INTRAUERINE INSEMINATION DERBYSHIRE COMMISSIONING POLICY

Transcription

1 INTRAUERINE INSEMINATION DERBYSHIRE COMMISSIONING POLICY Document History Date of publication Sept 2016 Version Number: 1 Review date Sept 2018 Consultation Consultee Which group Public Health Input Derbyshire Affiliated Commissioning Committee Has the consultation included patient representatives? Date CCPAG Consultant in Public Health No Policy sign off Reviewing body Review date Version no Document Status This is a controlled document, whilst this document may be printed; the electronic version posted on the 4 CCG s websites is the controlled copy, till it becomes available on the new policy amalgamated Derbyshire Medicines Management Intranet site. Any printed copies of this document are not controlled. As a controlled document, this policy should not be saved onto local network drives but should always be accessed from the Intranet. If you need help accessing this document it is available on request in other formats (for example large print, easy read, Braille or audio versions) and languages. Please call the Communications & Engagement Team on or communications@southernderbyshireccg.nhs.uk. v1, Intrauterine Insemination Policy Page 1 of 17

2 Version Control Draft Version/description of amendments Date Author 1 First draft 7/4/15 Mania Misirli 2 Comments received from: 19/05/15 Jilla Burgess-Allen David Fagg (Equality Lead, GEM) Steve Barr (Derbyshire Friend) Robyn Dewis (Derby City Public Health) 3 Comments received from: 28/05/15 Jilla Burgess-Allen Derbyshire CCGs Equality Steering Group 4 Comments received from: Vanessa Griffiths (SDCCG), and Claire Foreman (NHS England, Specialised Commissioning) 0/07/2015 Jilla Burgess-Allen 5 Comments received from: 16/07/2015 Jilla Burgess-Allen Clinical Policies Group (meeting held 9/7/15) Kate Brown (SDCCG) 6 Comments received from Derby Positive 07/08/2015 Jilla Burgess-Allen Support and Disabled People's Diversity Forum:- Comment: Should alcohol be included, since it affects fertility? Response: Alcohol is not included in the E.Mids IVF Policy so to be in line with that it has not been included in this policy. Comment: Should the policy cover a situation where testicular cancer affects male fertility or would this procedure not be appropriate in these circumstances? Response: fertility cryopreservation falls outside the scope of this policy. Comment: It seems hard for folks on a low income as they have to pay for 6 cycles before they qualify for any free help. It seems an awful lot of money to have to find if you are on a low income. 7 Appendix 1 added Fertility Assessment and Treatment Pathway and Appendix 2 Referral Form for Fertility Assessment and Treatment in Vito Fertilisation (IVF) Intracytopplasmic Sperm Injection (ICSI) 15/08/2016 Vanessa Griffiths v1, Intrauterine Insemination Policy Page 2 of 17

3 TABLE OF CONTENTS 1. Equality Statement Due Regard Introduction Background Definitions Full Details of Policy... 5 Epidemiology... 5 Referral Criteria... 7 Eligibility Criteria... 8 Inclusion Criteria... 9 Exclusion Criteria... 9 Analysis N/a... 9 Evaluation Refrences Monitoring and Review Appendices / Relevant Web Links Appendix 1 Fertility Assessment and Treatment Pathway Appendix 2 Referral Form for Fertility Assessment and Treatment In Vitro Fertilisation (IVF)/Intracytoplasmic Sperm Injection (ICSI) v1, Intrauterine Insemination Policy Page 3 of 17

