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临床试验/NCT05665010
NCT05665010招募中不适用

Precise Stratification of Genetic Risk of Ovarian Function Impairment

Tongji Hospital18 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
18
主要终点
Genetic variants

研究概览

简要总结

Aging is a common problem in human society at present. The fertility decline, perimenopausal symptoms and senile diseases caused by ovarian aging seriously affect women's own health, offspring's health, family and social stability, and endanger national population security. Accurate stratification of genetic risk of ovarian aging has practical significance. Early and accurate identification of high-risk groups of premature ovarian aging can help such women to start early protection of ovarian function, preserve fertility to a greater extent, improve fertility quality, and also be conducive to early prevention and treatment of other systemic diseases and prognosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women who meet the diagnosis of premature ovarian insufficiency (POI), diminished ovarian reserve (DOR) or early menopause and hope to find out the risk of premature ovarian impairment and clarify the cause of premature ovarian impairment;
  • •premature ovarian insufficiency (POI): the age of female is less than 40 years old, with menopause or sparse menstruation for 4 months, and basal FSH > 25IU / L for two consecutive times with an interval of more than 4 weeks.
  • •Diminshed ovarian reserve (DOR): before the age of 40, the number of antral follicles in both ovaries is less than 6, or AMH is less than 1.1ng/ml, or basal FSH is greater than 10 IU/L.
  • •Early menopause: women who enter menopause between the age of 40 and
  • •Informed consent, voluntary test.

排除标准

  • •Chromosome karyotype abnormality;
  • •Iatrogenic ovarian injury: history of radiotherapy, chemotherapy (reproductive toxic drugs such as alkylating agents) and ovarian surgery;
  • •Ovarian mass: there is abnormal echo in the ovary under ultrasound, and the maximum diameter is greater than 4cm.
  • •Pregnant and lactating women;
  • •Polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, hypothyroidism, adrenal dysfunction and other endocrine diseases affect ovulation;
  • •Patients with cardiovascular, liver, kidney, hematopoietic system and other serious primary diseases and psychosis;
  • •Patients who are participating in other clinical trials or have participated in other clinical trials in the past month;
  • •Other patients determined by the investigator to be unsuitable for participation in this study.

结局指标

主要结局

Genetic variants

时间窗: 2 year

Genetic variants that differed significantly between participants and the general population

次要结局

  • Menopause age(One year after the last menstruation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shixuan Wang

Professsor

Tongji Hospital

研究点 (18)

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