Primary Ovarian InsufficiencyClinical POINCT04082169
Causes and Consequences of Primary Ovarian Insufficiency
An observational study of Primary Ovarian Insufficiency and Premature Menopause, run by Haukeland University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Ovarian Insufficiency, Premature Menopause
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 11 Jan 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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
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
-
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
HaukelandUH
Bergen
Elinor Vogt, MD, +4793899380, elinor.vogt@uib.no
Marianne Oksnes, PHD
About this study
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.
- Conditions
- Primary Ovarian Insufficiency, Premature Menopause
- Medical subject headings
- Primary Ovarian Insufficiency, Menopause, Premature
What is being measured
The primary outcome is the main question the study is designed to answer.
Autoimmune
Prevalence of primary ovarian insufficiency (POI) with autoimmune etiology based on positive autoantibodies toward steroidogenic cells
Measured: one day
Genetic
Prevalence of POI with genetic etiology defined by detection of genetic defects in a NGS panel
Measured: one day
Endocrine disrupting chemicals
Characterize the cohort of women with POI, including testing for environmental factors
Measured: one day
Secondary outcomes (1)
Phenotype description
Describe phenotypical characteristics including menstrual characteristics, hormone profile, BMD
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start11 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Ovarian InsufficiencyStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kahtan Al-Azawy, MD, Study chair, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082169
- Sponsor's protocol ID
- 2018/1206
- Acronym
- Clinical POI
- Status last verified
- Aug 2019
- First submitted
- 20 Aug 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37953503
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes and Consequences of Primary Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT04082169
- Acronym / sponsor ID
- Clinical POI / 2018/1206
- Conditions
- Primary Ovarian Insufficiency, Premature Menopause
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Autoimmune
Time frame: one day
Prevalence of primary ovarian insufficiency (POI) with autoimmune etiology based on positive autoantibodies toward steroidogenic cells
Genetic
Time frame: one day
Prevalence of POI with genetic etiology defined by detection of genetic defects in a NGS panel
Endocrine disrupting chemicals
Time frame: one day
Characterize the cohort of women with POI, including testing for environmental factors
1 secondary outcome
Phenotype description
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Derived from this study: PubMed 37953503Vogt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kahtan Al-Azawy, MD study chair
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Ovarian Insufficiency and Premature Menopause, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eystein Husebye, prof (+4755975000, eyhu@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autoimmune (time frame: one day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.