4 1. EQUALITY STATEMENT Erewash, Hardwick, North Derbyshire and Southern Derbyshire Clinical Commissioning Groups (Derbyshire CCGs) aim is to design and implement policy documents that meet the diverse needs services, population and workforce, ensuring that none are placed at a disadvantage over others. It takes into account current UK legislative requirements, including the Equality Action 2010 and the Human Rights Act 1998, and promotes equal opportunities for all. This document has been designed to ensure that no-one receives less favourable treatment due to their protected characteristics of their age, disability, sex (gender), gender reassignment, sexual orientation, marriage and civil partnership, race, religion or belief, pregnancy and maternity. Appropriate consideration has also been given to gender identity, socio-economic status, immigration status and the principles of the Human Rights Act. 2. DUE REGARD In carrying out their functions, the Derbyshire Affiliated Commissioning Policy Committee made up of Erewash, Hardwick, North Derbyshire and Southern Derbyshire, Clinical Commissioning Groups, this policy has been reviewed in relation to having due regard to the Public Sector Equality Duty (PSED) of the Equality Act 2010 to eliminate discrimination, harassment, victimisation; to advance equality of opportunity; and foster good relations between the protected groups. 3. INTRODUCTION The purpose of this commissioning policy is to set out Derbyshire CCGs' commissioning responsibilities and the criteria for access to NHS funding for intrauterine insemination. This policy is an update of the existing Derbyshire County PCT "Commissioning Policy for Subfertility Services" published in December 2010 and has drawn on the revised NICE Clinical Guideline Fertility, assessment and treatment for people with fertility problems (CG156 February 2013). CG156 replaces the previous CG11 (2004), and includes updated recommendations regarding the effectiveness of intrauterine insemination (IUI) 1. This policy now covers Intrauterine Insemination (IUI) only, and should be read in conjunction with the East Midlands Commissioning Policy for In Vitro Fertilisation (IVF)/ Intracytoplasmic Sperm Injection (ICSI) within tertiary Infertility Services (April 2014). The scope of the NICE Guideline 156 and this policy makes it clear that it is intended for people who have a possible pathological problem (physical or psychological) to explain their infertility. 4. BACKGROUND 4.1 Fertility problems are common in the UK and it is estimated that they affect one in seven couples. 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%). In 30% of infertility cases the cause cannot be identified. 1 A NICE evidence update (March 2015) included no further evidence relating to IUI v1, Intrauterine Insemination Policy Page 4 of 17

5 4.2 Where a woman is of reproductive age and having regular unprotected vaginal intercourse two to three times per week, failure to conceive within 12 months should be taken as an indication for further assessment and possible treatment. 4.3 If the woman is aged 36 or over then such assessment should be considered after 6 months of unprotected regular intercourse since her chances of successful conception are lower and the window of opportunity for intervention is less. 4.4 For women aged up to 42 years who have not conceived after 2 years of regular unprotected intercourse or a course of artificial insemination (in line 5 with local CCG policy), this should be taken as an indication for consideration of IVF. 4.5 If, as a result of investigations, a cause for the infertility is found, the individual should be referred for appropriate treatment without further delay. 4.6 This policy reflects the NICE guidelines that access to high level treatments including IVF should be offered to women up to the age of 42. Ovarian stimulation should have been completed before the woman s 43rd birthday. 4.7 Women will be offered treatment provided their predicted ovarian response to gonadotrophin stimulation is satisfactory, as indicated by an Follicle Stimulation Hormone (FSH) of < 8.9 IU/l or one of the other measures recommended in NICE CG156 (section Ovarian reserve testing). 5. DEFINITIONS 5.1 Funding for IVF/ICSI will be available to couples who do not have a living child from their current relationship nor any previous relationships. 5.2 A child adopted by a couple is considered to have the same status as a biological child. This does not include foster children. 5.3 A couple who is accepted for treatment will cease to be eligible for treatment (i.e. additional cycles see section 12) if a pregnancy occurs naturally leading to a live birth or if the couple adopts a child. 6. FULL DETAILS OF POLICY Epidemiology NICE define infertility according to the period of time people should be trying to conceive after which it would be reasonable to initiate formal assessment and possible treatment. Where the woman is of reproductive age and having regular unprotected vaginal intercourse two to three times per week, this period is 12 months. Where the woman is aged over 36, the period is 6 months. For same-sex couples, referral for assessment and possible treatment would be reasonable after failure to conceive after 6 cycles of AI 2 within the 12 past months. 2 AI must be undertaken in a clinical setting with an initial clinical assessment and appropriate v1, Intrauterine Insemination Policy Page 5 of 17

6 Around 84% of couples attempting to conceive are successful after trying for one year. After two years this figure rises to 92%. Female fertility declines with age and for women aged 38 about 77 out of every 100 who have regular unprotected sexual intercourse will get pregnant after 3 years. At any point in time, the estimated prevalence of infertility is 1 in 7 couples in the UK. The need for fertility assessment and treatment may increase due to the trend towards later first pregnancies and an increasing number of new partnerships later in adulthood. Demand is increasing due to increased public awareness of treatment possibilities. It is likely that there is unexpressed and/or unmet demand, particularly from women with secondary infertility (those who have conceived before but do not necessarily have a child). Causes of Infertility Approximate proportions of principal causes based on studies of couples seeking treatment are given below. A significant proportion of couples will have more than one cause and the distribution varies between primary and secondary infertility. Unexplained infertility (no identified male or female cause) (25%) Ovulatory disorders (25%) Tubal damage (20%) Factors in the male causing infertility (30%) Uterine or peritoneal disorders (10%). There is evidence that infertility causes considerable emotional stress and distress, which may affect many areas of couples' lives and can have significant deleterious impact on social and mental wellbeing. Types of Fertility Treatment There are three main types of fertility treatment: medical treatment (such as drugs for ovulation induction); surgical treatment (e.g. laparoscopy for ablation of endometriosis); and assisted reproduction. Assisted reproduction techniques include: - In vitro fertilisation (IVF) - Intra-cytoplasmic sperm injection (ICSI) - Donor insemination (DI), oocyte (egg) donation and cryo-preservation (oocytes and/or embryos) - Intrauterine insemination (IUI) IUI is a form of treatment where faster sperm are separated from slower or non-moving sperm and then inserted into the uterine cavity around the time of ovulation. IUI can be carried out in a natural cycle, without the use of drugs, or the ovaries may be stimulated with oral anti-oestrogens or gonadotrophins. IUI can be undertaken using partner or donor sperm. Over 50% of women aged under 40 years will conceive within 6 cycles of IUI, and of those who do not conceive within 6 cycles of IUI, about half will do so with a further 6 cycles (cumulative pregnancy rate over 75%). Figure 1. investigations v1, Intrauterine Insemination Policy Page 6 of 17

7 Probability of conceiving a clinical pregnancy by number of cycles of insemination and age (Source: HFEA) Woman s age IUI using thawed semen 6 cycles 12 cycles 30-34yrs 63% 86% 34 yrs 50% 75% The data in figure 1 above reflect results using insemination with donor semen and not partner semen. If a partner s sperm is to be used then fresh sperm would be preferable. Exceptional Circumstances Cases may be considered via the CCG's Individual Funding Request route but must demonstrate robust, clinical exceptionality. Referral Criteria Figure 2 Woman s Age Should be referred by the age of 40 years Man s Age 55 years or younger Woman s BMI Within the range of Man s BMI BMI <35 3 Welfare of Child The welfare of any resulting children is paramount. In order to take into account the welfare of the child, the centre should consider factors which are likely to cause serious physical psychological or medical harm, either to the child to be born or to any existing children of the family. This is a requirement of the licensing body, Human Fertilization and Embryology Authority. Family Structure No living children from current or previous relationship(s), including adopted children, but excluding foster children. There needs to be an explicit and recorded assessment that the social circumstances of the family unit have been considered within the context of the assessment of the welfare of the child. Smoking Neither partner must be a current smoker. Ex-smokers must have been quit for at least 28 days before treatment commences and must continue to be non-smoking throughout treatment. Sterilisation Sterilised patients are not eligible for NHS funded treatment. In line with NICE guidance, unstimulated IUI may be considered as a treatment option in the following groups as an alternative to vaginal sexual intercourse: People who are using partner or donor sperm and who are unable to, or would find it very difficult to, have vaginal intercourse because of a clinically diagnosed physical disability or psychosexual problem 4 People in same-sex relationships 3 NICE recommends men who have a BMI of 30 or over should be informed that they are likely to have reduced fertility. 4 Where psychosexual problems prevent vaginal intercourse the couple should, in the first instance, be referred for psychosexual counselling v1, Intrauterine Insemination Policy Page 7 of 17

