OBJECTIVES: Previous research has shown that generic patient-reported outcome (PRO) measures underestimate the impact of polycystic ovary syndrome (PCOS) on quality of life (QoL). Following recent regulatory guidance, our review aimed to identify PCOS-specific QoL measures and establish whether their development history and measurement properties support their use in clinical trials. METHODS: A systematic search of MEDLINE and PsycINFO was conducted using terms synonymous with “PCOS” in combination with terms associated with “QoL” to identify PCOS-specific QoL measures completed by the patient. Articles were included if written in the English language and published since 1998. Following identification of measures, further searches were undertaken using the questionnaire name and abbreviation to explore its use, development history and demonstrated measurement properties. RESULTS: Sixty-five abstracts were identified and screened. Of these, 19 reported quantitative studies using a variety of PRO questionnaires (most commonly the SF-36). Only one PCOS-specific QoL questionnaire was identified: the PolyCystic Ovary Syndrome Questionnaire (PCOSQ). A search for use of the PCOSQ since its development publication (1998) returned ten papers, which were included in our review. The PCOSQ’s development history (including conceptual and endpoint models) is inadequate, with recent studies indicating that the PCOSQ does not have good content validity, e.g. the impact of acne on QoL is notably missing. The PCOSQ subscales demonstrate acceptable levels of reliability (0.54-0.93) and partial known-groups validity (p<0.05 between treatment and placebo groups on three of the five PCOSQ domains) as well as convergent/divergent validity with other PRO instruments. Responsiveness to change has been variable and minimally important differences (MIDs) have not been established. CONCLUSIONS: The PCOSQ has dominated research relating to the impact of PCOS on QoL. However, in order to fulfil current regulatory requirements, additional research is required to ensure its comprehensibility and sensitivity prior to including the PCOSQ in a clinical trial programme.