Causes and Consequences of Primary Ovarian Insufficiency

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04082169

Acronym

Clinical POI

Enrollment

100

Registered

2019-09-09

Start date

2019-01-11

Completion date

2022-12-31

Last updated

2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Menopause, Primary Ovarian Insufficiency

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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 \-

Design outcomes

Primary

Measure	Time frame	Description
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
Endocrine disrupting chemicals	one day	Characterize the cohort of women with POI, including testing for environmental factors

Secondary

Measure	Time frame	Description
Phenotype description	one day	Describe phenotypical characteristics including menstrual characteristics, hormone profile, BMD

Countries

Norway

Contacts

Primary ContactEystein Husebye, prof

eyhu@helse-bergen.no+4755975000

Outcome results