~ The Interim Patients’ Guide to DI and IVE Clinics 1998 HUMAN FERTILISATION EMBRYOLOGY AUTHORITY The Human Fertilisation and Embryology Authority The Human Fertilisation and Embryology Authority (HFEA) was set up in 1990 to license and regulate clinics which provide: e in vitro fertilisation (IVF) treatment e donor insemination (DJ) treatment e gamete intra fallopian transfer (GIFT) where donated sperm or eggs are used in treatment e storage of sperm or embryos. The HFEA also licenses clinics which carry out research involving human embryos. These activities can only be carried out if the clinic obtains a licence from the HFEA. As well as licensing research and treatment clinics, the HFEA also: e publishes a Code of Practice giving guidance to clinics on how they should carry out licensed activities; e keeps a confidential register of information about donors, patients and treatments; e gives advice and information to licensed clinics; e gives information and advice to people seeking fertility treatment, to donors and to people needing to store their sperm, eggs, or embryos as well as to the general public. More details can be obtained by contacting the HFEA at: Paxton House 30 Artillery Lane London E1 7LS Telephone: 0171 377 5077 Fax: 0171 377 1871 The data tables list all clinics licensed as of 1 November 1997 and intending to offer treatment services beyond 1 December 1998. Unlike previous editions of the Patients’ Guide, the individual live birth rates of clinics have not been adjusted statistically to take account of the different types of patient treated. The /ive birth rates published in this Interim Patients’ Guide are therefore not directly comparable. Date of publication: December 1998 |Ci m at eWn EnatiL i LaeC tS tOt HyM E trenton, f ©Human Fertilisation and Embryology Authority 1998 |G eneral Collections | P A DIT SL OLS FE EL SAAT OR TES LA a ey : “F Hepeo Son7 ger? nace The Patients’ Guide to /VF and D/ Clinics 4.7 Frequency of visits to the clinic..................... 10 4°8 ) Patient support groupsteh. eee 10 a.mane cost of treatment Ne. oe. rea dea. 10 ONO BTA CEU NAS 1 2B ada te aces cadas ohto cf tease eiead 10 3 The licensed treatments .... 4.11 What will happen if I get pregnant?.............. 10 Sol eDOnonmsemination, (1D) cscs. acti apa sdactnanes-s 6 4.12 What will happen if I don’t get pregnant?..... 11 Or PAP MS Perrin dONOTSs acc crete tert nee eee ee hae 6 3.2 Gamete Intra Fallopian Transfer (GIFT) using 5.1 Information about the treatment.................... 12 donaiedier eslonsperitiert.s.e2r2 d)e.c0isci.s 6 So seriney itro: Feriilisation (VF) Arr tes cerer aly 6 EE OURCSE T IO eel a eeeean a aval ad 12 3.3.1 Factors affecting the outcome of /VF 5:37 CONSENTN AMEN Ml AGO ONAN at eh egy 12 EYO ALIT CMU E Yee wes csete Siete cee astute oe a aetbveeas tetas 7 552) Number of embryos replaced Wain. fi, S.4eathe weltare. Ob (ne Cour ts et eee ee cacecess 12 3.4. Intra Cytoplasmic Sperm Injection (ICSI)....... 44 Somer ONT ICOTItality. wees eee meee ster ees ckeec see 12 3.5 IVF using donated eggs, sperm or embryos.... 7 6 Summary of questitoo ansk.s.. .. BrGmme Tams pOru SatCHtC LVL cscctoxsnceeauereeveaentcciatone4 7 Calm Ouestions forall cunics oct tk een 13 SW PeE MDIyO Mteezing and SLOTASE ci. ccecsc-eassae+ tn ee 8 6.2 Additional Questions for D/ clinics............... 13 3.7.1 Storage period for embryos and sperm......... 8 6.3 Additional Questions for /VF clinics............. 13 3.8 New treatments not yet licensed in the UK..... 8 4 Issues for patients to consider.....................9 4.1 Risk of multiple birth and treatment policy..... 9 4.2 Risk of Ovarian hyperstimulation syndrome ..9 AOL OSES ANG INVESAUU PON S cae is gece cet o oestrone 9 4 A= Treatments Offered DY CLINICS <..2..-ccccsserescotcose s 9 4.5 PROSITE ICLIONS OL) SEEQUCNI N saat 2.55. -02050- te pesceeeees 10 BEA Moa WWA LLO LISEG ee cenn ates ccten sth ctentre Pots crreptaeia ted SERVICE te, Bs wf Introduction Infertility affects many people. Up to one in six explains briefly what is involved in these couples have difficulties in conceiving and many treatments and describes some of the questions and seek medical advice and treatment. issues that you may wish to think about. It also gives information about all clinics licensed as of 1 Some patients will need only advice or reassurance. September 1997. You should also obtain Others may need drug therapy or surgery. But information from a number of clinics and then some will need to be referred to a clinic which decide which one best meets your needs. specialises in assisted conception techniques - mainly JVF and DJ. These treatments can be The data in this guide is based on the information provided only by clinics licensed by the HFEA. submitted to the HFEA by individual clinics. Each clinic is under a legal duty to provide accurate and There are many possible causes of infertility or up to date information about each licensed sub-fertility in both men and women. There are