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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Premature Ovarian Insufficiency
• Intervention / Treatment: Drug: hormone replacement therapy

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Women's Hospital School of Medicine Zhejiang University
      • Contact: Jianhong Zhou, MD,PhD; Phone Number: 15990008569; Email: zhoujh1117@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Females aged 18-39 who were diagnosed with POI

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Premature ovarian insufficiency group	Drug: hormone replacement therapy; hormone replacement therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Premature Ovarian Insufficiency
• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: ZDFY2022-4XA101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No