Background

The average maternal age at first birth has increased in many high-income countries [1], and more women are attempting to conceive when their fertility is declining [2, 3]. Elective egg freezing (egg freezing) is an increasingly popular option for women seeking to extend their fertile years [4, 5]. The main reason women freeze their eggs is the absence of a partner to co-parent with [6]. Other reasons include feeling pressure from their ‘biological clock’, to insure against future infertility, and to avoid potential regret if they are unable to conceive in the future [6].

Egg freezing may provide women with more time to achieve their reproductive goals and reduce the risk of aneuploidies and birth abnormalities associated with older eggs [7, 8]. However, for women who contemplate egg freezing, the decision is complex and involves many considerations. Firstly, the costs for egg freezing are substantial and often unaffordable [9]. Secondly, as women age, the number and quality of eggs they produce in response to hormone stimulation decreases, reducing their chances of a live birth from frozen eggs in the future [10]. For example, a study from the United States found that the number of frozen eggs that needed to be thawed to achieve one live birth increased from 41 for women aged < 35 years at egg collection to 122 for women aged > 41 years [10]. There are also serious but rare health risks associated with egg freezing procedures, including bleeding, infection, and other complications (reported in 0.1%, 0.01%, and 0.04% of cycles respectively) [11]. In addition, children born from frozen eggs appear healthy at birth [12], although their long-term health outcomes are unknown. Reassuringly, a six-year follow-up study of children born from frozen eggs found that their physical and mental development was comparable to naturally conceived children [13]. When considering egg freezing, women also need to know that there are many reasons for why they may not need or wish to use their stored eggs in the future. A 10–15 year follow up study reported that only 38% of women who had stored their eggs returned to use them [14]. Whilst some women conceive without needing their frozen eggs [15,16,17], many others do not use them because they lack a partner to co-parent with and do not wish to be a single parent [16,17,18]. Hence, women need to consider the value of egg freezing compared to its alternatives (e.g. embryo freezing; attempting conception naturally or with other assisted reproductive techniques; adoption; fostering; and living without children).

There is a small yet growing body of evidence highlighting the need for better egg freezing decision support. A South Korean study of women who attended egg freezing counselling at a fertility clinic reported high decisional conflict (a measure of decision uncertainty) in almost half (n = 40) their participants which was associated with older age (> 37 years) [19]. Another Canadian study found that almost one third of egg freezing patients (n = 26) found the decision difficult to make [20]. Decision regret is generally low amongst women who freeze their eggs [20,21,22], however, receiving inadequate information and support at the time of egg freezing is associated with a higher risk of regret [21]. A Decision Aid for egg freezing may help to address this need for better decision support.

Decision Aids are used for complex health decisions [23, 24], where there is more than one reasonable option to choose from, each with their own pros and cons, and a person's values determine which option is most suitable for them [25]. Decision Aids aim to inform users of their options, help clarify personal values, and facilitate discussions with healthcare providers [25]. Compared to standard care alone, Decision Aids improve knowledge, accuracy of risk perception, decision engagement, and alignment with personal values [24]. They also reduce decisional conflict [24] which may result in faster decision-making, higher satisfaction, and less decision regret [26]. Egg freezing clearly meets the criteria for a complex health decision which may benefit from a Decision Aid.

The primary aim of this study was to develop a Decision Aid for elective egg freezing, and in preparation for a randomised control trial, conduct a phase 1 study to assess its acceptability for decision-making. The study’s secondary aim was to evaluate the utility of the Decision Aid in reducing decisional conflict and improving knowledge of egg freezing and age-related infertility.

Decision Aid development

A collaborative group was formed with: a psychologist; a gynaecologist; a clinical researcher; a statistician; a female fertility specialist; three consumer representatives; five specialists in reproductive endocrinology and infertility; two specialists in fertility preservation decision-making, two in women’s health, and two in public education.

The Decision Aid website ‘Egg Freezing’ (version dated: June 2018), was developed using the International Patient Decision Aid Standards (IPDAS) and Ottawa Decision Support frameworks [25, 27]. Its design was adapted from existing fertility preservation Decision Aids [28, 29]. Content was developed using an iterative process: (1) The Decision Aid was drafted by SS and MP. Decisional needs were ascertained from: existing literature; anonymous counselling note summaries for 10 women considering egg freezing; free-text survey responses from 70 women about their experience with egg freezing (Fisher J, unpublished); and a survey of 20 women who attended an egg freezing information seminar (Peate M, unpublished). Both unpublished surveys received ethics approval before commencement. (2) Collaborators were emailed the draft Decision Aid to assess for clinical and consumer relevance. Contentious issues arising from the review were discussed by the group via email and final decisions were made by MP. Also, five consumers (three of whom were part of the collaborative group) were interviewed by SS for feedback about Decision Aid. Two of the consumers had previously frozen their eggs and three were contemplating egg freezing at the time. (3) Consumer and collaborator feedback was collated into a master Decision Aid document by SS. Several updates were made before the content was finalised and transferred to the website (Fig. 1).

