Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05527353
Status:
UNKNOWN
Last Update Posted:
2022-09-02
First Post:
2022-08-05
Brief Title:
AMH for the Identification of PCOM in PCOS Diagnosis
Sponsor:
Oulu University Hospital
Organization:
Oulu University Hospital
Study Overview
Official Title:
Human Anti-MülleRian Hormone for Diagnosis of PCOS Study
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
RECRUITING
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:
HARMONIA
Brief Summary:
The purpose of this study is to validate the anti-müllerian hormone AMH cut-off established and validated in the APHRODITE study for the determination of PCOM as part of the diagnosis of PCOS using the Elecsys AMH Plus immunoassay
Detailed Description:
The study participants will be women born July 1985-Dec 1987 in Northern Finland the study partially links to the Northern Finland Birth Cohort 1986 Female subjects included in this cohort will be invited to participate in the study with the aim to enroll up to 1800 subjects Each enrolled subject will have one study visit where the clinical data required for assessing their PCOS status will be recorded including a gynecological examination by transvaginal ultrasound to determine polycystic ovarian morphology PCOM status antral follicle count and ovarian volume Study subjects will also have blood drawn for serum collection where hormonal parameters relevant for PCOS will be measured The collected serum will also be used to measure the AMH levels using the Roche Elecsys AMH test
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