Past medical, and obstetric history; psychosexual and social history inc issues that may effect the welfare of existing or future child
General/Pelvic examination for the female; male genital examination with abnormal semen analysis/erectile dysfunction

Service improvement tools to help improve the pathway are available on the No Delays Achiever, & help to identify blocks & barriers along the pathway. Maximum Impact -Shorter Pathways outlines steps that can be taken to improve efficiency of pathways & services.

For points to consider before commissioning see the supplementary information. For support in commissioning successfully and identifying opportunities for service redesign see the No Delays Achiever.

Electronic Patient Assessment Questionnaire is an example of a technology that can help measure the patients quality of life before referral to specialist care and following treatment.

Clarification and expansion of primary assessment history and examination

For points to consider when commissioning specialist assessment services see the supplementary information. For support in commissioning successfully and identifying opportunities for service redesign see the No Delays Achiever.

Electronic Patient Assessment Questionnaire is an example of a technology that can help measure the patients quality of life before referral to specialist care and following treatment.

Clarification and expansion of prior assessment, history and examination

For support in commissioning successfully and identifying opportunities for service redesign see the No Delays Achiever.

Difficulty conceiving >12 months

Fertility problems affect one in seven couples in the UK.

See NICE guidelines. Folic acid, lifestyle changes (smoking, alcohol, body weight, drug use, caffeine), Sexual intercourse every 2-3 days not timed to any part of the cycle.

Can Pharmacy be used to deliver and support self assessment and self care and underpin the service pathway? Have you thought of using existing published frameworks to support self care such as for the management of obesity?

Education about the risks of unsafe sexual practices.
Female fertility declines with age, especially after 35, but that the effect of age on male fertility is less clear.

Absent periods, prev cancer Tx, prev STI, testicular trauma or surgery

+ve active Chlamydia refer for treatment and contact tracing

Suspicious findings at diagnostic level

Ultrasound
Direct access HSG (at specialist fertility centre)

Rubella, mid-luteal phase progesterone, Chlamydia

Couples should be referred in and seen together

Results of Ix for BOTH partners.

for weight management

As part of overall weight management; folate; to aid smoking cessation

Advanced endocrinology; Genetic Assessment

Ultrasound
MRI
Selective HSG

Advanced endocrinology; genetic assessment; ovarian reserve

Advanced Sperm analysis

Ovulation Induction

Tx laparoscopy; therapeutic hysteroscopy, selective salpingography, myomectomy

Good practice available

eg IUI, IVF, ICSI, donor gametes

Tubal Surgery, Advanced endometriosis surgery

Good practice available

NICE / PCT Guidelines

Refer PCT eligibility guidelines

assessment and treatment of couples with fertility problems

COMMISSIONING AND CONTRACTING

WORKFORCE

TECHNOLOGY AND EQUIPMENT

SERVICE IMPROVEMENT AND MODELS OF CARE

95% of women with regular menstrual cycles will be ovulating.
2.2.2. If pathology suspected arrange ultrasound e.g. fibroids or irregular cycles suggestive of PCOS.
Some centres may have the expertise to offer direct access HSG following local proforma guidelines - see fertility 18w web page.

2.2.3 General pre-conceptual counselling eg haemoglobinopathy screening / rubella / chicken pox history as appropriate.
If not rubella immune, vaccinate and advise contraception for one month.
See RCOG Greentop guidance for Chicken Pox in Pregnancy September 2007.

If periods are regular progesterone assay should be timed 7-10 days prior to next period.
If periods are irregular or absent measure FSH, LH, prolactin, testosterone and oestradiol (as per NICE)
Day 2-5 FSH may be performed in line with local referral guidelines.

Couples should be offered screening for Chlamydia trachomatis using an appropriately sensitive technique. If the test for Chlamydia trachomatis is positive, women and their sexual partners should be referred for appropriate treatment and contact tracing.

2.2.4 Sperm analysis (in accredited NEQAS laboratory): Normal count ≥20m, motility ≥50%, morphology ≥15%. If the result of a first semen analysis is abnormal, a repeat confirmatory test should be offered, ideally 3 months (female age, duration of subfertility and other factors permitting) after the initial analysis. However, if gross spermatozoa deficiency has been detected then the repeat test should be undertaken as soon as possible.

SERVICE IMPROVEMENT
A summary of service improvement knowledge for UK Radiologists is available. See the hyperlink or website for information.

COMMISSIONING AND CONTRACTING
Commissioning a World Class Imaging Service tool has been developed to support commissioners of imaging services. It aims to bring together a number of valuable resources about diagnostic imaging in one easy and convenient reference tool. For more information see the web page.

3.2.2 Ultrasound, HSG/HyCoSy, MRI
Diagnostic laparoscopy and hysteroscopy
See NICE guidelines pp48-49

3.2.3 Advanced endocrinology eg hyperprolactinaemia, hyperandrogenism, hypogonadotropism. Tests of ovarian reserve, as per local policies.

Genetic Assessment (Karyotyping, DNA analysis) eg severe oligo/azospermia, premature ovarian failure

3.2.4 Further semen analysis if required - Repeated severe oligospermia / azospermia requires onward direct referral to specialist/tertiary services.
Imaging eg ultrasound
Genetics
Endocrinology

The facility to progress from a diagnostic procedure to a theraputic procedure, with suitable indications, preparation of the patient and appropriate training of the surgeon, should be available.

Infertility should be defined as failure to conceive after regular, unprotected sexual intercourse for 2 years in the absence of known reproductive pathology. However it is reasonable to begin investigating some patients who have failed to conceive before 12 months
NICE produced guidance on infertility in 2004 and these have formed a large part of the development of this pathway.
http://www.nice.org.uk/nicemedia/pdf/CG011niceguideline.pdf
http://www.nice.org.uk/nicemedia/pdf/CG011algorithm.pdf

Fertility problems affect one in seven couples in the UK. Most couples (about 84%) who have regular sexual intercourse (that is every 2-3 days) and who do not use contraception will conceive within a year. About 92% who are trying to conceive will do so within 2 years. Women become less fertile as they get older. For women aged 35, about 94% who have regular unprotected sexual intercourse will conceive after 3 years of trying. For women aged 38, however, only 77% will do so. The effect of age on men's fertility is less clear.
In men, a fertility problem is usually because of low numbers or poor quality of sperm. A woman may have fertility problems because she does not produce eggs regularly or because her fallopian tubes are damaged or blocked and the sperm cannot reach her eggs.
For nearly one third of people, no reason can be found for their problem. This is known by healthcare professionals as having unexplained fertility problems.

Appropriate Folic Acid supplements
No smoking
Restrict alcohol intake in line with national guidelines
Body weight within BMI 20-25
Using recreational drugs, including anabolic steroids for body building, harms fertility.

Support for patients in understanding their condition and choices available through NHS Direct and NHS Choices. For more information see the pathway web page.

Support for patients in understanding their condition and choices available through NHS Direct and NHS Choices. For more information see the pathway web page.

Referral should only be made when primary investigations have been completed on BOTH partners, as per local guidelines. Couples therefore should be referred and seen together.
NICE guidelines:
- couples have failed to conceive after regular unprotected sexual intercourse for 1 year in the absence of known reproductive pathology
- referral prior to 1 year should be made if:
+ pre-disposing factors of infertility exist such as amenorrhoea, oligomenorrhoea, pelvic inflammatory disease, un-descended testes
+ female age >34
+ prior treatment for cancer
+ male or female partner has HIV, hepatitis B or C
+ significant gynae history

GP referral should therefore include:
i) the specific patient circumstances including age, duration of trying, relevant past or family history in either partner etc.
ii) results of all the investigations for both partners should be available
iii) current BMI, life style issues (smoking, alcohol, drugs etc):
iv) there are no concerns with respect to the welfare of an existing or a future child.

Patients should be made aware that local eligibility criteria might apply for some fertility treatments.

COMMISSIONING AND CONTRACTING
Can the quality of primary care be improved to help referrals?

TECHNOLOGY
Oldham Community PAS system for recording 18 week journeys through ICATs or other intermediate services

Female Age
Long duration of subfertility >3 years
Evidence of reduced ovarian reserve
Identified male factor
Tubal disease and severe endometriosis
Previous failed treatment eg failed ovulation induction

4.2.3 eg blood borne infection screening, STD screen, repeat as appropriate.

4.2.4 Advanced sperm assessment eg swim ups

SERVICE IMPROVEMENT
A summary of service improvement knowledge for UK Radiologists is available. See the hyperlink or website for information.

COMMISSIONING AND CONTRACTING
Generic Patient Reported Outcome Measures exist for this pathway (EQ5D). Currently clinical consensus has not been reached for a condition specific measure.

Counselling services for support, discussion of implications and alternatives such as adoption should be available.

COMMISSIONING AND CONTRACTING
Generic Patient Reported Outcome Measures exist for this pathway (EQ5D). Currently clinical consensus has not been reached for a condition specific measure.