8 For people in the above specific groups who have not conceived after 6 cycles of donor or partner insemination (self-funded 5 ), despite evidence of normal ovulation, tubal patency and semenalysis, a further 6 NHS funded cycles of unstimulated IUI should be offered before IVF is considered. For the purpose of access to NHS services, donor or partner insemination should be undertaken in a clinical setting with an initial clinical assessment and appropriate investigations. Same-sex couples considering surrogacy are referred to the EMSCG Policy for Surrogacy (2010). This Policy states that the NHS "will not provide routine funding for the medical treatment required to give effect to a surrogacy arrangement". Fertility treatment for people living with HIV is the commissioning responsibility of CCGs. We will fund IUI for people who are clinically indicated to receive IUI following a successful sperm washing procedure where the man is HIV positive. The rationale for funding initial rounds of IUI for this group of patients but not those above (who are unable to have vaginal intercourse due to clinically diagnosed physical disability or psychosexual problem, and people in same-sex relationships) is that IUI for couples where the male is HIV positive serves to prevent transmission of HIV to the woman and the child. Sperm washing should be offered to couples where the man is HIV positive and either he is not compliant with HAART or his plasma viral load is 50 copies/ml or greater, and who meet the criteria in table 1. Male partners who are hepatitis C (HCV) positive have a low likelihood of transmitting the virus through sexual intercourse (approximately 2%) and NICE state there is insufficient evidence about the value of sperm washing to reduce that risk even further; partners of individuals with hepatitis B should be vaccinated before fertility treatments begin and sperm washing is not be necessary. Patients who fail to achieve a pregnancy using IUI/DI will be considered for IVF. Eligibility Criteria All couples are eligible for consultation and advice in primary care. Refer to Appendix 1 Fertility Assessment and Treatment Pathway. Where a woman is of reproductive age and having regular unprotected vaginal intercourse two to three times per week, failure to conceive within 12 months should be taken as an indication for further assessment and possible treatment. If the woman is aged 36 or over then such assessment should be considered after 6 months of unprotected regular intercourse, since her chances of successful conception are lower and the window of opportunity for intervention is narrower. A summary of the eligibility criteria for IUI for different patient groups is given in figure 2. Couples must meet the referral criteria set out in Figure 3 before being referred by their GP for further investigation and assessment for assisted fertility treatment. For the referral form See Appendix 2, Referral Form for Fertility Assessment and Treatment in Vito Fertilisation (IVF) Intracytopplasmic Sperm Injection (ICSI) IUI, either with or without ovarian stimulation, should not be routinely offered to people with unexplained infertility, mild endometriosis or 'mild male factor infertility', who are having regular unprotected sexual intercourse, except in exceptional circumstances. NICE no longer 5 The CCG will not fund the initial 6 AI cycles but will fund access to a clinical consultation to discuss options for attempting conception, further assessment and appropriate treatment. The cost to couples self-funding AI is typically between 500 and 1000 per cycle. v1, Intrauterine Insemination Policy Page 8 of 17

9 recommends IUI for these groups of patients because a review of the literature concluded that IUI without stimulation is no better than expectant management (Bhattacharya et al. 2008; Wordsworth et al. 2011). It is unclear whether IUI with stimulation is more effective than expectant management for these groups; however it is likely to increase the risk of multiple pregnancies, which is the single biggest risk of fertility treatment. When people have social, cultural or religious objections to IVF, who have an underlying fertility problem, the option of IUI will be discussed as part of the assessment and treatment in the NHS. Figure 3. Inclusion Criteria N/a Exclusion Criteria N/a Analysis N/a Evaluation N/a v1, Intrauterine Insemination Policy Page 9 of 17

