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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision Aid | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| elective egg freezing decision aid | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Only biological female who has ovaries and oocytes are eligible for our study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jou-Chien Liao, Doctor | Contact | +886 987877611 | ruth5056@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan | 100 | Taiwan |
De-identified individual participant data (IPD) will not be made publicly available due to the sensitive nature of the data, which includes personal reproductive decision-making, psychological assessments, and qualitative responses that may carry a risk of re-identification.
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|
| baseline, 6 months, 24 months |
| 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). | baseline, 6 months, 24 months |
| 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). | baseline, 6 months, 24 months |
| 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. | From enrollment to the end of intervention at 2 years. |
| Number of oocytes cryopreserved per participant | The total number of mature oocytes (metaphase II oocytes) successfully retrieved and cryopreserved per participant during the study period will be recorded. If participants undergo multiple cycles, the cumulative number of oocytes cryopreserved will be reported. | From enrollment to the end of intervention at 2 years. |
| Ovarian stimulation cycle cancellation rate | Cycle cancellation is defined as initiation of ovarian stimulation without proceeding to oocyte retrieval. The cancellation rate will be calculated as the proportion of initiated cycles that are canceled prior to oocyte retrieval. | From enrollment to the end of intervention at 2 years. |
| baseline, 6 months, 24 months |