treatment commenced. Failure to supply such also many possible treatments. These include: information or the submission of inaccurate e drug therapy to control ovulation if a woman is information may result in sanctions, including not producing eggs regularly; withdrawal of the clinic’s licence to treat patients. e surgery to improve blocked or damaged fallopian tubes; This is an interim edition of the Patients’ Guide. e artificial insemination using the husband or partner’s sperm; Text and data have been compiled and prepared consistent with previous editions. Whilst all aspects e insemination using donor sperm (D/) if the of the Patients’ Guide are fundamentally reviewed husband or partner has no sperm or very poor during 1998/9, it has been decided only to make sperm or risks passing on an inherited disease; the raw data available this year without adjusted e in vitro fertilisation (VF); live birth rates. The individual live birth rates of clinics are therefore not directly comparable as e egg donation with /VF where the woman they will each have treated different types of cannot produce eggs; patients. e embryo donation; The HFEA is carrying out a thorough review of the e Gamete intra fallopian transfer (GIFT) using Guide during 1998/9. This includes examining how the couple’s own or donated sperm or eggs; best to present information in a format most useful to patients, and possible improvements to the data e Intra Cytoplasmic Sperm Injection (ICSI). collection process. The purpose of this Guide is to help people who are considering DJ, IVF, ICSI, or GIFT with donated sperm or eggs to understand the services For your assistance a glossary of terms can be offered by licensed clinics and to decide which found on pages 16-17. Words defined there are would be the best clinic for them. The Guide shown in Italics in the text of this guide. General advice when choosing a clinic No single clinic is going to be best for everyone as this. It is important that you understand the cause there is a range of clinics offering different types of of your infertility and why and how treatment will treatment. By obtaining information from several be given. You should always feel free to ask the clinics you can make a comparison of the services clinic any questions which you consider they offer and decide which best meets your needs. important. Whilst all aspects of the Patient’s Guide are Another important factor to consider is the Jive fundamentally reviewed during 1998/9, it has been birth rate for IVF and D/ treatment. The Jive birth decided only to make the raw data available this rate uses three different stages of the treatment year without adjusted Jive birth rates. The cycle for measuring outcomes. It refers to the individual live birth rates of clinics are not number of births (twins or triplets count as one adjusted to take account of factors such as the birth) for every 100: age of the woman and the type of infertility e treatment cycles commenced being treated, and therefore are not directly comparable as each clinic will have treated e egg collections different types of patients. e embryo transfers. Many people like to know that they will feel The implications of these are explained in more comfortable in the clinic and with the clinic’s staff. detail on page 18. If possible you should visit one or more clinic and talk to their staff so as to get a feel for the way in During the 12 month period covered by this Guide which you will be treated. This will give you an (1 April 1996 to 31 March 1997) the average live opportunity to discuss the cost of treatment, assess birth rate for IVF nation-wide was 16.7% (16.7 the amount of time needed to travel to and from the births for every 100 treatment cycles commenced). clinic and find out how long you will have to wait The average Jive birth rate for donor insemination for treatment to begin. These practical matters are (DI) was 9.6% (9.6 births for every 100 treatment very important in deciding which clinic to choose. cycles commenced). It is useful to decide which factors are the most However, these are only averages. Your important to you, make a list of priorities, and base individual circumstances will influence the your decision on these. Many people also find it likelihood of success in your own particular helpful to prepare a list of questions to ask when case. they approach a clinic. This Guide will help you do The licensed treatments If a couple cannot conceive because of problems with the man’s sperm it may be suggested that they consider insemination using donated sperm, the woman’s fallopian tubes or the causes of usually known as donor insemination (DJ). infertility cannot be explained, G/FT treatment may be offered. G/FT stands for Gamete Intra DI can also be used if the male partner carries an Fallopian Transfer and involves retrieving eggs inherited disease which might be passed on to a from the woman, mixing them with sperm and child of the couple. quickly replacing up to three eggs in one or other DI involves the use of sperm from a donor who has of the woman’s fallopian tubes so that they fertilise undergone HIV and other health screening, and inside the body. The HFEA does not regulate G/FT whose sperm has been quarantined for at least six if the woman’s own eggs and the partner’s sperm months. The sperm is placed in the woman’s are used. However, if necessary, this treatment can vagina, cervix (neck of the womb) or in the womb be carried out using donated sperm or eggs and itself (vaginal, cervical or uterine insemination). these treatments are regulated and recorded by the One or more inseminations may be carried out HFEA. In these circumstances, the Authority around the time at which the egg is released. allows no more than 3 eggs to be transferred in any single treatment cycle to lessen the risk of a Clinics can vary in the way they provide this multiple birth and the often severe problems which treatment. Some suggest that the woman monitor result (see page 9). her own Menstrual cycle (period) at home to establish the best moment for insemination. Others The number of these treatments in which donor may monitor the cycle by asking her to attend for a eggs or sperm is used is so small that clinics’ Jive series of hormone tests or ultrasound scans to birth rates are not reported in the Patients’ Guide. decide the best time for the insemination. Please refer to the section /VF using donated eggs, sperm or embryos on page 7 for more information Alternatively the clinic may propose that you take on the use of donor eggs or sperm. drugs to control your cycle so that they can fix the best time for insemination. The risk of Multiple Some clinics offer combined treatment cycles in birth rate is increased if the ovaries have been which both GIFT and In Vitro Fertilisation UVF) stimulated through the use of these drugs. Please are carried out together. Live birth rates for these refer to page 9 for information about treatment combined cycles are not reported in the Guide as policies and multiple pregnancies. there are too few to provide reliable statistics. However, you may wish to enquire whether a clinic carries out combined G/FT/IVF treatment cycles Sperm donors are recruited by clinics. They are and, if so, request the Jive birth rates and multiple carefully screened and given the opportunity to birth rates for these cycles. receive counselling. Fertilisati(oInVF ) | Donors are screened for HIV and certain other diseases and are required to give a full medical IVF treatment may be appropriate if, for example, a history. Sperm is stored for a minimum of six couple’s infertility is caused by the woman having months so that repeat HIV tests can be carried out blocked fallopian tubes or a man having very few on the donor before the sperm is used. sperm. Details of the donor’s physical appearance are Every month, a woman’s ovaries develop several recorded. Clinics will do their best to match the egg Follicles. Normally only one of these becomes physical characteristics of donors with the male fully mature and releases an egg into the fallopian partner, although a close match cannot always be tube for possible fertilisation. VF involves achieved. retrieval of one or more eggs from the ovaries prior to release. This procedure is done under sedation or The names of donors are not given to patients nor general anaesthetic. is the donor given information about patients. The donor does not have any rights or responsibilities Most /VF clinics usually recommend that the in respect of children who are born. woman takes drugs which cause the ovaries to 6 The licensed treatments mature several eggs in one monthly cycle. This (providing that more than two embryos were procedure is called Stimulated /VF.’ It increases created) is almost identical to the live birth rate for the chances of producing several embryos. Some treatments where three embryos are replaced. clinics prefer not to stimulate the ovaries, but Replacing three embryos increases the chances of collect the one egg that is naturally produced. multiple births. The risks to the patient and the children inherent in multiple births are explained After collection, the eggs are mixed with the man’s on page 9. There is no advantage, and there may be sperm in a dish and placed in an incubator to be a considerable risk, in replacing three embryos in fertilised and so produce one or more embryos. such circumstances. A maximum of three embryos may be replaced in It is advisable to discuss with the clinic how your the woman’s womb at any one time. If one or more individual circumstances might influence the embryo implants, a pregnancy begins. decision on the number of embryos that should be There are risks associated with stimulating replaced during your treatment. ovulation using drugs. The main risks are over- stimulation of the ovaries (‘Ovarian Hyperstimulation Syndrome’ or ‘OHSS’), and Multiple birth rate (twins, triplets or quadruplets). ICSI is a relatively