Abstract
The diagnosis of polycystic ovary syndrome (PCOS) remains challenging due to limited data regarding normative cut-offs for the diagnostic features in different subpopulations. We aim to conduct a systematic review, build a comprehensive repository of de-identified individual participant data (IPD), and define normative ranges and diagnostic cut-offs for all PCOS diagnostic features. We will conduct a systematic search of MEDLINE and EMBASE databases for studies that assessed PCOS diagnostic features in unselected women. Two reviewers will assess eligibility and perform quality appraisal. Authors of included studies will be invited to contribute IPD. Primary variables include directly assessed modified Ferriman Gallwey (mFG) scores; menstrual cycle lengths; follicle number per ovary (FNPO), ovarian volume (OV), anti-Müllerian hormone (AMH); circulating androgens, including total testosterone (TT), free testosterone, bioavailable testosterone, free androgen index (FAI), androstenedione (A4), and dehydroepiandrosterone sulphate (DHEAS). Normative ranges and cut-offs will be defined using cluster analysis. Monash University Human Research Ethics Committee granted ethical approval (26938/0 1/12/2020), all IPD will be de-identified and primary studies have ethical approval from their institutional ethics committees. Findings will clarify distinction between PCOS and non-PCOS populations, and inform the update of the international evidence-based guidelines for the assessment and management of PCOS.
Highlights
Polycystic ovary syndrome (PCOS) is a complex endocrine disorder affecting 8%to 13% of reproductive-aged women globally [1], making it a key public health burden.Women with polycystic ovary syndrome (PCOS) are at an increased risk of adverse reproductive, metabolic, psychological, oncological, pregnancy, and long-term offspring metabolic and developmental disorders, which impair their quality of life [2,3] in addition to straining health and economic resources [4]
The current international evidence-based guidelines for PCOS diagnosis and management [8,9] recommend the use of the 2003 Rotterdam criteria [10], which require the presence of any two of these features: (a) oligo-ovulation and/or anovulation, (b) biochemical or clinical hyperandrogenism, and (c) PCOM
This makes it difficult to distinguish between women with PCOS and those without, due to overlapping features
Summary
To 13% of reproductive-aged women globally [1], making it a key public health burden. The diagnosis of PCOS can be complicated by several factors including the current challenges in defining individual clinical features within the diagnostic criteria; clinical heterogeneity resulting in various phenotypes; ethnic differences, and variations in clinical features across the life course. Notwithstanding, the majority of studies in PCOS use summary measures such as means and standard deviations or arbitrary percentiles to define cut-off values for abnormal or normal ranges These measures limit understanding of the individual inherent features of PCOS. It is crucial to determine populationspecific normative ranges for each of the PCOS diagnostic features in order to standardize the differences between women with and without PCOS across regionally distinct populations This protocol describes the methodological approach by which we will collect and analyze international multi-ethnic data from well-characterized unselected (medically unbiased) populations of women to define normative cut-offs for menstrual cyclicity, clinical and biochemical hyperandrogenism, and ovarian morphology. Establishing association between PCOS diagnostic criteria and the outcomes as per the PCOS outcomes set is crucial in identification of individuals at risk and the need for monitoring
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