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

NCT ID: NCT06067529

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-12-31

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.

Conditions

Premature Ovarian Insufficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Premature ovarian insufficiency group

hormone replacement therapy

Intervention Type: DRUG

hormone replacement therapy

Interventions

hormone replacement therapy

hormone replacement therapy

Intervention Type: DRUG

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
• Severe anemia
• History of malignant tumors
• History of radiotherapy
• History of chemotherapy
• Mental impairment
• Cognitive impairment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Zhou Jianhong

Department director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Facility Contacts

Jianhong Zhou, MD,PhD

Role: primary

zhoujh1117@zju.edu.cn

15990008569

Other Identifiers

ZDFY2022-4XA101

Identifier Type: -

Identifier Source: org_study_id