NICE guidelines:
People who are concerned about their fertility should be informed that about 84% of couples in the general population will conceive within one year if they do not use contraception and have regular sexual intercourse. Of those who do not conceive in the first year, about half will do so in the second year (cumulative pregnancy rate 92%). People who are concerned about their fertility should be informed that female fertility declines with age, especially after 35, but that the effect of age on male fertility is less clear. With regular unprotected sexual intercourse, 94% of fertile women aged 35 years, and 77% of those aged 38 years, will conceive within 3 years of trying

COMMISSIONING AND CONTRACTING
See the Contractual Levers for 18 week Pathways for more detailed directions and guidance that underpin primary care contracting.
Before starting commissioning consider existing primary care medical contracts. Are you already paying for this work? Is it more appropriate to commission this stage of the pathway from primary care contractors? Have your Practice Based Commissioning (PBC) groups considered this pathway for any service redesign? Have you considered the contractual options to commission the pathway at primary care level? Is the current primary care contract fully utilised? Is there capacity to commission additional activity under additional or enhanced service arrangements?

Couples should be seen together.
NICE guidelines:
- couples have failed to conceive after regular unprotected sexual intercourse for 1 year in the absence of known reproductive pathology
- referral prior to 1 year should be made if:
+ pre-disposing factors of infertility exist such as amenorrhoea, oligomenorrhoea, pelvic inflammatory disease, un-descended testes
+ female age >34
+ prior treatment for cancer
+ male or female partner has HIV, hepatitis B or C

This law obliges all centres providing tertiary care treatment services to comply with the Human Fertilisation and Embryology Act 1990

The HFE Authority (HFEA) http://www.hfea.gov.uk is charged with regulating the centres that are regularly inspected. It also publishes a Code of Practice http://cop.hfea.gov.uk/cop/pdf/COP.pdf which provides specific guidance on how the services may be constructed and provided.

Elucidate risk factors and co-morbidities.

Infertility

Advise:
Sexual intercourse every 2-3 days, not timed to any part of the cycle
Restrict alcohol intake in line with national guidelines
Both partners have been offered a smoking cessation programme if applicable
Woman should aim for a BMI between 20 - 25, with referral to practice nurse/dietician for weight management as appropriate. Referral for weight management should not preclude referral into specialist assessment.

3.4.2 Fertility treatments are often stressful and it may take some time for patients to decide how to proceed. Therefore patients should be allowed time to reflect on their diagnosis and treatment options, which may start a period of active monitoring.

On non-admitted pathways, if the patient declines start of treatment on the next menstrual cycle then the clock can be stopped using Active Monitoring. The patient then contacts the trust when ready for treatment to start.

3.4.4 Ovulation induction following NICE Guidance

3.4.6 Therapeutic laparoscopy, hysteroscopy or open surgery eg myomectomy, tubal surgery, surgery for endometriosis, all performed by specialist with suitable training.

SERVICE IMPROVEMENT
For good practice pre-operative assessment guidance, use the hyperlink above or see the website.

4.4.1 If Counselling is the definitive treatment (and no other treatment planned) then this will stop the clock. Therefore, if other definitive treatments are planned then counselling does not stop the clock.

4.4.2 Fertility treatments are often stressful and it may take some time for patients to decide how to proceed. Therefore patients should be allowed time to reflect on their diagnosis and treatment options, which may start a period of active monitoring.

4.4.3 Ovulation induction following NICE Guidance, Gonadotrophin Induction of ovulation: refer NICE Guidance
Gonadotrophin stimulation of men with Hypogonadotrophic hypogonadism due to pituitary tumours, after pituitary surgery, Iron overload in thalassemia, Treatment for hyperprolactinaemia

4.4.4 IUI, IVF, ICSI, gamete donation, Embryo donation, Pre-implementation Genetic Diagnosis (PGD), surrogacy.

Due to the different types of treatment available and the variation of menstrual cycle and treatment start dates within the cycle, treatment can often not start immediately, therefore the clock stops using active monitoring at the DTT. If there are capacity restraints the clock keeps ticking as use of active monitoring to stop the clock where there are capacity (or funding) restraints is inappropriate. See also the Fertility Scenarios document.

Patients waiting for egg or sperm donation are included in 18 weeks. However, the clock should stop once they are placed on the appropriate waiting list for donation, similar to 18w rules for transplant surgery.

If more than one cycle of IVF is funded then subsequent treatments could be considered to be planned care but patients should not be disadvantaged because a clock has not been started.

4.4.6 Tubal Surgery: This should be performed by a specialist with suitable training.

Advanced endometriosis surgery: This should only be performed after a detailed discussion with the patient agreeing the objectives for surgery, potential benefits and risks including those that are severe and rare. In severe cases prior consultation with the colorectal surgeon is desirable and where ever possible surgery should be performed with the presence or immediate availability of the colo-rectal surgeons.

Where patient does not meet the eligibility criteria they can be referred back to primary care with the clock stopping. If the PCT criteria change then the patient can be re-referred.

SERVICE IMPROVEMENT
For good practice pre-operative assessment guidance, use the hyperlink above or see the website.