Olive BRANCH Fertility

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2 PATIENT INFORMATION ASSISTED CONCEPTION Assisted Conception at Olive Branch Fertility Infertility Infertility is a common and distressing problem, which often creates pressure in a previously stable and happy relationship. About one couple in seven will experience involuntary infertility. Most couples will initially seek help from their General Practitioner. Basic investigations can be performed in General Practice, but most will be referred on to a specialist fertility clinic unless the problem is quickly resolved. The choice of treatment will depend on the type (or cause) of infertility, which should be uncovered by a series of simple tests of the man's sperm quality and the woman's ovulation and health of the uterus and Fallopian tubes. All treatments have one thing in common - they try to give nature a helping hand, giving eggs and sperm a better chance of fusing and fertilising to form an embryo and eventually a healthy pregnancy in the womb. These treatment techniques are collectively known as 'assisted conception' or 'assisted reproduction'. All assisted reproduction treatments are often referred to as 'ART'. Peculiar to us in sub Saharan Africa, is the large premium our culture places on immediate procreation and child bearing. It is that once there is a slight delay, the pressure becomes immediately intense, and this comes from relatives, associates co-workers and friends. This may cause panic and couples become desperate they then sometimes engage in practices that will somewhat modify the situation, and this will usually be negatively. Awareness is the 1st line in combating the psychological morbidity of this sphere of medical endaevour and as much evidence based information about fertility and conception should consciouly be made available to prospective parents in a timely fashion. The Scale Of The Problem With a one in three chance of conceiving in the first month of trying, and nine out of ten couples who will ever conceive naturally will have done so within twelve months. After one year, about one couple in seven will still not have conceived, and they should be offered at least basic tests to see if there is an obvious cause for their problem. Of these couples, some will be helped to pregnancy by treatment for blocked Fallopian tubes, by induction of ovulation with tablets such as clomifene, or by lifestyle changes to improve fertility. However, most will require some type of ART to help them conceive. Others will conceive naturally, sometimes while, waiting for ART treatment to start. Hence ART should be seen as one approach, to be considered only if more simple but effective treatments have not been successful.

3 The Causes of infertility and their investigation: Investigations carried out by a family doctor or specialist clinic can demonstrate the most likely cause of infertility for most couples, although about 20% of couples will be labeled as having 'unexplained infertility' after completing the initial tests. Although it is important to reach a diagnosis for infertility where possible, ART treatments are effective in unexplained infertility and many clinics now suggest that couples move fairly quickly into treatment when infertility is unexplained, particularly if the woman is in her mid-30s or older. The tests required to determine a specific cause will assess ovulation and ovarian reserve (the number and quality of eggs left in the ovaries) using hormone tests, the function of the fallopian tubes and uterus in women; and sperm quality (number, movement and shape) in men. Male Infertility: The Causes Low sperm count; normally, men produce at least 15 million sperm per millilitre of semen. Poor sperm motility; sperms will then be unable to swim through the cervix and uterus to meet the egg in the fallopian tube. Normal motility should be seen in at least 40% of sperm.

4 Poor shape (known as 'morphology'), so that an individual sperm is unable to penetrate the outer layer of an egg. Methods of measuring sperm morphology vary, but the commonly used method should show at least 4 % totally normally shaped sperm. Non-production of sperm (because of testicular failure) or complete absence of sperm from the ejaculate (perhaps because of an obstruction); this condition is known as azoospermia Problems with sexual intercourse; perhaps because of ejaculatory failure or impotence Female infertility: The Causes Hormonal disorders; as a result, egg follicles might not grow within the ovary, or an egg might not be released (ovulation). These can be broadly divided into three types. The commonest, seen in about 7% of women of reproductive age, is polycystic ovary syndrome (PCOS), in which small egg follicles are trapped within the ovary instead of being released at ovulation. Women with PCOS may be overweight, have acne or excessive hair growth, and have infrequent or absent periods. About one woman in 100 will experience a premature menopause, in which she runs out of eggs before the age of 40. She may experience hot flushes and night sweats, and absent periods. Less common hormonal problems linked to infertility include hypogonadalhypogonadism, which follows excessive weight loss or exercise, and disorders of the thyroid or pituitary glands. All of these problems can easily be diagnosed from simple blood tests. Damaged or blocked fallopian tubes, which will prevent an egg and sperm meeting to fertilise. There may be a medical history of Chlamydia or other sexually transmitted infection, or abdominal surgery with internal scarring (adhesion), which can block tubes. Other women may have a problem within the uterus, such as an endometrial polyp or septum, requiring surgery to correct.

5 Endometriosis, in which tissue from the lining of the uterus invades and damages neighbouring reproductive tissues. There is often pelvic pain before or during a period, and there may be abnormal bleeding from the bowel or between periods. ART can help in most of these conditions. In particular, the technique of ICSI (intracytoplasmic sperm injection) now means that even the most severe kinds of male infertility are amenable to treatment. Formerly, men with low sperm counts had few options except donor insemination to have any chance of having children of their own. Women with blocked Fallopian tubes or some of the disorders of ovulation may be helped by IVF (in vitro fertilisation) or IUI (intrauterine insemination). Repeated cycles of ART can often restore fertility to near normal levels in young infertile couples. Assisted Reproduction Treatments Assisted reproduction is not usually a first resort in the treatment of infertility. The treatment chosen will depend on the result of investigations. For example, fertility drugs with timed intercourse will be no help to a couple whose infertility is a result of the female's blocked fallopian tubes; only surgical repair or IVF will help in this case. The range of options is wide, and decisions regarding treatment should be made jointly between the couple and their doctor. ART procedures available are ovulation induction (OI) using fertility drugs, artificial insemination with donor sperm (DI), intrauterine insemination with or without superovulation with fertility drugs (IUI), in vitro fertilisation/embryo transfer (IVF-ET), gamete intrafallopian transfer (GIFT), intracytoplasmic sperm injection (ICSI) and egg (oocyte) donation. Ovulation Induction Ovulation induction involves stimulation of the ovaries with fertility drugs to allow previously anovular women to ovulate and have chance of pregnancy after natural intercourse. Women most suited to this form of treatment are those with polycystic ovary syndrome or hypogonadalhypogonadism. Intercourse is timed to coincide with the ovulation which drug treatment has achieved. The response to treatment is monitored using blood tests or ultrasound, to identify the day of ovulation and hypogonadism. Intercourse is timed to coincide with the ovulation whichdrug treatment has achieved. The response to treatment is monitored using blood tests or ultrasound, to identify the day of ovulation and to check that not more than one or two egg follicles have grown, to avoid the risk of a triplet pregnancy or higher! The chance of conception after one cycle of ovulation induction treatment is between 10 and 25%, depending on the cause of the problem and the age of the woman.

6 Intrauterine Insemination Couples with unexplained infertility or mild to moderate male problems may be offered intrauterine insemination. The process of intrauterine insemination involves washing and preparation of a sperm sample, producing a preparation of the most actively motile sperm. This is then placed into the cavity of the uterus using a fine catheter (a hollow tube about 2mm in diameter). Insemination is carried out at the time of ovulation. IUI is commonly, combined with superovulation treatment using a low dose of an injectable fertility drug (gonadotropin) given to the woman in the days before ovulation. Research has shown that IUI without gonadotropin stimulation is no more successful than placebo (dummy treatment) in cases of unexplained infertility but gonadotropin stimulated IUI remains a less invasive and reasonably successful alternative to IVF. INTRAUTERINE INSEMINATION IUI Many couples prefer IUI to the more invasive and stressful techniques of IVF, but not all couples are suitable for IUI. Because fertilisation takes place in the natural environment of the fallopian tube, the female partner's tubes must be open. If there is a male fertility problem, it must not be too severe. A sperm count of more than 11 million motile sperm in the ejaculate is usually considered adequate. The chance of a pregnancy after IUI following ovarian stimulation is, at best, only about 15% per attempt, but if treatments are repeated then about 50% of couples will conceive in time. Since IVF treatments are more likely to result in pregnancy, a clinic may recommend between two and four attempts at IUI before moving to IVF.

7 Donor Insemination Donor insemination has been offered for many years to couples where the male partner has a severe sperm disorder, or does not make sperm. Sperm donors must be screened for infectious diseases and common genetic disorders, and frozen sperm samples can be thawed and simply placed at the cervix (neck of the uterus) at the time of ovulation. DI has become less commonly practiced following the introduction of ICS1 in the 1990s, since ICS1 allows the male partner to have a child with his own DNA. In Vitro Fertilisation IVF is the most widely practised assisted conception procedure in the world. IVF begins with drug treatment with gonadotropin injections to induce the ovaries to develop a number of egg follicles. Eggs are then removed from the ovary for fertilisation in the laboratory. Egg collection uses an ultrasound probe placed within the vagina. The probe contains a needle guide, which allows the needle to be pushed into each ovary in turn. The doctor can then remove eggs from the egg follicles using gentle suction. The entry of the needle through the vaginal skin and into the ovary is painful, and clinics will usually provide sedation and intravenous pain relieving drugs. The eggs are then processed and fertilised with the partner's sperm in he embryology laboratory. After two or three days, one or two embryos (fertilised eggs) are replaced in the cavity of the uterus to allow a chance of implantation and pregnancy. Occasionally, fertilised eggs will be grown or five days, to form blastocysts, large embryos with many cells. This is a useful technique when IVF has failed to lead to pregnancy after two or nore attempts, since it allows study of the early development of the embryo. IVF was developed to treat couples whose principal cause of infertility is tubal damage. However, the applications for the technique have expanded to include treatment for infertility linked to endometriosis and unexplained infertility. IVF also allows eggs to be injected with sperm in the laboratory (ICSI) for treatment of severe male infertility. Within Nigeria, the average chance of pregnancy and livebirth after one cycle of IVF treatment, if the woman is under 36, is about 37% per cent, although results differ between clinics.

8 Intracytoplasmic Sperm Injection ICSI uses a sophisticated microscope to stabilise the egg with a fine suction pipette, followed by injection of a single sperm with a fine glass needle (about seven times thinner than a hair) to fertilise the egg. About 70 per cent of eggs injected by ICSI can be expected to fertilise, and generally, one or two embryos will be replaced into the woman's uterus two or three days later. The number of sperm needed is low, generally 200 or more are adequate. This can be compared with the normal sperm count of 20 million or more. Embryos fertilised by ICSI give pregnancy and live birth rates as high as after IVF. ICSI STEPWISE ICSI offers the hope of a child to men with low sperm count. The method has been expanded to treat men who do not ejaculate any sperm at all. Sperm can frequently (but not always) be collected from the testicles or the epididymis (the sperm reservoir behind the testicles). Testicular sperm extraction (TESE) uses a fine needle with local anaesthetic to sample tissue from the testicles. If sperm are found they can be used in ICSI to fertilise the woman's eggs, producing embryos which can lead to pregnancy.

