Methods: A structured literature search of Medline, Embase, and the Cochrane Library (accessed in September 2015)<br>was conducted using pre-defined search terms. The identified publications were reviewed applying eligibility criteria to<br>select interventional female infertility studies using PROs. Infertility-specific PRO measures assessing QoL, treatment<br>satisfaction or psychiatric health, and included in studies by ≥2 research groups were selected and critically reviewed<br>in light of scientific and regulatory guidance (e.g. FDA PRO Guidance for Industry) for evidence of content validity,<br>psychometric strength, and patient acceptability.
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