Clinical trial NCT04984070: Research on Risk Factors and Interventions of Polycystic Ovary Syndrome Complicated With Depression and Anxiety
Official title: Research on Risk Factors and Comprehensive Intervention Measures of Polycystic Ovary Syndrome Complicated With Mental Diseases Such as Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Depression, Anxiety
Keywords: polycystic ovary syndrome
depression
anxiety
bipolar disorder
intervention
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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,

Exclusion Criteria:

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

Primary outcomes:
measure: Depression
timeFrame: one year
measure: Anxiety
timeFrame: one year
measure: Health Related Quality of Life in PCOS
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: OB & GYN Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: OB & GYN Hospital of Fudan University
name: Wei Zhang, Doctor
role: STUDY_DIRECTOR
References: