Premature Ovarian Insufficiency
Conditions
Keywords
Premature Ovarian Insufficiency
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.
Interventions
None listed
Sponsors
Women's Hospital School Of Medicine Zhejiang University
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Women with POI 1. Inclusion Criteria 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. Iatrogenic POI: Documented history of bilateral oophorectomy, or ovarian failure resulting from chemotherapy or radiotherapy. 1.3 Informed Consent: Willing to participate in the study, provide biological samples, and complete long-term follow-up assessments. 2.
Exclusion criteria
2.1 Current Pregnancy or Lactation: Women who were pregnant or breastfeeding at the time of enrollment. 2.2 Severe Systemic Conditions: Presence of severe somatic or psychiatric diseases (e.g., active malignancy not related to POI, severe heart/renal failure, or cognitive impairment) that would preclude adherence to the study protocol or long-term follow-up. Control 1. Inclusion Criteria: 1.1 Age: 18-50 years. 1.2 Menstrual History: Regular menstrual cycles (21-35 days) for the past 12 months. 1.3 Consent: Willingness to participate, provide biological samples, and provide written informed consent. 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone density | Baseline, 12 months, 24 months, 36 months | Measured by Dual Energy X-ray Unit: g/cm² |
| β-collagen degradation products | Baseline, 12 months, 24 months, 36 months | Bone resorption marker , β-collagen degradation products, are measured in peripheral venous blood. Unit: pg/mL |
| Osteocalcin | Baseline, 12 months, 24 months, 36 months | Bone formation markers, Osteocalcin, are measured in peripheral venous blood. Unit: ng/mL |
| Total type I collagen amino-terminal propeptide | Baseline, 12 months, 24 months, 36 months | Bone formation markers, Total type I collagen amino-terminal propeptide, are measured in peripheral venous blood. Unit: μg/L |
| Reproductive hormones | Baseline, 6 months, 12 months, 24 months, 36 months | Reproductive hormones, including follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), and testosterone (T), are measured in peripheral venous blood. These hormones are assessed together to evaluate female hormonal status. |
| Thyroid function test | Baseline, 12 months, 24 months, 36 months | Thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) are measured in peripheral venous blood. Results will be compared with reference ranges to evaluate thyroid function. |
| Symptoms related to low estrogen | Baseline, 6 months, 12 months, 24 months, 36 months | The symptoms related to low estrogen was quantified using the modified Kupperman Menopausal Index (mKMI). The total score is used to classify the symptom severity into four levels: asymptomatic (≤ 6), mild (7-15), moderate (16-30), and severe (≥ 31). A higher total score indicates more severe symptoms. |
| Sexual life | Baseline, 12 months, 24 months, 36 months | The assessment of Sexual life was conducted using the 6-item Female Sexual Function Index (FSFI-6). A total score ranging from 2 to 30, and a total score of 19 or less was defined as the diagnostic cutoff for identifying individuals with female sexual dysfunction. |
| Fasting blood glucose | Baseline, 6 months, 12 months, 24 months, 36 months | Fasting blood glucose is measured in peripheral venous blood. Results are compared with reference ranges to assess glucose metabolism. Unit: mmol/L |
| Insulin | Baseline, 6 months, 12 months, 24 months, 36 months | Insulin is measured in peripheral venous blood. Results are compared with reference ranges to assess glucose metabolism. Unit: μU/mL |
| Depressive symptoms | Baseline, 6 months, 12 months, 24 months, 36 months | Depressive symptoms were assessed using the 10-item Center for Epidemiologic Studies Depression Scale Revised (CES-D-10) . Total scores range from 0 to 30, and a cutoff score of ≥ 10 was utilized to identify individuals at risk for depression. |
| Anxiety | Baseline, 6 months, 12 months, 24 months, 36 months | Anxiety was evaluated using the Generalized Anxiety Disorder-7 (GAD-7). Total scores were categorized into four levels consisting of minimal anxiety (0-4), mild anxiety (5-9), moderate anxiety (10-14) and severe anxiety (≥ 15). |
| Subjective psychological well-being | Baseline, 6 months, 12 months, 24 months, 36 months | Subjective psychological well-being over the preceding two weeks was quantified through the World Health Organization Five Well-Being Index (WHO-5).A total raw score of \< 13 was considered indicative of potential psychological health issues. |
| Number of Participants with Affected Hepatic Function Tests After Treatment | Baseline, 6 months, 12 months, 24 months, 36 months | Hepatic function parameters are measured in peripheral venous blood. Affected is defined as any value outside the reference ranges below. The number of participants with at least one affected result attributed to HRT will be reported. Parameters and reference ranges: Total protein: 65.0-85.0 g/L Albumin: 40.0-55.0 g/L Albumin/Globulin ratio: 1.20-2.40 (unitless) Alanine aminotransferase (ALT): 7-40 U/L Aspartate aminotransferase (AST): 13-35 U/L Total bilirubin: ≤23.0 μmol/L Direct bilirubin: ≤4.0 μmol/L Indirect bilirubin: ≤19.0 μmol/L Alkaline phosphatase (ALP): 35-100 U/L Gamma-glutamyl transferase (GGT): 7-45 U/L |
| Number of Participants with Affected Renal Function Tests After Treatment | Baseline, 6 months, 12 months, 24 months, 36 months | Renal function parameters are measured in peripheral venous blood. Affected is defined as any value outside the reference ranges below. The number of participants with at least one abnormal result attributed to HRT will be reported. Parameters and reference ranges: Creatinine: 41-73 μmol/L Urea: 2.60-7.50 mmol/L Uric acid: 155-357 μmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Affected Complete Blood Count After Treatment | Baseline, 6 months, 12 months, 24 months, 36 months | 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 |
| Ultrasound examination of pelvic | Baseline, 6 months, 12 months, 24 months, 36 months | Ultrasound examination of pelvic is performed. Results are compared with reference imaging standards to assess and monitor participants' pelvic health. |
| Ultrasound examination of breast | Baseline, 6 months, 12 months, 24 months, 36 months | Ultrasound examination of breast is performed. Results are compared with reference imaging standards to assess and monitor participants' breast health. |
Countries
China
Contacts
CONTACTJianhong Zhou, Doctor of Medicine(M.D.)
Outcome results
None listed