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

Study Overview
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Brief Summary
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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.

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

Conditions
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Premature Ovarian Insufficiency

Intervention / Treatment
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* Drug: hormone replacement therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Premature ovarian insufficiency group<br> | Drug: hormone replacement therapy<br>* hormone replacement therapy<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| free triiodothyronine/free thyroxine | peripheral venous blood | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Ovarian Insufficiency