Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05780489
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-02-28
Brief Title:
Evaluation of Salivary ELISA for Hormone Monitoring in Donors
Sponsor:
Instituto Valenciano de Infertilidad IVI VALENCIA
Organization:
Instituto Valenciano de Infertilidad IVI VALENCIA
Study Overview
Official Title:
Evaluation of Salivary ELISA for Hormone Monitoring in Donors
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINT-II
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None