跳至主要内容
临床试验/NCT05184777
NCT05184777已完成不适用

Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients

Instituto Valenciano de Infertilidad, IVI VALENCIA2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
To evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients.

研究概览

简要总结

In assisted reproductive treatment (ART), it is necessary to follow closely the stimulation cycles of patients undergoing these treatments in order to monitor the number and size of developing follicles. Oestradiol (E2) and progesterone (P) are products of steroidogenesis and the concentrations of both hormones increase with the diameter of the growing follicle and accurate and reliable methods to measure E2 and P are essential to assess treatment response and support clinical decision. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients to undergo multiple blood draws. It is often a physically and emotionally painful process and the most convenient solution to this problem is the measurement of hormone concentration in other biological fluids. Salivary diagnostic tests are a less invasive, inexpensive and stress-free alternative to measurements of hormone concentration in other biological fluids. The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients. In addition, secondary objectives include the measurement of diurnal variability of salivary hormone levels and patient experience with saliva collection as users.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients undergoing IVF/ICSI treatment
  • Patients planned to embryo transfer (ET) undergoing hormonal replacement therapy
  • Aged from18-45 years old.
  • BMI 19-30 kg/m2
  • Signed written informed consent

排除标准

  • Patients suffering for any systemic disease or endocrine disorder will be excluded foe the study

结局指标

主要结局

To evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients.

时间窗: 12 months

between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations

次要结局

  • Diurnal variability of salivary progesterone and oestradiol levels(12 months)
  • Patient User Experience with saliva collection(12 months)

研究者

发起方
Instituto Valenciano de Infertilidad, IVI VALENCIA
申办方类型
Other
责任方
Sponsor

研究点 (2)

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