Decision Aid for Elective Egg Freezing

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20+
SponsorNational Taiwan University Hospital

About this trial

The goal of this clinical trial is to evaluate whether a culturally tailored decision aid can improve decision-making and clinical outcomes for Taiwanese women considering elective egg freezing.

The main questions it aims to answer are:

Does the decision aid improve women's knowledge about elective egg freezing and help clarify their personal values? Does the decision aid reduce decision regret and psychological distress after making a decision about egg freezing?

Researchers will compare women who use the decision aid with those who receive standard counseling to see if the tool improves knowledge, reduces distress and regret, and leads to better clinical outcomes (such as completing egg freezing or achieving a higher number of frozen oocytes).

Participants will:

* Complete questionnaires assessing their baseline knowledge, attitudes, and values regarding egg freezing * Receive either the decision aid or standard counseling * Complete follow-up questionnaires to assess knowledge, distress, and decision regret * Have their clinical outcomes recorded, including whether they undergo egg freezing and the number of oocytes retrieved and frozen

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 20 years or older.

Currently considering elective egg freezing (EEF).

Able to communicate and read Chinese fluently.

Have access to the internet and a mobile device (smartphone, tablet, or computer) to complete online questionnaires.

Disqualifiers

Individuals who have previously completed oocyte cryopreservation.

Women undergoing fertility preservation due to malignancy (i.e., breast cancer).

Postmenopausal women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • elective egg freezing decision aid

    Other intervention

    The EEF decision aid used in this study is an evidence-based educational tool designed to support shared decision making. Its primary function is to provide clear, balanced, and structured information to help women make decisions that align with their personal values and reproductive goals.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Decision AidExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Decision Regret Scale

The Decision Regret Scale (DRS) is a 5-item validated questionnaire used to assess distress or remorse after a healthcare decision. Each item is scored on a 5-point Likert scale. Scores are transformed to a 0-100 scale, with higher scores indicating greater decision regret (worse outcome).

Time frame
6 months, 24 months

Secondary outcomes

1

Knowledge score regarding elective egg freezing

Knowledge regarding elective egg freezing will be assessed using a self-developed questionnaire consisting of multiple-choice items covering fertility decline, success rates, risks, and procedural aspects. Each correct answer is awarded 1 point. Scores are transformed to a 0-100 scale, with higher scores indicating greater knowledge (better outcome).

Time frame
baseline, 6 months, 24 months
2

Decisional conflict scale

The Decisional Conflict Scale (DCS) is a 16-item validated instrument measuring personal perceptions of uncertainty in choosing options, modifiable factors contributing to uncertainty, and perceived effective decision-making. Each item is scored on a 5-point Likert scale. Scores are converted to a 0-100 scale, with higher scores indicating greater decisional conflict (worse outcome).

Time frame
baseline, 6 months, 24 months
3

Depression anxiety stress scale

The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item validated questionnaire assessing symptoms of depression, anxiety, and stress across three subscales. Each item is scored from 0 to 3. Subscale scores range from 0 to 21 (or 0-42 after standard multiplication), with higher scores indicating greater psychological distress (worse outcome).

Time frame
baseline, 6 months, 24 months
4

Elective egg freezing treatment completion rate

Treatment completion is defined as participants who undergo at least one completed oocyte retrieval cycle for elective egg freezing following enrollment. The completion rate will be calculated as the proportion of participants who complete treatment out of all enrolled participants.

Time frame
From enrollment to the end of intervention at 2 years.

Other outcomes

1

Elective egg freezing attitudes and expectations (qualitative assessment)

Participants' attitudes, expectations, and reproductive planning regarding elective egg freezing will be assessed using investigator-developed open-ended questions. Responses will be analyzed using qualitative content analysis to identify key themes related to decision-making, perceived benefits and concerns, and future reproductive intentions.

Time frame
baseline, 6 months, 24 months

Sponsors and contacts

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