Fig. 1
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Decision Aid development process

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The Decision Aid describes the decision in focus (whether to freeze eggs), the health exposure (age-related infertility), and other lifestyle factors impacting female fertility. Information covers the pros, cons, and implications of egg freezing, and its alternatives (Fig. 2). Content is written at an 8th grade reading level. Information is communicated with text, infographics and video animations. A hover-over definition function is used to explain medical terms. Live birth rates using in vitro fertilization with frozen eggs [30,31,32,33,34,35,36], frozen embryos [37,38,39,40,41], and fresh eggs [38,39,40,41] are described similarly to allow for direct comparisons to be made between the three options. There is also a question prompt list to aid communication with fertility specialists and/or clinics. References for the information provided in the Decision Aid are included in text and in a separate reference list. The Decision Aid also includes an explicit values clarification exercise with a novel feedback feature to guide user deliberation [42]. The exercise asks users eight questions about the pros and cons of egg freezing. Their responses are scored and displayed on a scale showing if they are leaning towards or away from egg freezing. Specifically, users are asked to rate the importance of four egg freezing pros (response options: ‘not really’ = 0, ‘somewhat’ = 1 and ‘very’ = 2) (Fig. 3a), and concern felt about four egg freezing cons (response options: ‘it doesn’t’ = 0, ‘a bit’ = -1 and ‘a lot’ = -2) (Fig. 3b). Scores from the eight questions are averaged and displayed on the scale (Fig. 3c). Free-text boxes are included after each question set for users to include any additional factors of importance or concern to them. A final question asks users if they agree with their results (yes/no). Three members of the research team conducted user testing to assess the accuracy of the feedback algorithm prior to this study.

Fig. 2
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Summary of the Decision Aid content

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Fig. 3
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Examples from the values clarification exercise. A Example question about the pros of egg freezing. Other pros participants are asked to rate are: ‘doing something about your fertility now rather than later’, ‘being able to look back and know that you tried to increase your chances of having a baby’, and ‘having a child who is blood related to you’. B. Example question about the cons of egg freezing. Other cons participants are asked to rate are: ‘egg freezing might be a difficult procedure to go through (e.g. because of time off work and possible side effects)’, ‘egg freezing is expensive (I’m worried that it is not worth the cost or that I cannot afford it)’, and ‘most frozen eggs are never used (I’m worried that it will be a wasted procedure or that I will need to dispose of my eggs)’. C Example result from the values clarification exercise. The placement of ‘Your answers’ on the scale is determined by the average score from the pros and cons question sets. The standard deviation is represented by the colour gradient and is intended to illustrate the variability in responses

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Methods

Design & setting

An online pre/post Decision Aid survey study in a community setting.

Participants

Participants were women living in Australia, aged 18–45 years, interested in receiving egg freezing information, with English language proficiency, and access to the internet. Women who had already completed their family or frozen eggs for medical reasons were excluded. We recruited women interested in receiving egg freezing information with the intention of gathering feedback about the Decision Aid from users at different stages of the decision-making trajectory (e.g. before: not previously considered egg freezing; during: actively considering egg freezing, and; after: made their decision).

Study procedures

Recruitment and pre Decision Aid survey

Participants were recruited June-December 2018, from the University of Melbourne staff newsletter, and paid Facebook advertising targeting females aged 18–45 years in Australia. We recruited participants for two studies at once. Those involved in our first study, a cross-sectional survey about egg freezing information and decision support needs [43], could then go on to participate in this study as well.

All study advertisements contained a link to the online participant information and consent form which detailed information about both studies. After providing informed consent, participants were immediately directed to complete the first study’s survey and indicate their interest in evaluating the Decision Aid. Those who were interested to take part were contacted consecutively based on their survey completion order up until the sample size target was reached. Participants’ pre-Decision Aid data used in this study (demographics, knowledge and decisional conflict) were obtained from their first study survey responses (Fig. 4).

