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

Human Anti-MülleRian Hormone for Diagnosis of PCOS Study

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.

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome

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 Type: Observational
• Enrollment (Anticipated): 1800

Contacts and Locations

• Study Contact: Name: Terhi T Piltonen, Professor; Phone Number: +358 8 3153051; Email: terhi.piltonen@oulu.fi
• Study Contact Backup: Name: Riikka K Arffman, PhD

Study Locations

• Finland
  • Oulu, Finland, 90220
    • Recruiting
    • Oulu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 32 years to 37 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

As the study is population-based, all non-pregnant women born in Northern Finland between July 1985-December 1987 will be invited to participate in the study. Most women will be white with a small minority (estimated below 3%) of indigenous Sámi people.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Women with PCOS; Women born in Northern Finland during 1985-1987 fulfilling ≥2 Rotterdam criteria.
Controls; Women born in Northern Finland during 1985-1987 who are PCOM negative with no other diagnostic features of PCOS according to the Rotterdam criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The validation of the performance of the AMH cut-off, established in the APHRODITE study, to diagnose PCOM in the context of PCOS diagnosis.	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).	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of PCOS in general population	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).	Baseline

Collaborators and Investigators

• Sponsor: Oulu University Hospital
• Collaborators: Roche Diagnostics
• Investigators: Principal Investigator: Terhi T Piltonen, Professor, Oulu University Hospital, University of Oulu

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2020
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: polycystic ovary syndrome; PCOS; AMH; antral follicle count; anti-müllerian hormone; polycystic ovarian morphology
• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome
• Other Study ID Numbers: 49/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be deposited into the Arctic Biobank as part of the Northern Finland Birth Cohort 1986 data.
• IPD Sharing Time Frame: Data is available on request 10 years from study completion
• IPD Sharing Access Criteria: Data available according to policies of the NFBC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No