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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06067529
Other study ID # ZDFY2022-4XA101
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2023
Est. completion date December 31, 2025

Study information

Verified date September 2023
Source Women's Hospital School Of Medicine Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria: - Age 18-39 years old - Meet POI diagnostic criteria - Volunteer to participate in this study and willing to cooperate with the investigation Exclusion Criteria: - Reproductive endocrine disease - Those receiving hormone supplementation and other steroid-containing drug therapy now or within half a year - Chromosomal abnormalities - Pregnancy and breastfeeding women - Uncontrolled endocrine system diseases - Uncontrolled cardiovascular system diseases - Uncontrolled autoimmune related diseases - Abnormal liver function - Abnormal kidney function - Abnormal coagulation function - Severe anemia - History of malignant tumors - History of radiotherapy - History of chemotherapy - Mental impairment - Cognitive impairment

Study Design


Intervention

Drug:
hormone replacement therapy
hormone replacement therapy

Locations

Country Name City State
China Women's Hospital School of Medicine Zhejiang University Hangzhou Zhejiang
China Women's Hospital School of Medicine Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary bone density Dual Energy X-ray 1 year
Primary procollagen type I carboxyl-terminal propeptide peripheral venous blood 1 year
Primary fasting blood glucose peripheral venous blood 1 year
Primary Low-density lipoprotein cholesterol/High-density lipoprotein cholesterol peripheral venous blood 1 year
Primary Estradiol/follicle stimulating hormone peripheral venous blood 1 year
Secondary free triiodothyronine/free thyroxine peripheral venous blood 1 year
See also
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