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Recommendations From The 2023 International Evidence-Based Guideline For The Assessment and Management of Polycystic Ovary Syndrome
Recommendations From The 2023 International Evidence-Based Guideline For The Assessment and Management of Polycystic Ovary Syndrome
https://doi.org/10.1093/ejendo/lvad096
Advance access publication 15 August 2023
Clinical Practice Guideline
Abstract
Study question: What is the recommended assessment and management of those with polycystic ovary syndrome (PCOS), based on the best
available evidence, clinical expertise, and consumer preference?
Summary answer: International evidence-based guidelines address prioritized questions and outcomes and include 254 recommendations and
practice points, to promote consistent, evidence-based care and improve the experience and health outcomes in PCOS.
What is known already: The 2018 International PCOS Guideline was independently evaluated as high quality and integrated multidisciplinary and
consumer perspectives from 6 continents; it is now used in 196 countries and is widely cited. It was based on best available, but generally very low-
to low-quality, evidence. It applied robust methodological processes and addressed shared priorities. The guideline transitioned from consensus-
based to evidence-based diagnostic criteria and enhanced accuracy of diagnosis, whilst promoting consistency of care. However, diagnosis is
still delayed, the needs of those with PCOS are not being adequately met, the evidence quality was low, and evidence-practice gaps persist.
Study design, size, and duration: The 2023 International Evidence-based Guideline update re-engaged the 2018 network across professional
societies and consumer organizations with multidisciplinary experts and women with PCOS directly involved at all stages. Extensive evidence
synthesis was completed. Appraisal of Guidelines for Research and Evaluation II (AGREEII)-compliant processes were followed. The Grading of
Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, feasibility,
acceptability, cost, implementation, and ultimately recommendation strength, and diversity and inclusion were considered throughout.
Participants/materials, setting, and methods: This summary should be read in conjunction with the full guideline for detailed participants and
methods. Governance included a 6-continent international advisory and management committee, 5 guideline development groups, and paediatric,
consumer, and translation committees. Extensive consumer engagement and guideline experts informed the update scope and priorities.
Engaged international society-nominated panels included paediatrics, endocrinology, gynaecology, primary care, reproductive endocrinology,
obstetrics, psychiatry, psychology, dietetics, exercise physiology, obesity care, public health, and other experts, alongside consumers, project
management, evidence synthesis, statisticians, and translation experts. Thirty-nine professional and consumer organizations covering 71 countries
engaged in the process. Twenty meetings and 5 face-to-face forums over 12 months addressed 58 prioritized clinical questions involving 52
systematic and 3 narrative reviews. Evidence-based recommendations were developed and approved via consensus across 5 guideline panels,
modified based on international feedback and peer review, independently reviewed for methodological rigour, and approved by the Australian
Government National Health and Medical Research Council.
Received: July 28, 2023. Editorial Decision: July 28, 2023. Accepted: July 28, 2023
© The Author(s) 2023. Published by Oxford University Press on behalf of European Society of Endocrinology.
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/
licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For
commercial re-use, please contact journals.permissions@oup.com
G44 European Journal of Endocrinology, 2023, Vol. 189, No. 2
Main results and the role of chance: The evidence in the assessment and management of PCOS has generally improved in the past 5 years but
remains of low to moderate quality. The technical evidence report and analyses (∼6000 pages) underpin 77 evidence-based and 54 consensus
recommendations, with 123 practice points. Key updates include the following: (1) further refinement of individual diagnostic criteria, a simplified
diagnostic algorithm, and inclusion of anti-Müllerian hormone levels as an alternative to ultrasound in adults only; (2) strengthening recognition of
broader features of PCOS including metabolic risk factors, cardiovascular disease, sleep apnoea, very high prevalence of psychological features,
and high risk status for adverse outcomes during pregnancy; (3) emphasizing the poorly recognized, diverse burden of disease and the need for
greater healthcare professional education, evidence-based patient information, improved models of care, and shared decision-making to improve
patient experience, alongside greater research; (4) maintained emphasis on healthy lifestyle, emotional well-being, and quality of life, with
awareness and consideration of weight stigma; and (5) emphasizing evidence-based medical therapy and cheaper and safer fertility management.
Limitations and reasons for caution: Overall, recommendations are strengthened and evidence is improved but remains generally low to moderate
quality. Significantly greater research is now needed in this neglected, yet common condition. Regional health system variation was considered and
acknowledged, with a further process for guideline and translation resource adaptation provided.
