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In Vitro Fertilisation (IVF) & Intra-Cytoplasmic Sperm Injection (ICSI) Information for Patients and Partners Date of Issue:14.09.15 Doc 389 Issue 10 1 of 14

What is this leaflet about and who is it for? This leaflet is produced to inform couples what is involved when undergoing In Vitro Fertilisation (IVF) or Intra-Cytoplasmic Sperm Injection (ICSI). The difference between IVF and ICSI is the way the sperm is used to fertilise the eggs. Your consultant will inform you whether IVF or ICSI is the recommended treatment choice for you. You will be placed on the NHS list (if eligible) for treatment at the Leicester Fertility Centre. In due course an appointment will be arranged for you to see the nursing staff to discuss your treatment and arrange any further tests. If you have already undergone unsuccessful IUI treatment then you will be given an appointment to discuss IVF or ICSI. What is IVF? IVF is the process of fertilising eggs outside of the body in a Petri dish. The eggs and the sperm are mixed together in a dish and are incubated overnight to allow fertilisation to occur. In the event of the sperm quality being insufficient for IVF on the day of egg collection we will convert you to having ICSI treatment. Details of the ICSI procedure can be found below. The main indications for IVF are: Blocked or damaged fallopian tubes Endometriosis Borderline sperm count and/or motility Unsuccessful IUI What is ICSI? Intra-Cytoplasmic Sperm Injection (ICSI) refers to the technique of injecting a single sperm into the egg. This overcomes any barriers that the sperm has to penetrate the egg and is particularly beneficial in couples with severe male factor infertility or those who have had a previous failure of fertilisation in an IVF cycle. Eggs are prepared for Date of Issue:14.09.15 Doc 389 Issue 10 2 of 14

injection by removing the outer (cumulus) cells from the egg. A highpowered microscope is used to assess egg maturity (not all eggs may be mature) and all the mature eggs are carefully injected with a single sperm. The main indications for ICSI are: Low percentage of normal sperm Low percentage of motile sperm Very low sperm count Surgically retrieved sperm (PESA/TESA) Previous failed or low fertilisation during a conventional IVF cycle Presence of anti-sperm antibodies What preparation is needed for IVF or ICSI? For your safety and to ensure the best response to treatment your Body Mass Index (BMI) should be between 19 and 30. Male partners who require a surgical sperm retrieval procedure should have a BMI under 35. Your BMI is calculated by your body weight in kilograms divided by your height in metres squared. If your BMI is above or below these levels you will be offered help and advice to reach the required weight before commencing treatment. Screening blood tests are carried out on both partners for Hepatitis B and C HIV, and Syphilis. An updated hormone profile taken in the first part of the menstrual cycle is needed within 3 months before commencing treatment. A semen analysis is carried out to ensure that sperm can be adequately prepared for your treatment. What is the procedure? Once you are ready to commence your treatment you will have a planning appointment with one of the nurse specialists or medical staff. You will both need to sign a number of consent forms relating to your treatment and the use and storage of your eggs, sperm and embryos. For further information about the consent forms please visit the HFEA website: http://www.hfea.gov.uk Date of Issue:14.09.15 Doc 389 Issue 10 3 of 14

You will need to have a trans-vaginal ultrasound scan on day 2-4 of your cycle to count the number of small follicles that are normally present in your ovaries. This scan will help us to decide the type and dosage of drugs required for you. This is called an antral follicle count (AFC). The nurses will then arrange an injection lesson appointment, if necessary. Your drugs will be ordered and you will be contacted by the drug delivery company to arrange delivery of your medication. Standard long IVF protocol Most women will be on a standard drug protocol. This involves a daily injection of Suprecur (starting a week before your period is due) to switch off the pituitary gland which controls your ovaries. You will then have a period and contact the nurses to arrange a baseline scan and blood test. This is to check that you have responded to the injections. You then commence a second injection of Menopur or Gonal-F daily and appointments will be made for you to attend on alternate days for blood tests and scans to check that your ovaries are responding. The dose of your drugs will be altered dependant on your response. Short protocol If you have had a cycle of IVF previously cancelled because of a poor response or if you have a high FSH level on your blood tests or a low AFC on your ultrasound scan you may require a short cycle. You will contact the nurses on day 1 of your period and attend the next working day for a blood test and scan. You then commence your daily injection of Suprecur and will be told when to start the second injection of Menopur or Gonal F. Appointments will be made for you to attend on alternate days for blood tests and scans to check that your ovaries are responding. Date of Issue:14.09.15 Doc 389 Issue 10 4 of 14

What happens next? Once the ultrasound scan shows that there are a sufficient number of mature follicles, you will be instructed to give a hormone injection of hcg (pregnyl) which matures the eggs before they are collected. 35 37 hours after the hcg injection, the eggs will be removed from the ovaries. The eggs are collected by means of a fine needle being passed through the vaginal wall into the ovaries under ultrasound guidance. You will be given sedation anaesthesia and not feel or remember the procedure. The medications that we use for your sedation anaesthesia include: Propofol, Alfentanil, Midazolam, these medications make you drowsy and provide pain relief. Diclofenac suppository can also be given rectally to provide pain relief for up to 18 hours after your egg collection On the day of egg retrieval your partner will be required to produce a sperm sample at the clinic. We advise abstinence of 2 or 3 days prior to producing sperm sample. Our embryology team will prepare this so that the best sperm are isolated and used to inseminate your eggs. How are my embryos put back? Two, three or five days after the egg collection you will have one or two of the best embryos transferred into the uterus through the cervix. You will need to have a full bladder at the time of the transfer. This is a painless procedure and does not require any anaesthetic. You will be required to remain horizontal for a short time after the embryo transfer and can then return home. To support the womb lining to encourage implantation you will be asked to use progesterone pessaries vaginally twice a day starting the morning after egg collection. Date of Issue:14.09.15 Doc 389 Issue 10 5 of 14

What happens with the other embryos? We have the facility for embryo freezing and this will be offered to you to store suitable 'spare' good quality embryos for your own future use. The use of eggs, sperm or embryos for training At the end of your treatment cycle there may be unused sperm, unfertilised eggs and embryos that are unsuitable for freezing. On your HFEA WT & MT consent forms you have the option to allow eggs/ sperm/ embryos to be used for training purposes prior to their discard. You can either tick no in which case the eggs/ sperm/ embryos that were not used in your treatment will be discarded or you can tick yes. If you are being treated with your partner then you both must agree on what is to happen to your embryos. If you tick yes for training then nothing will be done until the end of your treatment cycle. You can withdraw your consent at any time prior to their use in training. There is no financial benefit from consenting for your eggs/ sperm/ embryos for training. Selecting either yes or no for the use of your sperm/ eggs/ embryos for training will not impact on the care you receive. Your consent forms will be checked prior to treatment and your wishes will be logged on the laboratory paperwork. If, at the end of your treatment cycle, the eggs/ sperm/ embryos are to be used for training purposes then two members of the embryology team will recheck the HFEA WT and MT consent forms to confirm that valid consent is in place. Any eggs/ sperm/ embryos to be used in training will be transferred to a new container and kept in a separate incubator space to any eggs/ sperm/ embryos in use. A log is kept of all eggs/ sperm/ embryos used for training, including which staff member has used them and for what technique. The eggs/ sperm/ embryos could be used for the purpose of training staff in embryo biopsy, embryo storage or other embryological techniques as per the HFE act 2008 (for example moving embryos or Date of Issue:14.09.15 Doc 389 Issue 10 6 of 14

