Risks of treatment Research projects

The IVF Pathway Treatment Risks MULTIPLE PREGNANCY AND THE ONE AT A TIME INITIATIVE Our wish is for you to achieve a healthy pregnancy and live birth which is more likely with a single baby Twins and more carry higher risks to mother and babies In couples with the highest chance of success, it is not wise to take unnecessary risks by transferring more than one embryo The final section of this presentation explains some of the risks of IVF treatment. Generally speaking, IVF treatment is a safe process but everything has some risk and it is important that all patients are fully informed of the potential hazards of treatment. The first and most significant risk is multiple pregnancy and the potential consequences of it. Fertility treatment has developed a bad reputation over the years for twins, triplets and more. The risks of multiple pregnancy are many, to the mother, the baby and the family unit, as well as society at large. For the mothers, PET is 3x higher in twins, and 9x higher in triplets. The risk of GDM is increased as is the risk of CHD. Most worrying is that having a multiple pregnancy doubles the maternal mortality risk. Multiple pregnancy risks to the baby include miscarriage, both early and late, and pre-term delivery with associated complications. Increased risk of low birth weight babies and development of CP. Neonatal death is 5x higher in twins and 9x higher in triplets compared to singleton babies. The chance of a pregnancy overall is closely related to female age (and egg quality) and to the performance of the clinic as a whole Our figures show that if we have two good quality blastocysts and we transfer both together, there is a 50% chance that a pregnancy will result, and a 50% chance that the pregnancy will be a multiple (twin). If we only transfer one, the overall chance of a pregnancy is less than 1% lower (ie >49%) than if two were transferred and the chance of twinning is <1%. (single embryos will rarely split producing identical twins…) The law permits the transfer of maximum of two embryos in women less than 40 years of age. In women over 40 years, the maximum number permitted is 3 at any one time. LCRM multiple pregnancy rate x (6-7)% see slide 43 success rates above LCRM POLICY IN LINE WITH HFEA CODE OF PRACTICE: Single embryo transfer in women under 38 years, during the first or second cycle of treatment, where the embryo development has been good overall

The IVF Pathway Treatment Risks Ovarian Hyperstimulation Syndrome (OHSS) All patients experience a mild form of OHSS Women at highest risk are those with polycystic ovaries 1% will get significant symptoms We take special precautions in women at high risk Stimulation may be abandoned We may freeze all embryos The second important risk of IVF treatment is ovarian hyperstimulation syndrome All pts experience a mild form Risk inc wth PCOS 1% significant We are always on the lookout and can often remedy the situation to allow treatment to continue safely. Occasionally: stimulation may be abandoned and restarted with different dose / treatment regimen we freeze all embryos because if you were to get pregnant with OHSS, the risks are greater You may be prescribed additional medications such as blood thinning injections as a precaution

The IVF Pathway Treatment Risks Ovarian Hyperstimulation Syndrome (OHSS) OHSS symptoms Bloating Abdominal discomfort Nausea and vomiting Diarrhoea Risks of Severe OHSS Blood clots (thrombosis) Dehydration Kidney problems OHSS can feel quite unpleasant producing….. Serious problems that may not be obvious to you include an increased risk of developing a blood clot and kidney failure. Therefore it is much safer to call and allow us to check you over than to hope you’ll feel better tomorrow… If you suspect you may have symptoms of OHSS, please contact us directly as LCRM for advice (NOT your local hospital or GP)

The IVF Pathway Treatment Risks Miscarriage 20-30% risk of miscarriage <5% risk of miscarriage once a fetal heart has been identified Ectopic pregnancy If unidentified, it may burst and cause serious internal bleeding The risk is greater when tubal problems have been identified Other risks of treatment include: Miscarriages: 20-30% risk of miscarriage after positive pregnancy test (same as for natural conceptions) <5% risk of miscarriage once a fetal heart has been identified Risk related to age, family history and whether the pregnancy is a multiple pregnancy Ectopics: Occurs when the embryo drifts into the Fallopian tube where it implants If unidentified, it may burst and cause serious internal bleeding The risk is greater when tubal problems have been identified, and an early scan should be performed (6+ weeks)

The IVF Pathway Treatment Risks Risks of the egg collection surgical procedure Infection Bleeding or internal injury Risks of equipment failure Service contracts and safety checks in place Risks related to the treatment processes include: Risk of infection is greater if you already have infected tubes or an active vaginal infection, if you have endometriosis or internal scarring involving the bowel Both partners should undergo sexual health screening before treatment The woman will be prescribed an antibiotic cream to use during treatment Bleeding is extremely rare as is bowel injury Despite all our efforts, and very very rarely, equipment failure may lead to loss of eggs or embryos. This is a Category A incident that will be immediately notified to HFEA, LTHT and to you There would be a thorough investigation and steps taken to prevent a recurrence The HFEA also operates an Alert system which all clinics use to learn from serious incidents that have occurred in clinics elsewhere

The IVF Pathway Treatment Risks RISKS OF INTRACYTOPLASMIC SPERM INJECTION (ICSI) Used worldwide for >20 years Potential concerns regarding the risk of passing on a genetic reproductive problem Studies so far are small and do not include effects that may be seen in older children and future generations It is worth saying a few words about the ICSI procedure and what we know about its safety- ICSI is an unnatural and invasive technique and may use sperm that would not otherwise be able to fertilise an egg No clear evidence that ICSI results in more birth defects than occur with natural conception No clear evidence giving concerns about the physical and intellectual development of ICSI children

The IVF Pathway Treatment Failure POSSIBLE REASONS Failure to produce enough eggs to collect eggs from ovaries of eggs to fertilise of embryos to divide and develop Unexpected illness in either partner A negative pregnancy test often results with no clear explanation These are all UNCOMMON Finally, there is the ever present risk that the treatment may not work for you this time- Sometimes the treatment process will reveal problems with egg or embryo quality which the treatment is not able to solve. It is more common for a pregnancy not to result when everything has apparently gone well, and sometimes we may not have an explanation In most cases we suspect that the embryos were faulty in their genetic make-up and never destined to produce a baby. This is not something we would necessarily identify in the short time the embryos are observed in the laboratory before transfer. However, it is the commonest finding when embryos are examined for their genetic detail. Genetic faults become very much more common as the eggs (woman) gets older. By the age of 43y, >90% eggs are abnormal. Unfortunately, the IVF process is not the answer for this problem, unless younger eggs are used…

The IVF Pathway Research There is still so much work to do to improve the likelihood of success, and we urge that you consider participating in our research projects Assessing male reproductive health using ejaculated sperm Non-invasive assessment using left over semen not required for your treatment HAB select: Hyaluronic Acid Binding sperm selection for ICSI What is the best way to select sperm for ICSI? Randomization into current method v. Hyaluronic Acid Binding (HAB) Best sperm binds to naturally occurring substance “hyaluronan” NO extra visits

Thank you We hope that you have found this presentation useful, helpful and reassuring. We look forward to supporting you through your treatment and wish you the very best of luck.