NCT05527353

AMH for the Identification of PCOM in PCOS Diagnosis

Human Anti-MülleRian Hormone for Diagnosis of PCOS Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,800 (estimated)
• Sponsor: Oulu University Hospital · Academic / Other
• Sex: Female
• Age: 32 Years – 37 Years
• Healthy volunteers: Accepted

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.

Conditions

• Polycystic Ovary Syndrome

Timeline

• Start date: 2020-05-13
• Primary completion: 2022-10-31
• Completion: 2022-12-31
• First posted: 2022-09-02
• Last updated: 2022-09-02

Locations

1 site across 1 country: Finland