Wider implications of the findings: The 2023 International Guideline for the Assessment and Management of PCOS provides clinicians and patients
with clear advice on best practice, based on the best available evidence, expert multidisciplinary input, and consumer preferences. Research
recommendations have been generated, and a comprehensive multifaceted dissemination and translation programme supports the guideline with
an integrated evaluation programme.
What does this mean for those with polycystic societies and organizations, multidisciplinary experts, and pri
ovary syndrome? mary care representatives. This comprehensive evidence-based
Guideline is constructed from a rigorous, Appraisal of
Building on the 2018 International Evidence-Based Guideline Guidelines for Research and Evaluation-II (AGREEII)-
for the Assessment and Management of Polycystic Ovary compliant, evidence-based guideline development process. It
Syndrome (PCOS), this guideline updates and expands clinical provides a single source of international evidence-based rec
questions, aiming to ensure that women with PCOS receive ommendations to guide clinical practice with the opportunity
optimal, evidence-based care that meets their needs and im for adaptation in relevant health systems. Together with an ex
proves health outcomes. The guideline and translation pro tensive translation program, the aim is to reduce worldwide
gramme were developed with full consumer participation at variation in care and promote high quality clinical service pro
all stages including priority topics and outcomes for those vision to improve health outcomes and quality of life in women
with PCOS. The aim is to support women and their healthcare with PCOS. The Guideline is supported by a multifaceted
providers to optimize diagnosis, assessment, and management international translation programme with co-designed resour
of PCOS. There is an emphasis on improved education and ces to enhance the skills of healthcare professionals and to em
awareness of healthcare professionals, partnership in care, power women with PCOS, with an integrated comprehensive
and empowerment of women with PCOS. Personal character evaluation program. Here, we summarize recommendations
istics, preferences, culture, and values are considered, in add from the 2023 International Evidence-based Guideline for
ition to resource availability across different settings. With the Assessment and Management of PCOS.
effective translation, the guideline will address priorities iden
tified by women with PCOS, upskill healthcare professionals,
empower consumers, improve care and outcomes, identify key Materials and methods
research gaps, and promote vital future research.
Best practice evidence-based guideline development methods
were applied and are detailed in the full Guideline and the
technical reports, which are available online (www.monash.
Introduction edu/medicine/mchri/pcos).8 In brief, extensive healthcare pro
Polycystic ovary syndrome (PCOS) is the most common endo fessional and consumer or patient engagement informed the
crinopathy affecting reproductive-aged women, with impacts Guideline priority areas. International society-nominated pan
across the lifespan from adolescence to post menopause. els from across 3 leading entities, 4 partner organizations and
PCOS prevalence is between 10% and 13% as confirmed in 32 collaborating entities included consumers and experts in
the guideline process.1,2 PCOS aetiology is complex; clinical paediatrics, endocrinology, gynaecology, primary care, repro
presentation is heterogeneous with reproductive, metabolic, ductive endocrinology, psychology, dietetics, exercise physi
and psychological features.1,2 Women internationally experi ology, sleep, bariatric/metabolic surgery, public health, other
ence delayed diagnosis and dissatisfaction with care.3-5 co-opted experts, project management, evidence synthesis
Clinical practice in the assessment and management of PCOS re and translation. Governance included an international advis
mains inconsistent, with ongoing key evidence-practice gaps. ory and a management committee, 5 guideline development
Following on from the 2018 International Evidence-based groups (GDGs) with 56 members, and paediatric, consumer,
Guideline for the Assessment and Management of Polycystic and translation committees. The 5 GDGs covered:
Ovary Syndrome,6,7 independently evaluated as high quality, (1) Screening, diagnostic and risk assessment and life stage;
this extensive update integrates current literature with previous (2) Psychological features and models of care; (3) Lifestyle
systematic reviews and extends to new clinical questions priori management; (4) Management of nonfertility features; and
tized by consumers. Ultimately, we aim to update, extend and (5) Assessment and management of infertility. The leading en
translate rigorous, comprehensive evidence-based guidelines tities; the Australian National Health and Medical Research
for diagnosis, assessment and treatment, to improve the lives Council (NHMRC) Centres for Research Excellence in
of those with PCOS worldwide. Women’s Health in Reproductive Life and in Polycystic
To do so, the Guideline leverages substantive government Ovary Syndrome, led by Monash University, partnered with
and society investment and brings together extensive consumer the American Society for Reproductive Medicine, the
engagement and international collaboration with leading Endocrine Society, the European Society of Endocrinology
Teede et al. G45
Table 1. Categories of PCOS guideline recommendations. Table 2. Quality (certainty) of evidence categories (adapted from GRADE).