10 7. REFRENCES NICE (2013). CG156: Fertility: Assessment and treatment for people with fertility problems Derbyshire County PCT Commissioning Policy for Subfertility Services, December 2010 EMSCG Policy for Surrogacy (2010) HFEA (Human Fertilisation & Embryology Authority) Bhattacharya, S., et al. "Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomised controlled trial." BMJ 337 (2008). Wordsworth, S., et al. "Clomifene citrate and intrauterine insemination as first-line treatments for unexplained infertility: are they cost-effective?." Human reproduction 26.2 (2011): ESHRE Capri Workshop Group. "Intrauterine insemination." Human Reproduction Update (2009). 8. MONITORING AND REVIEW N/a 9. APPENDICES / RELEVANT WEB LINKS Appendix 1 Fertility Assessment and Treatment Pathway Appendix 2 Referral form for Fertility Assessment and Treatment v1, Intrauterine Insemination Policy Page 10 of 17

11 Appendix 1 Fertility Assessment and Treatment Pathway Patients with fertility problems go to the GP GP Advice and Assessment GP to inform patient of access criteria for NHS-funded assisted conception. Investigations and tests: Refer for advice Heterosexual Couples should be referred together. Female same sex relationship referred after IUI 6 attempts Female Tests Rubella (provide results if taken in the 5 years prior to referral) Chlamydia serology (provide results if taken in the last 6 months prior to referral), Basic haematology screen, Serum LH, Serum FSH Day 1-4, Serum TSH, Serum Prolactin Serum Progesterone (taken in the 5 years prior to referral) Male Tests Semen analysis (if abnormal then also FSH/LH/testosterone Rejected referrals sent back to GP Referral accepted by chosen NHS fertility services 1 st Outpatient appointment (Couple seen together if heterosexual) Female Tests Chlamydia serology (if no result identified in Primary Care Rubella (if no result identified in Primary Care Referral Clock starts Additional investigations (in accordance with agreed protocols) Tests in Secondary Care Hepatitis B surface antigen Hepatitis B core antibody Hepatitis C serology HIV screening Follow up appointment arranged to discuss further test results and diagnosis Male Factor (sperm issues) Endometriosis Tubal defect Ovulation Issues Unexplained Primary Ovarian Failure Drug Therapy i.e Gonadotrophin Laparoscopy + Surgery Tubal Surgery E.g. Clomifene Donor Insemination Intrauterine Insemination Treatment started - Clock stops IVF/ICSI Tertiary Fertility v1, Intrauterine Insemination Policy Page 11 of 17

12 Primary Care Phase including initial investigations GP Practices GP actions/responsibilities prior to referral to NHS Fertility Clinic and Tertiary Fertility Provider GP advice and assessment : GP to inform patients of access criteria for NHS Funded Assisted Conception and treatments which include: 1. Intrauterine Insemination (IUI) undertaken in secondary care access criteria applies - NICE Guideline recommends that 6 unsuccessful (self-funded cycles) of artificial insemination (AI) at one of the HFEA licensed fertility centres should be attempted, before they would be considered to be at risk of having an underlying problem and be eligible to be referred for assessment and possible treatment. 2. Donor Insemination (DI) undertaken in secondary care access criteria applies 3. IVF/ICSI undertaken at Tertiary Fertility Providers access criteria applies : For women BMI less than 30 For women age range no lower age limit upper age limit years One cycle of IVF/ICSI funded for those eligible for NHS funding. Referrals must be sent with the Referral Proforma to secondary care providers for further investigations to ascertain reasons for fertility problems. Patients will be accepted for assessment following initial investigation by the GP. All referrals must be made in the name of the woman being referred. The following test results must be received by the service along with the referral. Where the woman has regular menstrual cycles Serum FSH/LH (day 1-4) (taken in the 6 months prior to referral for IVF treatment) Serum Progesterone (Day 21) i.e. 1 week before expected period Rubella (taken in the 5 years prior to referral) Chlamydia (taken in the last 6 months prior to referral) For the male Semen analysis (taken in the 12 months prior to referral) FSH/LH/testosterone (if semen analysis is abnormal) Where the woman has irregular menstrual cycles Serum FSH/LH (taken in the 6 months prior to referral for IVF treatment) Serum TSH Serum Prolactin Serum Rubella (taken in the 5 years prior to referral) Chlamydia (taken in the last 6 months prior to referral) For the male Semen analysis (taken in the 12 months prior to referral) FSH/LH/testosterone Referrals will be returned to the GP where the required test results are not provided as these are essential for the first outpatient appointment to take place. v1, Intrauterine Insemination Policy Page 12 of 17

