Causes and Consequences of Primary Ovarian Insufficiency

• Conditions: Primary Ovarian Insufficiency; Premature Menopause

• Registration Number: NCT04082169
• Lead Sponsor: Haukeland University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-11
• Status Verified: 2019-08
• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-09-05
• Last Update Submitted: 2019-09-05
• Study First Posted: 2019-09-09
• Last Update Posted: 2019-09-09
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endocrine disrupting chemicals	one day	Characterize the cohort of women with POI, including testing for environmental factors
Autoimmune	one day	Prevalence of primary ovarian insufficiency (POI) with autoimmune etiology based on positive autoantibodies toward steroidogenic cells
Genetic	one day	Prevalence of POI with genetic etiology defined by detection of genetic defects in a NGS panel

Secondary Outcome Measures

Name	Time	Method
Phenotype description	one day	Describe phenotypical characteristics including menstrual characteristics, hormone profile, BMD

Trial Locations

Locations (1)

HaukelandUH; 🇳🇴 Bergen, Norway