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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age10-65
SponsorWomen's Hospital School Of Medicine Zhejiang University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

1.1 Age at Diagnosis: Less than 40 years of age. 1.2 Diagnosis of POI: Met one of the following diagnostic criteria based on ESHRE guidelines: Spontaneous POI: Oligomenorrhea or amenorrhea for at least 4 months, combined with elevated FSH levels (> 25 IU/L) on two occasions at least 4 weeks apart.

Disqualifiers

None

Trial population

Women with POI; Control; Ovarian Surgery group; Oophorectomy group

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

1,080 Participants
are grouped into 4 trial groups
Group A: Women with POI
Group B: Control
Group C: Ovarian Surgery group
Group D: Oophorectomy group

Trial outcomes

Primary outcomes

1

Bone density

Measured by Dual Energy X-ray Unit: g/cm²

Time frame
Baseline, 12 months, 24 months, 36 months
2

β-collagen degradation products

Bone resorption marker , β-collagen degradation products, are measured in peripheral venous blood. Unit: pg/mL

Time frame
Baseline, 12 months, 24 months, 36 months
3

Osteocalcin

Bone formation markers, Osteocalcin, are measured in peripheral venous blood. Unit: ng/mL

Time frame
Baseline, 12 months, 24 months, 36 months
4

Total type I collagen amino-terminal propeptide

Bone formation markers, Total type I collagen amino-terminal propeptide, are measured in peripheral venous blood. Unit: μg/L

Time frame
Baseline, 12 months, 24 months, 36 months

Secondary outcomes

1

Number of Participants with Affected Complete Blood Count After Treatment

Complete blood count (CBC) parameters are measured in peripheral venous blood. A participant is considered to have affected CBC if any of the following parameters falls outside the established reference range listed below. The number of participants with at least one affected test result after treatment will be reported. Parameters and reference ranges: White blood cell count: 3.5-9.5 × 10⁹/L Red blood cell count: 3.80-5.10 × 10¹²/L Hemoglobin: 115-150 g/L Platelet count: 125-350 × 10⁹/L

Time frame
Baseline, 6 months, 12 months, 24 months, 36 months
2

Ultrasound examination of pelvic

Ultrasound examination of pelvic is performed. Results are compared with reference imaging standards to assess and monitor participants' pelvic health.

Time frame
Baseline, 6 months, 12 months, 24 months, 36 months
3

Ultrasound examination of breast

Ultrasound examination of breast is performed. Results are compared with reference imaging standards to assess and monitor participants' breast health.

Time frame
Baseline, 6 months, 12 months, 24 months, 36 months

Other outcomes

Sponsors and contacts

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