Knowledge, Decision-making, and Oocyte Cryopreservation Outcomes in Taiwanese Women Considering Elective Egg Freezing: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Decision Regret Scale
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Individuals who have previously completed oocyte cryopreservation.
- •Women undergoing fertility preservation due to malignancy (i.e., breast cancer).
- •Postmenopausal women.
研究组 & 干预措施
Decision Aid
干预措施: elective egg freezing decision aid (Other)
Control
结局指标
主要结局
Decision Regret Scale
时间窗: 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).
次要结局
- Knowledge score regarding elective egg freezing(baseline, 6 months, 24 months)
- Decisional conflict scale(baseline, 6 months, 24 months)
- Depression anxiety stress scale(baseline, 6 months, 24 months)
- Elective egg freezing treatment completion rate(From enrollment to the end of intervention at 2 years.)
- Number of oocytes cryopreserved per participant(From enrollment to the end of intervention at 2 years.)
- Ovarian stimulation cycle cancellation rate(From enrollment to the end of intervention at 2 years.)