跳至主要内容
临床试验/NCT05780489
NCT05780489Unknown不适用

Evaluation of Salivary ELISA for Hormone Monitoring in Donors

Instituto Valenciano de Infertilidad, IVI VALENCIA4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年4月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
4
主要终点
E2 and P4 on Day 1

研究概览

简要总结

In donors or patients undergoing assisted reproduction treatments (ART) it is necessary to closely control ovarian stimulation to monitor the number and size of developing follicles.

Oestradiol (E2) and progesterone (P4) are products of steroidogenesis. Their concentrations increase with the diameter of the growing follicle. In order to assess treatment response and support clinical decisions, accurate and reliable methods to measure E2 and P4 are essential. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients or donors to undergo multiple blood draws. It is often a physically and emotionally painful process, and the most convenient solution is the measurement of hormones concentrations in other biological fluids, such as saliva. Salivary diagnostic tests are a less invasive, inexpensive, and stress-free alternative.

The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations in oocyte donors, and, also, evaluate the feasibility of doing saliva E2 and P4 determinations in the IVIRMA clinic labs.

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
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Informed consent form dated and signed
  • Woman undergoing COS for oocyte donation
  • Age 18-35, inclusive
  • Regular menstrual cycles
  • In good health and not suffering from any mental or medical condition(s) that would preclude participation in the study

排除标准

  • Simultaneous participation in other clinical study, that at the investigator's criteria could interfere with the results of this study.

研究组 & 干预措施

DONORS UNDER CONTROLLED OVARIAN STIMULATION

Experimental

Saliva samples will be analyzed using oestradiol and progesterone ELISA kits.

干预措施: Determination of progesterone and oestradiol (Diagnostic Test)

结局指标

主要结局

E2 and P4 on Day 1

时间窗: 1 YEAR

Measurement of saliva E2 adn P4 values on day 1 stimulation

E2 and P4 on Triggering day

时间窗: 1 YEAR

Measurement of saliva E2 adn P4 values on triggering day

E2 and P4 on Day 8

时间窗: 1 YEAR

Measurement of saliva E2 adn P4 values on day 8 of stimulation

次要结局

  • DONOR'S AGE(1 year)
  • NUMBER OF OOCYTES(1 YEAR)
  • BODY MASS INDEX(1 year)

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 (4)

Loading locations...

相似试验