AMH for the Identification of PCOM in PCOS Diagnosis

Human Anti-MülleRian Hormone for Diagnosis of PCOS Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05527353

Acronym

HARMONIA

Enrollment

1800

Registered

2022-09-02

Start date

2020-05-13

Completion date

2022-12-31

Last updated

2022-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

polycystic ovary syndrome, PCOS, anti-müllerian hormone, AMH, antral follicle count, polycystic ovarian morphology

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

32 Years to 37 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
The validation of the performance of the AMH cut-off, established in the APHRODITE study, to diagnose PCOM in the context of PCOS diagnosis.	Baseline	The performance (sensitivity and specificity) of the AMH cut-off will be calculated by comparing the AMH values to the PCOM status of the subjects based on the TVUS findings (AFC & Ovarian volume).

Secondary

Measure	Time frame	Description
Prevalence of PCOS in general population	Baseline	PCOS is diagnosed based on the Rotterdam Criteria with the presence of at least two of the following symptoms: 1. Polycystic ovarian morphology by trans-vaginal ultrasound (\>=20 follicles in either ovary or ovarian volume \>= 10 mL), 2. Hyperandrogenism, either clinical or biochemical (testosterone/free androgen index) and 3. oligo-amenorrhea (\< 8 menstruations/year).

Countries

Finland

Contacts

Primary ContactTerhi T Piltonen, Professor

terhi.piltonen@oulu.fi+358 8 3153051

Backup ContactRiikka K Arffman, PhD

Outcome results