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Causes and Consequences of Primary Ovarian Insufficiency (Clinical POI)

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ClinicalTrials.gov Identifier: NCT04082169
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Primary Ovarian Insufficiency Premature Menopause

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Causes and Consequences of Primary Ovarian Insufficiency
Actual Study Start Date : January 11, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022





Primary Outcome Measures :
  1. Autoimmune [ Time Frame: one day ]
    Prevalence of primary ovarian insufficiency (POI) with autoimmune etiology based on positive autoantibodies toward steroidogenic cells

  2. Genetic [ Time Frame: one day ]
    Prevalence of POI with genetic etiology defined by detection of genetic defects in a NGS panel

  3. Endocrine disrupting chemicals [ Time Frame: one day ]
    Characterize the cohort of women with POI, including testing for environmental factors


Secondary Outcome Measures :
  1. Phenotype description [ Time Frame: one day ]
    Describe phenotypical characteristics including menstrual characteristics, hormone profile, BMD


Biospecimen Retention:   Samples With DNA
serum


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Ovarian insufficiency
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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
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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082169


Contacts
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Contact: Eystein Husebye, prof +4755975000 eyhu@helse-bergen.no

Locations
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Norway
HaukelandUH Recruiting
Bergen, Norway
Contact: Elinor Vogt, MD    +4793899380    elinor.vogt@uib.no   
Sub-Investigator: Marianne Oksnes, PHD         
Sponsors and Collaborators
Haukeland University Hospital
Investigators
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Study Chair: Kahtan Al-Azawy, MD Haukeland University Hospital

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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT04082169     History of Changes
Other Study ID Numbers: 2018/1206
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Primary Ovarian Insufficiency
Menopause, Premature
Gonadal Dysgenesis
Turner Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn