To hear about similar clinical trials, please enter your email below
Trial Title:
AMH for the Identification of PCOM in PCOS Diagnosis
NCT ID:
NCT05527353
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Conditions: Keywords:
polycystic ovary syndrome
PCOS
anti-müllerian hormone
AMH
antral follicle count
polycystic ovarian morphology
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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
Gender:
Female
Gender based:
Yes
Gender description:
Subjects born in Northern Finland in July 1985- December 1987 who were assigned female at
birth and currently register as females.
Minimum age:
32 Years
Maximum age:
37 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Oulu University Hospital
Address:
City:
Oulu
Zip:
90220
Country:
Finland
Status:
Recruiting
Start date:
May 13, 2020
Completion date:
December 31, 2022
Lead sponsor:
Agency:
Oulu University Hospital
Agency class:
Other
Collaborator:
Agency:
Roche Diagnostics GmbH
Agency class:
Industry
Source:
Oulu University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05527353
