NCT04082169UnknownNot Applicable
Causes and Consequences of Primary Ovarian Insufficiency
Haukeland University Hospital1 site in 1 country100 target enrollmentStarted: January 11, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Endocrine disrupting chemicals
Study Overview
Brief Summary
100 women with primary ovarian insufficiency will be included for extensive diagnostic workup to improve diagnostic precision by extended autoantibody screening and genetic and toxicological testing.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women 40 years or younger, more than 4 months amenorrhea, more than 2 FSH measurements in menopausal range (drawn at least 2 months apart), ability to provide informed concent -
Exclusion Criteria
- •History of oophorectomy, chemotherapy or radiation
Outcomes
Primary Outcomes
Endocrine disrupting chemicals
Time Frame: one day
Characterize the cohort of women with POI, including testing for environmental factors
Autoimmune
Time Frame: one day
Prevalence of primary ovarian insufficiency (POI) with autoimmune etiology based on positive autoantibodies toward steroidogenic cells
Genetic
Time Frame: one day
Prevalence of POI with genetic etiology defined by detection of genetic defects in a NGS panel
Secondary Outcomes
- Phenotype description(one day)
Investigators
Study Sites (1)
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