Research on Risk Factors and Interventions of Polycystic Ovary Syndrome Complicated With Depression and Anxiety

NCT ID: NCT04984070

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries; Depression, Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PCOS treatment

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.

Group Type: EXPERIMENTAL

Oral Contraceptives, Combined

Intervention Type: DRUG

One of the three medications like ethinylestradiol (35 μg) and cyproterone acetate, drospirenone and ethinylestradiol tablets (I) and (Ⅱ) will be used as an antiandrogen.

Metformin Pill

Intervention Type: DRUG

Metformin is used to lower insulin resistance or to modulate hyperinsulinism.

lifestyle intervention

Intervention Type: OTHER

Weight control including calorie restriction and moderate exercise will be recommended to obese PCOS patients

Interventions

Oral Contraceptives, Combined

One of the three medications like ethinylestradiol (35 μg) and cyproterone acetate, drospirenone and ethinylestradiol tablets (I) and (Ⅱ) will be used as an antiandrogen.

Intervention Type: DRUG

Metformin Pill

Metformin is used to lower insulin resistance or to modulate hyperinsulinism.

Intervention Type: DRUG

lifestyle intervention

Weight control including calorie restriction and moderate exercise will be recommended to obese PCOS patients

Intervention Type: OTHER

Other Intervention Names

Danie-35; Drospirenone and Ethinylestradiol Tablets (I); Drospirenone and Ethinylestradiol Tablets (Ⅱ); Metformin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhang Wei

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Zhang, Doctor

Role: STUDY_DIRECTOR

OB & GYN Hospital of Fudan University

Locations

OB & GYN Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hexia Xia, Doctor

Role: CONTACT

xhx0101@hotmail.com

13601843476

Wei Zhang, Doctor

Role: CONTACT

zhangwei623@hotmail.com

13611699901

Facility Contacts

Hexia Xia, Doctor

Role: primary

hexia_xia@fudan.edu.cn

13601843476

Other Identifiers

FudanU2021-07-19

Identifier Type: -

Identifier Source: org_study_id