new technique which may be Please refer to page 10 for information about OHSS appropriate where the male partner has very few and treatment policies and multiple birth. sperm. With /CS/ a single sperm is injected directly You may wish to discuss with the clinic the into the egg previously retrieved from the woman. question of whether to transfer one, two or three If the egg fertilises, it can be transferred to the embryos and the availability and implications of womb in the way described for VF. The live birth treatment with or without drugs. rate for ICSI treatment is slighty higher to standard IVF. There are a number of factors that may affect the outcome of /VF treatment. Research carried out on IVF treatment may be available using donated the data held on the HFEA register has shown that sperm if the male partner is infertile or using the main factor that influences the outcome of the donated eggs if, for example, the woman has no treatment is the age of the woman whose eggs are eggs or responds poorly to ovarian stimulation. used in treatment. The graph below shows that Donation might also be used if one of the couple is when a woman has /VF treatment using her own at risk of passing on a serious inherited disease. eggs the Jive birth rate decreases significantly from the age of 35 years. Other factors that influence the IVF treatment using donated embryos may also be outcome of treatment include the duration of offered if both partners are infertile but the woman infertility and the quality of the sperm. is able to carry a baby to full term. The availability of these treatments will depend on whether the clinic has access to supplies of donated eggs and sperm and if it has appropriate embryo storage facilities: Predicted rate Sperm donors are recruited in the same way as those used for D/. Egg donors are usually women 3 who have completed their families and are undergoing sterilisation, who are themselves Lb(riia%rtv)tee h having /VF treatment, or who simply wish to help others. Similar selection and screening criteria 20 25 30 35 40 45 50 55 apply as for sperm donors except that there is no Age of woman (years) six month storage period as eggs cannot be safely frozen. Some clinics do not wish to take even this You may wish to discuss the cause of your slight risk of HIV transfer from the egg and infertility with your doctor in order that you have a quarantine all embryos created from donated eggs reasonable expectation as to how helpful a for a period of six months. The donor is then particular treatment might be. retested. embryos replaced. 3.6 Transport/Satellite(VF = It is often thought that replacing the maximum of three embryos gives the greatest chance of A number of clinics offer services known as achieving a pregnancy. However, data collected by Transport or Satellite /VF. In Transport JVF the the HFEA suggest that the Jive birth rate for woman has the egg collection procedure at a treatments where two embryos are replaced hospital close to her home. The eggs are then The licensed treatments transported in an incubator to a licensed /VF clinic torage period for embryos and sperm — where they are fertilised. Embryo transfer will also Patients storing embryos or sperm should be aware take place at the licensed clinic. that genetic material may not be stored indefinitely. In Satellite /VF the woman begins the Parliament set a limit of 10 years on the storage of superovulatory drugs and is monitored at a clinic or sperm and a limit of 5 years on the storage of hospital closer to her home than the licensed VF embryos, although these periods may be exceeded clinic. When the woman is ready for the egg in certain circumstances. collection she travels to the licensed /VF clinic When the period of storage that is allowed where the egg collection, the fertilisation and the comes to an end the sperm or embryos must be embryo transfer take place. removed from storage and allowed to perish if The live birth rate for transport JVF is not always they have not been used in the meantime. It is the same as for conventional JVF. You may wish to therefore important that you know the period of ask clinics if they have a transport or satellite storage which applies to any embryos or sperm that arrangement with a hospital which is more local to you have in storage and that you know when this you. period expires. It is also important that you understand how the law in this regard affects sperm, eggs or embryos obtained from donors. This will help you to plan any future treatments with Many embryos may be produced during /VF those embryos or sperm and give you time to treatment. As noted above, the clinic is permitted consider whether or not you wish to donate them to only to replace up to three embryos in a woman’s another couple or for use in research. womb during any one treatment cycle as replacing more than three increases the likelihood of Multiple Your clinic will carry out regular reviews of the birth rate which could be dangerous