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

September 1, 2022 updated by: Oulu University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Riikka K Arffman, PhD

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 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).
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of PCOS in general population
Time Frame: 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).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oulu University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Diagnostics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Terhi T Piltonen, Professor, Oulu University Hospital, University of Oulu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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