of artificial insemination (including 6 or more by intrauterine insemination). The use of intracytoplasmic sperm injection (ICSI) should not preclude the provision of the appropriate number of IVF cycles. [Fertility (NICE guideline CG156), recommendation 1.11.1.3]
Full cycle of IVF
A full cycle should include 1 episode of ovarian stimulation and the transfer of any resultant fresh and frozen embryo(s). [Fertility (NICE guideline CG156)]
Any previous full cycle, whether self- or NHS-funded, should count towards the total of 3 full cycles offered by the NHS. [Fertility (NICE guideline CG156)], recommendation 1.11.1.6]

Equality and diversity considerations

The existence of living children should not be a factor that precludes the provision of fertility treatment.
The statements include reference to specific age groups. This is to promote effective care because age was found to be the only robust factor in determining IVF success.
The statement focuses on people who have a possible pathological problem to explain their infertility. It includes women in same-sex relationships and women with or without a partner having artificial insemination.

IVF for women aged 40–42 years

This quality statement is taken from the fertility problems quality standard. The quality standard defines clinical best practice in fertility problems and should be read in full.

Quality statement

Women aged 40–42 years who meet the criteria for in vitro fertilisation (IVF) are offered 1 full cycle of IVF.

Rationale

The overall chance of having a live birth after IVF treatment falls with rising female age and also decreases as the number of unsuccessful cycles increases. Access to the appropriate number of full cycles of IVF for women who meet the criteria for IVF will increase the likelihood of those women becoming pregnant. IVF should be considered as an option only if expectant management and first-line treatments for women have not led to a pregnancy. This staged approach to treatment supports the efficient and equitable use of healthcare resources.

Quality measures

Structure
Evidence of a locally agreed policy on provision of 1 full cycle of IVF for women aged 40–42 years who meet the criteria for IVF.
Data source: Local data collection. National data on provision of IVF and intracytoplasmic sperm injection (ICSI) are available from the Human Fertilisation and Embryology Authority.
Process
Proportion of women aged 40–42 years who meet the criteria for IVF who are offered 1 full cycle of IVF.
Numerator – the number in the denominator who receive 1 full cycle of IVF.
Denominator – the number of women aged 40–42 years who meet the criteria for IVF.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (specialist fertility services) ensure that policies are in place on provision of 1 full cycle of IVF for women aged 40–42 years who meet the criteria for IVF.
Healthcare professionals (in specialist fertility services) adhere to policies on provision of 1 full cycle of IVF for women aged 40–42 years who meet the criteria for IVF.
Commissioners (clinical commissioning groups) should commission sufficient capacity within specialist fertility services to provide 1 full cycle of IVF for women aged 40–42 years who meet the criteria for IVF.

What the quality statement means for patients

Women aged 40 to 42 finding it difficult to get pregnant who have been trying for 2 years or longer or they have had 12 cycles of artificial insemination (which is the direct insertion of sperm into a woman's womb or the neck of the womb) are offered 1 full cycle of IVF if all of the following apply:
  • they have never had IVF before
  • tests show that their ovaries would respond normally to fertility drugs
  • they have discussed the risks of IVF and becoming pregnant at this age with their doctor.
A full cycle of IVF involves collecting eggs and sperm, fertilising the eggs outside the woman's body, and placing 1 or 2 fertilised eggs (embryos) into the womb to start a pregnancy.

Source guidance

  • Fertility (2013) NICE guideline CG156, recommendation 1.11.1.4 (key priority for implementation).

