OBJECTIVES:  Infertility has a negative impact on quality of life (QoL) and well-being of affected individuals and couples. This review aimed to a) identify patient-reported outcome (PRO) measures used in infertility interventional studies and b) assess validation evidence to identify a reliable, valid PRO to measure changes in QoL or treatment satisfaction in clinical studies with female subjects following treatment with novel therapies. METHODS:  A structured literature search of Medline, Embase, and the Cochrane Library (accessed September 2015) was conducted using pre-defined search terms. Articles were reviewed against eligibility criteria to identify interventional female infertility studies using PROs. PROs developed to assess infertility-related QoL, treatment satisfaction, or psychiatric health; and included in studies by at least 2 research groups were selected and critically reviewed against scientific and regulatory guidance (e.g. FDA PRO Guidance for Industry) for evidence of content validity, psychometric strength, and patient acceptability. RESULTS:  The literature search and hand-searching yielded 112 publications; 78 unique PROs used to assess treatment satisfaction, QoL, or psychiatric health were identified. Eligibility criteria were applied to identify five key PROs for review: FertiQoL, Fertility Problem Inventory (FPI), Fertility Problem Stress (FPS), Illness Cognitions Questionnaire adapted for Infertility (ICQ-Infertility), and Infertility Questionnaire (IFQ). No single PRO met all criteria for validation. The FertiQoL was the most widely used QoL assessment in interventional infertility studies with reasonable evidence for content validity, psychometric strength, and linguistic validation. Gaps in evidence remain including test-retest reliability and thresholds for interpreting clinically important changes. The FPI demonstrated reasonable evidence for content and psychometric validity, however, utility as an outcome measure is limited by a lack of recall period. CONCLUSIONS:  The FertiQoL is a potentially useful assessment of infertility-related QoL in interventional studies. Additional research is recommended to address evidence gaps and confirm the FertiQoL as a stable assessment of patient outcomes.