AMH for the Identification of PCOM in PCOS Diagnosis (HARMONIA)

Oulu University Hospital

Status: Enrolling

Conditions: Polycystic Ovary Syndrome

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05527353

49/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,800 estimated patients

Sex: Female

Ages: 32 to 37 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female
• Born July 1985-Dec 1987 in Northern Finland
• Signed informed consent regarding ROCHE collaboration

Exclusion criteria

• Unwilling to undergo gynecological examination including transvaginal ultrasound (TVUS)
• Unwilling to have blood drawn
• Pregnancy

Trial design

1,800 participants in 2 patient groups

Women with PCOS

Description:

Women born in Northern Finland during 1985-1987 fulfilling ≥2 Rotterdam criteria.

Controls

Description:

Women born in Northern Finland during 1985-1987 who are PCOM negative with no other diagnostic features of PCOS according to the Rotterdam criteria.