Fig. 4
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Overview of participant recruitment and study completion. *Pre-Decision Aid data were obtained from participants’ first study survey responses

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Decision Aid dissemination and follow up procedures

Participants were emailed a link to the Decision Aid website and asked to read the content and complete the values clarification exercise. Two weeks later, they were emailed a link to their follow up survey. Up to three attempts were made to contact participants who had not completed their follow up survey (Fig. 4).

Data source

Survey content was informed by the clinical and research expertise of the authors, and a review of the existing literature including similar Decision Aid studies [29, 42, 44, 45].

Study measures

Pre-Decision Aid measures

  1. (a)

    Participant Characteristics: Demographics, stage of decision-making (multiple responses from a list), and whether they had consulted an in vitro fertilization specialist (yes/no).

Post-Decision Aid measures

  1. (a)

    Decision Aid Use: Time spent using the Decision Aid, amount of content read, and if participants shared the tool with others (Additional file 1: Appendix 1).

  2. (b)

    Acceptability: These measures were adapted from other Decision Aid evaluation studies [29, 44]. Eleven items assessed perceptions of the amount and clarity of information provided in the Decision Aid; how well the Decision Aid presented information; its utility, visual appeal, and readability; helpfulness of the Decision Aid in explaining options for future parenthood and for making egg freezing decisions; and satisfaction with the information provided, order of topics, and the Decision Aid overall. To quantify acceptability across these measures, we assigned ‘pass’/‘fail’ responses to each question (Table 3). ‘Pass’ responses scored one point and ‘fail’ responses scored none. Total scores equalled the sum of ‘pass’ responses (range: 0–11). Scores > 6 were deemed to indicate overall acceptability of the Decision Aid (Additional file 1: Appendix 1).

  3. (c)

    Recommendations: Whether participants would recommend the Decision Aid to other women considering egg freezing (Additional file 1: Appendix 1).

  4. (d)

    Content: Whether the information in the Decision Aid should be more detailed, parts could be removed, and if anything was confusing. Perceptions of information balance; the level of guidance provided; what information women should be given about egg freezing; the Decision Aid’s take-home message; and any other feedback were also obtained (Additional file 1: Appendix 1).

  5. (e)

    Design and Format: Perceptions of the website’s font size and colour palette, preferences for a different information delivery format, what participants liked about the website, and suggestions for improvement (Additional file 1: Appendix 1).

  6. (f)

    Emotional Impact: One item adapted from other Decision Aid studies asked about worry or concern raised by the Decision Aid content [28, 46]. We categorised responses of ‘very much so’ as a serious concern. Another study-specific item asked about worry or shame felt from the information in the Decision Aid relating to female age-related infertility (Additional file 1: Appendix 1).

  7. (g)

    Perceived Improvement in Knowledge: Perceptions of the amount of new information received, and whether the Decision Aid improved knowledge of egg freezing, other options for future parenthood, and their respective pros and cons (Additional file 1: Appendix 1).

  8. (h)

    Values Clarification Exercise: Completion of the values clarification exercise, usefulness of the exercise, if any additional pros or cons should be included, suggestions for improvements, and any other feedback (Additional file 1: Appendix 1). Data exported from the Decision Aid website measured participants’ completion of the activity, agreement with their result (yes/no/unsure), and the number of additional pros or cons added when completing the exercise.

  9. (i)

    Timing of Information Delivery: Perceptions of when women should be provided with egg freezing information (Additional file 1: Appendix 1).

Pre- and post-Decision Aid measures

  1. (a)

    Decisional Conflict: The 10-item low literacy Decisional Conflict Scale (Additional file 1: Appendix 1) assessed participants’ decisional conflict about egg freezing [26]. The measure is shown to have good reliability (α > 0.80), validity [26, 47], and can be used before, during and after decision-making [48]. Total scores were calculated using the Decisional Conflict Scale user manual (range: 0–100) [26]. Higher scores indicate greater decisional conflict. Scores > 37.5 are classified as high [26].

  2. (b)

    Knowledge: Fourteen purposively developed true/false questions assessed participants’ general understanding of egg freezing and age-related infertility (Additional file 1: Appendix 1). Correct responses scored one point. Total knowledge scores were calculated as the sum of correct responses (range: 0–14).

Sample size

Target sample size was 30 participants as suggested for phase 1 studies [49, 50]. Given published data from similar studies show that 15–25 participants are sufficient to evaluate Decision Aids [28, 44, 46, 51], this target was considered adequate.

Data management and statistical analysis

All consent and survey data were collected using REDCap electronic data capture tools hosted by the University of Melbourne [52, 53]. Values clarification data were exported from the Decision Aid website.

Continuous data were summarised as means with standard deviations if normally distributed, or medians with interquartile ranges (IQR) if skewed. Categorical data were described as counts with proportions. Decision Aid utility was examined by comparing knowledge and Decisional Conflict Scale scores pre- and post-Decision Aid review using the Wilcox signed-rank test. The analyses included participants with results at both timepoints.

Free-text comments were analysed thematically. SS coded the comments into themes by identifying key words, concepts and reflections as per the Miles & Huberman framework [54]. The comments and their corresponding themes were subsequently reviewed and verified by MP. Illustrative quotes are provided to give context to the quantitative data.

All quantitative survey data were analysed using Stata (v15.1) [55]. Free-text survey responses and data exported from the values clarification exercise were analysed using Microsoft Excel.

Results

Overall, 115/290 women who completed the first study’s survey expressed interest in evaluating the Decision Aid and provided their contact details. Assuming a 70% uptake rate, we contacted the first 42 participants. Thirty-six confirmed their interest to take part and were given access to the tool. Twenty-six participants completed the post-Decision Aid survey (Fig. 4).

Participant characteristics

Median age was 35 years (IQR: 29, 38). Most participants had completed (or were completing) university qualifications, worked full-time in professional occupations, and were childless. Five (19%) participants had consulted an in-vitro fertilization specialist about egg freezing. Half were single, and most were considering egg freezing at the time of reviewing the Decision Aid (Table 1).

Table 1 Participant characteristics
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Decision Aid use

The majority of participants read most to all of the Decision Aid content, spending about 30 min to 1 h (Table 2).

Table 2 Decision Aid outcome measures
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Acceptability

For most acceptability measures, almost all (88–100%) participants provided a ‘pass’ response. Fewer (69%) found the Decision Aid helpful for reaching an egg freezing decision. It was commonly felt that additional decision support was still needed by those who reported the tool unsatisfactory for decision making (Table 4). Median total acceptability score was 11 (IQR: 10-11). Almost all participants found the Decision Aid acceptable overall (Table 3).

Table 3 Acceptability of the Decision Aid (n, %)
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Recommendations

Most participants would recommend the Decision Aid to others considering egg freezing (Table 2).

Content

Participants generally believed the Decision Aid content was balanced, and almost all liked the level of guidance it provided. Most felt that the information was easy to understand and wanted it all retained. Some wanted more information included for example, about egg freezing costs and alternatives (Table 2). Participants commonly thought the Decision Aid’s take-home messages were: ‘egg freezing is a personal decision’, ‘egg freezing is a complex decision’, and ‘egg freezing has alternatives’ (Table 4). When asked what egg freezing information women should be provided, many reported that the information in the Decision Aid addressed their needs. Others suggested information about egg freezing costs, success rates and procedures. Suggestions for improvement included having personal stories from women who had considered or used egg freezing.

Table 4 Quotes illustrating the key themes derived from participants’ free-text comments
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Design and format

Participants generally liked the website’s font, colors, and format. Some wanted additional videos incorporated into the design (Table 4). Suggestions for improvement were updating the website design and changing the animation voice-overs for better engagement.

Emotional impact

Overall, the Decision Aid did not raise any serious worry or concern for participants. However, over half reported feeling some concern, which commonly related to the information about egg freezing costs, health risks, and the uncertainty of outcomes (Table 4). Over half the participants also felt some concern from the information about female age-related infertility, particularly about reduced success rates with age and feeling an urgency to decide about egg freezing (Table 2).

Values clarification exercise

From the website data export, 24 participants started the values clarification exercise, nine added in their own pros or cons, and 19 finished the activity. Most participants completing the exercise agreed with their automated result, and found it helpful. Few found the exercise unhelpful for decision-making (Table 2). No additional pros or cons were suggested to include in the question sets.

Timing of information delivery

Most participants believed women should receive egg freezing information early in the consideration process (Table 4).

Perceived improvement in knowledge

Most participants perceived an improvement in their understanding of egg freezing, its alternatives, and their respective pros and cons. Almost all reported that at least some of the information in the Decision Aid was new to them (Table 2).

Utility of the Decision Aid (knowledge and decisional conflict)

Participants’ knowledge scores increased by a median of 3 points (IQR: 0-4) post-Decision Aid review. Median knowledge scale score was 8.5/14 (IQR: 7-11) pre-Decision Aid and 11/14 (IQR: 10-12) (p = 0.01) post-Decision Aid review (Fig. 5). Participants’ Decisional Conflict Scale scores decreased by a median of 50 points (IQR: -65--5) post-Decision Aid review. Median Decisional Conflict Scale score was 65/100 (IQR: 45-80) pre-Decision Aid and 7.5/100 (IQR: 0-37.5) post-Decision Aid review (p < 0.001) (Fig. 6).

