Assisted Reproductive Technology, Decision Aid, Egg Freezing, Elective Egg Freezing, Fertility Preservation, Oocyte Cryopreservation, Shared Decision Making
Conditions
Keywords
elective egg freezing, planned oocyte cryopreservation, fertility preservation, decision aid, shared decision making, assisted reproductive technology, randomized controlled trial
Brief summary
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
Interventions
OTHERelective egg freezing decision aid
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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Individuals who have previously completed oocyte cryopreservation. * Women undergoing fertility preservation due to malignancy (i.e., breast cancer). * Postmenopausal women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision Regret Scale | 6 months, 24 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge score regarding elective egg freezing | baseline, 6 months, 24 months | 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). |
| Decisional conflict scale | baseline, 6 months, 24 months | 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). |
| Depression anxiety stress scale | baseline, 6 months, 24 months | 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). |
| Elective egg freezing treatment completion rate | From enrollment to the end of intervention at 2 years. | 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. |
| Number of oocytes cryopreserved per participant | From enrollment to the end of intervention at 2 years. | 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. |
| Ovarian stimulation cycle cancellation rate | From enrollment to the end of intervention at 2 years. | 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. |
Countries
Taiwan
Contacts
CONTACTJou-Chien Liao, Doctor
Outcome results
None listed