PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesPCOSNCT04984070
Research on Risk Factors and Interventions of Polycystic Ovary Syndrome Complicated With Depression and Anxiety
A study testing Oral Contraceptives, Combined, Metformin Pill and lifestyle intervention in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries and Depression, Anxiety, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Depression, Anxiety
- What is being tested?
- Oral Contraceptives, Combined, Metformin Pill and lifestyle intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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,
Who cannot join
- Any other related diseases, such as adrenal congenital hyperplasia, Cushing's syndrome, androgen-secreting tumors, Hashimoto's thyroiditis, hyperthyroidism or hypothyroidism
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
OB & GYN Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011
Hexia Xia, Doctor, 13601843476, hexia_xia@fudan.edu.cn
Hexia Xia, Doctor
About this study
Official title: Research on Risk Factors and Comprehensive Intervention Measures of Polycystic Ovary Syndrome Complicated With Mental Diseases Such as Depression and Anxiety
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.
Read the 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.
- Being tested
- Oral Contraceptives, Combined, Metformin Pill, lifestyle intervention
- Keywords
- polycystic ovary syndrome, depression, anxiety, bipolar disorder, intervention
- Medical subject headings
- Polycystic Ovary Syndrome, Depression, Anxiety Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Contraceptives, CombinedDrug
Also called Danie-35, Drospirenone and Ethinylestradiol Tablets (I), Drospirenone and Ethinylestradiol Tablets (Ⅱ)
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 PillDrug
Also called Metformin
Metformin is used to lower insulin resistance or to modulate hyperinsulinism.
lifestyle interventionOther
Weight control including calorie restriction and moderate exercise will be recommended to obese PCOS patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Oral Contraceptives, Combined; Drug: Metformin Pill; Other: lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
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.
Measured: one year
Anxiety
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.
Measured: one year
Health Related Quality of Life in PCOS
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Wei, Fudan University
- Investigators
- Wei Zhang, Doctor, Study director, OB & GYN Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984070
- Sponsor's protocol ID
- FudanU2021-07-19
- Acronym
- PCOS
- Status last verified
- Oct 2022
- First submitted
- 24 Jul 2021
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Risk Factors and Comprehensive Intervention Measures of Polycystic Ovary Syndrome Complicated With Mental Diseases Such as Depression and Anxiety
- ClinicalTrials.gov ID
- NCT04984070
- Acronym / sponsor ID
- PCOS / FudanU2021-07-19
- Keywords
- polycystic ovary syndrome, depression, anxiety, bipolar disorder, intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCOS treatment | Experimental | Drug: Oral Contraceptives, Combined, Drug: Metformin Pill, Other: lifestyle interventionLifestyle 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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,
Key exclusion criteria (1 listed)
- Any other related diseases, such as adrenal congenital hyperplasia, Cushing's syndrome, androgen-secreting tumors, Hashimoto's thyroiditis, hyperthyroidism or hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Contraceptives, CombinedAlso: Danie-35, Drospirenone and Ethinylestradiol Tablets (I), Drospirenone and Ethinylestradiol Tablets (Ⅱ)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. | Drug | PCOS treatment |
| Metformin PillAlso: MetforminMetformin is used to lower insulin resistance or to modulate hyperinsulinism. | Drug | PCOS treatment |
| lifestyle interventionWeight control including calorie restriction and moderate exercise will be recommended to obese PCOS patients | Other | PCOS treatment |
Primary outcome
Depression
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Zhang, Doctor study director
OB & GYN Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Contraceptives, Combined, Metformin Pill and lifestyle intervention in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries and Depression, Anxiety, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hexia Xia, Doctor (13601843476, xhx0101@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.