People who are experiencing fertility problems should be able to get the most appropriate and effective medical treatment earlier, thanks to new updated guidelines published today (Wednesday 20 February) by the National Institute for Health and Care Excellence (NICE).

Sir Andrew Dillon, NICE Chief Executive, said: Infertility affects more people than you might think; around one in seven heterosexual couples in the UK. It is a recognised medical condition that can occur at any age and for a variety of reasons, such as endometriosis, polycystic ovary syndrome or naturally low ovarian reserve. Whatever the cause, we know fertility problems can have a potentially devastating effect on people's lives; causing significant distress, depression and possibly leading to the breakdown of relationships.

“The good news is that, thanks to a number of medical advances over the years, many fertility problems can be treated effectively. It is because of these new advances that we have been able to update our guideline on fertility, ensuring that the right support, care and treatment is available to those who will benefit the most.”

The updated guideline makes a number of recommendations to ensure people who are having trouble conceiving receive only the most effective treatments and in a more timely manner. For instance, it recommends that people with unexplained infertility, mild endometriosis or mild male factor infertility should attempt to conceive through regular vaginal intercourse for two years rather than receive intrauterine insemination (apart from specific groups as outlined in the guideline). This is because new evidence in this area shows that this treatment is no better at achieving a live birth than people attempting to conceive through regular vaginal intercourse. Meanwhile, the updated guideline recommends IVF treatment for eligible women who have been unable to conceive after two years of regular vaginal intercourse (or 12 cycles of artificial insemination). This is one year earlier than was previously recommended.

The update also confirms that women aged 40-42 years who have not conceived after two years of regular unprotected intercourse or 12 cycles of artificial insemination (where six or more are by intrauterine insemination), should now be offered one full cycle[1] of IVF, with or without intracytoplasmic sperm injection (ICSI), provided the following criteria are fulfilled: they have never previously had IVF treatment; there is no evidence of low ovarian reserve; there has been a discussion of the additional implications of IVF and pregnancy at this age. Previously, NICE did not recommend IVF for women older than 39.

Tim Child, Consultant Gynaecologist and Director of the Oxford Fertility Unit, was part of the Guideline Development Group (GDG) that developed the updated guideline on behalf of NICE. He said: “Recommending IVF treatment for a very select group of women over 40 was not a decision that was taken lightly. When a woman reaches her mid-30's her fertility begins to decline, even more so from her late 30's. However, many women do conceive naturally in the 40-42 year age group, but for those who can't, and who have been diagnosed with the medical condition of infertility, then improvement in IVF success rates over the last decade mean that we are now able to offer cost effective treatment with a single IVF cycle. This decision was taken after considerable discussion and close analysis of the available evidence.”

Kate Brian, who helped to develop the guideline and who herself conceived with the help of IVF treatment, said:"Finding out that you may not be able to conceive is devastating, and can have an impact on every aspect of your life. I spent four years trying unsuccessfully to get pregnant, and I know how miserable, lonely and isolated it can make you, how it leaves you feeling as if you are a failure and how difficult everyday social situations can become.

“Starting down the path of fertility tests and treatments is not something people take lightly and it can be a long and emotional process. These guidelines should make it much easier for people to be seen sooner and get them the best care to help them conceive. I hope these updated guidelines will make a real difference to the lives of men and women who experience fertility problems.”

The guideline's previous recommendations relating to the use of oral ovarian stimulation agents have been updated and, for the first time, the guideline includes groups of people such as same-sex couples, those who carry an infectious disease (such as Hepatitis B or HIV) and those who are unable to have intercourse (for example, if they have a physical disability). The updated guideline also makes recommendations for people who are preparing for cancer treatment who may wish to preserve their fertility.

Other new or updated recommendations include:

• For people with unexplained infertility, mild endometriosis or ‘mild male factor infertility', who are having regular unprotected sexual intercourse:
  • do not routinely offer intrauterine insemination, either with or without ovarian stimulation (exceptional circumstances include, for example, when people have social, cultural or religious objections to IVF)
  • advise them to try to conceive for a total of 2 years (this can include up to one year before their fertility investigations) before IVF will be considered
• Women aged under 40 years who have not conceived after two years of regular unprotected intercourse or 12 cycles of artificial insemination (where six or more are by intrauterine insemination), should be offered three full cycles of IVF, with or without ICSI. If the woman reaches the age of 40 during treatment, the current full cycle should be completed but no further cycles offered.
• Do not offer oral ovarian stimulation agents (such as clomifene citrate, anastrozole or letrozole) to women with unexplained infertility.
• When considering the number of fresh or frozen 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 1 or more top-quality embryos are available. Consider using 2 embryos if no top-quality embryos are available; in the third full IVF cycle transfer no more than 2 embryos.
  • For women aged 37-39 years: In the first and second full IVF cycles use single embryo transfer if there are 1 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 2 embryos.
  • For women aged 40-42 years consider double embryo transfer.

The updated guideline is relevant to a range of NHS professionals, including GPs. Dr Clare Searle, a Hertfordshire GP and GDG member, said: “This guideline should help GPs to actively manage the possibility of infertility in people, from offering lifestyle advice to referring people for further investigations. The guideline sets out a clear pathway of care for GPs and other healthcare professionals to follow. This will help identify fertility problems in a timely manner and give people access to the most effective, appropriate treatments.”

Clare Lewis-Jones, GDG member and Chief Executive of Infertility Network UK, said: “NICE clinical guidelines are widely regarded as best practice by healthcare professionals throughout England and Wales, and demonstrates the level of care to which the NHS should aspire. It is often the case that conditions that are viewed by some as ‘lifestyle choices' should not be given the same priority as others. However, it is important to remember that infertility is a medical condition that needs medical intervention to treat it. The recommendations in this updated guideline are based on a thorough analysis of the best available evidence and I hope this will give the NHS a new push to make fertility services more available to those who need them.”

Although the NHS is not legally obliged to follow NICE clinical guidelines, they are considered to be best practice. This is because recommendations are based on the best available evidence. In 2011, the NHS Deputy Chief Executive reminded NHS commissioners to have regard for the NICE guideline on fertility and continue to make treatments and services available to those experiencing fertility problems.

Ends

Notes to Editors

• The updated guideline on the assessment and treatment for people with fertility problems will be available on the NICE website from 20 February 2013. Please contact the press office for an embargoed copy of the updated guideline.
• This update replaces some but not all parts of the original 2004 guideline on the treatment of infertility.

About fertility treatment

1. Infertility affects around one in seven heterosexual couples in the UK and it is estimated that no more than 5% of all referrals for NHS fertility services are from same-sex couples.

2. In 2011, 48,147 women had a total of 61,726 cycles of IVF or intracytoplasmic sperm injection (ICSI) and 2,087 women had a total of 4,091 cycles of donor insemination.

3. A total of 89,648 embryos were transferred during the course of fertility treatment which started in 2011. Of these, 30,337 fresh embryos were transferred during IVF treatment, 40,340 fresh embryos were transferred during ICSI treatment and 17,635 thawed embryos which had previously been frozen were transferred.

4. A total of 13,703 pregnancies were reported as a result of IVF treatment which started in 2011. In the UK, 201,811 babies have been born after IVF treatment between 1991 and 2010.

5. Of the women who received fertility treatment during 2011, they were, on average, 35-years-old and had been trying to conceive for around 4 years (4.6 for IVF , 4 for donor insemination)

6. Four in ten (40.3%) IVF treatment cycles were funded by the NHS in 2011. For people undergoing donor insemination, 17.9% of cycles were funded by the NHS in the same year. 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 2011 - trends and figures” published in 2013.

1. A full cycle of fresh IVF can cost the NHS around £3,000 (which includes ovarian stimulation, removing the woman's eggs, insemination of the eggs in the laboratory, embryo culture, transfer of 1 or 2 embryos back into the body, and freezing of any spare suitable embryos). A cycle of intracytoplasmic sperm injection (ICSI) costs the NHS about an extra £500 in addition to the £3,000 figure above. The thawing and transfer of frozen IVF embryos costs the NHS significantly less than fresh IVF.

About NICE

1. The National Institute for Health and Care 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.