13 Note that IVF can be offered to women up to the age of 42. When making a referral please note the timescales, and that ovarian stimulation must be completed before the woman s 43 rd birthday. Secondary Care Investigation Phase NHS Fertility Clinic Responsibilities Patients will be accepted for assessment following initial investigation by the GP. All referrals must be made in the name of the woman being referred. The fertility referral proforma must be attached to the referral to confirm discussions held with the couple being referred. 18 week referral to treatment pathway It is the responsibility of the provider to understand the 18 Week Principles and Definitions. They must be applied to all aspects of the individual s pathway, and referrals and waits will be managed and measured accordingly. 1 st definitive treatment within specialist fertility services should commence within 18 weeks of the referral into secondary care. Where further tertiary treatment is required, this should be completed within 18 weeks of the decision to treat. Investigation Phase In addition to tests carried out by GP, further tests in Secondary Care or NHS fertility clinic will be provided, these may include: A full hormone profile taken between days 2-4 of a period to assess for any hormone imbalance. Blood tests to find out if ovulating. An ultrasound scan to look at the uterus and ovaries. Hysterosalpingogram an x-ray to check fallopian tubes or Hysterosalpingo-contrast sonography (HyCoSy) a vaginal ultrasound probe is used to check the fallopian tubes for blockages. Laparoscopy an operation in which a dye is injected through the cervix as the pelvis is inspected via a telescope (laparoscope) with a tiny camera attached to check for tubal blockage. Hysteroscopy a telescope with a camera attached is used to view the uterus to check for conditions such as fibroids or polyps. Occasionally, a tissue sample may be taken from the endometrium lining of the uterus to be analysed. For men Semen analysis to check sperm numbers and quality. Sperm antibody test to check for protein molecules that may prevent sperm from fertilising an egg. FSH/LH/testosterone Karyotype o Cystic Fibrosis Screening v1, Intrauterine Insemination Policy Page 13 of 17

14 Please note that IVF can be offered to women up to the age of 42. When making a referral to IVF Fertility Providers please note the timescales, and that ovarian stimulation must be completed before the woman s 43 rd birthday Treatment Phase IUI and Donor Insemination depending on contractual arrangements will be undertaken in Secondary Care and/or at Tertiary Fertility Providers IVF/ICSI referrals onwards to Tertiary Fertility Providers For NHS Funded IVF/ICSI Information on Treatment The patient will be provided with further information from the Fertility Provider of their choice. Screening of patients Before processing patient sperm, eggs or embryos for treatment and/or storage, the fertility clinic must carry out a number of screening tests to assess the risk of contamination. The clinic will test patients for: HIV 1 and 2: Anti-HIV 1, 2 Hepatitis B: Surface antigen and Core Antibody - HBsAg/Anti-HBc Hepatitis C: Serology Anti-HCV-Ab Testing for HTLV-1, malaria and other conditions may also be performed if a patient s medical and/or recent travel history indicates they may be at risk. Patients who donate their eggs, sperm or embryos must also be screened for according to professional body guidelines ( Patients will progress to the treatment phase for IUI, DI and IVF/ICSI following discussion with GP and Consultant, following tests and investigations and once eligibility criteria has been confirmed. For all referrals, please complete the Referral Form for Fertility Assessment and Treatment. v1, Intrauterine Insemination Policy Page 14 of 17

