Abstract
BackgroundControlled Ovarian Stimulation (COS) is the first step for in vitro fertilization (IVF) treatment, a treatment often described and experienced as stressful to patients and their partners. COS also requires concerted efforts by the patients in administering medication and general compliance to treatment protocols. Little is known about the impacts on patients that may be specific to this important first step in treatment. The absence of a conceptually sound and well-validated measure assessing patient experience and functioning during ovarian stimulation has been an obstacle to understanding the impacts of ovarian stimulation on women pursuing IVF. To address this gap, the Controlled Ovarian Stimulation Impact Measure (COSI) was developed based upon accepted methods for designing patient reported outcome (PRO) measures. The purpose of this study was to psychometrically validate the COSI.Methods267 patients from three countries (Ireland, United Kingdom, United States) were administered the COSI. Psychometric validation was conducted according to an a priori statistical analysis plan.ResultsThe final 28-item COSI was found to have robust scale structure with four domains: Interference in Daily Life (Work and Home), Injection Burden, Psychological Health and Compliance Worry. Internal consistency of all domains was adequate (between 0.80 to 0.87) as was test-retest reliability (between 0.72-0.87). All a-priori hypotheses for convergent and known-groups validity tests were met.ConclusionsThere is a measurable impact of COS on patient functioning and well-being. The COSI is a well-developed and validated PRO measure of this impact. Future work should include examination of responsiveness and confirmation of concepts in non-western countries.
Highlights
Controlled Ovarian Stimulation (COS) is the first step for in vitro fertilization (IVF) treatment, a treatment often described and experienced as stressful to patients and their partners
Women receiving Controlled Ovarian Stimulation (COS) for IVF and/or intracytoplasmic sperm injection (ICSI) treatment were enrolled in the study
All eligible women who had appointments to proceed to human chorionic gonadotrophin administration as part of their treatment were consecutively asked to participate in the study
Summary
Controlled Ovarian Stimulation (COS) is the first step for in vitro fertilization (IVF) treatment, a treatment often described and experienced as stressful to patients and their partners. There is some evidence that infertility-related stress, anxiety, and depressive symptoms may negatively affect infertility treatment outcome [15,16,17,18,19], there are conflicting results in this research area [20] Despite these reports, little attention has been given to discrete procedures within the IVF treatment process and impacts on patients that may be specific to these procedures and treatment phases. This study demonstrated that the frequent injection and monitoring associated with COS contributed to the burden specific to COS, impacting psychological and daily functioning Despite this one study, little is known about the specific extent and burden of COS impacts on women pursuing IVF as currently the only validated measure of the impact of fertility problems on quality of life is the FertiQoL. The FertiQoL does not focus on the impact of COS and no COS treatment specific patient reported outcome measure (PRO) of the impacts has been available
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