NICE fertility guidelines. Hemlata Thackare MPhil MSc MRCOG Deputy Medical Director London Women s Clinic

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1 NICE fertility guidelines Hemlata Thackare MPhil MSc MRCOG Deputy Medical Director London Women s Clinic

2 About the LWC 4 centres around the UK London Cardiff Swansea Darlington The largest sperm bank in the country with the first UK donor sperm on-line catalogue A wealth of experience, the busiest clinic for lesbian couples and single women and donor insemination cycles Proud sponsors of the Want2be Parenting Show 8 th June 2013

3 What s special about LWC Providing fertility treatment in Wales since 1995 Cardiff clinic - Great location State of the Art facilities No waiting lists for consultation or treatment Experienced and friendly team First clinic in UK to offer egg share treatment First clinic in Wales to offer on-site sperm retrievals fresh and frozen First clinic in Wales offering mild stimulation IVF and embryo screening Own donor bank with on-line catalogue Consistent success rates over 15 years, verified by HFEA Packages available for cost effective treatments for IUI,IVF and egg freezing

4 Epidemiology of infertility Infertility affects 1 in 7 heterosexual couples in the UK The main causes of infertility in the UK are unexplained fertility (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%) In about 40% of cases disorders are found in both the man and the woman

5 The effect of maternal age on the average rate of pregnancy

6 Cumulative probability of conceiving a clinical pregnancy by the number of menstrual cycles Age category (years) Pregnant after 1 year (12 cycles) (%) Pregnant after 2 years (24 cycles) (%)

7 NICE Definitions Infertility Lack of spontaneous conception in a woman of reproductive age despite regular unprotected sexual intercourse in the absence of reproductive pathology Unexplained infertility Normal semen analysis, confirmation of spontaneous ovulation and no tubal or pelvic pathology Mild male factor infertility Two or more semen analyses reporting one or more sperm parameters below 5 th centile (WHO 2010 standards) Expectant management Formally encouraging conception through unprotected vaginal sexual intercourse

8 NICE Definitions Assisted conception Conception occuring by any other means and not by vaginal coitus Full cycle of IVF One episode of ovarian stimulation and oocyte collection followed by transfer of all resultant fresh and frozen embryos Natural cycle IVF IVF with oocyte retrieval in natural cycle without use of any drugs Low egg reserve Total antral follicle count less than four follicles 2-10mm AMH less than 5.4 pmol/l Day 3 FSH > 8.9 IU

9 Semen analysis (WHO 2010 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.

10 Ovarian reserve Woman's age as an initial predictor of her overall chance of success through natural conception or with in vitro fertilisation Use one of the following measures to predict the likely ovarian response to gonadotrophin stimulation in IVF: total antral follicle count of less than or equal to 4 for a low response and greater than 16 for a high response anti-müllerian hormone of less than or equal to 5.4 pmol/l for a low response and greater than or equal to 25.0 pmol/l for a high response FSH greater than 8.9 IU/l for a low response and less than 4 IU/l for a high response

11 Ovulation assessment and Tubal patency Mid-luteal Progesterone > 30 nmol/l confirms spontaneous ovulation offer this even if regular menstrual cycles Tubal patency tests either HSG or HyCoSy if no pelvic or tubal pathology Lap and dye if suspected pelvic pathology

12 Folic acid supplementation Folic acid 0.4 mg per day before conception and up to 12 weeks' gestation reduces the risk of having a baby with neural tube defects. Folic acid 5 mg per day for women who have previously had an infant with a neural tube defect who are receiving anti-epileptic medication who have diabetes

13 Assisted Conception Treatments HFEA statistics Egg/ embryo Freezing 1% Egg Sharing/ donation PGS PGD % Surrogacy IVF 60,000 cycles IUI ICSI DI 4091 cycles

14 IVF success in terms of live births per 100 embryo transfers

15 Key Priority Assessment and Referral Clinical investigations for both partners After one year of trying spontaneous conception if less than 36 years Early specialist referral for investigations, assessment and treatment If 36 years or older Known fertility problem Predisposing factors for infertility Generalist and specialist care People who experience fertility problems should be treated by a specialist team because this is likely to improve the effectiveness and efficiency of treatment and is known to improve people's satisfaction with treatment. [2004, amended 2013]

16 Key Priority -Unexplained infertility Do not routinely offer ovulation induction drugs such as Clomiphene or Letrozole for women with unexplained infertility

17 Key Priority - Intrauterine Insemination 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 Women who are ovulating regularly should be offered a minimum of 6 natural cycles of donor insemination Couples using donor sperm should be offered intrauterine insemination in preference to intracervical insemination In the absence of suspected tubal pathology, tubal patency test can be deferred in couples attempting donor insemination

