Ignite Creation Date:
2024-05-06 @ 1:56 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04168892
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2019-11-16
Brief Title:
Anti-Müllerian Hormone AMH Measured With Fully Automated Assay Versus AFC in the Prediction of Ovarian Response
Sponsor:
Andros Day Surgery Clinic
Organization:
Andros Day Surgery Clinic
Study Overview
Official Title:
Prospective Observational Multivariate Study to Evaluate the Best Predictor of Ovarian Response Between AMH Measured With Fully Automated Assay and AFC
Status:
COMPLETED
Status Verified Date:
2023-01
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:
None
Brief Summary:
The primary objective of this prospective observational multivariate study will be to compare the reliability of automated AMH measured with Access AMH assay Beckman-Coulter Diagnostics USA with that of antral follicle count AFC evaluated ultrasonographically always by the same operator and with the same ultrasound scanner in terms of the number of oocytes recovered from oocyte sampling in couples subjected to in vitro fertilization
Detailed Description:
Individual variability in ovarian response to a starting dose of gonadotropins is a well-known aspect during controlled ovarian stimulation COS and many efforts have been made for obtaining the personalization of the treatment identifying different biomarkers that may predict the ovarian response such as age basal Follicle Stimulating Hormone FSH AMH and antral follicle count AFC The number of oocytes retrieved is the main expression of ovarian response and it remains a relevant prognostic marker in women undergoing In Vitro Fertilization IVFIntracytoplasmic Sperm Injection ICSI cycles Consistent evidence shows that an optimal - rather than a maximal - oocyte yield is the preferred achievement after COS when fresh embryo transfer is scheduled In fact live birth rates steadily increase when an optimal number of oocytes is collected whereas low response and hyper-response are associated with lower implantation rates increased obstetrical risks and at least when considering hyper response increased risk of ovarian hyperstimulation syndrome OHSS in the fresh cycle Among the different biomarkers AMH and AFC seem to have the best performance in predicting ovarian response to exogenous FSH
Nevertheless until now there is often discordance between the AMH level and AFC in clinical practice In cases of discordance which indicator should be chosen to individualize the starting dose of gonadotropins Until now no direct comparison of the new automated immunoassay of AMH with AFC has been carried out considering the number of retrieved oocytes as primary endpoint
Nevertheless until now there is often discordance between the AMH level and AFC in clinical practice In cases of discordance which indicator should be chosen to individualize the starting dose of gonadotropins Until now no direct comparison of the new automated immunoassay of AMH with AFC has been carried out considering the number of retrieved oocytes as primary endpoint
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