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

Обзор

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.

Первичные конечные точки

• Bone density [Срок оценки: Baseline, 12 months, 24 months, 36 months]
• β-collagen degradation products [Срок оценки: Baseline, 12 months, 24 months, 36 months]
• Osteocalcin [Срок оценки: Baseline, 12 months, 24 months, 36 months]
• Total type I collagen amino-terminal propeptide [Срок оценки: Baseline, 12 months, 24 months, 36 months]
• Reproductive hormones [Срок оценки: Baseline, 6 months, 12 months, 24 months, 36 months]
• Thyroid function test [Срок оценки: Baseline, 12 months, 24 months, 36 months]
• Symptoms related to low estrogen [Срок оценки: Baseline, 6 months, 12 months, 24 months, 36 months]
• Sexual life [Срок оценки: Baseline, 12 months, 24 months, 36 months]
• Fasting blood glucose [Срок оценки: Baseline, 6 months, 12 months, 24 months, 36 months]
• Insulin [Срок оценки: Baseline, 6 months, 12 months, 24 months, 36 months]

Вторичные конечные точки (3)

• Number of Participants with Affected Complete Blood Count After Treatment [Срок оценки: Baseline, 6 months, 12 months, 24 months, 36 months]
• Ultrasound examination of pelvic [Срок оценки: Baseline, 6 months, 12 months, 24 months, 36 months]
• Ultrasound examination of breast [Срок оценки: Baseline, 6 months, 12 months, 24 months, 36 months]

Критерии участия

Women with POI

• 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.

• 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

• 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.

• Exclusion Criteria:

2.1 Physiological Status: Pregnancy, breastfeeding, or clinical perimenopause/postmenopause.

2.2 Reproductive Disorders: History of PCOS, endometriosis, or other reproductive pathologies.

2.3 Iatrogenic \& Toxic Factors: Prior ovarian surgery (e.g., cystectomy), chemotherapy, or radiotherapy.

2.4 Systemic Diseases: History of endocrine (e.g., thyroid dysfunction), autoimmune, cardiovascular, liver, kidney, or hematological diseases, or malignancy.

2.5 Genetic \& Familial Background: First-degree relatives with POI or early menopause (< 45 years). Family history of hereditary diseases. 2.6 Medication: Use of hormonal drugs or contraceptives within the last 6 months.

Ovarian Surgery group

• Inclusion Criteria:

1.1 Age: 18-60 years. 1.2 Patients with ovarian surgery: women scheduled to undergo ovarian surgery for gynecological disease.

1.3 Informed Consent: Willing to participate in the study, provide biological samples, and sign the informed consent.

• Exclusion Criteria:

2.1 Reproductive Disorders: History of PCOS, endometriosis, or other reproductive pathologies.

2.2 Medication: Use of hormonal drugs or contraceptives within the last 6 months.

2.3 Genetic or chromosomal abnormalities: Turner syndrome, or other genetic disease.

2.4 Physiological Status: Pregnancy, breastfeeding, or seeking the help of assisted reproductive technology.

2.5 Severe systemic Diseases: History of endocrine (e.g., thyroid dysfunction), autoimmune, cardiovascular, liver, kidney, hematological diseases, malignancy, or cognitive impairment.

Oophorectomy group

• Inclusion Criteria:

1.1 Age: 45-65 years. 1.2 Patients with oophorectomy: women scheduled to undergo oophorectomy due to gynecological diseases and met criteria for being menopausal.

1.3 Menopausal status: at least 12 consecutive months of amenorrhea without other medical causes.

1.3 Informed Consent: Willing to participate in the study, provide biological samples, and sign the informed consent.

• Exclusion Criteria:

2.1 Reproductive Disorders: History of PCOS, endometriosis, or other reproductive pathologies.

2.2 Medication: Use of hormonal drugs or contraceptives within the last 6 months.

2.3 Genetic or chromosomal abnormalities: Turner syndrome, or other genetic disease 2.4 Physiological Status: Pregnancy, breastfeeding, or seeking the help of assisted reproductive technology.

2.5 Severe systemic Diseases: History of endocrine (e.g., thyroid dysfunction), autoimmune, cardiovascular, liver, kidney, hematological diseases, malignancy, or cognitive impairment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 2 центра

• Women's Hospital School of Medicine Zhejiang University — Ханчжоу
• Women's Hospital School of Medicine Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT06067529 · ZDFY2022-4XA101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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