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Establishing of an Early Warming System of Premature Ovarian Insufficiency

Establishing of an Early Warming System of Premature Ovarian Insufficiency

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03518944
Enrollment
500
Registered
2018-05-08
Start date
2017-07-01
Completion date
2021-07-01
Last updated
2018-05-08

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

Conditions

Primary Ovarian Insufficiency

Brief summary

Premature ovarian insufficiency (POI) is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. The POI guideline development group of ESHRE recommends the following diagnostic criteria: oligo/ amenorrhea for at least 4 months and an elevated follicle stimulating hormone (FSH) level \>25 mIU/mL on two occasion \>4 weeks apart. Some clinicians and researchers proposed that POI was a progressive disease and there were three stages of POI: occult POI, biochemical POI, overt POI. However, there is lack of reliable indicators to assess the different stages of POI. The present study is to explore the change of menstruation condition, basal follicle-stimulating hormone, anti-müllerian hormone and antral follicle count during the development of POI, and whether those marks can assess the different stages of POI.

Interventions

None listed

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Serum FSH levels ≥10mIU/ml/ serum AMH levels ≤1.0pg/ml/ AFC ≤5, on at least two occasion \>4 weeks apart

Exclusion criteria

* Polycystic Ovarian Syndrome * other causes of amenorrhea

Design outcomes

Primary

MeasureTime frameDescription
the change of serum follicle-stimulating hormone levelsEvery 3 months from date of recruit until the date of study completion, assessed up to 48 monthsthe serum FSH levels between day 2 to day 5 of menstrual cycle
the change of menstruation situationEvery 3 months from date of recruit until the date of study completion, assessed up to 48 monthsMenstrual cycle
the change of serum anti-mullerian hormone levelsEvery 3 months from date of recruit until the date of study completion, assessed up to 48 monthsthe serum anti-mullerian hormone levels between day 2 to day 5 of menstrual cycle
the change of antral follicle countEvery 3 months from date of recruit until the date of study completion, assessed up to 48 monthsAntral follicle count between day 2 to day 5 of menstrual cycle

Countries

China

Contacts

Primary ContactShiling Chen, M.D./Ph.D.
chensl_92@163.com+86-020-62787604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026