Definitions of terms used in this quality statement

Criteria for IVF for women aged 40–42 years
Women aged 40–42 years should be offered 1 full cycle of IVF if they have not conceived after 2 years of regular unprotected vaginal intercourse or 12 cycles of artificial insemination (including 6 or more by intrauterine insemination) and have never had IVF treatment before, have no evidence of low ovarian reserve (when a women doesn't have many eggs left) and have had a discussion of the additional implications of IVF and pregnancy at this age. The use of ICSI should not preclude the provision of the appropriate number of IVF cycles. [Fertility (NICE guideline CG156), recommendation 1.11.1.4].
Full cycle of IVF
A full cycle should include 1 episode of ovarian stimulation and the transfer of any resultant fresh and frozen embryo(s). [Fertility (NICE guideline CG156)]
Equality and diversity considerations
The existence of living children should not be a factor that precludes the provision of fertility treatment.
The statements include reference to specific age groups. This is to promote effective care because age was found to be the only robust factor in determining IVF success.
The statement focuses on people who have a possible pathological problem to explain their infertility. It includes women in same-sex relationships and single women having artificial insemination.

Intracytoplasmic sperm injection

This quality statement is taken from the fertility problems quality standard. The quality standard defines clinical best practice in fertility problems and should be read in full.

Quality statement

Women having in vitro fertilisation (IVF) are offered intracytoplasmic sperm injection (ICSI) only if there are severe deficits in semen quality, obstructive azoospermia, non-obstructive azoospermia or if previous IVF treatment resulted in failed or very poor fertilisation.

Rationale

ICSI is a technique in which a single sperm is injected into an egg to achieve fertilisation. It is sometimes used in addition to IVF and improves the chances of conception. However, given the added resources involved, its use should be determined by clinical need.

Quality measures

Structure
Evidence of local arrangements to ensure that ICSI is offered only if there are severe deficits in semen quality, obstructive azoospermia, non-obstructive azoospermia or if previous IVF treatment resulted in failed or very poor fertilisation.
Data source: Local data collection.
Process
Proportion of women having IVF with ICSI because of severe deficits in semen quality, obstructive azoospermia, non-obstructive azoospermia or because previous IVF treatment resulted in failed or very poor fertilisation.
Numerator – the number in the denominator having ICSI because of severe deficits in semen quality, obstructive azoospermia, non-obstructive azoospermia or because previous IVF treatment resulted in failed or very poor fertilisation.
Denominator – the number of women having IVF with ICSI.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (specialist fertility services) ensure that policies are in place to offer ICSI to women having IVF only if there are severe deficits in semen quality, obstructive azoospermia, non-obstructive azoospermia or if previous IVF treatment resulted in failed or very poor fertilisation.
Healthcare professionals (in specialist fertility services) offer ICSI to women having IVF only if there are severe deficits in semen quality, obstructive azoospermia, non-obstructive azoospermia or if previous IVF treatment resulted in failed or very poor fertilisation.
Commissioners (clinical commissioning groups) monitor the use of ICSI for women having IVF in the services they commission.

What the quality statement means for patients

Women having IVF are offered an additional procedure to improve their chances of getting pregnant only if problems with the sperm mean that it is unlikely to fertilise the egg without it, or if there was poor or no fertilisation with IVF in the past. The procedure involves injecting a sperm directly into the egg and is called intracytoplasmic sperm injection (ICSI for short).

Source guidance

  • Fertility (2013) NICE guideline CG156, recommendation 1.13.1.1.

Definitions of terms used in this quality statement

Severe deficits in semen quality
Low quality sperm identified through comparison of sperm analysis results to the reference values in the World Health Organization laboratory manual. [Expert opinion]
Intracytoplasmic sperm injection (ICSI)
A procedure sometimes used in addition to IVF, which involves injecting a single sperm into the inner cellular structure of an egg. [Fertility (NICE guideline CG156)]
Non-obstructive azoospermia
No sperm in the ejaculate due to testicular failure. [Adapted from Fertility (NICE guideline CG156)]
Obstructive azoospermia
The testes produce sperm as normal but a blockage prevents entry to the ejaculate. [Adapted from Fertility (NICE guideline CG156)]

Number of embryos transferred

This quality statement is taken from the fertility problems quality standard. The quality standard defines clinical best practice in fertility problems and should be read in full.

Quality statement

Women having in vitro fertilisation (IVF) have 1 or 2 embryos transferred according to the woman's or donor's age, the cycle number and the quality of the embryos.

