Polycystic Ovary SyndromeHARMONIANCT05527353
AMH for the Identification of PCOM in PCOS Diagnosis
An observational study of Polycystic Ovary Syndrome, run by Oulu University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 1,800 participants
- Where
- 1 siteFinland
- Study dates
- 13 May 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Female
- Born July 1985-Dec 1987 in Northern Finland
- Signed informed consent regarding ROCHE collaboration
Who cannot join
- Unwilling to undergo gynecological examination including transvaginal ultrasound (TVUS)
- Unwilling to have blood drawn
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Riikka K Arffman, PhD contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- polycystic ovary syndrome, PCOS, anti-müllerian hormone, AMH, antral follicle count, polycystic ovarian morphology
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (1)
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start13 May 2020
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Terhi T Piltonen, Professor, Principal investigator, Oulu University Hospital, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527353
- Sponsor's protocol ID
- 49/2019
- Acronym
- HARMONIA
- Status last verified
- Sep 2022
- First submitted
- 5 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be deposited into the Arctic Biobank as part of the Northern Finland Birth Cohort 1986 data.
Publications
Piltonen TT, Kinnunen J, Komsi E, Kangasniemi MH, Luiro K, Rajecki M, Jokelainen J, Kiviniemi E, Allegranza D, Hund M, Olziersky AM, Logan CA, Buck K, Savukoski SM, Arffman RK. Prospective validation of anti-Mullerian hormone cutoff to determine polycystic ovarian morphology: HARMONIA study. Fertil Steril. 2025 Sep;124(3):543-552. doi: 10.1016/j.fertnstert.2025.05.147. Epub 2025 May 19.
PubMed 40398715Piltonen TT, Allegranza D, Hund M, Buck K, Sillman J, Arffman RK. Validation of an Anti-Mullerian Hormone Cutoff for Polycystic Ovarian Morphology in the Diagnosis of Polycystic Ovary Syndrome in the HARMONIA Study: Protocol for a Prospective, Noninterventional Study. JMIR Res Protoc. 2024 Feb 6;13:e48854. doi: 10.2196/48854.
PubMed 38319689
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Anti-MülleRian Hormone for Diagnosis of PCOS Study
- ClinicalTrials.gov ID
- NCT05527353
- Acronym / sponsor ID
- HARMONIA / 49/2019
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- polycystic ovary syndrome, PCOS, anti-müllerian hormone, AMH, antral follicle count, polycystic ovarian morphology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 13 May 2020 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 32 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Female
- Born July 1985-Dec 1987 in Northern Finland
- Signed informed consent regarding ROCHE collaboration
Key exclusion criteria (3 listed)
- Unwilling to undergo gynecological examination including transvaginal ultrasound (TVUS)
- Unwilling to have blood drawn
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Prevalence of PCOS in general population
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Derived from this study: PubMed 40398715Piltonen TT, Kinnunen J, Komsi E, Kangasniemi MH, Luiro K, Rajecki M, Jokelainen J, Kiviniemi E, Allegranza D, Hund M, Olziersky AM, Logan CA, Buck K, Savukoski SM, Arffman RK. Prospective validation of anti-Mullerian hormone cutoff to determine polycystic ovarian morphology: HARMONIA study. Fertil Steril. 2025 Sep;124(3):543-552. doi: 10.1016/j.fertnstert.2025.05.147. Epub 2025 May 19.
- Derived from this study: PubMed 38319689Piltonen TT, Allegranza D, Hund M, Buck K, Sillman J, Arffman RK. Validation of an Anti-Mullerian Hormone Cutoff for Polycystic Ovarian Morphology in the Diagnosis of Polycystic Ovary Syndrome in the HARMONIA Study: Protocol for a Prospective, Noninterventional Study. JMIR Res Protoc. 2024 Feb 6;13:e48854. doi: 10.2196/48854.
- Individual participant dataSharing planned: Yes. Data will be deposited into the Arctic Biobank as part of the Northern Finland Birth Cohort 1986 data.
Related trials for Polycystic Ovary Syndrome
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riikka K Arffman, PhD contact
Terhi T Piltonen, Professor principal investigator
Oulu University Hospital, University of Oulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Oulu University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Terhi T Piltonen, Professor (+358 8 3153051, terhi.piltonen@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05527353, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.