eggs from one dish to another or egg injections). We would not attempt to create any embryos when training with eggs and sperm. The gametes would also not be used to test or validate equipment as per the HFE act 2008. Patients using donor sperm and/or donor eggs may / may not be able to donate their embryos for training depending on what the donor has consented to. If you wish to find out if your donor has consented to training, please speak to a member of the clinical team. As not all eggs/ sperm/ embryos available from patients who consented to training are required by staff, it is not guaranteed that samples will always be used in training. If you would like to know, after your treatment cycle is complete, you can ask if your samples were used and for what technique. Once the training has been completed the eggs/ sperm/ embryos would be discarded and not used for any other purpose. By allowing your eggs/ sperm/ embryos to be used for training you are helping the embryologists and patients of tomorrow and we thank you for your help. When can I do a pregnancy test? 15 days after the egg retrieval, you will be asked to return to the unit for urine and blood pregnancy tests. It is important to attend for the blood test even if you have started a period so we can exclude the possibility of ectopic pregnancy. What risks are involved? The egg collection involves sedation anaesthesia and therefore it is important that you tell us about any other medical conditions that you have or medication that you may be taking. Anaesthetic side effects include postoperative nausea and vomiting (usually last for 1-2 hours and can be controlled with medications), postoperative shivering, chest infection (very rare with sedation anaesthesia), awareness (becoming conscious during some part of operation; the majority of patients who are aware do not feel any pain, but may have memories of events in the operating theatre), allergic reaction to anaesthetic, very rarely anaphylaxis (risk is 1 in 10,000), risk of death or brain damage during anaesthesia (in general the risk is Date of Issue:14.09.15 Doc 389 Issue 10 7 of 14

1 in 100,000 but should be even rarer in sedation for minor procedures There is a very small risk of pelvic infection after the egg collection. Symptoms include fever, moderate to severe lower abdominal pain or malodorous vaginal discharge (rare). Vaginal bleeding/vaginal laceration requiring stitches (very rare) Injury to bowel, bladder, pelvic blood vessel or nerve (very rare) When ICSI is carried out there is a risk of damage to the eggs (approximately 5-10%) due to the injection procedure. Damaged eggs cannot be used for treatment. Very rarely, some eggs or embryos could be lost by accident due to human error. Cancelled cycles due to poor or excessive response to the drugs Failure of eggs to fertilise (IVF or ICSI) which would result in the cancellation of your cycle Failure of embryos to cleave (divide) which would result in the cancellation of your cycle Failure to transfer embryo via the cervical route Ectopic Pregnancy Multiple pregnancies:- The risk of multiple pregnancy (mainly twins) after transferring two embryos is 30%. The risk of monozygotic (identical) twins after IVF is 1.5%. Monozygotic twins occur even after transfer of a single embryo. Multiple pregnancies carry more risks to the mother and baby. See leaflet about multiple pregnancy for more information. Date of Issue:14.09.15 Doc 389 Issue 10 8 of 14

Common side effects of medication Suprecur: Tiredness, headache, hot flushes, irritability and injection site irritation redness, swelling, bruising or pain. Gonadotrophins- Menopur or Gonal F: F Headache, tiredness, nausea, vomiting, diarrhoea, abdominal discomfort, bloating and injection site irritation redness, bruising, swelling or pain Multiple pregnancy. OHSS see section below Doxycycline:(an antibiotic to be taken for 5 days after egg collection to help prevent any infection developing) May cause nausea, vomiting, diarrhoea, oesophageal irritation and photosensitivity. Please read the information leaflets provided with your medication and if you have any concerns please discuss with the nurses Ovarian hyperstimulation syndrome (OHSS): OHSS occurs when there are too may follicles produced in the ovary. In severe cases, which are fortunately rare, fluid can collect in the abdomen and chest causing discomfort and difficulty in breathing. This may lead to a greater tendency for the blood to clot causing thrombosis. How do I know if I m developing OHSS? The following are the symptoms that you may develop as a result of OHSS: Mild OHSS mild abdominal swelling or bloating, abdominal discomfort and nausea. You will be advised to drink plenty of oral fluids at home and report to us if you have other symptoms or if your symptoms get worse. Moderate OHSS symptoms of mild OHSS but the swelling and bloating is worse because fluid is building up in the abdomen. There is abdominal pain and vomiting Date of Issue:14.09.15 Doc 389 Issue 10 9 of 14

Severe OHSS symptoms of moderate OHSS plus extreme thirst and dehydration because so much fluid is building up in the abdomen, passing very small amounts of urine which is very dark in colour (concentrated), difficulty breathing because of build-up of fluid in the chest and a red, hot, swollen and tender leg due to a clot in the leg or lungs (thrombosis). If you develop any of these symptoms then you should contact the Fertility Specialist Nurses on (0116) 258 5922. If outside clinic hours please use the emergency mobile number on the answer phone What will happen then? ACU staff will arrange for you to be reviewed by the nursing and medical staff in the ACU during working hours or at the Gynaecology Assessment Unit (GAU) at the LRI out of hours. Sometimes it is necessary to recommend admission to hospital to closely monitor and observe you. It may be necessary to give you blood-thinning injections to prevent clotting and transfusion of intravenous fluids to encourage the kidneys to produce urine in normal amounts. Rarely, if there is a large fluid collection in the tummy and/or chest that has to be drawn off to improve comfort. If admission is recommended, you really must be admitted. Since IVF commenced in the UK there have been a few UK deaths related to OHSS. Can anything be done to stop me developing OHSS? At the time of the final scan (before the hcg injection) we will have made a fairly accurate estimate of the number of eggs that are likely to be collected on the day of retrieval. You will be told if we think you are at increased risk of developing OHSS. Rarely, we may decide to cancel your egg collection if we think that the risk of developing severe OHSS is very high. In this case we will ask you to stop your gonadotrophin injections (menopur or Gonal F) and continue with the suprecur for 2 weeks. Date of Issue:14.09.15 Doc 389 Issue 10 10 of 14

Occasionally, when a high number of eggs is expected along with very high level of your hormone we may decide to do egg retrieval with no embryo transfer. This will be based on your symptoms and clinical judgment. IVF will be carried out in the embryology laboratory and all suitable embryos will be stored by freezing for your future use in subsequent months. You will be placed on a medication which reduces the risk of OHSS called Cabergoline given for eight days from the day of hcg injection. Sometimes, although your hormone levels are high and we anticipate a high number of eggs, we may still be able to continue with egg collection and embryo transfer, and may prescribe Cabergoline (as mentioned above). We will give the prescription from the hospital and the medication needs to be collected from the hospital pharmacy. There are no major side effects of this medication. What follow up care is available after our IVF or ICSI cycle? We would normally offer you and your partner a follow-up clinic appointment if your treatment has not been successful. We understand that this is a very difficult time for you both emotionally. Should you wish to access any supportive counselling during your fertility treatment you may wish to contact the Leicester Fertility Centre to arrange an appointment with the unit s counsellor. This information was correct at the time of printing. While the Trust makes every reasonable effort to keep its information leaflets up to date, very recent changes may not be reflected in the guidance and you should discuss this with the clinical staff at the time of your appointment. Date of Issue:14.09.15 Doc 389 Issue 10 11 of 14

Our commitment to patients We are constantly striving to improve our services to patients and we will welcome your comments or suggestions for improvement. Leicester Fertility Centre Contact Details Tel: 0116 2585922 E-mail: enquiries@leicesterfertilitycentre.org.uk Fax: 0116 2587688 Website: www.leicesterfertilitycentre.org.uk Useful addresses: Human Fertilisation and Embryology Authority NICE guidelines: www.hfea.gov.uk www.nice.org.uk NHS - Response line: 0870 155 5455 NHS - Smoking Helpline: www.givingupsmoking.co.uk / 0116 295 4141 Infertility Network UK www.infertilitynetworkuk.com / 0800 0087464 National Gamete Donation Trust www.ngdt.co.uk / 0845 2269193 Do you feel that you are at risk of verbal or physical abuse? If so, you may find the following numbers useful: Domestic Violence Helpline Leicester City: SAFE 0300 123 0918 Leicester County: Women s Aid 0300 303 0844 Date of Issue:14.09.15 Doc 389 Issue 10 12 of 14

Questions If you have any questions write them down here to remind you what to ask when you speak to your consultant. Date of Issue:14.09.15 Doc 389 Issue 10 13 of 14

Today s research is tomorrow s care We all benefit from research. Leicester s Hospitals is a research active Trust so you may find that research is happening when you visit the hospital or your clinic. If you are interested in finding out how you can become involved in a clinical trial or to find out more about taking part in research, please speak to your clinician or GP. Date of Issue:14.09.15 Doc 389 Issue 10 14 of 14