15 Appendix 2 Referral Form for Fertility Assessment and Treatment In Vitro Fertilisation (IVF)/Intracytoplasmic Sperm Injection (ICSI) EFFECTIVE FROM 1 ST April 2014 ALL NEW GP REFERRALS Criteria for Referral for Assessment by Fertility Services: 1. In order to refer a woman for assessment by the Fertility services for IVF/ICSI, all questions MUST be answered. 2. Any No responses will mean that the person(s) do NOT qualify for other assisted conception treatments (IVF/ICSI). 3. Please refer to your local CCG policy for details of eligibility criteria for assisted conception treatments including Intrauterine Insemination (IUI), Donor Insemination (DI), Oocyte Donation (OD) Woman s Name, Address, DOB GP Length of subfertility Form to be completed by GP as part of referral to Fertility Services within Secondary Care. Partners Name, Address, DOB GP Women s Age Follicle Stimulation Hormone Levels (FSH) Eligibility Criteria Is under 40 years YES NO Person(s)s who have self-funded will be entitled to 1 NHS cycle provided they have not received more than 2 cycles Frozen embryo transfers from a privately funded IVF cycle will not be funded by the NHS even if NHS IVF funding has been approved. Can demonstrate an inability to conceive after having regular unprotected vaginal intercourse two to three times per week within 12 months, or has received Intrauterine Insemination (IUI) through a licensed fertility centres, six times. Between years provided: YES NO a) They have never previously had IVF. b) There is no evidence of low ovarian reserve i.e <8.9 c) There has been a discussion about the implications of IVF and pregnancy at this age The woman has a FSH level of <8.9 YES NO Women s BMI More than 19 and less than 30 YES NO Welfare of the child The welfare of any resulting children is paramount. In order to take into account the welfare of the child, the centre should consider factors which are likely to cause serious physical psychological or medical harm, either to the child to be born or to any existing children of the family. This is a requirement of the licensing body, Human Fertilization and Embryology Authority. YES NO Family Structure Smoking All person(s) referred must not have had a living child from current or any previous relationship, excluding foster children. NB: A child adopted by the patient or adopted in a previous relationship is considered to have the same status as a biological child. All person(s) referred must be non-smoking in order to access any fertility treatment and must continue to be non-smoking throughout treatment v1, Intrauterine Insemination Policy Page 15 of 17 YES YES NO NO

16 To be completed by the person(s) being referred We have read and understood the eligibility for funding of IVF/ICSI and confirm we do meet the criteria for this treatment. Signed: Signed: Date: Date: To be completed by the GP Please confirm: I have informed the person(s) that this intervention is only funded where criteria are met. The person(s) are aware of the limits of treatments offered under the NHS under this care pathway Signed: Date: Print Name: Referring GP/Consultant : Contact Address: Telephone No: To be completed by GP prior to referral to secondary care Investigations Date Female Serum FSH Level Serum LH Level Serum Progesterone at Day 21: Serum Prolactin: Serum Rubella: ABO Blood group & haemolytic antibodies Serum TSH Serum Testosterone Surgical Investigations Date Tubal Surgery: Yes No Laparoscopy & Dye: Yes No Hysteroscopy Yes No Hysterosalpingogram Yes No Semen Analysis: Count Motility Morphology Male (complete if relevant) To be completed by GP/Secondary Care prior to referral to Fertility Provider Screening Test Female Male (complete if relevant) Neg/Positive Date Neg/Positive Date HIV Screening Hep B Surface Antigen Hep B Core Antibody Chlamydia Screening Hep C Cervical Swab Please confirm I recommend proceeding to IVF/ICSI for my patient(s) Signed: Consultant Name: Date: v1, Intrauterine Insemination Policy Page 16 of 17

17 List of Fertility Providers To ensure that choice has been made available to your patient please note the list of Fertility Providers that hold contracts for Fertility Treatment within the East Midlands area. Provider Address/Website details Please tick chosen provider Care Fertility, Nottingham Satelitte Outpatient Clinics available at Derby Peterborough Lincoln Care Fertility, Northampton Care Fertility, Sheffield NURTURE Satelitte Outpatient Clinic at Burton Centre for Reproductive Medicinel Oxford Fertility Centre Cambridge IVF Care Fertility John Webster House 6 Lawrence Drive Nottingham Business Park Nottingham NG8 6PZ W: Care Fertility 67 The Avenue Cliftonville Northampton NN1 5BT W: Care Fertility Glen Road Sheffield S7 1RA W: NURTURE University of Nottingham University Park Nottingham NG7 2RD W: Oxford Fertility Unit Institute of Reproductive Sciences Oxford Business Park North Oxford OX4 2HW W: Cambridge IVF Kefford House Maris Lane Cambridge CB2 9LG W: v1, Intrauterine Insemination Policy Page 17 of 17