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NCT04082169 Clinical Trial

Causes and Consequences of Primary Ovarian Insufficiency

Primary Ovarian Insufficiency Clinical Trial

— Clinical POI  

Official title:
Causes and Consequences of Primary Ovarian Insufficiency

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04082169
Other study ID # 2018/1206
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 11, 2019
Est. completion date December 31, 2022

Study information
Verified date August 2019
Source Haukeland University Hospital
Contact Eystein Husebye, prof
Phone +4755975000
Email eyhu@helse-bergen.no
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

-

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Norway HaukelandUH Bergen

Sponsors (1)
Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Autoimmune Prevalence of primary ovarian insufficiency (POI) with autoimmune etiology based on positive autoantibodies toward steroidogenic cells one day
Primary Genetic Prevalence of POI with genetic etiology defined by detection of genetic defects in a NGS panel one day
Primary Endocrine disrupting chemicals Characterize the cohort of women with POI, including testing for environmental factors one day
Secondary Phenotype description Describe phenotypical characteristics including menstrual characteristics, hormone profile, BMD one day
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