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临床试验/NCT04984070
NCT04984070招募中不适用

Research on Risk Factors and Comprehensive Intervention Measures of Polycystic Ovary Syndrome Complicated With Mental Diseases Such as Depression and Anxiety

Fudan University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Depression

研究概览

简要总结

The current study intends to establish a prediction method and evaluation system for polycystic ovary syndrome (PCOS) complicated with affective disorder, such as depression and anxiety, through the epidemiological investigation. Randomized controlled studies on the efficacy of various intervention methods should be carried out to develop early intervention measures and methods in order to reduce the harm of psychological disorders, to facilitate the mental health of PCOS patients, and thus to improve the quality of life.

详细描述

PCOS is one of the most common reproductive endocrine and metabolic diseases in women of adolescence and childbearing age. The prevalence of PCOS in reproductive women is as high as 5-10%, about 50-80% of whom are infertile and need ovulation induction or in vitro fertilization-embryo transfer (IVF-ET). Ovulation/anovulation and hyperandrogenemia are two main features of PCOS. Moreover, about 50-60% of PCOS patients present insulin resistance/hyperinsulinemia. The probability of miscarriage in PCOS is also higher than that of control women. Pregnancy complications in PCOS patients, such as gestational diabetes, preeclampsia, etc., and long-term complications of metabolic syndrome and endometrial cancer are more likely to happen. These not only greatly affect women's reproductive health, but also seriously endanger their psychological status. A large sample of data has shown that the risk of depression in women with PCOS is 3.78 times higher than that of the control women, 5.62 times for anxiety, and 1.78 times for bipolar disorder. With the economic development, more and more attention is paid to the quality of life including their mental health. However, there is few data on the risk factors of depression, anxiety and other psychological disorders in women with PCOS. There is a lack of effective evaluation and prediction systems. It is urgent to establish a risk assessment system for PCOS complicated with psychological diseases through scientific and systematic research, to formulate comprehensive intervention measures to improve the quality of life of women with PCOS and to reduce the incidence of affective disorders.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Patients diagnosed as PCOS according to Rotterdam criteria 2003, aged between 18 and 40 years old, and no willing to get pregnant in a year.
  • At least two of the following three criteria were met: clinical and/or biochemical signs of hyperandrogenism, oligo- and/or anovulation, and polycystic ovary on ultrasonography,

排除标准

  • Any other related diseases, such as adrenal congenital hyperplasia, Cushing's syndrome, androgen-secreting tumors, Hashimoto's thyroiditis, hyperthyroidism or hypothyroidism

研究组 & 干预措施

PCOS treatment

Experimental

Lifestyle intervention, oral contraceptive pills and metformin will be given to improve the symptoms of PCOS patients, such as obesity, hyperandrogegism, and insulin resistance, and to compare the different psychological status in PCOS.

干预措施: Oral Contraceptives, Combined (Drug)

PCOS treatment

Experimental

Lifestyle intervention, oral contraceptive pills and metformin will be given to improve the symptoms of PCOS patients, such as obesity, hyperandrogegism, and insulin resistance, and to compare the different psychological status in PCOS.

干预措施: Metformin Pill (Drug)

PCOS treatment

Experimental

Lifestyle intervention, oral contraceptive pills and metformin will be given to improve the symptoms of PCOS patients, such as obesity, hyperandrogegism, and insulin resistance, and to compare the different psychological status in PCOS.

干预措施: lifestyle intervention (Other)

结局指标

主要结局

Depression

时间窗: one year

The self-rating depression scale(SDS) is assessed before and after intervention. The SDS score multiplied by 1.25 is a standard score, which is between 25-100. A score no less than 50 is consider as depression.

Anxiety

时间窗: one year

The self-rating anxiety scale(SAS) is assessed before and after intervention. The SAS score multiplied by 1.25 is a standard score, which is between 25-100. A score no less than 50 is consider as anxiety.

Health Related Quality of Life in PCOS

时间窗: one year

The scores of Health Related Quality of Life Questionnaire are assessed before and after treatment, which range from 30 to 210. Higher scores indicate higher quality of life of PCOS patients with less influence from PCOS.

次要结局

未报告次要终点

研究者

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

Zhang Wei

professor

Fudan University

研究点 (1)

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