EBR Evidence-based recommendations: evidence sufficient to inform High ⊕⊕⊕⊕ Very confident that the true effect lies close to
a recommendation made by the guideline development group. that of the estimate of the effect.
CR Consensus recommendations: In the absence of adequate Moderate ⊕⊕⊕◯ Moderate confidence in the effect estimate.
evidence, a consensus recommendation has been made by the The true effect is likely to be close to the
guideline development group, also informed by evidence from estimate of the effect, but there is a
the general population. possibility that it is different.
PP Practice points: Evidence not sought. A practice point has been Low ⊕⊕◯◯ Limited confidence in the effect estimate.
made by the guideline development group where important The true effect may be substantially
issues arose from discussion of evidence-based or consensus different from the estimate of the effect.
recommendations. Very Low ⊕◯◯◯ Very little confidence in the effect estimate.
The true effect is likely to be substantially
PCOS, polycystic ovary syndrome. different from the estimate of the effect.
Table 4. Recommendations for the assessment and management of polycystic ovary syndrome (PCOS). © Monash University on behalf of the NHMRC
Centre for Research Excellence in Women’s Health in Reproductive Life, 2023.
Table 4. Continued
Table 4. Continued
Table 4. Continued
Table 4. Continued
Table 4. Continued
Table 4. Continued
Table 4. Continued
3.6.5 PP Increasing awareness of weight stigma among family members of women and adolescents with PCOS should be
considered.
4 Management of non-fertility features
4.1 Pharmacology treatment principles in PCOS
PP Shared decision-making between the patient (and parent/s or guardian/s, if the patient is a child) and the healthcare
professional is required.
PP An individual’s characteristics, preferences, and values must be elicited and considered when recommending any
intervention alone or in combination.
PP Understanding how individual adults and adolescents value treatment outcomes is essential when prescribing
medications.
PP Medical therapy is generally not approved for use specifically in PCOS, and recommended use is therefore evidence
based, but off-label. Healthcare professionals need to inform adults, adolescents, and their parents/s or guardian/s
and discuss the evidence, possible concerns, and side effects. Regulatory agencies should consider approval of
evidence-based medications for use in PCOS.
4.2 Combined oral contraceptive pills
4.2.1 EBR Combined oral contraceptive pills (COCP) could be recommended in reproductive age adults with PCOS for ❖❖❖
management of hirsutism and/or irregular menstrual cycles. ⊕◯◯◯
(continued)
G54 European Journal of Endocrinology, 2023, Vol. 189, No. 2
Table 4. Continued
Table 4. Continued
4.7 Inositol
4.7.1 EBR Inositol (in any form) could be considered in women with PCOS based on individual preferences and values, noting ❖❖❖
limited harm, potential for improvement in metabolic measures, yet with limited clinical benefits including in ⊕◯◯◯
ovulation, hirsutism, or weight.
4.7.2 EBR Metformin should be considered over inositol for hirsutism and central adiposity, noting that metformin has more ❖❖❖
gastrointestinal side effects than inositol. ⊕◯◯◯
4.7.3 PP Women taking inositol and other complementary therapies are encouraged to advise their healthcare professional.
4.7.4 PP Specific types, doses, or combinations of inositol cannot currently be recommended in adults and adolescents with
PCOS, due to a lack of quality evidence.
4.7.5 PP Shared decision-making should include discussion that regulatory status and quality control of inositol in any form
(like other nutrient supplements) can differ from those for pharmacological products and doses and qualities may
vary.
4.7.6 PP Policy makers and healthcare professionals have a responsibility to ensure women have access to unconflicted,
evidence-based information to inform shared decision-making, whilst also acknowledging and respecting
individual values and preferences, including for complementary therapies.
4.8 Mechanical laser and light therapies for hair reduction
4.8.1 EBR Mechanical laser and light therapies should be considered for reducing facial hirsutism and for related depression, ❖❖❖
anxiety, and quality of life in women with PCOS. ⊕◯◯◯
4.8.2 EBR A greater number of laser treatment sessions may be required in women with PCOS, compared with women with ❖❖❖
idiopathic hirsutism, to achieve hair reduction. ⊕◯◯◯
4.8.3 CR Adverse effects appear limited in the hands of experienced and suitably qualified providers, and women should be ❖❖❖❖
encouraged to seek hair reduction therapies from such providers.
4.8.4 PP Where laser hair removal is prescribed, the following need to be considered:
• Wavelength and delivery of laser treatment vary by skin and hair colour.
• Laser is relatively ineffective in women with blond, grey, or white hair.
• The addition of combined oral contraceptive pills (COCP), with or without anti-androgens, to laser treatment
may provide greater hair reduction and maintenance compared to laser alone.
• Low- and high-fluence lasers appear to have similar efficacy in reducing facial hair, while low-fluence laser has
reduced associated pain.
4.8.5 PP Mechanical hair removal with Intense Pulse Light (IPL) could be considered, albeit benefits may be less pronounced
compared to laser treatment. There is no evidence to support the efficacy of home-based IPL kits.
4.8.6 PP Policy makers should consider funding this evidence-based effective therapy for women with PCOS to alleviate
distressing symptoms of hirsutism and related negative impact on quality of life, body image, and psychological
health.
(continued)
G56 European Journal of Endocrinology, 2023, Vol. 189, No. 2
Table 4. Continued
Table 4. Continued
Table 4. Continued
Table 4. Continued
Figure 1. Algorithm 1—diagnostic algorithm for polycystic ovary syndrome (PCOS). *Exclusion of other causes = TSH, prolactin, 17-OH progesterone,
applying the GRADE framework if justified. The comprehen menstrual cycles and hyperandrogenism are present, diagnosis
sive evidence reviews, profiles, and GRADE frameworks sup is simplified and ultrasound or AMH are not required for diag
porting each recommendation can be found in the Technical nosis. In adolescents, both hyperandrogenism and ovulatory
Report. The administrative report on guideline development, dysfunction are required, with ultrasound and AMH not rec
disclosure of interest process and declarations, peer review ommended due to poor specificity. AMH was highlighted as
feedback and responses can also be found online. Here, we a rapidly evolving area in 2018 and evidence is now strong
present the evidence-based and consensus recommendations enough to make this new recommendation. This will signifi
and practice points (Table 4). This summary, the full cantly change practice and offers women a low cost, conveni
Guideline and technical reports are supported by a compre ent option, without evidence of overdiagnosis.
hensive co-designed translation program to optimize dissem Insulin resistance is recognized as a key feature of PCOS,
ination and impact with resources freely available online yet routinely available measures of insulin resistance are in
(www.monash.edu/medicine/mchri/pcos). accurate and clinical measurement is not currently recom
Two algorithms are provided to support recommendations mended. Once diagnosed, assessment and management
on diagnosis (Figure 1) and infertility management (Figure 2). should address reproductive, metabolic, cardiovascular, der
matologic, sleep, and psychological features. A lifelong
health plan is recommended including a focus on healthy life
Discussion style, prevention of excess weight gain, optimization of fertil
The International Evidence-based Guideline for the Assessment ity and preconception risk factors, and prevention and
and Management of PCOS and the related translation program treatment of diverse clinical features. These include metabol
aims to provide a high quality, reliable source of international ic risk factors, diabetes, cardiovascular disease, and sleep dis
evidence-based recommendations to guide consistent clinical orders, which are all increased in PCOS. PCOS should be
practice and to empower women with evidence-based informa considered a high-risk condition in pregnancy with women
tion. All recommendations were formulated after an assessment identified and monitored. An increased premenopausal risk
of the best available evidence, multidisciplinary clinical expert of endometrial cancer should also be recognized, whilst abso
ise, consumer preferences and structured review by 5 GDGs. lute risks remain low.
The guideline provides 77 evidence-based and 54 consensus rec Symptoms of depression and anxiety are significantly in
ommendations, with 123 practice points underpinned by a creased and should be screened for in all women with
technical report on evidence synthesis and GRADE detailed PCOS, with psychological assessment and therapy as indi
considerations (∼6000 pages). The evidence has generally im cated. Greater awareness of psychological features including
proved over the past 5 years but remains of low to moderate eating disorders and impacts on body image and quality of
quality, requiring significant research investment into this ne life is needed.
glected, yet common condition. Dissatisfaction with PCOS diagnosis and care is high and sig
Key recommendations and updates include that PCOS nificant improvement in education and awareness is strongly
should be diagnosed using the 2018 International Evidence- recommended for women and healthcare professionals includ
based Guideline criteria, which built on the consensus based ing high quality, evidence-based resources. Shared decision-
2003 Rotterdam criteria. This requires the presence of 2 of making and self-empowerment are fundamental and integrated
the following: (1) clinical/biochemical hyperandrogenism; (2) models of care should be codesigned, funded and evaluated.
