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LAUNCH OF PCOS CLINICS FOR FERTILITy PATIENTS – SEPTEMBER 2011 Approximately 20% of women presenting Prof Norman is the leading expert on PCOS for fertility treatment have polycystic and infertility in Australia and was part ovarian syndrome (PCOS). As the New of the team that developed the NHMRC NHMRC Guidelines for the assessment guidelines for PCOS. The following is a and management of polycystic ovarian summary of the recommendations from syndrome are being launched this year the Guidelines. These guidelines will be Welcome to our new format Fertility SA by the PCOS Alliance and Jean Hailes published on the Jean Hailes Foundation Newsletter. It has been a wonderful Foundation for Women's Health few months; our success rates continue we would like to provide you with to be well above national and an update of the fertility options international benchmarks; patient available for women with PCOS feedback has been fantastic and we at Fertility SA.
are very excited about the launch of Most of the fertility issues faced by our specialist fertility clinics for patients women with the condition centre with Polycystic Ovarian Syndrome in around anovulation (a condition September this year. where eggs are not released from the ovaries appropriately). We hope you enjoy reading our news While some women with PCOS but if you have any suggestions for will ovulate intermittently and improving the content, please contact become pregnant spontaneously, our General Manager, Lee Battye. ovulation is often not regular and can make intercourse timing On behalf of all our fertility specialists – difficult. Ovulation kits may Dr Alex Hubczenko, Dr Louise Hull, not be effective as hormonal Prof Rob Norman, A/Prof Ossie changes associated with PCOS Petrucco, Dr Michelle Wellman and (consistently high LH levels) can me – thanks for your support.
interfere with their readings. Fertility treatments for PCOS include lifestyle modification, ovulation induction with Clomid, FSH and metformin, and where required, IVF. In September 2011, Fertility SA will support website from 28th August 2011. The dedicated infertility clinics for PCOS guidelines emphasise lifestyle management Fertility SA Consulting Clinic
patients as we believe that patients with and weight loss particularly in women with PCOS are in particular need of specialist a BMI greater than 35. No particular 345 Carrington Street gynaecological attention to manage their diet has been found to be more effective fertility treatment options. These clinics in the treatment of PCOS and the For all appointments & enquiries
will be run by Dr Michelle Wellman and recommendation is to reduce dietary energy Professor Rob Norman who have a special (caloric) intake in the setting of healthy Phone (08) 8100 2900 interest and vast experience in the fertility Fax (08) 8223 1319 management of PCOS. Continued next page.
Personalised care by leading fertility specialists monitoring these cycles in order to optimise used for women who do not respond to outcome and to reduce the risk of clomiphene. In some situations they can multiple pregnancy. be used as first line. These ovulation induction cycles often require more intense This is generally a low risk and low cost ontinued from previous page. education, supervision and monitoring to treatment. The rates of twin pregnancy A referral to a dietician may enhance the and triplets with clomiphene citrate are primary infertility care plan. 5 - 7% and 0.3%, respectively. Again, our team at Fertility SA are highly key messages for women with PCOS are experienced in the management of The incidence of ovarian hyper-stimulation that achievable weight loss goals (such these cycles.
syndrome (OHSS) is less than 1%. as 5% to 10% loss of body weight) yield Studies with clomiphene citrate have significant clinical improvements. shown an ovulation rate of 60 - 85% At least 150 minutes of exercise per week and a pregnancy rate of 30 - 50% after is recommended, and 90 minutes per 6 ovulatory cycles. week of this should be aerobic activity at moderate to high intensity (60% - 90% Case Study - Fertility SA Patient B
of maximum heart rate) .
A patient with PCOS who had several Behavioural change techniques, including clomiphene citrate cycles without success motivational interviewing are advocated was referred to Fertility SA for fertility in addition to providing information and treatment. A further clomiphene citrate education. Interventions can be individual, cycle was monitored very closely with blood group or mixed mode, in a range of tests and scans. An injection to induce settings, delivered by a range of health ovulation was given at the time the follicle had developed to the correct size and timed intercourse recommended. An Case Study - Fertility SA Patient A
ongoing pregnancy resulted, much to A 43 year old patient with PCOS and a the patient's delight. BMI of 42 had had numerous cycles of Take home message: when clomiphene
IVF and ovulation induction over a 15 year does not appear to work, referral for
period of time. After review at Fertility SA, closer hormonal tracking and possible
an intensive lifestyle management plan intercourse timing should be considered.
