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

NCT06067529 | Unknown

• 1 other identifier: ZDFY2022-4XA101
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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

Keywords

Premature Ovarian Insufficiency

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• free triiodothyronine/free thyroxine

  1 year

Study Arms (1)

Premature ovarian insufficiency group

Drug: hormone replacement therapy

Interventions

hormone replacement therapy DRUG

hormone replacement therapy

Premature ovarian insufficiency group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Females aged 18-39 who were diagnosed with POI

You may qualify if:

• Age 18-39 years old
• Meet POI diagnostic criteria
• Volunteer to participate in this study and willing to cooperate with the investigation

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Hormone Replacement Therapy

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department director

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: October 5, 2023
• Study Start: November 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)