to the woman embryos and sperm which they have in storage and and to the Fetuses. will try to remain in contact with you. It is important that you keep your clinic informed of Some clinics have storage facilities so that spare any changes of address and respond to any embryos can be frozen for use in a later treatment correspondence they send you. This will enable cycle if required. This may avoid the need for your clinic to ensure that you have plenty of time repeated drug stimulation, egg retrieval, sperm to deal with any issues arising from the storage of collection and fertilisation. However, not all your embryos or sperm. embryos survive freezing and thawing, and the Jive birth rate from frozen embryos is usually lower than fresh embryo transfers. You should find out before you start /VF treatment whether the clinic offers embryo freezing. There are a number of new clinical procedures which, while technically possible, have not yet Should any remaining embryos not be required for been proven safe for both the intended child and further treatment of the patient, they can be the mother. For this reason, treatment of patients donated for the treatment of others, donated for using techniques such as the use of Spermatids in research or allowed to perish. The individuals who ICSI are prohibited in this country. Patients are gave their consent for their eggs or sperm to be warned that undergoing such techniques abroad used have the final choice in this matter. Their may expose both their hoped for child and they consents must agree before an embryo can be used themselves to risks. or donated for treatment or research. Issues for patients to consider It is essential to consider a clinic’s policy for Ovarian hyperstimulation syndrome (OHSS) is a reducing the chances of multiple births. Some rare but serious side-effect of the drugs used to clinics have a policy of replacing only two embryos stimulate the ovaries. Severe cases carry a in each JVF cycle or of not using stimulation drugs significant risk to a woman’s health and occur in in DJ. These policies are designed to reduce the up to 2% of women whose ovaries have been chance of multiple birth. The clinic should discuss stimulated with drugs. If there is any risk of OHSS these issues with you thoroughly in the light of the cycle may be abandoned. If there have been your Own circumstances. any embryos created from the cycle then they may be frozen and used in a later treatment cycle. Although the prospect of twins or triplets may seem attractive there are many Serious risks Patients should ask clinics for information about involved in multiple births. Research has shown their policy for avoiding OHSS and also the signs that multiple births can lead to a much higher risk for which patients should look. of: e complications during pregnancy, The first thing to understand is the cause of your e premature birth and low weight birth, infertility. If this is investigated thoroughly you are e disability and death of infants at or within 28 more likely to get the treatment which is most days of birth (known as Neonatal death). suitable for you. Usually the cause of infertility will be investigated following a referral from your Low birth weight babies are much more likely to GP to an infertility clinic. suffer from serious life-long health problems such as cerebral palsy. The average birth weights are If the cause of your infertility has not been 2.5 kg for twins and 1.8 kg for triplets compared investigated previously, you may wish to ask to the average birth weight of 3.3 kg for single whether a particular clinic can carry out the babies’. necessary tests. These tests may include an analysis of the man’s semen and the conditions of the The risk of Stillbirth and Neonatal death is also woman’s womb, fallopian tubes and cervical greater in a multiple birth than for single babies. mucus. Some clinics have a routine set of For single births from JVF treatment the rate of investigations and you should ask what these Stillbirth and Neonatal death is 8.8 per thousand include. birth events. The rate is 46.8 for twin births and If tests have been done during previous treatment 82.6 for triplet births?. you should ask whether it is necessary to repeat In addition to the serious risks to the babies’ health, them. If you have already undergone investigations a multiple birth can create enormous strains for the you should nevertheless enquire whether additional parents, including financial difficulties and tests will be required by the clinic. emotional and physical exhaustion. In some cases, Even after tests some infertility remains the joys of parenthood are greatly reduced by these unexplained, but that does not mean that it cannot problems. be treated successfully. The cause of infertility may You should give very careful consideration to be unexplained in as many as 30% of couples. limiting the number of embryos replaced to two in order to minimise the chance of triplets. Treatments offered by clinics —_—/ Different causes of infertility require different treatments. It is important for you to be confident that the treatment you are being offered by a clinic is appropriate for your type of infertility. Not all ! Bryan EM, Twins and Higher Order Births. A Guide to their Nature clinics offer all forms of treatment. While some and Nurture. Edward Amold, 1992. Fig. 16.2, p195. specialise in one treatment, others provide a variety ? HFEA Annual Report 1997. of treatments and may be able to offer the option of 9 Issues for patients to consider a different approach if one type of treatment is not st oft reatment successful. It is important to be clear from the start (whether or The doctor at any clinic should be able to explain not you are receiving NHS treatment) if there are why a particular fertility treatment is being charges and exactly what they cover. recommended. Most clinics offer wholly private treatment. If you have a private health scheme you should find out tions ont reatment _ whether your scheme will fund any part of the Some clinics have an upper age limit for women investigations or treatment. beyond which they will not usually offer treatment. The cost of fertility treatment varies from clinic to Where the treatment is provided on the NHS, this clinic. D/ treatment can cost between about £100 limit is usually decided by the Health Authority and £500, and JVF can cost between about £700 which is paying for the treatment. and £2,500 per treatment cycle. Other clinics, as a matter of policy, do not offer Each clinic should give you clear information treatment to single women or to unmarried couples. about its current charges, though the way in which A clinic should make it clear in their patient clinics do this varies. Some quote a standard literature if they have any blanket restrictions on amount for a complete treatment cycle (each treatment. attempt at achieving a pregnancy is called a The final decision on whether or not to offer ‘treatment cycle’). Other clinics list separately their treatment to a particular person rests with the charges for different tests, the drugs required, the doctor concerned. The reasons for any decision not various stages of treatment and counselling, to offer treatment should be fully explained to the follow-up consultations and embryo freezing and patient who should be given advice on what to do storage. next. It is therefore important always to be clear about how much a full treatment cycle will cost including any additional charges for items such as drugs, You should enquire how long the waiting lists are consultations or embryo storage. for a consultation appointment and for treatment. In addition it is helpful to ask how much of the fee For some treatments the waiting list may be longer is refundable if a treatment cycle is abandoned. than for others. For example there is often a long waiting time for treatment with donated eggs as these are generally in short supply. Some clinics operate under the NHS and offer treatment free of charge to patients sponsored by their local health authority. There is no clear way Fertility treatment may require several visits to the of showing which clinics operate in this way as clinic or to your general practitioner for injections, some local health authorities contract out such blood tests and scans. You should discuss this with services to otherwise private clinics. Similarly, the clinic before making your decision to proceed some clinics located on NHS premises are funded with treatment. You may have to travel frequently separately and may make a charge for treatment. to and from the clinic, which may mean time off (In these circumstances the treatment is not NHS work. This factor may need to be taken into treatment.) account, particularly when considering treatment at a clinic located some distance away from your If you are seeking treatment on the NHS, you will home. need first to find out whether your local health authority is willing to pay for treatment and, if so, -atient support groups. under what conditions. Whether your treatment is available to you on the NHS depends upon a Some clinics have patient support groups which number of factors. Each health authority decides may be a useful source of information about the what funding they will allocate to the treatment of treatment provided. They can also provide an infertility and the types of treatment they will offer. opportunity for you to talk to other people who are If they do fund treatment most heath authorities having treatment. have eligibility criteria for access to that funding. If there is no patient support group at a clinic, you For further information contact NIAC (see page 15 should consider contacting one of the national for details). groups for advice (see page 14). 4.11. What will happen if | get pregnant? The extent to which clinics remain involved after treatment will vary. Some clinics may carry out a pregnancy test and some provide ante-natal care. 10