9 A related technique, percutaneous epididymal sperm aspiration(pesa) again uses local anaesthetic with a fine needle inserted into the back of the scrotum into the epididymis. This is often offered to men who wish to father a child after an earlier vasectomy, with high chances of successful pregnancy. Embryo freezing Embryo freezing (cryopreservation) allows further attempts at pregnancy after an IVF treatment. The couple may have had a successful IVF pregnancy and wish another child some years later, or frozen embryos may be used a few months after an unsuccessful IVF treatment. Embryos are stored in liquid nitrogen at minus 198 degrees Celcius, and in Nigeria can be kept in storage for up to ten years. The science of cryopreservation has advanced in the last few years and pregnancy can occur in 15 20%of attempts. Not all embryos are suitable for freezing: poorer quality embryos will not survive the process and it may be better to repeat another 'fresh' IVF cycle. Vitrification Recently, a new method for freezing human eggs and embryos has been developed. Called vitrification, literally, making into glass, it involves rapid freezing in liquid nitrogen. With vitrification the success rates of pregnancy and livebirth from eggs that have been frozen and later thawed and fertilised with ICSI have improved dramatically, although there are still only a few hundred frozen egg babies in the World and it is too soon to state an absolute chance of success with certainty. Vitrification of eggs allows women without a male partner to try to 'freeze their fertility' until later in life. This is clearly advantageous for a young woman about to undergo treatment for cancer that may render her infertile, and, more questionably, allows unattached single women to try to avoid pregnancy and childbirth until they are older. The latter approach seems risky - if the frozen eggs do not produce a child then it may well be too late to try naturally or with IVF. Further research into the long term health risks to the children from frozen eggs is also still needed. This method is still largely unavailable in Nigeria Egg Donation And Egg Sharing About one woman in a hundred will enter menopause before 40 years of age. Although the cause for this may not be known, some will have undergone chemotherapy or radiotherapy for cancer, or have a family history of early menopause. These women have 'run out of eggs' the ovaries do not contain fertile eggs so treatment with ovulation induction drugs is not helpful.

10 Many patients with premature menopause have a healthy uterus and can carry a pregnancy normally. They can be helped to conceive using eggs donated by another woman, either anonymously or from a family member or friend. An egg donor will usually be under 27years of age (to ensure that her eggs are fertile). She will go through the IVF process of drug injection and vaginal ultrasound egg collection, allowing her eggs to be given to the recipient. Once the eggs are collected from the donor, they are fertilised with sperm from the recipient's partner. Although it is possible to transfer embryos two or three days later, embryos are more usually frozen for transfer later once the recipient's uterine lining has been prepared for pregnancy with hormone tablets of estrogen and progestogen. Egg donation is the only treatment for women who are unable to produce their own eggs. Despite its success, use of egg donation remains limited because of shortage of volunteer egg donors. One solution to the shortage of volunteer egg donors is 'egg sharing'. The egg donor is herself an infertility patient undergoing IVF who is prepared to donate some of her eggs to another patient. The donor may receive free or reduced cost IVF treatment in return. The Risks Of Assisted Conception Assisted conception is not a 100% success process and although chances of pregnancy have risen steadily throughout the last decade, less than half of couples will achieve a pregnancy per IVF attempt, even in the best centers. Most couples will experience the disappointment of a negative pregnancy test at the end of an often-stressful process, although most will conceive if they have the patience and fortitude to undergo multiple treatment cycles, particularly if the woman is under 36years of age. IVF treatment has evolved into a medically safe procedure, with little short term risk to the woman. Improvements in drug manufacture, in the quality of ultrasound scanning equipment and in the techniques of egg collection have improved safety and reduced side effects considerably over the past decade. Concurrent improvements in laboratory practice have reduced the risk of laboratory error to an extremely low level. Multiple pregnancy is associated with risk of premature birth and hence lifelong handicap, problems which can be avoided if no more than one or two embryos are replaced in a treatment cycle. As pregnancy rates from

11 frozen embryo transfers have improved, more and more centres across Europe are recommending single embryo transfer to their 'good quality' patients; those who have the highest chance of an IVF pregnancy. Couples expect a healthy child from their treatment and this is best achieved by achieving a single pregnancy at a time. No medical treatment is entirely free from risk and infertility treatment is no exception. However, while it is important to have information about the risks of treatment, it is also important to appreciate that most women go through IVF and other assisted conception treatments without serious problems. Superovulation with gonadotropin drugs is most common in IVF treatment. This allows production of a number of eggs, which in turn provides a selection of embryos from which to choose the one or two for transfer, with the possibility of embryo freezing for the remainder. However, superovulation carries the risk of 'ovarian hyperstimulation syndrome' (OHSS), which occurs when the patient over responds to the drugs used for superovulation. As drug doses have been reduced over the years, the risk of OHSS has fallen, but cases still occur, particularly in women with polycystic ovary syndrome. Your clinic will provide information on OHSS and its symptoms. The possible long-term risks of treatment with fertility drugs have been intensively studied. Whilst some studies have suggested a slightly higher rate of ovarian cancer among IVF patients than among similar women in the general population, more recent studies have failed to confirm this finding. Women who have had children seem to be healthier and to live longer than those who remain childless, so IVF treatment, when successful, may bring health benefits. Nevertheless, it makes sense to keep drug doses as low as possible and to maximise the chances of pregnancy from a single cycle of IVF treatment by using both fresh and frozen embryo treatments when possible. Specific risks to offspring have been identified for patients undergoing ICSI for male infertility. Men who are infertile because of microdeletions of DNA that cause azoospermia can be successfully helped to have children after collection of sperm from the testes, but they have a high chance of passing their infertility to their sons. Others may have conditions such as cystic fibrosis or chromosome disorders, which should be screened for before treatment is started. Genetic counselling will then be offered to help the couple decide on the best approach to their problem. While the risk is low, ICSI should only be used where the magnitude of the sperm problem rules out a realistic chance of pregnancy after IVF alone. A further drawback to ICSI is that the woman (who may well be normally fertile) has to go through the processes of drug injection and vaginal ultrasound guided egg collection, since her eggs have to be in the laboratory to allow sperm injection to take place. There are therefore the same risks of ovarian hyperstimulation syndrome and multiple pregnancy as seen in IVF

12 Counselling During ART Fertility treatment can be a frustrating and disappointing pathway for many couples. Many couples can be helped to cope with the stress and disappointment involved in treatment by expert counseling from a trained fertility counselor. All Nigerian clinics should provide access to counseling as part of treatment. Effective counseling will support couples at all stages of treatment, from helping to decide which treatment to choose, through the anxiety of drug treatment, egg collection and embryo transfer and up to and beyond the day of the first pregnancy test. Even couples that achieve pregnancy may later have to cope with miscarriage or ectopic pregnancy, and counseling can again be helpful in coping with these sad events. Following treatment, dilemmas remain, and couples may well benefit from discussion with a trained counselor over issues such as - what to do about spare frozen embryos, when.to move to sperm or egg donation and when to decide to stop treatment? Female Age And Lifestyle Issues That Affect Chances Of Pregnancy From ART Female age is the most significant determinant of success or failure of IVF treatment. Using the national average success rates, chances of a livebirth fall from over 32% per cycle when the woman is under 36 years of age to less than 15% when she is 40. As more and more women delay their attempts to conceive until mid 30s or older, clinics are seeing increasing numbers of women in their late 30s and 40s who have repeatedly unsuccessful attempts at IVF treatment. The major cause of the decline in chances of livebirth with age seems to be the fall in egg quality as women age, a feature that is not seen to such an extent in sperm quality as men grow older. Couples can make lifestyle changes to improve fertility and chances of IVF pregnancy - stopping smoking, reducing alcohol intake and taking moderate exercise may all bring benefit. As the number of embryos transferred per IVF cycle has been reduced to two and now, in some cases to one, couples have been encouraged to see ART treatment as a series of embryo transfers and to accept the cumulative livebirth rate over a series of treatments as the most useful statistic. If pregnancy does not occur at the first attempt, but the treatment goes well otherwise, further attempts may well lead to pregnancy.

13 IUI in a nutshell (There are variations) 1. Gonadotropin injections for days to encourage growth of one to four egg follicles 2. Monitoring of the response to gonadotropins using repeated ultrasound scans 3. Single injection of hcg to ensure ovulation, usually given when the largest egg follicle reaches mm in diameter 4. Intrauterine insemination using a prepared sperm sample is usually performed about 34 hours later 5. Pregnancy test two weeks after IUI 6. Ultrasound scan two weeks later to check health of the developing fetus and look for multiple pregnancy)

14 IVF in a nutshell (There are variations to this protocol) 1. Treatment with a GnRH agonist or antagonist to prevent natural ovulation. GnRH agonist treatment by injections for one to two weeks before gonadotropin injection is started. GnRH antagonist treatment by injection some days after starting gonadotropin injection will reduce this treatment phase by more than a week 2. Gonadotropin injection for days (higher dose than IUI) to encourage growth of several egg follicles 3. Monitoring of the response to gonadotropins using repeated ultrasound scans and / or blood tests 4. Single injection of hcg to ensure ovulation, usually given when the largest egg follicle reaches mm in diameter 5. Egg collection using transvaginal ultrasound needle guidance is performed hours after the hcg injection. Collection of sperm by masturbation or using PESA/ TESE 6. Fertilisation in the laboratory (possibly using ICSI) followed by culture of embryos for 2-5 days 7. Replacement of one to three embryos, usually with ultrasound scan guidance to monitor replacement into the cavity of the uterus. Possible freezing of 'spare' embryos 8. Progestogen drugs by vagina (cyclogest), for 14 + days to encourage and maintain implantation 9. Pregnancy test days after the embryo transfer. 10. Ultrasound scan two weeks later to check health of the developing fetus and look for multiple pregnancy

15 PATIENT INFORMATION RISKS ASSCOCIATED WITH ASSISTED CONCEPTION This information sheet has been written to provide general advice for patients considering assisted conception treatment. This includes the following treatments: Use of drugs to induce ovulation in women intrauterine insemination (IUI) along with drugs to stimulate egg production In vitro fertilisation (IVF) and related treatments such as intra cytoplasmic sperm injection (ICSI) and egg donation The risks of these treatments can be considered in four areas: 1. The risks associated with the drugs used to stimulate egg production 2. The surgical risks associated with egg removal during IVF, ICSI and egg donation 3. The risks associated with pregnancy resulting from any treatment 4. The risks of producing an abnormal baby following IVF, ICSI or egg donation Risks associated with drugs used to stimulate egg production Excess stimulation of the ovaries -Ovarian Hyperstimulation Syndrome (OHSS) Stimulation of the ovaries is a deliberate consequence of IVF treatment in order to obtain more eggs than would arise in a natural cycle. When the ovaries are too strongly stimulated there is a possibility of OHSS developing. The majority of cases are a mild to moderate form, occurring in up to 5% of all patients undergoing IVF treatment. This is manifest by abdominal distension, abdominal discomfort and nausea. These cases settle in a few days and require observation, possible blood tests but no specialist treatment. Less commonly a more severe case occurs. This happens in % of all IVF cycles. This is manifest by more marked abdominal distension, nausea and vomiting, decreased output of urine and some difficulty with breathing. This requires admission to hospital for treatment that may include replacement of lost fluids, replacement of protein (albumin) and drainage of fluid from the abdominal cavity. This condition normally responds to treatment and resolves completely in 1-2 weeks. Rarely OHSS can be life threatening and fatalities have been reported. However you are 10 times more likely to die after natural childbirth than from IVF treatment. One of the purposes of monitoring the IVF cycle is to detect early signs of OHSS and modify or cancel the treatment if there are indications that this is developing. Treatments may be modified by reducing the strength of stimulation, coasting the stimulation (continuing the treatment but stopping the stimulation for several days) or going ahead with the egg collection but freezing the embryos as we know pregnancy aggravates OHSS and can prolong and worsen its course.

