Title of Guideline (must include the word Guideline (not protocol, policy, procedure etc)

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1 Title of Guideline (must include the word Guideline (not protocol, policy, procedure etc) Guideline for the Investigation and Management of Polycystic Ovary Syndrome Author: Contact Name and Job Title Directorate & Speciality Nivedita Das ST3, Obstetrics & Gynaecology, William Atiomo, Consultant Gynaecologist. Family Health Date of submission 10 th Jan 2018 Explicit definition of patient group to which it applies (e.g. inclusion and exclusion criteria, diagnosis) Gynaecology clinics Version 1 If this version supersedes another clinical guideline please be explicit about which guideline it replaces including version number. Statement of the evidence base of the guideline has the guideline been peer reviewed by colleagues? Evidence base: (1-6) 1 NICE Guidance, Royal College Guideline, SIGN (please state which source). 2a meta analysis of randomised controlled trials 2b at least one randomised controlled trial 3a at least one well-designed controlled study without 3b randomisation at least one other type of well-designed quasiexperimental study 4 well designed non-experimental descriptive studies (ie comparative / correlation and case studies) 5 expert committee reports or opinions and / or clinical experiences of respected authorities 6 recommended best practise based on the clinical experience of the guideline developer Ratified by: Gynae guidelines group Date: 10 Feb 2018 Target audience Review Date: (to be applied by the Integrated Governance Team) A review date of 5 years will be applied by the Trust. Directorates can choose to apply a shorter review date, however this must be managed through Directorate Governance processes. NA 1.RCOG - Green-top Guideline No. 33 November 2014 Long Term Consequences of Polycystic Ovary Syndrome. 1.NICE guidance, February, 2013 on Polycystic Ovary Syndrome. 5.Morley LC, Tang TMH, Balen AH on behalf of the Royal College of Obstetricians and Gynaecologists. Metformin Therapy for the Management of Infertility in Women with Polycystic Ovary Syndrome. Scientific Impact Paper No. 13. BJOG 2017;124:e306 e313. General gynaecologists, primary healthcare professionals 10 th Feb 2021 This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date.

2 Algorithm 1 for the Investigation and Management of PCOS Investigations to rule out other causes of oligomenorhoea: a) LH & FSH, oestradiol b) Prolactin c) ft4, ft3 and TSH Diagnosis of PCOS Rotterdam consensus criteria Investigations: a) Total Testosterone b) SHBG c) Free Androgen Index d) Pelvic USS MANAGEMENT General lifestyle advice to all women with PCOS 1) Diet (Reduce daily calories by 600 kcal/day. Ideally aim for no more than 1400/day total intake) 2) Physical Activity (150 minutes of aerobic exercise per week non occupation related) 3) Stop Smoking 1) Obesity 2) Irregular menstruation 3)Preventing Diabetes 4) Preventing Endometrial cancer 5) Hirsutism 6) Infertility (see separate flow chart) 1) Weight reduction drugs (Orlistat) maybe helpful in reducing hyperandrogenaemia. Metformin* might also help. 2) Bariatric Surgery maybe an option for the morbidly obese (BMI 40 ) Offer the combined oral contraceptive or Dianette if not contra indicated. a) Annual monitoring of fasting glucose (impaired fasting glucose mmol/l ) and/or HBA1c (pre diabetes 41-47mmol/mol).This is esp in case of overweight & high risk patients. No evidence that metformin* confers any long term benefit. 1) Induce withdrawal bleed with Gestogens (Medroxyprogesterone) 10mg OD for 12 days to help in withdrawal bleed every 3 to 4 months, insert Mirena IUCD or prescribe oral contraceptive pills if not contraindicated. 2) If endometrium > 7mm or there is endometrial polyp consider endometrial biopsy +/- hysteroscopy. 1) If testosterone levels >5nmol/L, further investigations needed to rule out androgen secreting tumours. 2) Reduce weight 3) Mechanical Methodsshaving/waxing /bleach/electrolysis Drugs:- Dianette, Lucette, Spironolactone in some cases with precaution

3 Algorithm 2 for the management of Infertility in PCOS PCOS - Infertility 1) Clomifene citrate or 2) Metformin* or 3) Clomifene citrate and Metformin* If no response 1) Clomifene citrate & Metformin* if not given already Or, 2) Laparoscopic drilling Or, 3) Gonadotrophins * Please note U&E baseline required prior to metformin Background Polycystic ovary syndrome (PCOS) is the most common cause of infertility in women, frequently becomes manifest during adolescence, and is primarily characterized by ovulatory dysfunction and hyperandrogenism. It has lifelong implications with increased risk for metabolic syndrome, type 2 diabetes mellitus, and possibly cardiovascular disease, endometrial carcinoma, dyslipidaemia, fatty liver, and obstructive sleep apnoea. 2 out of 3 of the following Rotterdam consensus criteria being diagnostic of the condition: 1) polycystic ovaries (either 12 or more follicles or increased ovarian volume [> 10 cm3]), 2) oligo-

4 ovulation or anovulation,3) clinical and/or biochemical signs of hyperandrogenism. PCOS should be suspected a) irregular menstruation, b) symptoms of hyperandrogenism (acne, hirsutism, male-pattern hair loss) and c) presence of obesity. Appendix 1 Diagnostic investigations: 1) Total testosterone normal to moderately elevated in PCOS, 2) Sex hormone-binding globulin normal to low in PCOS (surrogate measurement of the degree of hyperinsulinaemia), 3) Free androgen index (normal range usually <5) normal or elevated in PCOS. {Total testosterone value (in nmol/l x 100) by the sex hormone-binding globulin value (in nmol/l)}. If there are signs of virilisation / rapidly progressing hirsutism / testosterone levels are more than normal then androgen-secreting tumours and late-onset/non-classical Congenital Adrenal Hyperplasia (CAH) should be excluded. 17-hydroxyprogesterone (17OHP) should be measured in the follicular phase and will be raised in CAH. If testosterone levels are very high (> 10nmol/l), then confirmation is required with a fasting cortisol and ACTH plus a Synacthen test with 17OHP measurement. Overweight (BMI 25 kg/m 2 ) patients are high risk where there is advanced age (> 40 years), personal history of gestational diabetes mellitus or family history of type II diabetes mellitus. Impaired fasting glucose (fasting plasma glucose level 6.1 mmol/l to 6.9 mmol/l) or impaired glucose tolerance (fasting glucose of <7mmol/l and a plasma glucose of 7.8 mmol/l to11.0 mmol/l after a 2-hour oral glucose tolerance test) or prediabetes (HBA1c of 41mmol/molto 47 mmol/mol). In diabetes, fasting plasma glucose is 7mmol/l and/or HbA1c is 48mmol/mol.

5 References RCOG - Green-top Guideline No. 33 November 2014 Long Term Consequences of Polycystic Ovary Syndrome. NICE Clinical Knowledge Summary, February, 2013 on Polycystic Ovary Syndrome available at: Morley LC, Tang TMH, Balen AH on behalf of the Royal College of Obstetricians and Gynaecologists. Metformin Therapy for the Management of Infertility in Women with Polycystic Ovary Syndrome. Scientific Impact Paper No. 13. BJOG 2017;124:e306 e313.

Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Definition: the diagnostic criteria Evidence of hyperandrogenism, biochemical &/or clinical (hirsutism, acne & male pattern baldness). Ovulatory dysfunction; amenorrhoea; oligomenorrhoea