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临床试验/NCT03162809
NCT03162809Unknown不适用

Venopuncture-Free Monitoring During IVF: Are More Frequent Sequential Salivary Hormone Measurements More Informative Than Daily Serum Monitoring of IVF Patients?

Boston IVF1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年5月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
Boston IVF
入组人数
300
试验地点
1
主要终点
Measurement of multiple Progesterone levels as an aid during an IVF cycle

研究概览

简要总结

Salivary diagnostic testing is emerging as a less invasive, inexpensive alternative to serum analyte measurements with proven diagnostic accuracy in clinical settings. This study aims to continue analyzing aspects of the performance of salivary hormone competitive immunoassays for monitoring patient's reproductive hormone profiles in the reproductive cycle. Hormone levels will be monitored during treatment cycles for infertility.

详细描述

This study will be a prospective study to measure salivary and serum estrogen and progesterone levels in subject's voluntarily undergoing monitored infertility treatment cycles including controlled ovarian stimulation (COS) with oral agents or gonadotropins and controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF). 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

年龄范围
25 Years 至 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of infertility.
  • Cycle start age of 25 -43 years.
  • Undergoing controlled ovarian stimulation for IVF.
  • All monitoring scheduled at the participating IVF facility.

排除标准

  • Prior cancelled cycle due to hyperstimulation.

结局指标

主要结局

Measurement of multiple Progesterone levels as an aid during an IVF cycle

时间窗: 1 month

To determine if collecting multiple salivary Progesterone levels versus a single serum hormone sample could assist in predicting the administration of Human Chorionic Gonadotropin (HCG) during an IVF cycle.

次要结局

  • Measurement of salivary Estradiol level as an aid during fertility treatment(1 month)
  • Measurement of salivary Progesterone level as an aid during fertility treatment(1 month)

研究者

发起方
Boston IVF
申办方类型
Other
责任方
Sponsor

研究点 (1)

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