Fig. 5
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Distribution of knowledge scores pre and post-Decision Aid review. Sample sizes: Pre-Decision Aid (n = 26) and post-Decision Aid (n = 25). Twenty-five participants had knowledge scores at both timepoints

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Fig. 6
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Distribution of Decisional Conflict Scale Scores pre and post-Decision Aid review. Sample sizes: Pre-Decision Aid (n = 25) and post-Decision Aid (n = 24). Twenty-three participants had Decisional Conflict Scale scores measured at both timepoints

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Discussion

This study reports on the development and phase 1 evaluation of an online Decision Aid for elective egg freezing. Participants reported that the tool was useful, acceptable and that they would recommend it to others considering egg freezing. Further evaluation of the Decision Aid is intended using a randomised control trial.

The Decision Aid was well received by most participants. This may reflect using existing frameworks to guide the Decision Aid’s content and design [25, 27]. Also, online formats are preferred by women seeking information about egg freezing and fertility [56,57,58].

Most questions relating to the acceptability of the Decision Aid were scored positively by almost all participants, however, fewer women found the Decision Aid as helpful for reaching an egg freezing decision. Traditionally, Decision Aids are used to supplement clinician advice [24] and support shared decision-making [59]. In the context of egg freezing, information such as individualized success rates and costs [60] can only be provided with clinical input. Although the Decision Aid provides estimates of this information, it refers users to healthcare practitioners for personalized advice. This may explain why fewer respondents endorsed that the Decision Aid was useful in helping to reach an egg freezing decision. Women who decide to clinically pursue egg freezing will require specialist counselling to achieve informed consent and facilitate treatment. If implemented, the Decision Aid may help women decide whether to engage with a fertility specialist for personalized advice, and for those who do, it may be used to complement the clinical information received.

While no serious worry or concern was raised from the Decision Aid, more than half the participants reported some distress from the content, including the information about female age-related infertility and its impact on success rates. This was in turn driving a sense of urgency to decide about egg freezing. Participants were typically in their mid-30 s, coinciding with the beginning of fertility decline [61]. Improving egg freezing and fertility awareness at younger ages may help to alleviate some of the time pressure felt and allow for earlier reproductive planning [56, 62,63,64]. However, even women at younger ages may still find information about the female age-related infertility concerning [65, 66].

Most participants who completed the values clarification exercise agreed with their automated result and considered the task useful to some extent. However, less than a third found the activity very or extremely helpful. This is consistent with previous research suggesting that the effectiveness of values clarification exercises varies amongst individuals and information alone may be sufficient [67]. Also, some participants added in their own pros or cons when completing the activity. These were not scored or included in the feedback algorithm, which may have reduced the utility of the output. The exercise has now been updated to allow users to rate the importance/concern felt about any additional pros or cons they include which is subsequently incorporated into their feedback result.

Participants suggested adding personal stories to the Decision Aid that illustrate the experiences of women considering and undertaking egg freezing. It is contentious whether personal stories effectively support decision-making [68]. However, in response to our participants’ request, we added six personal stories to the Decision Aid. These follow the experiences of four women who froze their eggs, one who decided against egg freezing, and one who was undecided.

Improvements in knowledge and reductions in decisional conflict were observed post-Decision Aid review. Most participants also perceived a greater understanding of egg freezing, its alternatives, and their respective pros and cons. Our study was not powered to detect a statistically meaningful effect of the Decision Aid, however, these results suggest the tool may favorably impact knowledge and decisional conflict outcomes. This will be further evaluated in a future randomised controlled trial.

Study strengths include the first to describe the development and phase 1 evaluation of a Decision Aid for elective egg freezing. It addresses a gap in comprehensive and independent decision support for women considering the option. Limitations include potential bias from self-selection. Free-text sections were included in the survey for participants to add context to their answers, however, the study design limits the clarification or further exploration of their responses. Also, some participants had already decided about egg freezing which may have affected their perceptions of the Decision Aid and its utility.

Conclusion

Our egg freezing Decision Aid appears to be an acceptable and useful decision support tool. It improved knowledge, reduced decisional conflict, and did not raise any serious concern. Most participants considered the Decision Aid helpful for explaining their options, reaching egg freezing decision, and would recommend it to others. Whilst the findings from this study are promising, the Decision Aid will be further evaluated in a prospective randomised controlled trial. The results from the trial will inform whether the Decision Aid will be made publicly available for women who are contemplating egg freezing.