Timing Frozen Embryo Transfer by Following Two Different Methods
Proof of Concept Study To Assess Women's Likability and Stress in Timing Frozen Embryo Transfer by Following Two Different Methods
研究概览
详细说明
The study will evaluate the ability of home ovulation tests to accurately time Frozen Embryo Transfer (FET) directly compared to standard clinical procedures. In addition, women's likability and stress associated with timing a FET cycle using both methods will be evaluated by collecting qualitative data using standardised questionnaires.
The impact of psychological stress on FET outcome such as implantation rates and viability at first scan will be considered in order to gather information for the design of a larger clinical study and basic financial data will also be collected, in order to pilot a cost-effectiveness evaluation of the two FET timing methods.
A subset of volunteers will collect daily urine samples from day after embryo transfer until confirmation of pregnancy.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
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New South Wales
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Bondi Junction、New South Wales、澳大利亚、NSW 2022
- IVFAustralia - Bondi Junction
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Women aged 24 to 45 years of age
- Undergoing no more than 5frozen embryo transfer
- Average cycle length between 26 and 35 days
- Willing to provide written informed consent to participate in the study and comply with all study procedures
Exclusion Criteria:
- More than five IVF frozen embryo cycle
- Undergoing FET following cancer treatment
- Self-reported drug or alcohol dependency
- Self-reported history of depression, anxiety and panic attacks
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Ovulation test use
Use of both ovulation tests and standardised care
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Use of home ovulation test to predict ovulation
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of volunteers where ADOT use enables equivalent timing of FET compared to clinic visit
大体时间：9 months
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Examination as to whether using ADOT would have enabled correct timing of FET when compared to clinic visit
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9 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Measurement of women's psychological distress
大体时间：9 months
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Use of validated questionnaire to assess stress level
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9 months
|
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Positive and negative experience in using ovulation tests in FET
大体时间：9 months
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Qualitative assessment of women's FET treatment experience when using ADOT compared to standard clinical procedures during the study via a semi-structured interview following embryo transfer
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9 months
|
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FET success
大体时间：9 months
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Implantation rate
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9 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- PROTOCOL-0897
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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