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

Not yet recruiting

• Conditions: Premature Ovarian Insufficiency
• Interventions: Drug: hormone replacement therapy

• Registration Number: NCT06067529
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-06
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-27
• Last Update Submitted: 2023-09-27
• Study First Posted: 2023-10-05
• Last Update Posted: 2023-10-05
• Study Start: 2023-11-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Premature ovarian insufficiency group	hormone replacement therapy	-

Primary Outcome Measures

Name	Time	Method
bone density	1 year	Dual Energy X-ray
procollagen type I carboxyl-terminal propeptide	1 year	peripheral venous blood
Low-density lipoprotein cholesterol/High-density lipoprotein cholesterol	1 year	peripheral venous blood
Estradiol/follicle stimulating hormone	1 year	peripheral venous blood
fasting blood glucose	1 year	peripheral venous blood

Secondary Outcome Measures

Name	Time	Method
free triiodothyronine/free thyroxine	1 year	peripheral venous blood

Trial Locations

Locations (1)

Women's Hospital School of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China