PCOS Phenotype in Unselected Populations Study (P-PUP): Protocol for a Systematic Review and Defining PCOS Diagnostic Features with Pooled Individual Participant Data
Sylvia Kiconco,
Aya Mousa,
Ricardo Azziz,
Joanne Enticott,
Larisa V. Suturina,
Xiaomiao Zhao,
Alessandra Gambineri,
Fahimeh Ramezani Tehrani,
Bulent O. Yildiz,
Jin-Ju Kim,
Helena J. Teede,
Anju E. Joham
Affiliations
Sylvia Kiconco
Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, VIC 3800, Australia
Aya Mousa
Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, VIC 3800, Australia
Ricardo Azziz
Departments of Obstetrics, Gynaecology and Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, AL 35294, USA
Joanne Enticott
Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, VIC 3800, Australia
Larisa V. Suturina
Department of Reproductive Health Protection, Scientific Center for Family Health and Human Reproduction, 664003 Irkutsk, Russia
Xiaomiao Zhao
Reproductive Endocrinology and Infertility Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Yanjiang Road 107, Guangzhou 510120, China
Alessandra Gambineri
Department of Medical and Surgical Science, University of Bologna, 40138 Bologna, Italy
Fahimeh Ramezani Tehrani
Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran P.O. Box 19395-4763, Iran
Bulent O. Yildiz
Division of Endocrinology and Metabolism, Hacettepe University of Medicine, Ankara 06100, Turkey
Jin-Ju Kim
Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, Healthcare System Gangnam Center, Seoul National University Hospital, Seoul 03080, Korea
Helena J. Teede
Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, VIC 3800, Australia
Anju E. Joham
Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, VIC 3800, Australia
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.