18 Key priority - Access criteria for IVF Three full cycles of IVF In women aged under 40 years who have not conceived after 2 years of regular unprotected intercourse or 12 cycles of artificial insemination (where 6 or more are by intrauterine insemination), If the woman reaches the age of 40 during treatment, complete the current full cycle but do not offer further full cycles. One full cycle of IVF In women aged years who have not conceived after 2 years of regular unprotected intercourse or 12 cycles of artificial insemination (where 6 or more are by intrauterine insemination), provided the following 3 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. Where investigations show that IVF/ICSI is the only effective treatment, refer the woman directly to a specialist team for IVF treatment

19 IVF Laboratory Process Fertilised Egg Day 2 Embryo Day 3 Embryo Day 5 Embryo Blastocyst

20 Proportion of treatment cycles started IVF types and DI, % Fresh donor eggs 17% Frozen own eggs 0.50% Frozen donor eggs 6.60% DI 73.40% Fresh own eggs Fresh own eggs Frozen own eggs Fresh donor eggs Frozen donor eggs DI

21 Percentage of all IVF cycles performed, by age group, 2011 Percentage IVF cycles started by age 3.50% % % % % %

22 Time-lapse video fertilised egg to blastocyst

23 Proportion of all embryo transfers (fresh and frozen), by number of embryos transferred, % TET 16.80% eset eset non-elective eset 18.70% Non-eSET Double embryo transfer 60.20% DET Triple embryo transfer

24 Key priority -Reducing multiple pregnancy risk HFEA licence condition - Multiple live birth rate 10% with fresh and frozen embryo transfer 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 one or more top-quality embryos are available. In the third full IVF cycle transfer no more than 2 embryos. For women aged years: In the first and second full IVF cycles use single embryo transfer if 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 2 embryos. For women aged years consider double embryo transfer. For women undergoing IVF treatment with donor eggs, use an embryo transfer strategy that is based on the age of the donor. No more than 2 embryos should be transferred during any one cycle of IVF treatment. [2013]

25 Key priority - Cryopreservation Offer cryo-preservation to store any remaining embryos after fresh embryo transfer Offer sperm / egg / embryo freezing to men and adolescent boys and women of reproductive age preparing for medical treatment of cancer likely to make them infertile For women normal age criteria for referral for IVF should not apply Use vitrification Store gametes and embryos initially for 10 years The stored tissue can remain in storage for maximum 55 years if evidence of significant or premature infertile

26 NICE cost implications Wales number of IVF and DI cycles 1100 cycles of IVF and DI registered with HFEA 1 in 6 to 7 couples are diagnosed with infertility 60,000 IVF and DI cycles per year 2% of all births conceived with IVF 40% IVF cycles and less than 20% DI cycles currently funded by NHS Full implementation of NICE guideline estimated provision for 93% of all IVF cycles Improved access for IVF and updating practice to meet NICE guidelines expected rise in cost by 40% Some cost off-set by strategy reducing multiple live births Good vitrification programme will be essential Storage costs for oncology patients need to be taken care of Patient education is required to focus on cumulative pregnancy rate from one full IVF cycle

27 NICE cost implications Based on live birth rate of 29.5% per cycle, cost of one IVF cycle and likelihood of providing 2.2 cycles With full implementation - total cost for population of 100,000 Non-recurrent cost 201,000, split across three years Annual recurrent cost of 125,000 from year three onwards Saving of 4000 for reduction in multiple births from IVF Excludes cost of providing IVF to women aged years Excludes cryo-preservation cost, extended blastocyst culture, increased staffing levels and consummables Has not looked at egg donation / PGD / Surrogacy

28 NICE - cost implications Cost of implementing guideline during first five years for a population of 100,000

29 Conclusion NICE has made recommendations for fertility assessment, investigations and treatment Significant cost implications In England almost 40% PCTs pay only for one IVF cycle and a few do not fund IVF at all Wales has reasonable provision with two fresh and two frozen embryo transfers Patient groups will pressurise NHS into full implementation of the guideline Local savings can be made with referral to specialist clinics and avoiding wastage with inappropriate investigations and treatments Pressure on IVF clinics to improve pregnancy rate without increasing multiple pregnancy rate

30 THE LONDON WOMEN S CLINIC WALES Egg Sharing IVF ICSI Egg Freeze PGS PGD Surrogacy IUI DI Tel wales@londonwomensclinic.com

31

32 What is egg-sharing?

33 Why egg-share? Brings together a surplus and a shortage Reduces egg wastage Promotes practical altruism Achieves a therapeutic balance between risk and reward Reduces dependence on non-patients

34 Egg-sharing inclusion criteria Egg-sharers Egg recipients 34 years or under Established need for egg donation Healthy No contraindication to pregnancy Clear family history Non-smokers Age up to 50 years. Above this, treatment may be offered subject to counselling and Ethics Committee review and support BMI less than 28 No more than two previous unsuccessful IVF attempts despite good embryo quality Financially solvent

35 Egg-sharing success rates Clinical Pregnancy Rate (2011) Egg-sharer 48% Egg-share recipient 54%

36

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