16 Cancer Ovarian cancer. It has been suggested that the use of drugs used to stimulate ovaries may increase the risk of ovarian cancer. Two studies from North America suggested that the risk of ovarian cancer developing increased in women using the drug clomifene. Subsequent studies have not confirmed this risk. Women who have never been pregnant are known to be at slightly increased risk of ovarian cancer. The current position is that if a risk of ovarian cancer exists it is very low and unconfirmed. Uterine cancer. There is no association between the use of drugs to stimulate ovulation and the development of uterine cancer. Cervical Cancer. There is no association between the use of drugs to stimulate ovulation and the development of cervical cancer. Breast cancer. There is no association between the use of drugs to stimulate ovulation and the development of breast cancer The surgical risks associated with egg removal during IVF and related procedures General anaesthetic and intravenous sedation Patients undergoing IVF and related treatments will receive either intravenous sedation or general anaesthetic. This is a safe procedure but very occasionally there will be an adverse reaction to drugs or other complication. The risk of serious harm is very low 1 in 10,000 and is similar to that of other elective surgery. Egg collection and risk of damage to other structures The ovaries are surrounded by important structures, including bowel, bladder, and major blood vessels. It is theoretically possible to puncture one of these structures although the likelihood is very low. The risk of a significant haemorrhage from an internal blood vessel is approximately 1 in 2,500. If this occurred it would require immediate abdominal surgery to rectify the problem. Pelvic infection Removal of eggs involves passing a needle through the vaginal wall into the ovary and it is possible to introduce infection into the ovary. This possibility is increased if there is an endometriotic cyst in the ovary at the time of treatment. This complication may cause pelvic pain and other signs of infection developing in the weeks after the procedure. It is treated with antibiotics but may rarely require abdominal surgery to drain an abscess. The risk of serious pelvic infection is likely to be less than 1 in 500.

17 The risks associated with pregnancy resulting from any treatment Multiple pregnancy Multiple pregnancy can result from any treatment involving the use of drugs to stimulate egg production or when more than one embryo is replaced during IVF / ICSI or egg donation treatment. The likelihood of a twin pregnancy resulting from clomifene treatment is approximately 10%, following IVF when two embryos are replaced 20-30% and following IUI treatment 10-20%. Triplet pregnancy can also result from any of these treatments but is less likely. After clomifene therapy less than 0.5% and following IUI treatment 1-2%. The risk of triplets following IVF and related treatments is very low if 1 or 2 embryos are replaced although occasionally an embryo can split. If three embryos are replaced the likelihood of triplets increases. The complications of multiple pregnancy are: Increased risk of miscarriage Increased risk of premature labour Increased risk of pregnancy associated problems such as haemorrhage and high blood pressure Increased requirement for caesarian section and its complications Increased loss of a baby (still birth) Increased risk of a baby with physical or learning disability (as a result of premature birth) Increased risk of an abnormal baby Ectopic pregnancy (pregnancy occurring outside the womb) IVF and related treatments increase the likelihood of an ectopic pregnancy. The incidence of ectopic pregnancy is 1-3 % of all pregnancies resulting from embryo transfer, about twice the normal rate. Patients who become pregnant following these treatments should have an early scan to ensure the pregnancy is correctly positioned. Ectopic pregnancy is usually treated surgically either by removing the fallopian tube or removing the ectopic pregnancy from the fallopian tube. If the ectopic pregnancy is very early it may be possible to use a drug called Methotrexate to dissolve the pregnancy tissue. Heterotopic pregnancy This is a twin pregnancy with one in the Fallopian Tube (or other abnormal place) and one correctly situated in the uterine cavity. Although this is a rare condition its incidence increases following IVF and related treatments. This should be excluded by careful ultrasound undertaken in the early stages of pregnancy following these treatments.

