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

• Sponsor: Women's Hospital School Of Medicine Zhejiang University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06067529
• Collaborator: (none)
• Enrollment: 400
• Locations: 2
• Anticipated Duration (Months): 26
• Patients Per Site: 200
• Patients Per Site Per Month: 7.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Ovarian Insufficiency	Drug: hormone replacement therapy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Multicenter Observational Study on the Development and Health Effects of Premature Ovarian Insufficiency
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. bone density [1 year]

   Dual Energy X-ray

2. procollagen type I carboxyl-terminal propeptide [1 year]

   peripheral venous blood

3. fasting blood glucose [1 year]

   peripheral venous blood

4. Low-density lipoprotein cholesterol/High-density lipoprotein cholesterol [1 year]

   peripheral venous blood

5. Estradiol/follicle stimulating hormone [1 year]

   peripheral venous blood

Secondary Outcome Measures

1. free triiodothyronine/free thyroxine [1 year]

   peripheral venous blood

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women's Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang	China	310000
2	Women's Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

• Women's Hospital School Of Medicine Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhou Jianhong, Department director, Women's Hospital School Of Medicine Zhejiang University
• ClinicalTrials.gov Identifier: NCT06067529
• Other Study ID Numbers: ZDFY2022-4XA101
• First Posted: Oct 5, 2023
• Last Update Posted: Oct 5, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhou Jianhong, Department director, Women's Hospital School Of Medicine Zhejiang University: Premature Ovarian Insufficiency
• Additional relevant MeSH terms: Premature Birth; Menopause, Premature; Primary Ovarian Insufficiency; Hormones

Study Results

No Results Posted as of Oct 5, 2023