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

Premature Ovarian Insufficiency Clinical Trial

— POI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06067529
• Other study ID #: ZDFY2022-4XA101
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Insufficiency
• Primary Ovarian Insufficiency

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