NCT04082169

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 9, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

August 20, 2019

Last Update Submit

September 5, 2019

Conditions

Primary Ovarian InsufficiencyPremature Menopause

Outcome Measures

Primary Outcomes (3)

  • Autoimmune

    Prevalence of primary ovarian insufficiency (POI) with autoimmune etiology based on positive autoantibodies toward steroidogenic cells

    one day

  • Genetic

    Prevalence of POI with genetic etiology defined by detection of genetic defects in a NGS panel

    one day

  • Endocrine disrupting chemicals

    Characterize the cohort of women with POI, including testing for environmental factors

    one day

Secondary Outcomes (1)

  • Phenotype description

    one day

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOvarian insufficiency
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

100 women with primary ovarian insufficiency defined as absence of menstruation more than 4 months and serum level of follicle stimulation hormone (FSH) in menopausal range at 2 or more occations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaukelandUH

Bergen, Norway

RECRUITING

Related Publications (1)

  • Vogt EC, Bratland E, Berland S, Berentsen R, Lund A, Bjornsdottir S, Husebye E, Oksnes M. Improving diagnostic precision in primary ovarian insufficiency using comprehensive genetic and autoantibody testing. Hum Reprod. 2024 Jan 5;39(1):177-189. doi: 10.1093/humrep/dead233.

    PMID: 37953503DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Primary Ovarian InsufficiencyMenopause, Premature

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Kahtan Al-Azawy, MD

    Haukeland University Hospital

    STUDY CHAIR

Central Study Contacts

Eystein Husebye, prof

CONTACT

+4755975000eyhu@helse-bergen.no

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2019

First Posted

September 9, 2019

Study Start

January 11, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

September 9, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)