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Clinical Trials/NCT06067529
NCT06067529
Not yet recruiting
Not Applicable

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

Women's Hospital School Of Medicine Zhejiang University1 site in 1 country400 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
hormone replacement therapy
Conditions
Premature Ovarian Insufficiency
Sponsor
Women's Hospital School Of Medicine Zhejiang University
Enrollment
400
Locations
1
Primary Endpoint
procollagen type I carboxyl-terminal propeptide
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zhou Jianhong

Department director

Women's Hospital School Of Medicine Zhejiang University

Eligibility Criteria

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

Arms & Interventions

Premature ovarian insufficiency group

Intervention: hormone replacement therapy

Outcomes

Primary Outcomes

procollagen type I carboxyl-terminal propeptide

Time Frame: 1 year

peripheral venous blood

bone density

Time Frame: 1 year

Dual Energy X-ray

Low-density lipoprotein cholesterol/High-density lipoprotein cholesterol

Time Frame: 1 year

peripheral venous blood

Estradiol/follicle stimulating hormone

Time Frame: 1 year

peripheral venous blood

fasting blood glucose

Time Frame: 1 year

peripheral venous blood

Secondary Outcomes

  • free triiodothyronine/free thyroxine(1 year)

Study Sites (1)

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