NCT05527353

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 2, 2022

Status Verified

September 1, 2022

Enrollment Period

2.5 years

First QC Date

August 5, 2022

Last Update Submit

September 1, 2022

Conditions

Polycystic Ovary Syndrome

Keywords

polycystic ovary syndromePCOSanti-müllerian hormoneAMHantral follicle countpolycystic ovarian morphology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Prevalence of PCOS in general population

    Baseline

Study Arms (2)

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.

Eligibility Criteria

Age32 Years - 37 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSubjects born in Northern Finland in July 1985- December 1987 who were assigned female at birth and currently register as females.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Female
  • Born July 1985-Dec 1987 in Northern Finland
  • Signed informed consent regarding ROCHE collaboration

You may not qualify if:

  • Unwilling to undergo gynecological examination including transvaginal ultrasound (TVUS)
  • Unwilling to have blood drawn
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, 90220, Finland

RECRUITING

Related Publications (2)

  • 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.

    PMID: 40398715DERIVED

  • 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.

    PMID: 38319689DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Terhi T Piltonen, Professor

    Oulu University Hospital, University of Oulu

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Terhi T Piltonen, Professor

CONTACT

+358 8 3153051terhi.piltonen@oulu.fi

Riikka K Arffman, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2022

First Posted

September 2, 2022

Study Start

May 13, 2020

Primary Completion

October 31, 2022

Study Completion

December 31, 2022

Last Updated

September 2, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

Data will be deposited into the Arctic Biobank as part of the Northern Finland Birth Cohort 1986 data.

Time Frame
Data is available on request 10 years from study completion
Access Criteria
Data available according to policies of the NFBC.
More information

Locations

FI(1)