ovulatory dysfunction; and (3) polycystic ovaries on ultra Supported healthy lifestyle remains vital throughout the life
sound; and here in 2023, alternatively anti-Müllerian hormone span in PCOS, with a strong focus on overall health, prevention
(AMH) can now be used instead of ultrasound. Exclusion of of weight gain and, if required, on weight management.
other aetiologies is needed. Importantly, where irregular Recognizing the benefits of many diet and physical activity
Teede et al. G61
regimens, there is no 1 specific regimen that has benefits over are ineffective or contraindicated. Anti-obesity agents and bari
others in PCOS. Weight bias and stigma should be minimized atric/metabolic surgery may be considered based on general
and healthcare professionals should seek permission to weigh population guidelines, balancing potential for benefits and side
women, with explanation of weight-related risks. effects.
Combined oral contraceptive pills are the first line pharmaco Letrozole is the preferred first line pharmacological infertil
logical treatment for menstrual irregularity and hyperandrogen ity therapy, with clomiphene in combination with metformin;
ism, with no specific recommended preparation and a preference Gonadotrophins or ovarian surgery primarily having a role as
for lower ethinyl estradiol dose preparations and those with less second line therapy. In vitro fertilization (IVF) could be of
side-effects. Metformin is recommended primarily for metabolic fered, potentially with in vitro maturation, as third line ther
features and has greater efficacy than inositol, which offers lim apy, where other ovulation induction therapies have failed
ited clinical benefits in PCOS. Metformin is not routinely recom and in the absence of an absolute indication for IVF in women
mended for use in pregnant women with PCOS. Mechanical with PCOS and anovulatory infertility. Given the underlying
laser therapy is effective for hair reduction in some subgroups, risk for pregnancy complications in PCOS, single embryo
whilst anti-androgens have a limited role where other therapies transfer should be preferred.
G62 European Journal of Endocrinology, 2023, Vol. 189, No. 2
Overall, evidence in PCOS is low to moderate quality. Based Collaborating and engaged societies and consumer groups
on high prevalence and significant health impact, greater pri providing in-kind support include:
ority, education, models of care, funding, and research are rec Androgen Excess and Polycystic Ovary Syndrome Society
ommended. Guideline translation will be extensive including (AEPCOS)
multilingual education outputs and evidence-based resources Asia Pacific Paediatric Endocrine Society (APPES)
for consumers (the ASKPCOS app), healthcare professionals Asia Pacific Initiative on Reproduction (ASPIRE)
and policy makers. Australia and New Zealand Society for Paediatric
The guideline recommendations are protected under copy Endocrinology and Diabetes (ANZSPED)
right, however a clear process for adaption of guideline recom Australian Diabetes Society (ADS)
mendations to regional context is available by contacting the Brazilian Society of Endocrinology and Metabolism
author for correspondence online (www.monash.edu/ (SBEM)
medicine/mchri/pcos). The translation program will be free British Fertility Society (BFS)
and internationally accessible, building on the existing range Canadian Society of Endocrinology and Metabolism
of codesigned resources including the patient focused, (CSEM)
Royal Australasian College of Physicians (RACP) fellowship. The international advisory panel, guideline technical team,
Guideline development group members were volunteers. paediatric, consumer and translation committees, the
Travel expenses were covered by the partnering organizations. Indigenous cultural advisor and the extended early career sup
Conflict of interest: Disclosures of interest were declared at port network who assisted with evidence synthesis, can be
the outset and updated throughout the guideline process, found online (www.monash.edu/medicine/mchri/pcos).
aligned with National Health Medical Research Council
(NHMRC) guideline processes. These are available online Guideline development members and key
(www.monash.edu/medicine/mchri/pcos). Of named authors contributors (in addition to listed authors)
H.J.T., C.T.T., A.D., L.M., L.R., J. Boyle, and A.M. have no Wiebke Arlt, University of Birmingham, UK
conflicts of interest to declare. J.L. declares grant from Ricardo Azziz, University of Alabama at Birmingham, USA
Ferring and Merck; consulting fees from Ferring and Titus Adam Balen, Leeds Teaching Hospital; British Fertility
Health Care; speaker’s fees from Ferring; unpaid consultancy Society, UK
for Ferring, Roche Diagnostics and Ansh Labs; and sits on ad Lisa Bedson, Repromed, Australia
visory boards for Ferring, Roche Diagnostics, Ansh Labs, and Lorna Berry, Polycystic Ovary Syndrome Association of
Duru Shah, PCOS Society of India; Centre for Women’s metabolic manifestations that impacts on health across the
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