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

• ClinicalTrials.gov Identifier: NCT05527353
• Recruitment Status: Recruiting
• First Posted: September 2, 2022
• Last Update Posted: September 2, 2022
• Sponsor: Oulu University Hospital
• Collaborator: Roche Diagnostics GmbH
• Information provided by (Responsible Party): Oulu University Hospital

Study Description

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.

Condition or disease
Polycystic Ovary Syndrome

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

• Study Type: Observational
• Estimated Enrollment: 1800 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Human Anti-MülleRian Hormone for Diagnosis of PCOS Study
• Actual Study Start Date: May 13, 2020
• Estimated Primary Completion Date: October 31, 2022
• Estimated Study Completion Date: December 31, 2022

Groups and Cohorts

Group/Cohort
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.

Outcome Measures

Primary Outcome Measures :

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. [ 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).

Secondary Outcome Measures :

1. 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).

Biospecimen Retention:   Samples Without DNA

Serum

Eligibility Criteria

• Ages Eligible for Study: 32 Years to 37 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Subjects born in Northern Finland in July 1985- December 1987 who were assigned female at birth and currently register as females.
• Accepts Healthy Volunteers: Yes
• 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.

Criteria

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

Contacts and Locations

Contacts

Contact: Terhi T Piltonen, Professor; +358 8 3153051; terhi.piltonen@oulu.fi

Contact: Riikka K Arffman, PhD

Locations

Finland

Oulu University Hospital; Recruiting

Oulu, Finland, 90220

Sponsors and Collaborators

Oulu University Hospital

Roche Diagnostics GmbH

Investigators

• Principal Investigator: Terhi T Piltonen, Professor; Oulu University Hospital, University of Oulu

More Information

• Responsible Party: Oulu University Hospital
• ClinicalTrials.gov Identifier: NCT05527353
• Other Study ID Numbers: 49/2019
• First Posted: September 2, 2022
• Last Update Posted: September 2, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.
• URL: https://www.oulu.fi/en/university/faculties-and-units/faculty-medicine/northern-finland-birth-cohorts-and-arctic-biobank/nfbc-aineistopyynto

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Oulu University Hospital:

polycystic ovary syndrome; PCOS; anti-müllerian hormone; AMH; antral follicle count; polycystic ovarian morphology

Additional relevant MeSH terms:

Polycystic Ovary Syndrome; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases