Venopuncture-Free IVF: Can "Patient-friendly" Salivary Hormone Measurements Replace Serum Monitoring of IVF Patients?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Boston IVF
- 入组人数
- 335
- 试验地点
- 6
- 主要终点
- Equivalence of Salivary Steroid Monitoring to Blood Based Monitoring
研究概览
简要总结
This study aims to determine the performance of a salivary hormone competitive immunoassay for monitoring patients during treatment for infertility.
详细描述
The goal of this study is to determine the performance of a salivary hormone competitive immunoassay for monitoring patient estrogen and progesterone levels during treatment for infertility using controlled ovarian stimulation (COH) and in vitro fertilization (IVF). Specifically, inter- and intra-assay precision, correlation with serum measurements (the gold-standard), and user satisfaction will be determined. Ultimately, the potential applicability and reliability of salivary steroid monitoring in IVF cycles will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center
排除标准
- 未提供
结局指标
主要结局
Equivalence of Salivary Steroid Monitoring to Blood Based Monitoring
时间窗: 1 month
The potential applicability and reliability of salivary steroid monitoring during infertility treatment will be measured as a progression during a patient's IVF stimulation cycle. Concurrent saliva and blood draw measurements of Estradiol and Progesterone will be taken between 3-5 times during a 2-week monitoring period. Equivalence will be determined by the matched progression of Estradiol and progesterone levels (pg/ml) in the same patient at the concurrent times. Saliva Estradiol and Progesterone levels are of a magnitude of 100-200 less than serum based values and are converted using an algorithm to adjust to serum equivalence. Matched T-test will be used to test the hypothesis that the two methods are not statistically different.
次要结局
未报告次要终点
研究者
Alison Zimon
Reproductive Endocrinologist
Boston IVF