Clinical trial NCT06067529: A Multicenter Observational Study on the Development and Health Effects of Premature Ovarian Insufficiency
Official title: A Multicenter Observational Study on the Development and Health Effects of Premature Ovarian Insufficiency
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Premature Ovarian Insufficiency
Keywords: Premature Ovarian Insufficiency
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females aged 18-39 who were diagnosed with POI

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.


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

Primary outcomes:
measure: bone density
timeFrame: 1 year
measure: procollagen type I carboxyl-terminal propeptide
timeFrame: 1 year
measure: fasting blood glucose
timeFrame: 1 year
measure: Low-density lipoprotein cholesterol/High-density lipoprotein cholesterol
timeFrame: 1 year
measure: Estradiol/follicle stimulating hormone
timeFrame: 1 year
Secondary outcomes:
measure: free triiodothyronine/free thyroxine
timeFrame: 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital School of Medicine Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Women's Hospital School of Medicine Zhejiang University
state: Zhejiang
Study officials:
References: