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| Name | Class |
|---|---|
| Roche Diagnostics GmbH | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
Subjects born in Northern Finland in July 1985- December 1987 who were assigned female at birth and currently register as females.
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Terhi T Piltonen, Professor | Contact | +358 8 3153051 | terhi.piltonen@oulu.fi | |
| Riikka K Arffman, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Terhi T Piltonen, Professor | Oulu University Hospital, University of Oulu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Recruiting | Oulu | 90220 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40398715 | Derived | 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. | |
| 38319689 |
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Data will be deposited into the Arctic Biobank as part of the Northern Finland Birth Cohort 1986 data.
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Data is available on request 10 years from study completion
Data available according to policies of the NFBC.
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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Serum
| Baseline |
| Derived |
| Piltonen 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. |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |