AMH for the Identification of PCOM in PCOS Diagnosis

Recruiting

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT05527353
• Lead Sponsor: Oulu University Hospital

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 Timeline

• Study Start: 2020-05-13
• Study First Submitted: 2022-08-05
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-01
• Last Update Submitted: 2022-09-01
• Study First Posted: 2022-09-02
• Last Update Posted: 2022-09-02
• Primary Completion: 2022-10-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland