Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06067529 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Multicenter Observational Study on the Development and Health Effects of Premature Ovarian Insufficiency

Study acronym: POI
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 9 more changesShow less
    • Enrollment target: 400 to 1080
    • Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026
    • Primary endpoints: 5 to 15
    • Start date changed from estimate of Nov 1, 2023 to Oct 10, 2023
    • Interventions: hormone replacement therapy (Drug) to not stated
    • Eligibility criteria expanded, about 411 words
    • Secondary endpoints: 1 to 3
    • Site details revised at 2 of 2 sites
    • Study arms: 1 to 4
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Premature ovarian insufficiency (POI) refers to the occurrence of ovarian hypofunction in women before the age of 40, which seriously affects women's overall health and quality of life. However, there is currently insufficient understanding of the risk factors, pathogenesis, short-term and long-term health effects of POI, and the health effects of the disease, and there is a lack of high-quality evidence to support clinical diagnosis and treatment decisions. This study intends to construct a hospital-based multi-center POI case-control and prospective special disease cohort, after baseline assessment and follow-up monitoring, collect disease characteristics, lifestyle, social psychology, environmental and occupational exposure, biological samples and other data, aiming to observe POI The natural occurrence, progression and health impact of POI, clarify the risk factors of POI, evaluate the impact of POI on women's health and disease risk, and discuss the benefits, risks and options of HRT for POI patients. The results of this study will deepen and expand the understanding of the occurrence and development of POI and its short-term and long-term health effects, provide high-level evidence for optimizing POI prevention, diagnosis and treatment strategies, and establish a long-term management system, laying the foundation for interventional research.
Trial Details
NCT Number NCT06067529
Lead Sponsor Women's Hospital School Of Medicine Zhejiang University
Conditions
(from sponsor)
Premature Ovarian Insufficiency
Related terms Primary Ovarian Insufficiency
Enrollment 1,080 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov