Proof of Concept Study To Assess Women's Likability and Stress in Timing Frozen Embryo Transfer by Following Two Different Methods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Proportion of volunteers where ADOT use enables equivalent timing of FET compared to clinic visit
研究概览
简要总结
This proof of concept study is designed to determine the practicality of using home ovulation tests to enable optimum timing for transfer of frozen embryos in a natural menstrual cycle in comparison to the standard ultrasound and serum monitoring currently conducted by many IVF clinics.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 24 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Proportion of volunteers where ADOT use enables equivalent timing of FET compared to clinic visit
时间窗: 9 months
Examination as to whether using ADOT would have enabled correct timing of FET when compared to clinic visit
次要结局
- Measurement of women's psychological distress(9 months)
- Positive and negative experience in using ovulation tests in FET(9 months)
- FET success(9 months)