was instituted for both partners. Another IVF cycle was planned but There has been some confusion as to the cancelled when a positive pregnancy test place of metformin in the treatment of was found. A single fetal heart was seen women with PCOS and infertility. It should on a subsequent scan. not be used as a substitute for lifestyle change. Contrary to what was initially Take home message: Lifestyle
Our nursing staff are available to answer thought, metformin appears to be more management should be applied even
any questions about these cycles and effective in restoring ovulation in women if IVF is planned. Patient spent many
provide instruction on administration with a BMI less than 30 if used alone. hundreds of thousands of dollars on
and timing of medication. It is rare for fertility treatment when correct advice
It may be effective in improving response women with PCOS not to respond to could have worked.
to Clomid in those women who may appear clomiphene resistant regardless of BMI.
The recommended first line Occasionally cycles may need to be pharmacological treatment for PCOS is Ovulation induction with gonadotropins recommenced if there is an over-response clomiphene citrate. The staff at Fertility SA (subcuticular injections of FSH, trade to medication, in order to avoid multiple have extensive experience in tracking and names Puregon or Gonal F) are generally Case Study - Fertility SA Patient C
PCOS INFORMATION SESSIONS A 26 year old anovular patient with PCOS Professor Norman and Dr Wellman will be providing an update for doctors on the new and a normal BMI was previously seen by guidelines in September 2011 and are planning a public information session for PCOS an IVF clinic who recommended IVF. fertility patients soon afterwards. She was commenced on a standard dose Professor Norman will also be conducting a general information session for PCOS of FSH, become severely hyper-stimulated patients in conjunction with the Jean Hailes Foundation and Women's and Children's and was admitted to hospital for several Hospital in October 2011. weeks without a pregnancy. She vowed never to have IVF again. At Fertility SA we Doctors seeking a specialist opinion for their PCOS patients who are not concerned with commenced ovulation induction with a very fertility issues may refer patients to Professor Norman at his clinic at the Royal Adelaide low dose of FSH seeking to develop one Hospital. Doctor Michelle Wellman is happy to provide initial advice and ongoing follicle and time intercourse without IVF management plan through her rooms in North Adelaide.
treatment. She was very happy when she became pregnant and a single fetus was seen on an ultrasound scan. Take home message: PCOS and infertility
FRANZCOG FRCPA CREI should be seen by a person with
experience in other forms of fertility
• Fertility Specialist • Fertility Specialist management and who is skilled in
• Specialist Surgical • Reproductive ovulation induction. IVF can be risky
Endocrinologist for patients with PCOS.
Often laparoscopy is performed as part of the assessment of infertility. As a number the ability of the sperm to fertilise the egg at Fertility SA, it was clear that because of of our specialists have extensive experience in vivo! However if IVF is needed, Fertility her husband's low sperm count, IVF was still in laparoscopic surgery, women with SA has an outstanding pregnancy rate in the best fertility treatment. PCOS can be advised if this is appropriate these patients.
management for them. Laparoscopic A final IVF cycle was monitored closely and ovarian drilling may also be an option in CASE STUDY- Fertility SA Patient D
several careful dose adjustments were made women who fail to respond to clomiphene. during the cycle. The ovaries responded A patient with PCOS undertook IVF This procedure may restore ovulation in up appropriately and the patient became because her partner had a low sperm count. to 60 - 80% of women with PCOS and can pregnant. In her first cycle, multiple follicles developed sometimes be offered as an alternative to and although she conceived, she developed She was monitored closely as an outpatient FSH ovulation induction or IVF.
severe over hyperstimulation syndrome in early pregnancy by her own doctor at If women do not respond to these requiring admission to a public hospital, IV both Fertility SA's consulting rooms and at more simple treatments or there are fluid therapy, catheterisation and drainage St Andrews Hospital but did not develop other infertility factors, IVF may be an of ascites (an abdominal fluid collection). hyperstimulation syndrome. A single live appropriate course of treatment. Caution Unfortunately the pregnancy miscarried. fetus was identified at an 8 week however needs to be exercised as women pregnancy scan. Another IVF cycle was cancelled because with PCOS are at significantly increased of over response, then in a third IVF cycle Take home message: For women
risk of ovarian hyper-stimulation syndrome.
there were some difficulties obtaining with PCOS that require IVF, careful
For this reason, even if there appears to be medical advice and the dose was initially monitoring, continuity of care and
an abnormal semen analysis, more simple too low, then increased to a level that again specialist medical input is required during
and safer techniques are often better used resulted in an over response of the ovaries an IVF cycle and in early pregnancy,
first line. The best test of male fertility is and a cancelled cycle. After seeking advice to minimise hyperstimulation.
Personalised care by leading fertility specialists Our success rates for the period ending 31st March 2011 are shown in the opposite graph. This demonstrates clearly that our success rates are outstanding by comparison to national and international benchmarks. However, success rates do not tell the whole story and for some patients, the dream of having a baby will not become a reality. For this reason, we hold regular in-house education meetings, learn about the latest innovations at national and international conferences, run several research projects and promote the use of new techniques and technologies to ensure that we remain at the cutting edge of Clinical heart beat developments to help enhance the prospects of pregnancy for our patients.
GENERAL MANAGER'S UPDATE from the desk of Lee Battye ESHRE CONFERENCE, STOCkHOLM Professor Norman gave a plenary lecture to 4,000 participants at the European Society Consulting locations –
for Human Reproduction and Embryology (ESHRE). ESHRE is one of the two premier For patients' convenience, organisations on IVF and reproduction. Dr Alex Hubczenko consults from Calvary Central District Hospital, 25-37 Jarvis Rd, Professor Norman's speech was entitled "Redefining success of assisted reproductive Elizabeth Vale every fortnight and Dr Ossie technology: how do we assess the best results?" In it, he pointed out that success is more than Petrucco holds consultations for country claiming high pregnancy rates - live birth, fresh and frozen results, a low multiple rate and patients periodically at various locations high patient satisfaction are also important. in South Australia and Darwin. He defined the PERFECT clinic as one with high pregnancy rates, the best trained Dr Jodie Semmler and Dr Michelle gynaecological specialists, a high investment in education and research, a strong focus on Wellman also consult from their respective patient care, emotional engagement, outstanding controlled quality systems and truth in private rooms in North Adelaide. all aspects of patient care, results, effective treatments and marketing. Fertility SA has All of our specialists also consult from our set its standards to be among the very few elite units in the world to achieve all these rooms at 345 Carrington St, Adelaide. goals and has a clear plan to excel in all these areas. PATIENT SATISFACTION SURVEyS New brochure – Some of you may have
already seen our new brochure for patients.
If you would like more brochures or any
We have been thrilled with feedback from our patients, with 92% of patient responses other materials, please contact myself or rating our overall service as good or excellent and 94% of respondents saying they would Janet McBride on (08) 8100 2900.
recommend our clinic to a friend or family member. Welcome - We are delighted to be
Patient comments mainly centre on the friendly, supportive and personalised service welcoming Jo Patterson and Jane Gard we provide and many patients have contrasted this to the "production line" they have to our nursing team, Rochelle Owens to experienced elsewhere. We are aiming to improve this even further and to this end we our admin team and Meghan Inge to our have recently been gathering feedback from referring doctors as well. laboratory team. Sadly, one of our lovely We understand that occasionally we may not meet our desired service levels however fertility nurses Rosie Bell will be leaving and if you have an experience that you would like to share, please contact me later this year to return to Victoria and on (08) 8100 2900.
she will be greatly missed by all of us.
Prof. Dr. Thomas Koller II VORLESUNG ZUM OBLIGATIOENRECHT BT 1. TEIL: VORBEMERKUNGEN UND INNOMINATKONTRAKTE A Aufbau und Funktion des OR BT I. Aufbau II. Funktion • Rationalisierung Die meisten Verträge passen in einen der gesetzlichen Vertragstypen, dies trotz der Vertragstypenfreiheit. Es ist möglich, einen Vertrag bewusst oder unbewusst lücken-haft zu belassen, weil man darauf vertrauen kann, dass Detailfragen bereits im Ge-setz geregelt sind. Der Aufwand bei Vertragsschluss kann so erheblich gesenkt wer-den.
The 2nd European Carotid Surgery Trial (ECST-2) Protocol Version 2.00 1 May 2013 International Standard Randomised Controlled Trial Number: ISRCTN97744893 ECST-2 Protocol v 2.0 – page 2 CONTENTS ECST-2 Protocol v 2.0 – page 3 PROTOCOL SUMMARY BACKGROUND Randomised trials have established the benefit of revascularisation by carotid endarterectomy (CEA) for moderate and severe carotid stenosis. However, a risk model derived from one of these trials and validated in another, showed that only patients with a high risk of stroke under medical therapy benefited from CEA. For a large range of patients there was neither clear benefit nor harm from CEA. Medical therapy for stroke prevention has improved since these original trials, with more widespread use of statins, more active lowering of blood pressure and more effective antiplatelet regimes. Lower optimum targets have been set for risk factor control e.g. blood pressure. Therefore CEA may not be beneficial in many patients with carotid stenosis treated by modern optimized medical therapy (OMT). HYPOTHESIS We hypothesize that in patients with carotid stenosis at low and intermediate risk for stroke, OMT alone is as effective in the long-term prevention of cerebral infarction and myocardial infarction (MI) as revascularisation and OMT combined. STUDY DESIGN ECST-2 is a multicentre, randomised, controlled, open, prospective clinical trial with blinded outcome assessment. We will use a risk model based on clinical characteristics to calculate a 5-year Carotid Artery Risk (mCAR) score, which will stratify patients as at high risk (≥15%), intermediate risk (7.5-15%), or low risk (<7.5%) of future stroke using predictive data from previous trials recalibrated to take account of the likely benefit of OMT. An interim analysis using MRI to determine the 2-year rates of cerebral infarction and haemorrhage after randomisation will be performed to assess safety and feasibility of the design and inform the design and sample size calculations for the full trial. ECST-2 will incorporate baseline imaging of carotid plaque where possible to investigate the predictive value of plaque characteristics. CENTRE REQUIREMENTS A neurologist or physician with an interest in stroke; a surgeon with expertise in CEA; if available, an interventionist with expertise in CAS. Access to MRI. INCLUSION CRITERIA Patients with symptomatic or asymptomatic atherosclerotic carotid artery stenosis (> 50%, NASCET criteria), suitable for revascularisation with CAR score indicating low or intermediate risk. MAIN EXCLUSION CRITERIA Patients with a CAR score indicating high risk, patients refusing either treatment, unable to consent or unsuitable for revascularisation due to anatomy, ill-health or disabling stroke (current Rankin >2). Recent contralateral carotid revascularisation, cardiac or other major surgery. RANDOMISATION AND TREATMENTS Patients will be randomly allocated in equal proportions to be treated by 1) immediate carotid revascularisation with OMT or 2) OMT alone (in the latter arm, revascularisation may be performed at a later stage if it becomes more clearly indicated e.g. because of TIA during follow up). Randomisation will be stratified by centre, type of planned revascularisation, symptom status and CAR score. A web-based randomisation system will be used. We anticipate that revascularisation will be by CEA in most patients, but carotid stenting (CAS) may be used if considered more appropriate. Centres will prespecify whether a patient will receive CEA or CAS if allocated to revascularisation. Randomisation and analysis will be stratified by the pre-specified intervention. The randomisation form will include entry of data to confirm a CAR score of <15%. OMT in both arms will consist of all three of: 1) optimal antiplatelet therapy; 2) statin or other cholesterol lowering treatment with target total cholesterol of <4 mmol/l and LDL cholesterol of <2 mmol/L; 3) antihypertensive treatment, if required, with target blood pressure of 135/85 mmHg. Patients will also undergo risk factor modification e.g. advice on smoking. FOLLOW UP The planned duration of follow up is a minimum of 5 years up to a maximum of 10 years. Recruitment and follow up will be supervised by the neurologist or stroke physician. Follow up will include ECG and troponin at 48 hours after revascularisation, with MRI at baseline and at 2 and 5 years follow up. SAMPLE SIZE The planned sample size is 320 patients for the safety MRI analysis and 2000 patients for the full trial. PRIMARY OUTCOME MEASURES For the full trial: any stroke at any time, plus non-stroke death occurring within 30 days of revascularisation. For the safety MRI analysis: The combined 2-year rate of cerebral infarction, cerebral haemorrhage, MI or periprocedural death after randomisation as assessed by follow up MRI and screening for MI. SECONDARY OUTCOME MEASURES Ipsilateral stroke, myocardial infarction, transient ischaemic attack or any hospitalisation for vascular disease during follow up. Disabling stroke during follow up. New cerebral infarction or haemorrhage on post procedural MRI. Ipsilateral restenosis or stenosis progression. Cognitive impairment. Further treatment procedure. Adverse events attributed to medical treatment or CEA. Quality of life and economic measures.