Rationale

An effective embryo transfer strategy minimises the chance of multiple pregnancies following IVF and improves the outcome of IVF with the birth of more single, healthy babies. Multiple pregnancies represent a significant health risk to mothers and babies.

Quality measures

Structure
Evidence of local arrangements to implement an agreed embryo transfer strategy in which 1 or 2 embryos are transferred according to the woman's or donor's age, the cycle number and the quality of the embryos.
Data source: Local data collection.
Process
a) Proportion of IVF cycles in which embryo transfers are carried out in line with Fertility (NICE guideline CG156) (see also the definitions section below).
Numerator – the number in the denominator carried out in line with Fertility (NICE guideline CG156).
Denominator – the number of embryo transfers in IVF cycles.
Data source: Local data collection. Data can be collected using the NICE clinical audit tool for fertility: embryo transfer strategies: audit standards 4–7.
Outcome
a) Proportion of embryo transfers that are elective single embryo transfers.
Data source: Local data collection. National data on elective single embryo transfers are available from the Human Fertilisation and Embryology Authority.
b) Number of IVF treatments resulting in multiple pregnancy.
Data source: Local data collection. National data on multiple pregnancy rates following IVF treatment are available from the Human Fertilisation and Embryology Authority.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (specialist fertility services) ensure that systems are in place to monitor the number of embryos transferred during IVF cycles.
Healthcare professionals (in specialist fertility services) transfer the appropriate number of embryos during IVF, taking into account the woman's or donor's age, the cycle number and the quality of the embryos.
Commissioners (clinical commissioning groups) ensure that the services they commission have policies in place on embryo transfer strategies that take into account the woman's or donor's age, the cycle number and the quality of the embryos.

What the quality statement means for patients

Women having IVF have 1 or 2 embryos transferred into their womb, depending on the woman's age (or the donor's age), the number of IVF treatments she has had and the quality of the embryos.

Source guidance

  • Fertility (2013) NICE guideline CG156, recommendations 1.12.6.5, 1.12.6.8 (key priorities for implementation), 1.12.6.6 and 1.12.6.7.

Definitions of terms used in this quality statement

Embryo transfer according to age, cycle number and quality of embryos
The number of embryos transferred should be determined by the age of the woman, cycle number and quality of embryos as follows.
Age
Cycle
Quality of embryos 1
Number of embryos to transfer
Under 37
1st
N/A
1
Under 37
2nd
1 or more top-quality embryos available
1
Under 37
2nd
If no top-quality embryos are available
No more than 2
Under 37
3rd
N/A
No more than 2
37–39
1st or 2nd
1 or more top-quality embryos available
1
37–39
1st or 2nd
If no top-quality embryos are available
No more than 2
37–39
3rd
N/A
No more than 2
40–42
N/A
N/A
No more than 2
N/A
N/A
Top-quality blastocyst available
1
1 Embryo quality is evaluated at both cleavage and blastocyst stages, according to the Association of Clinical Embryologists (ACE) and UK National External Quality Assessment Service (UK NEQAS) for Reproductive Science Embryo and Blastocyst Grading schematic.
[Adapted from Fertility (NICE guideline CG156)]

Equality and diversity considerations

The existence of living children should not be a factor that precludes the provision of fertility treatment.

Cryopreservation before cancer treatment

This quality statement is taken from the fertility problems quality standard. The quality standard defines clinical best practice in fertility problems and should be read in full.

Quality statement

People preparing to have treatment for cancer that is likely to result in fertility problems are offered cryopreservation.

Rationale

Some treatments for cancer can cause fertility problems. Cryopreservation of men's sperm or women's oocytes or embryos may give people with cancer the option of having children in the future.
Structure
Evidence of local arrangements to ensure that people preparing to have treatment for cancer that is likely to result in fertility problems are offered cryopreservation.
Data source: Local data collection.
Process
a) Proportion of males having treatment for cancer that is likely to result in fertility problems who receive sperm cryopreservation.
Numerator – the number in the denominator who receive sperm cryopreservation.
Denominator – the number of males having treatment for cancer that is likely to result in fertility problems.
Data source: Local data collection.
b) Proportion of females having treatment for cancer that is likely to result in fertility problems who receive oocyte or embryo cryopreservation.
Numerator – the number in the denominator who receive oocyte or embryo cryopreservation.
Denominator – the number of females having treatment for cancer that is likely to result in fertility problems and:
  • who are well enough to undergo ovarian stimulation and egg collection
  • whose condition will not worsen with cryopreservation
  • who have enough time before the start of their cancer treatment.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (specialist fertility services) ensure that agreed referral pathways are in place to provide cryopreservation to people who are preparing to have treatment for cancer that is likely to result in fertility problems.
Healthcare professionals (in specialist fertility services) offer cryopreservation to people preparing to have treatment for cancer that is likely to result in fertility problems.
Commissioners (clinical commissioning groups) ensure there is sufficient capacity within fertility services to provide cryopreservation for people preparing to have cancer treatment that is likely to result in fertility problems, with agreed referral pathways in place.

What the quality statement means for patients

People preparing to have treatment for cancer that is likely to result in fertility problems are given the option to preserve (freeze and store) their eggs or sperm for possible use in the future.

Source guidance

  • Fertility (2013) NICE guideline CG156, recommendations 1.16.1.8 and 1.16.1.10.

Equality and diversity considerations

The existence of living children should not be a factor that precludes the provision of fertility treatment.
There should not be a lower age limit for cryopreservation for fertility preservation in people diagnosed with cancer.
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Effective interventions library

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Implementation

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These resources will help to inform discussions with providers about the development of services and may include measurement and action planning tools.
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These resources provide help with planning ahead for NICE guidance, understanding where you are now, and conducting improvement initiatives.

Information for the public

NICE produces information for the public that summarises, in plain English, the recommendations that NICE makes to healthcare and other professionals.
NICE has written information for the public explaining its guidance on each of the following topics.

Pathway information

Professional responsibilities

The recommendations in this pathway represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients or service users. Applying the recommendations in this pathway is at the discretion of health and care professionals and their individual patients or service users and does not override the responsibility of health and care professionals to make decisions appropriate to the circumstances of the individual, in consultation with them and/or their carer or guardian.
Commissioners and/or providers have a responsibility to enable the recommendations to be applied (and to provide funding required for technology appraisal guidance) when individual health and care professionals and their patients or service users wish to use them. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this pathway should be interpreted in a way that would be inconsistent with compliance with those duties.

Patient-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Supporting information

Glossary

Treatments designed to lead to conception by means other than sexual intercourse.
Body mass index
A formal approach that encourages conception through unprotected vaginal intercourse. It involves supportively offering an individual or couple information and advice about the regularity and timing of intercourse and any lifestyle changes which might improve their chances of conceiving. It does not involve active clinical or therapeutic interventions.
A full cycle of IVF treatment, with or without ICSI comprises 1 episode of ovarian stimulation and the transfer of any resultant fresh and frozen embryo(s).
Intracytoplasmic sperm injection
In vitro fertilisation
Defined for the purposes of this pathway as meaning when 2 or more semen analyses have 1 or more variables below the 5th centile (as defined by the WHO, 2010). The effect on the chance of pregnancy occurring naturally through vaginal intercourse within 2 years would then be similar to people with unexplained infertility or mild endometriosis.
An IVF procedure in which one or more oocytes are collected from the ovaries during a spontaneous menstrual cycle without the use of drugs.
World Health Organization Group I ovulation disorders are classified as hypothalamic pituitary failure (hypothalamic amenorrhoea or hypogonadotrophic hypogonadism).
World Health Organization Group II ovulation disorders are classified as hypothalamic-pituitary-ovarian dysfunction (predominately polycystic ovary syndrome).

Paths in this pathway

Pathway created: February 2013 Last updated: August 2016

© NICE 2016

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