Clinical trial · Observational
AMH for the Identification of PCOM in PCOS Diagnosis
Human Anti-MülleRian Hormone for Diagnosis of PCOS Study
NCT05527353CI-TRIAL-00060667HARMONIAunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Women with PCOS
- description
- Women born in Northern Finland during 1985-1987 fulfilling ≥2 Rotterdam criteria.
- label
- Controls
- description
- Women born in Northern Finland during 1985-1987 who are PCOM negative with no other diagnostic features of PCOS according to the Rotterdam criteria.
Primary outcomes (1)
- 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.
- timeFrame
- Baseline
- description
- 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 outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 32 Years
- Maximum age
- 37 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDPiltonen 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. PMID 40398715
- DERIVEDPiltonen 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. PMID 38319689