Randomized control trial of a decision aid for women considering elective egg freezing: The Eggsurance study protocol

Abstract

Background: Uptake of elective egg freezing has increased globally. The decision to freeze eggs is complex, and detailed, unbiased information is needed. To address this, we developed an online Decision Aid for women considering elective egg freezing. Decision Aids are the standard of care to support complex health decisions. Objectives: This study will measure the impact of the Decision Aid on decision-making (e.g. decisional conflict, engagement in decision-making, distress, and decision delay) and decision quality (e.g. knowledge, level of informed choice, and regret). Methods and Analysis: A single-blinded two-arm parallel-group randomized controlled trial. Women considering elective egg freezing will be recruited using social media, newsletters, and fertility clinics. Data will be collected at baseline (recruitment), 6-month, and 12-month post-randomization. The primary hypothesis is that the intervention (Decision Aid plus Victorian Assisted Reproductive Technology Authority website) will reduce decisional conflict (measured using the Decisional Conflict Scale) at 12 months more than control (Victorian Assisted Reproductive Technology Authority website only). Secondary outcomes include engagement in decision-making (Perceived Involvement in Care Scale), distress (Depression, Anxiety, and Stress Scale), decision delay, knowledge, informed choice (Multi-dimensional Measure of Informed Choice), and decisional regret (Decisional Regret Scale). Ethics: The study was approved by the University of Melbourne Human Research Ethics Committee (Ethics ID: 2056457). Informed consent will be obtained from all participants prior to enrolment. Discussion: This is the first international randomized controlled trial that aims to investigate the effect of an elective egg freezing Decision Aid on decision-related outcomes (e.g. decisional conflict, informed choice, and regret). It is anticipated that participants who receive the Decision Aid will have better decision and health outcomes. Registration details: ACTRN12620001032943: Comparing different information resources on the process and quality of decision-making in women considering elective egg freezing.

Eggsurance? A randomized controlled trial of a decision aid for elective egg freezing

“…Study measures are detailed in our protocol ( Peate et al , 2022 ) and pre-specified statistical analysis plan ( Supplementary Data File S1 ).…”

“…These measures were related to the decision-making process or decision quality at 12 months. Their psychometric properties (where applicable) are included in the study protocol ( Peate et al , 2022 ). Process-related items were: level of distress (Depression, Anxiety and Stress Scale, DASS-21 ( Lovibond and Lovibond, 1995 )), and whether a decision was made about EEF.…”

“…The protocol for this study is published elsewhere ( Peate et al , 2022 ) and was approved by the University of Melbourne Human Research Ethics Committee (2056457). All methods performed followed applicable regulations and guidelines.…”

Outcomes of Social Egg Freezing: A Cohort Study and a Comprehensive Literature Review

“…In the UK, a 460% increase in oocyte cryopreservation cycles has been reported between 2010 and 2016 [2]. Similarly, an 880% and a 507% increase between 2010 and 2015 have been reported in the USA and Australia and New Zealand, respectively [3,4]. Advancements in cryopreservation techniques, particularly oocyte vitrification (or ultra-rapid freezing) in last decade, have led to remarkable improvements in the efficacy of oocyte cryopreservation, post-thaw oocyte survival, fertilisation, and pregnancy rates, and therefore broad acceptability and applicability of this reproductive option [1,5].…”

“…They concluded there is disconnect between providers and patients in their views on how to navigate decision making, and these should be addressed to improve shared decision making [ 11 ]. To help women with this decision process, a decision aid tool has been developed that aims to investigate the effects of an elective egg freezing decision aid on decision-related outcomes (e.g., decisional conflict, informed choice, and regret), expecting better and satisfactory decisions by women [ 4 ]. Studies also evaluated reproductive intentions and actions after oocyte cryopreservation [ 12 ].…”