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1 ISO 9001:2008 certified 1 ASSISTED CONCEPTION UNIT STAFF CONTACT NUMBERS OPENING HOURS INTRODUCTION WHAT IS IVF? WHY IVF? RESULTS CONSENT FORMS Drugs EGG RECOVERY FERTILISATION IN THE LABORATORY EMBRYO TRANSFER EMBRYO FREEZING RISKS OF DRUGS/TREATMENT GENERAL ADVICE Folic Acid Smoking Alcohol Rubella Weight COSTS WHAT DO YOU DO NOW? INTRACYTOPLASMIC SPERM INJECTION...14 M Rajkhowa, August 2006 Authorised QM A McConnell Page 1 of 19 Reviewed by M Wood/A McConnell: April 2011 Due for review: April 2012 G:\ACU Documents\patient information leaflets\ivf and icsi.docpl017

2 19 SPERM RECOVERY TECHNIQUES EGG DONATION Egg sharing SCREENING HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY (HFEA) WELFARE OF THE CHILD PARENTAL RESPONSIBILITY COUNSELLING FUNDRAISING COMPLAINTS USEFUL ADDRESSES...19 M Rajkhowa, April 2007 Page 2 of 19

3 IVF/ICSI 1 ASSISTED CONCEPTION UNIT STAFF Medical Staff Nursing Staff Dr V Kay, Consultant Dr S Kini, Consultant Dr M Metwally, Consultant Dr E Lowe, Associate Specialist Dr J Anderson, Anaesthetist Dr L Scullion, Anaesthetist Dr F McQueen, Anaesthetist Sister M Wood Sister A Mills Sister H Reid Sister S Wallace Sister S Grossett Sister S Cobain Sister P Black Sister E Barratt Ms M Henderson Scientific Staff Mrs K Whalley Ms E Drew Mr P Milne Ms S Adamiak Ms A Rice Andrologist Mrs C Tee Business Manager/Quality Manager Miss A McConnell Secretarial/Clerical Staff Mrs A Fisher Miss K Clark Mrs M Christie Mrs L Mudie Ms L Kelly Counsellor Mrs A Chien M Rajkhowa, April 2007 Page 3 of 19

4 2 CONTACT NUMBERS Ward (answering machine outwith 8.00 am 5 pm) calls may be transferred to the answering machine at other times but calls will be returned as soon as possible. Anne McConnell (voic outwith 8 am 5.30 pm) anne.mcconnell@nhs.net Appointments secretary (8.45 am 4.45 pm) Dr Kay/Dr Kini Dr Lowe / Emergency calls for medical staff outwith 8.00 am 5 pm: mobile phone If there is no reply from this number, you should contact the hospital switchboard ( ) who will contact one of the consultant staff for you. 3 OPENING HOURS The Unit is open; 8 am to 5 pm Monday Friday 8 am 12 noon, Saturday M Rajkhowa, April 2007 Page 4 of 19

5 4 INTRODUCTION In vitro fertilisation has been provided at Ninewells since 1985 and in August 1994, the Assisted Conception Unit in Ward 35 opened. This is a four-bedded self-contained Unit, with its own theatre and laboratory facilities. The Unit has its own medical, nursing, scientific and administrative staff. 5 WHAT IS IVF? All pregnancies begin with the joining together of a single sperm and egg, this process is known as fertilisation. The single cell that results will usually go on to develop into an embryo and hopefully later a baby. This would normally take place in the woman s fallopian tubes, which allows eggs to pass from the ovaries into the womb. With in vitro fertilisation (IVF), fertilisation is allowed to happen by mixing each egg with a number of prepared sperm in a test tube (hence the name test tube baby treatment ). Whilst this has obviously been a major advance in the treatment of infertility it can almost be considered as simply changing the site for fertilisation and all other major steps remain the same. Once fertilisation has occurred, the resulting embryos are transferred to the woman s uterus. 6 WHY IVF? Only certain groups of patients who are infertile are suitable for IVF. The treatment was originally developed for women who have damaged or blocked fallopian tubes. However, it has been shown that these techniques will also increase the chance of pregnancy in other groups of patients including those where there is no obvious cause (unexplained infertility). The main indications are: Tubal disease (ie, blocked/damaged fallopian tubes) Male sub-fertility (ie, reduced sperm count) Endometriosis (a condition causing inflammation and scarring in the pelvis) M Rajkhowa, April 2007 Page 5 of 19

6 Failure of ovulation (for example polycystic ovary syndrome) Unexplained infertility The technique of introducing a single sperm into an egg (intracytoplasmic sperm injection) is a development of IVF that has allowed us to treat patients where the sperm count is really very low. A separate information leaflet about ICSI is available. Please note: There is a reasonable chance for some patients to conceive naturally without treatment, even when IVF has been offered IVF. However IVF is recommended in these cases to improve the chances of pregnancy. 7 RESULTS Success rates vary from time to time and can be expressed in a number of ways. The actual number of babies born alive for each treatment cycle started, for the year ending 31 st December 2009 (this includes cycles which have been abandoned because of various reasons) was: Age < >42 Ninewells 35.2% 24% 15% 5\55 0\3 patients National 28.2% 23.6% 15% 10.6% 3.2% average Continuing pregnancy rates per cycle started for 2010 are: Age < > % % 3/47 0/2 Results do go up and down from year to year; it is very important to discuss the likelihood of each individual or couple establishing a pregnancy because there are so many different reasons for success and failure. For those eligible for NHS treatment, most purchasing M Rajkhowa, April 2007 Page 6 of 19

7 health boards agree to fund up to two or three treatment cycles, however, any treatment cycles funded yourselves may count towards this. This means that if you self-fund one cycle, your health board may only provide two. If you do have successful treatment, you will no longer be eligible for NHS-funded treatment. If treatment has to be abandoned before egg recovery takes place, this cycle would not be counted towards the total number of attempts. 8 CONSENT FORMS Before starting your treatment, we will ask you to sign some consent forms. If seeking treatment as a couple, it is very important that you both understand the forms fully before signing. The forms are as follows: 1. Consent to disclosure of information; this should be completed when you first attend the clinic and gives us your permission to contact your own general practitioner(s) and any other person concerned with your care. (This is explained in detail under the section on the HFEA) 2. Consent to treatment (IVF or ICSI) 3. Consent to use of eggs (and freezing of embryos, where appropriate) 4. Consent to use of sperm (and freezing of embryos, where appropriate) We may also offer you a form to consent to the use of eggs which have failed to fertilise, for training embryologists or for research. Any research would be carried out only after discussion with you both. M Rajkhowa, April 2007 Page 7 of 19

8 9 Drugs Purchasing Health Boards have asked us to provide the necessary drugs, and we will supply you with a complete package. Self-funding patients can also purchase all these drugs if required and this is described in the tariff. The drugs most commonly used in treatment cycles are: 1. Suprecur - a nasal spray that suppresses the hormones controlling the ovary. This is referred to as downregulation and a scan will be carried out to confirm this has happened before starting injections of Gonal-F/Menopur to stimulate the ovaries. Suprecur is continued while you are having the injections. Occasionally you may be prescribed injections (Buserelin) for downregulation instead of the nasal spray. 2. Gonal-F/Menopur - an injection that stimulates the ovaries. During stimulation, careful ultrasound monitoring is necessary to assess the response of the ovaries by measuring the number and size of the follicles. When the follicles, which should each contain an egg, are the correct size you will be given another drug - 3. Ovitrelle - an injection which brings about final maturation of the eggs. 4. Crinone- a vaginal gel to be used to support the lining of the womb following egg collection. In some patients alternative regimes may be recommended. This will be discussed on an individual basis. 10 EGG RECOVERY This is done using a vaginal ultrasound probe to guide a needle into each ovary. The fluid in each follicle is then aspirated until oocytes are obtained. This is all done under deep sedation M Rajkhowa, April 2007 Page 8 of 19

9 (like a light general anaesthetic) or by patient-controlled sedation and we have an anaesthetist present at virtually all egg recoveries. You will be able to go home once fully recovered and will start a course of Crinone gel to maintain hormone levels. 11 FERTILISATION IN THE LABORATORY Any eggs recovered in theatre are taken to the laboratory and, later in the day, each egg will be mixed with a sample of the prepared sperm; abstinence is required for 2-3 days prior to the sample being produced, but no longer than this. Your partner will have been asked to produce a sample in the Unit earlier in the morning. Occasionally, the sample is poorer than expected and we may request a second sample. The following day, under the microscope, the eggs will be examined to confirm whether or not fertilisation has taken place. There is no guarantee that fertilisation will occur in any treatment cycle. If there is a failure of fertilisation, the significance of this will be discussed with you. After microscopic examination of the eggs, any fertilised eggs (embryos) will be allowed to develop for a further 24 to 48 hours in the laboratory, prior to embryo transfer. 12 EMBRYO TRANSFER We usually transfer embryos to the womb approximately 48 hours after egg recovery. We normally recommend that the best one or two embryos are transferred. The HFEA state that a maximum of two embryos may be transferred in women aged less than 40; three may be transferred in exceptional circumstances only in women aged 40 or over. When donor eggs are used, no more than two embryos can be transferred. The reason for restricting the number of embryos transferred is to avoid the risk of multiple pregnancy. Twins, but more particularly pregnancies with triplets or more, carry significant risks to both the mother and babies. There is still a small chance that a triplet pregnancy will occur, even when only two embryos are transferred. There is an increased risk of miscarriage and premature labour with multiple pregnancies and because of prematurity the babies are also at increased risk of long term health problems or serious handicap. In some circumstances, we may therefore M Rajkhowa, April 2007 Page 9 of 19

10 recommend a single embryo transfer but there will be a chance to discuss this with the clinician/embryologist supervising your treatment. Around one fourth of ongoing pregnancies are twins and less than 1% are triplets. Embryo transfer is rather like having a smear test and does not require an anaesthetic. A fine soft catheter containing the embryos is passed through the neck of the womb (cervix). This is not painful and requires a full bladder. You can go home after a short rest and should continue the course of Crinone gel until the day of the pregnancy test a date for this will be given to you by the nurses. 13 EMBRYO FREEZING If there are sufficient embryos of good quality, we will offer to freeze them for your use in another cycle. An embryologist will discuss this with you. 14 RISKS OF DRUGS/TREATMENT It is important to understand that few forms of medical treatment are entirely without risk. The stimulation drugs can occasionally lead to over-stimulation and formation of cysts in the ovary, which are temporary. There is putative risk of cancer of the ovaries with fertility treatment, though to date, there is no evidence to directly relate IVF treatment with an increased risk of ovarian or other cancers in previously healthy individuals. In about 5% of all cases, patients over-respond to the drugs resulting in a condition called Ovarian Hyperstimulation Syndrome. This usually settles without any specific measures but does require monitoring. It can very occasionally become severe with very serious risks to your health including rare reports of fatality. This may require hospital admission and, if we think that there is a high chance of this occurring, we may advise that we freeze all the embryos for later replacement, because we know that the condition can be made worse by becoming pregnant in the treatment cycle. Should you at any time M Rajkhowa, April 2007 Page 10 of 19

11 feel that you have abdominal distension, pain, nausea or shortage of breath at any time during or after your treatment, then this could indicate that you have developed this problem. It is important that you should contact us directly (preferable) or with your own general practitioner, and do let him/her know that you are aware of the risk. You can contact the Unit by telephoning the following: During office hours: Ward Anne McConnell Business Manager Ninewells main switchboard Out of hours: Unit Mobile Ninewells main switchboard - ask to speak to Dr Kay,Dr Kini, Dr Metwally or Dr Lowe, failing that, to the Duty Gynae. Registrar The technique of egg recovery could inadvertently damage organs close to the ovaries, such as blood vessels, bowel or bladder. These complications are very rare but it is only right that you should be aware of them. Bleeding or infection can also occur but are usually easily managed. We cannot guarantee that you will become pregnant, nor can we guarantee that any child will be perfectly normal. Previous evidence from studies of children born after IVF would suggest that the risks to the babies born are the same as occurs naturally. More recent evidence suggests up to 1-2% increase in the risk of major congenital abnormalities, particularly those related to the genital tract. However, it is unclear whether this increase maybe related to infertility itself rather than to assisted conception treatment. There is an increased chance of multiple pregnancy (twins). This is because we usually transfer two embryos to the uterus to increase the likelihood of pregnancy. As mentioned previously, we believe that the risks involved in a triplet pregnancy are very real and there is an unacceptable likelihood of premature birth and damaged babies M Rajkhowa, April 2007 Page 11 of 19

12 resulting from this. (It is possible for a triplet pregnancy to result when only two embryos are transferred). There is also a risk of ectopic pregnancy, i.e. a pregnancy occurring out with the cavity of the womb, the most common site being the fallopian tube. A pregnancy occurring in the tube cannot continue and most often necessitates surgery and removal of the affected tube. Sometimes we have to abandon an attempt at IVF after we have started treatment because the ovaries do not respond as well as expected. This is obviously disappointing for you but we cannot always guarantee that eggs will develop. In most cases, it can be corrected by repeating the treatment with a higher dose of injections or changing to a different treatment protocol. 15 GENERAL ADVICE 15.1 Folic Acid There is very real evidence that the incidence of abnormalities of the brain and spine of a baby are greatly reduced if patients are taking Folic Acid at the time of conception and thereafter. Please have a word with your own doctor about this, or you can buy appropriate supplements at any chemist. Please start to take these supplements at any time prior to treatment Smoking There is data available to show that the likelihood of IVF being successful is reduced if either partner smokes. We cannot emphasise too strongly the advantages of stopping at this stage. M Rajkhowa, April 2007 Page 12 of 19

13 15.3 Alcohol We do recommend that couples trying to conceive should take less than 5 units of alcohol per week Rubella We would expect all patients to have had a check that they are immune to rubella prior to starting treatment Weight Our policy is not to recommend treatment in patients with a BMI of greater than 35. We can offer support to lose weight by giving advice on healthy eating and exercise. 16 COSTS We have negotiated contracts with a number of purchasing Health Boards. If we have a contract with your Health Board, and if they have agreed to treatment being appropriate in your case, then there will be no charge for you. If you are funding your own treatment, then the costs in the financial year commencing 1 ST June 2010 are: IVF ICSI 2,605 (excluding drugs) 2,805 (excluding drugs) Sperm retrieval/testicular biopsy 615 Drugs We can provide a 'package' at a cost of 700, or 800 for patients on a higher dose of drugs. However, for patients who use more than 30 ampoules (40 for those on a higher dose) of Menopur or 2250 (3000) units of Gonal-F, we will charge 10 per additional ampoule (75 IU). M Rajkhowa, April 2007 Page 13 of 19

14 If any embryos are frozen, the cost of each subsequent embryo transfer will be 835 if the transfer is carried out in a 'natural' cycle or 925 in a cycle using drugs; there is no charge made at the time of freezing. 17 WHAT DO YOU DO NOW? The waiting time for treatment will be discussed with you in the clinic. Waiting times for NHS patients vary according to the health board area in which you live, but please remember that if your treatment cycle is not successful, then your name will be returned to the end of the waiting list. If you want to enquire about your place on the waiting list at any time, or if you would like to consider self-funding, please contact Anne McConnell. If your treatment is successful, you would no longer be eligible for NHS-funded treatment and any further cycles would have to be self-funded. Should you wish a review appointment with the medical or nursing staff, Anne can arrange this for you. You will receive notification of a patient information evening prior to starting your treatment. This will give you an opportunity to meet some of the staff involved in the whole process and Anne will send you details of this meeting, along with detailed instructions about your treatment. A copy of the instructions will be sent to your own general practitioner and you should feel free to talk things over with him/her. The procedures and drugs involved may change from time to time and a more detailed summary will be sent to you before you start treatment. NB - The following two sections do not apply to all patients. 18 INTRACYTOPLASMIC SPERM INJECTION Intracytoplasmic sperm injection (ICSI) involves the injection of a single sperm into an egg. It is a technique which has been developed to assist fertilisation in couples where sperm characteristics would prevent an attempt at conventional IVF. Couples experiencing M Rajkhowa, April 2007 Page 14 of 19

15 fertilisation failure following IVF may be candidates for this treatment, if the problem is attributable to the sperm. ICSI is a specialised version of IVF and consequently for the couple there is no apparent difference from that of conventional IVF. However, the handling of the eggs and sperm in the laboratory is very different, requiring special treatment of the eggs to permit the injection procedure. This technique has been available in our Unit since If this technique applies to you, we will give you a separate information leaflet. 19 SPERM RECOVERY TECHNIQUES Again, a separate information sheet is available for these procedures. 20 EGG DONATION Primary or premature ovarian failure has been estimated to occur in approximately 1% of women. For such women, their only hope of a pregnancy lies in the use of eggs donated by a healthy female volunteer. The same technique may also apply to women whose ovaries have been removed or where she is at risk of passing on some genetic disorder. This treatment may also be recommended to some couples with previous failed IVF attempts. Separate information leaflets are available Egg sharing We have recently introduced egg sharing, where patients can receive treatment at a reduced cost in exchange for donating some of their eggs. If you are interested in this, please ask for further information. 21 SCREENING The Human Fertilisation and Embryology Authority has stated that, from 1 st December 2004, all patients who request storage of sperm, eggs or embryos must be screened for Hepatitis B and C and HIV. These tests can usually be done from a single blood sample, which we will M Rajkhowa, April 2007 Page 15 of 19

16 obtain when you attend the clinic prior to starting treatment. At this appointment, the female partner will also have a blood sample taken to check her anti-mullerian hormone (AMH) level. Results are normally available within four weeks. 22 HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY (HFEA) The HFEA sets standards for Assisted Conception Units. They inspect them annually and license only those Units which meet their standards. We are a licensed Centre, which means; We are legally required to inform the HFEA of all couples undergoing assisted reproduction techniques. If you become pregnant as a result of treatment, we are obliged to notify the Authority of the pregnancy and of its outcome. It is important, therefore, that if you are successful in achieving a pregnancy, you let Anne know details of the outcome. Until 2005, donors could choose to remain anonymous and, although they had to give identifying details for the HFEA register, these remained confidential. However, on 1 st April 2005, the law changed to allow people conceived through donation to find out who the donor was, once they reach the age of 18; these changes only apply automatically to donations made after 1 st April Please refer to the information leaflet What you need to know about donating sperm, eggs or embryos, produced by the HFEA. The HFEA make a charge for each treatment cycle and this is included in the cost of your treatment. Following the Human Fertilisation and Embryology Authority (Disclosure of Information Act) 1992, we may legally disclose information about your treatment with your consent to: 1. Any person named by you. 2. Your GP or anyone involved in providing you with medical, surgical or obstetric services for whom it is important to know about your treatment. 3. Any person who needs to know about your treatment for purposes of medical or M Rajkhowa, April 2007 Page 16 of 19

17 financial audit. You may also give consent to identifying information being used in research. 23 WELFARE OF THE CHILD The Human Fertilisation and Embryology Act of 1990 requires that the welfare of the child (or any existing children) must be taken into account before treatment can start. (A separate leaflet covering the HFEA statement on this is included). 24 PARENTAL RESPONSIBILITY From 6 th April 2009, the law with regards to parenthood changed for couples having treatment with donated sperm. Where couples are unmarried, it will now be possible for the male partner to be legally recognised and named on the child s birth certificate, but only if both partners consent to this. We will provide you with these consent forms. Same sex couples who are not in a legal partnership can also consent to the partner who does not give birth being named as the second legal parent. For married couples, the situation has not changed. The husband will be the legal father of any child born as a result of treatment (unless he does not consent to this treatment). 25 COUNSELLING It is recognised that having treatments such as those mentioned can be a stressful and challenging process. For some people, talking can be very helpful and Elaine Pritchard, our independent counsellor, is available to give you the time and the space to explore your thoughts and feelings around your treatment. You can be assured that counselling is not part of an assessment process and will not adversely affect your treatment. Any discussion with the counsellor is confidential. If you would like an appointment to see Elaine, please contact Anne McConnell on and she will arrange this. Alternatively, you can write to Elaine at the Unit. M Rajkhowa, April 2007 Page 17 of 19

18 26 FUNDRAISING We have an active fundraising group (BirthTay) and this has been of enormous benefit to patients. If you would like to be involved with this, Anne McConnell is the president of BirthTay and you can obtain more information from her. Twice-yearly newsletters are sent to all patients. 27 COMPLAINTS If you feel that there is any area for complaint regarding your treatment, there are various ways to deal with this; 1. Contact Anne McConnell at the Assisted Conception Unit. 2. Contact the Consultant in charge of your care. 3. The Trust also has its own complaints procedure which you may wish to use. The normal process would be for patients to write to the Chief Executive of the Trust; however, any correspondence may be read by other members of his staff or those working in the Patient Liaison Service, therefore you must bear in mind that, although the normal rules of confidentiality would apply, the special protection offered by the Human Fertilisation and Embryology Act for patients undergoing assisted conception treatment would not be followed. You may therefore wish to address any letters of complaint to either of the following, c/o the Assisted Conception Unit, Ward 35; Hazel Scofield, Patient Liaison Manager Mr G Marr, Chief Executive The above are both named on our licence held by the HFEA. M Rajkhowa, April 2007 Page 18 of 19

19 28 USEFUL ADDRESSES You may find the following of help: Name Telephone Website Infertility Support Network (national support group) ACEBABES (support for families following successful treatment) Donor Conception Network The Endometriosis Society Miscarriage Association DAISY network (support group for women who have suffered premature menopause) TAMBA (twins and multiple births association) British Agencies for Adoption and Fostering COTS (Childlessness overcome through surrogacy) Verity (support and information for women with polycystic ovarian syndrome) Fertility friends Baby greenhouse (information/support group) M Rajkhowa, April 2007 Page 19 of 19