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Clinical Trials/NCT04082169
NCT04082169
Unknown
Not Applicable

Causes and Consequences of Primary Ovarian Insufficiency

Haukeland University Hospital1 site in 1 country100 target enrollmentJanuary 11, 2019
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ConditionsPrimary Ovarian InsufficiencyPremature Menopause

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Ovarian Insufficiency
Sponsor
Haukeland University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Endocrine disrupting chemicals
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
January 11, 2019
End Date
December 31, 2022
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Haukeland University Hospital
Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

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