18 Miscarriage Early miscarriage is very common in naturally conceived pregnancies. IVF and related treatments neither prevent nor increase the risk of miscarriage. Risk of an abnormal baby following IVF / ICSI and related technologies To date there have been over a million babies born following IVF and ICSI treatment worldwide. In the UK between 1 and 2% of all babies are conceived following IVF and its related technology. Concerns have been raised about the possible genetic risk to such children because of the manipulation of the egg and sperm during the process. Many studies have reported the incidence of abnormal babies but most have been too small or of insufficient quality to provide a reliable answer. One recent study has reviewed much of the available data and has concluded that compared to the risk of an abnormal baby arising following natural conception of 2% (i.e. 2 abnormal babies in 100 born) the risk of abnormal baby following IVF/ICSI treatment rises to 2.6% (i.e. 2-3 abnormal babies in every 100 born). There is no conclusive date to link IVF with any specific abnormality although some recent studies have shown an increase in imprinting disorders which can lead to intellectual impairment. These are normally very rare disorders and the recent data indicates that although they may be increased as a result of IVF they are still rare. At this time we cannot conclusively say whether or not there is a cause and effect relationship between IVF / ICSI and specific abnormalities, however, it is clear that, if such a risk exists, it is small and that further monitoring of children resulting from such treatment is necessary to answer this question. ICSI, and other treatments which combines with ICSI e.g. Surgical Extraction of Sperm A proportion of men with severe sperm abnormalities have a genetic basis for this, usually an abnormality of the Y chromosome. This is likely to be inherited by male offspring following ICSI. There has also been reports of an increase in abnormalities in the number of the X or Y chromosomes in infants conceived following this treatment. These usually cause no serious abnormality but may be associated with infertility and occasionally can cause intellectual impairment (1 in 166, compared with 1 in 500 in naturally conceived children). Embryo cryopreservation and thawed embryo transfer This technique has been carried out since The number of babies born is considerably less than by IVF. To date there has been no conclusive evidence of any increased incidence of abnormalities in babies born following replacement of thawed embryos.

19 Psychological and emotional risks Undoubtedly infertility can lead to stress. Stress can also lead to infertility in some cases. Treatment for infertility is also stressful because of the emotional roller coaster of expectation, disappointment and success and the marked hormonal changes that occur during the cycle of treatment. This can in turn place strain on the relationship. Support should be provided by the staff of the infertility unit during this difficult time and additionally patients may find benefit from counselling. Laboratory risks The processing of sperm and eggs in the laboratory is a complex and skilled process carried out by qualified laboratory personnel. It involves a number of stages including gamete preparation, fertilisation, embryo assessment and culture and replacement. Additionally there may be a requirement to freeze spare embryos and prepare them for storage. Protocols and quality assurance are rigorous and designed to minimise errors in laboratory procedures. While serious mistakes are rare, things can and do go wrong. There will be occasions when an unforeseen problem with equipment or the culture media may give rise to adverse conditions and lead to one of the following: Lower than expected or failure of fertilisation Low percentage of embryos dividing after fertilisation Lower quality of embryos than would normally be expected Problems of this nature are uncommon, nevertheless all IVF laboratories will experience such problems from time to time. Patients may also, quite reasonably, be concerned about the possibility of a mix up in sperm, eggs or embryos. Procedures in the UK include specific measures to minimise the likelihood of such an event. The regulatory authority, the Human Fertilisation and Embryology Authority, inspects laboratories on an annual basis to ensure these procedures are in place. Embryo transfer The placement of the embryos back inside the cavity of the uterus (womb) is a relatively simple procedure. There are virtually no risks to the female in carrying this out. Occasionally, however, one or more of the embryos may be lost during the course of placement. This is because the fine catheter that is used has to passed through the canal of the cervix which is normally very narrow and contains mucus. Despite taking great care with this procedure the catheter does not always pass through the cervix easily and sometimes the embryos get caught in the mucus

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