PCOS (Polycystic Ovary Syndrome)PCOSNCT07739940
Clinical Research Cohort for Polycystic Ovary Syndrome
An observational study of PCOS (Polycystic Ovary Syndrome), run by Guangdong Women and Children Hospital at 1 site in China.
Trial summary
Polycystic Ovary Syndrome (PCOS) is a multifactorial metabolic-endocrine disorder characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphology. According to the 2023 International Evidence-based Guidelines for the Assessment and Management of PCOS, its global prevalence ranges from 10%… Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2025to 1 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 45 years
- Women only
- Child, Adult
Study population: This study will enroll patients diagnosed with Polycystic Ovary Syndrome (PCOS) according to the 2023 International Evidence-based Guidelines for the Assessment and Management of PCOS, as well as age- and BMI-matched healthy controls with regular menstrual cycles. Participants will be recruited from the outpatient clinics of Guangdong Women and Children Hospital. Eligible participants will be consecutively enrolled on a voluntary basis after signing informed consent. Baseline clinical data including hormonal, metabolic, and ultrasound parameters will be collected at enrollment. All participants will be followed longitudinally to assess pregnancy-related outcomes and long-term complications.
Who may be able to join
- Meets the above PCOS diagnostic criteria; Voluntarily signs the informed consent form; Has complete baseline clinical data (including hormonal, metabolic, and ultrasound parameters).
- Age- and BMI-matched healthy females; Regular menstrual cycles (21-35 days); No clinical manifestations or biochemical evidence of hyperandrogenism.
Who cannot join
- Other conditions causing hyperandrogenism or ovulatory dysfunction; Use of hormonal medications within 3 months; Concurrent severe cardiac, hepatic, or renal diseases; Mental disorders that preclude compliance with follow-up.
- Control Group
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Research Cohort for Polycystic Ovary Syndrome (PCOS)
Polycystic Ovary Syndrome (PCOS) is a multifactorial metabolic-endocrine disorder characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphology. According to the 2023 International Evidence-based Guidelines for the Assessment and Management of PCOS, its global prevalence ranges from 10% to 13%, making it one of the major diseases affecting women's health across the entire lifespan. The clinical manifestations of PCOS are highly heterogeneous, leading to menstrual disturbances (such as amenorrhea and abnormal uterine bleeding), infertility, insulin resistance, and an increased risk of type 2 diabetes mellitus in adolescent and reproductive-aged women. In the long term, it may further result in serious complications including diabetes, cardiovascular disease, endometrial hyperplasia, and even malignancy. In addition, pregnant women with PCOS have a significantly increased risk of adverse obstetric outcomes such as spontaneous miscarriage and preeclampsia. Therefore, PCOS requires long-term, systematic clinical management and multidisciplinary collaborative intervention.
However, the long-term follow-up management of PCOS patients faces considerable challenges. Clinical studies have shown that the majority of patients find it difficult to adhere to regular follow-up protocols. On the one hand, this is due to patients' insufficient awareness of the disease, often neglecting its potential long-term health risks; on the other hand, it is attributed to the unequal distribution of healthcare resources, particularly the lack of comprehensive follow-up management systems in primary healthcare facilities. Furthermore, existing clinical research data have notable limitations, making it difficult to provide precise guidance for clinical practice. Therefore, establishing a standardized PCOS clinical research cohort is of significant clinical value. Through the systematic collection of long-term follow-up data, it is possible to comprehensively evaluate the evolution patterns of health risks across different life stages of patients. Cohort studies are conducive to in-depth analysis of the key factors influencing disease progression and provide a scientific basis for clinical risk-stratified management.
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Medical subject headings
- Polycystic Ovary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy-related outcomes and long-term complications
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start28 Jul 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (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)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Guangdong Women and Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Li, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739940
- Sponsor's protocol ID
- GuangdongWCH-Li Li
- Other IDs
- 20250131
- Acronym
- PCOS
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Cohort for Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT07739940
- Acronym / sponsor ID
- PCOS / GuangdongWCH-Li Li
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Guangdong Women and Children HospitalUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 31 Jul 2026 (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.
Polycystic Ovary Syndrome (PCOS) is a multifactorial metabolic-endocrine disorder characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphology. According to the 2023 International Evidence-based Guidelines for the Assessment and Management of PCOS, its global prevalence ranges from 10% to 13%, making it one of the major diseases affecting women's health across the entire lifespan. The clinical manifestations of PCOS are highly heterogeneous, leading to menstrual disturbances (such as amenorrhea and abnormal uterine bleeding), infertility, insulin resistance, and an increased risk of type 2 diabetes mellitus in adolescent and reproductive-aged women. In the long term, it may further result in serious complications including diabetes, cardiovascular disease, endometrial hyperplasia, and even malignancy. In addition, pregnant women with PCOS have a significantly increased risk of adverse obstetric outcomes such as spontaneous miscarriage and preeclampsia. Therefore, PCOS requires long-term, systematic clinical management and multidisciplinary collaborative intervention.
However, the long-term follow-up management of PCOS patients faces considerable challenges. Clinical studies have shown that the majority of patients find it difficult to adhere to regular follow-up protocols. On the one hand, this is due to patients' insufficient awareness of the disease, often neglecting its potential long-term health risks; on the other hand, it is attributed to the unequal distribution of healthcare resources, particularly the lack of comprehensive follow-up management systems in primary healthcare facilities. Furthermore, existing clinical research data have notable limitations, making it difficult to provide precise guidance for clinical practice. Therefore, establishing a standardized PCOS clinical research cohort is of significant clinical value. Through the systematic collection of long-term follow-up data, it is possible to comprehensively evaluate the evolution patterns of health risks across different life stages of patients. Cohort studies are conducive to in-depth analysis of the key factors influencing disease progression and provide a scientific basis for clinical risk-stratified management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- This study will enroll patients diagnosed with Polycystic Ovary Syndrome (PCOS) according to the 2023 International Evidence-based Guidelines for the Assessment and Management of PCOS, as well as age- and BMI-matched healthy controls with regular menstrual cycles. Participants will be recruited from the outpatient clinics of Guangdong Women and Children Hospital. Eligible participants will be consecutively enrolled on a voluntary basis after signing informed consent. Baseline clinical data including hormonal, metabolic, and ultrasound parameters will be collected at enrollment. All participants will be followed longitudinally to assess pregnancy-related outcomes and long-term complications.
Key inclusion criteria (2 listed)
- Meets the above PCOS diagnostic criteria; Voluntarily signs the informed consent form; Has complete baseline clinical data (including hormonal, metabolic, and ultrasound parameters).
- Age- and BMI-matched healthy females; Regular menstrual cycles (21-35 days); No clinical manifestations or biochemical evidence of hyperandrogenism.
Key exclusion criteria (2 listed)
- Other conditions causing hyperandrogenism or ovulatory dysfunction; Use of hormonal medications within 3 months; Concurrent severe cardiac, hepatic, or renal diseases; Mental disorders that preclude compliance with follow-up.
- Control Group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pregnancy-related outcomes and long-term complications
Time frame: 1year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
Related trials for PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for PCOS
Polycystic Ovary Syndrome (PCOS), Polycystic Ovary Syndrome
Enrolling by invitation
Nutrition Intervention for Women With Polycystic Ovary Syndrome
PCOS- Polycystic Ovary Syndrome, Nutrition Intervention
Recruiting
Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With PCOS
PCOS (Polycystic Ovary Syndrome), Insulin Resistance
Not yet recruiting
High Intensity Interval Training Versus Mat Pilates in Women With PCOS
Polycystic Ovarian Syndrome (PCOS), Quality of Life
Recruiting
PMOS in OSA Pilot Study
PCOS, PCOS (Polycystic Ovary Syndrome)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCOS (Polycystic Ovary Syndrome), run by Guangdong Women and Children Hospital 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 2 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: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy-related outcomes and long-term complications (time frame: 1year). 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 31 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.