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The National Institute for Health and Clinical Excellence (NICE) is currently updating its 2004 NHS guidance on the assessment and treatment of couples with fertility problems. Yesterday (22 May), NICE has issued a draft version of the updated guideline for public consultation.

Dr Gill Leng, Deputy Chief Executive, NICE, said: "Infertility is a medical condition that can cause significant distress for those trying to have a baby. This distress can have a real impact on people's lives, potentially leading to depression and the break-down of relationships. However, in many cases infertility can be treated effectively - there are thousands of babies and happy parents thanks to NHS fertility treatment - which is why the NHS provides services and why NICE produces guidance on the topic.

"NICE reviews all guidance at regular intervals to ensure recommendations are based on the most up-to-date evidence available. Since the original recommendations on fertility were published in 2004 there have been many advances in both treatments and in the understanding of different techniques. For this update we are using the latest statistical and clinical evidence to make sure that treatment for infertility is offered at a time and in a way which is most likely to result in pregnancy.

"The updated draft guideline issued today for public consultation includes a number of new and updated recommendations. These include new specific recommendations on the number of embryos to be implanted and a broadening of the criteria for the provision of in vitro fertilization (IVF) to include some women aged 40 to 42.

"New groups of the population have also been included in this update. These groups include people who are preparing for cancer treatment who may wish to preserve their fertility, those who carry an infectious disease, such as Hepatitis B or HIV, same-sex couples and those who are unable to have intercourse, for example, if they have a physical disability.

"The aim of these new and updated recommendations is to ensure that everyone who has problems with fertility has access to the best levels of help. We are now consulting on this draft guideline and we welcome comments from interested parties."

When published, the update will replace some but not all parts of the original fertility guideline. Until then, NHS bodies should continue to follow the recommendations from the current guideline.

Key changes and updates include:

• Predictors of IVF success: The 2004 guideline recommends that couples in which the woman is aged 23-39 years at the time of treatment and who have an identified cause for their fertility problems or who have infertility of at least three years' duration should be offered up to three stimulated cycles of IVF treatment.

The new draft recommendations published for consultation recommend that in women aged 39 years and younger and who have not conceived after two years of regular unprotected intercourse or after 12 cycles of artificial insemination (where 6 or more are intrauterine insemination) are offered three full treatment cycles of IVF with or without intracytoplasmic sperm injection1.

The new guidance also recommends that in women aged 40 to 42 years who have not had IVF treatment, consider one full cycle of IVF, with or without intracytoplasmic sperm injection, where there is no chance of pregnancy with expectant management ('absolute infertility') and where IVF is the only effective treatment.

• Embryo transfer strategies in IVF: In 2004 it was recommended that no more than two embryos should be transferred during any one cycle of in vitro fertilisation treatment. In the updated draft guidance this recommendation has been expanded:
  
  - When performing single embryo transfer in IVF treatment, transfer a single blastocyst2 if possible.
  
  - When considering the number of embryos to transfer in IVF treatment:
  
  - For women aged under 37 years:
  
  In the first full IVF cycle use single embryo transfer.
  
  In the second full IVF cycle use single embryo transfer if one or more top-quality embryos are available. Consider using two embryos if no top-quality3 embryos are available.
  
  In the third full IVF cycle transfer no more than two embryos
  
  - For women aged 37-39 years:
  
  In the first and second full IVF cycles use single embryo transfer if there are one or more top-quality embryos. Consider double embryo transfer if there are no top-quality embryos.
  
  In the third full IVF cycle transfer no more than two embryos
  
  - For women aged 40-42 years consider double embryo transfer.
• Unexplained infertility: The new draft guidance does not recommend oral ovarian stimulation agents (such as clomifene citrate, anastrozole or letrozole) for women with unexplained infertility. (The 2004 guideline says that these women ‘should be informed that clomifene citrate treatment increases the chance of pregnancy, but that this needs to be balanced by the possible risks of treatment, especially multiple pregnancy.)
• Intrauterine insemination (IUI): The 2004 guidance recommended that couples with mild male factor fertility problems, unexplained fertility problems or minimal to mild endometriosis should be offered up to six cycles of intra-uterine insemination.

New draft recommendations do not support the use of IUI in this group as it has been shown that couples are more likely to become pregnant if they continue to try to conceive for two years without medical intervention (80% chance they will become pregnant).

• Consider unstimulated intrauterine insemination as a treatment option in the following groups as an alternative to vaginal sexual intercourse:
  
  - people who are unable to, or would find it very difficult to have vaginal intercourse because of a physical disability or psychosexual diagnosis who are using partner or donor sperm
  
  - people with conditions that require specific consideration in relation to methods of conception
  
  - people who are in same-sex relationships

For people who have not conceived after six cycles of donor or partner insemination, despite evidence of normal ovulation, tubal patency and semenalysis, offer a further six cycles of unstimulated intrauterine insemination before IVF is considered.

• HIV: treatments for HIV have improved significantly since the 2004 guideline was published, and the updated draft guideline says healthcare professionals should advise couples where the man is HIV positive that the risk of HIV transmission to the female partner is negligible through unprotected sexual intercourse when all of the following criteria are met: the man is complying with highly active antiretroviral therapy (HAART); the man has a plasma viral load of less than 50 copies/ml; there are no other infections present; unprotected intercourse is limited to the time of ovulation

Ends

Notes to Editors

About the draft guidance

1. The draft recommendations will be available on the website from 22 May 2012 - http://guidance.nice.org.uk/CG/WaveR/90. Please contact the press office for an embargoed copy of the draft guideline.

2. The 2004 guideline can be found here: http://publications.nice.org.uk/fertility-cg11

About fertility treatment

3. Infertility affects around one in six heterosexual couples in the UK.

4. In 2010, 47,249 women received fertility treatment. Of these:

• 45,264 women had a total of 57,652 cycles of IVF or intra-cytoplasmic sperm injection (ICSI).
• 1,985 women had a total of 3,878 cycles of donor insemination.
• In nearly three-quarters of cases (73.5%), the woman's own freshly collected eggs were used for the fertility treatment cycles.
• They were, on average, around 35 years-old and had been trying to conceive for over 4 years (4.7 for IVF, 4.1 for donor insemination).

5. A total of 1,254 cycles of IVF were performed in 2009 using donated eggs. This resulted in 417 births, and 550 babies being born.

6. A minority (40.6%) of IVF treatment cycles was funded by the NHS in 2010. The majority (59.4%) were funded privately. These figures are broadly similar to the year before.

Please note: The majority of these statistics are taken from the Human Fertilisation and Embryology Authority (HFEA) publication, Fertility treatment in 2010 - trends and figures published in 2011.

7. A cycle of IVF can cost the NHS around £1,300 ((if the embryos implanted inside the woman's uterus were originally frozen) or just over £3,000 (if the woman's eggs had been removed, inseminated and the embryos implanted back into the body without having to be frozen). A cycle of intracytoplasmic sperm injection (ICSI) costs the NHS about an extra £500 in addition to the £3,000 figure above.

About NICE

1. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

2. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

3. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

2 A blastocyst is an embryo that has developed for five to six days after fertilisation. With blastocyst transfer, embryos are cultured in the laboratory incubator to the blastocyst stage before they are transferred to the womb.

3 This is based on the Association of Clinical Embryologists (ACE/UK) National External Quality Assessment Service (NEQAS) for Reproductive Science embryo and Blastocyst Grading schematic.