PCOS (Polycystic Ovary Syndrome)NCT07739953
Development and Clinical Application of ApoC3 Protein as a Predictive Biomarker for Insulin Resistance in 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 the most common reproductive endocrine disorder causing infertility and miscarriage in women. The insulin resistance state in PCOS patients (PCOS with insulin resistance, PCOS-IR) not only affects their fertility but is also associated with a range of health issues, including type 2… Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- observational study
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 30 Jun 2027
- 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
- Healthy volunteers accepted
- Child, Adult
Study population: This study included PCOS patients diagnosed according to the 2003 Rotterdam criteria (at least 2 of: oligo/anovulation, clinical/biochemical hyperandrogenism, or polycystic ovaries on ultrasound). Patients were divided into two groups: PCOS-IR group: met PCOS criteria plus at least one of: HOMA-IR ≥ 2.5, fasting insulin ≥ 15 μIU/mL, or diagnosed IGT/T2DM. PCOS-non-IR group: met PCOS criteria with HOMA-IR < 2.5 and no glucose metabolism abnormalities. Exclusion criteria: other endocrine disorders, medication use, severe systemic diseases, pregnancy/lactation, or poor sample quality.
Who may be able to join
- Meets the 2003 Rotterdam diagnostic criteria for PCOS (at least 2 of the following 3 items):
- ① Oligo-ovulation or anovulation;
- ② Clinical or biochemical signs of hyperandrogenism;
- ③ Polycystic ovaries on ultrasound (unilateral or ovarian volume ≥ 10 mL).
- Insulin resistance (IR), meeting at least 1 of the following 3 criteria:
- ① HOMA-IR ≥ 2.5;
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- ② Fasting insulin ≥ 15 μIU/mL;
- ③ Diagnosed impaired glucose tolerance (IGT) or type 2 diabetes mellitus (T2DM).
- Meets the PCOS diagnostic criteria (as above), with HOMA-IR < 2.5 and no glucose metabolism abnormalities.
Who cannot join
- Other endocrine disorders; Medication effects; Severe systemic diseases; Special physiological conditions (e.g., pregnancy, lactation); Poor sample quality.
- PCOS without Insulin Resistance (PCOS-non-IR)
Trial locations and contacts
1 site in 1 country.
About this study
Polycystic Ovary Syndrome (PCOS) is the most common reproductive endocrine disorder causing infertility and miscarriage in women. The insulin resistance state in PCOS patients (PCOS with insulin resistance, PCOS-IR) not only affects their fertility but is also associated with a range of health issues, including type 2 diabetes mellitus, endometrial cancer, and spontaneous abortion during pregnancy. There is an urgent clinical need to explore sensitive serum biomarkers for the diagnosis of insulin resistance in PCOS. Our preliminary studies have demonstrated that apolipoprotein C-III (ApoC3) exhibits diagnostic efficacy for PCOS-IR and is positively correlated with HOMA-IR, for which we were granted a national invention patent in China in 2016. Building on our research foundation in PCOS insulin resistance, we have developed a rapid detection kit for the ApoC3 protein, enabling early screening of insulin resistance in PCOS. Furthermore, point-of-care testing (POCT) products can achieve rapid quantitative detection of biomarkers. This project has recently been funded by the Guangdong Provincial Department of Science and Technology under the 2024 Guangdong-Hong Kong-Macao Greater Bay Area International Innovation Center Construction Initiative (Guangdong-Hong Kong-Macao Joint Innovation Field).
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- observational study
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
Observational Study
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse pregnancy outcomes and long-term complications such as type 2 diabetes mellitus
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 start1 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 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
- 200 participants (estimated)
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
- NCT07739953
- Sponsor's protocol ID
- GuangdongWCH-Li Li4
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Individual data sharing
- 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
- Development and Clinical Application of ApoC3 Protein as a Predictive Biomarker for Insulin Resistance in Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07739953
- Acronym / sponsor ID
- GuangdongWCH-Li Li4
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guangdong Women and Children HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 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 the most common reproductive endocrine disorder causing infertility and miscarriage in women. The insulin resistance state in PCOS patients (PCOS with insulin resistance, PCOS-IR) not only affects their fertility but is also associated with a range of health issues, including type 2 diabetes mellitus, endometrial cancer, and spontaneous abortion during pregnancy. There is an urgent clinical need to explore sensitive serum biomarkers for the diagnosis of insulin resistance in PCOS. Our preliminary studies have demonstrated that apolipoprotein C-III (ApoC3) exhibits diagnostic efficacy for PCOS-IR and is positively correlated with HOMA-IR, for which we were granted a national invention patent in China in 2016. Building on our research foundation in PCOS insulin resistance, we have developed a rapid detection kit for the ApoC3 protein, enabling early screening of insulin resistance in PCOS. Furthermore, point-of-care testing (POCT) products can achieve rapid quantitative detection of biomarkers. This project has recently been funded by the Guangdong Provincial Department of Science and Technology under the 2024 Guangdong-Hong Kong-Macao Greater Bay Area International Innovation Center Construction Initiative (Guangdong-Hong Kong-Macao Joint Innovation Field).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This study included PCOS patients diagnosed according to the 2003 Rotterdam criteria (at least 2 of: oligo/anovulation, clinical/biochemical hyperandrogenism, or polycystic ovaries on ultrasound). Patients were divided into two groups: PCOS-IR group: met PCOS criteria plus at least one of: HOMA-IR ≥ 2.5, fasting insulin ≥ 15 μIU/mL, or diagnosed IGT/T2DM. PCOS-non-IR group: met PCOS criteria with HOMA-IR < 2.5 and no glucose metabolism abnormalities. Exclusion criteria: other endocrine disorders, medication use, severe systemic diseases, pregnancy/lactation, or poor sample quality.
Key inclusion criteria (9 listed)
- Meets the 2003 Rotterdam diagnostic criteria for PCOS (at least 2 of the following 3 items):
- ① Oligo-ovulation or anovulation;
- ② Clinical or biochemical signs of hyperandrogenism;
- ③ Polycystic ovaries on ultrasound (unilateral or ovarian volume ≥ 10 mL).
- ① HOMA-IR ≥ 2.5;
Key exclusion criteria (2 listed)
- Other endocrine disorders; Medication effects; Severe systemic diseases; Special physiological conditions (e.g., pregnancy, lactation); Poor sample quality.
- PCOS without Insulin Resistance (PCOS-non-IR)
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 |
|---|---|---|
| observational studyObservational Study | Other | – |
Primary outcome
adverse pregnancy outcomes and long-term complications such as type 2 diabetes mellitus
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.
- Individual participant dataSharing planned: No
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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.
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 9 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?
adverse pregnancy outcomes and long-term complications such as type 2 diabetes mellitus (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.