NCT07739953Active, not recruiting
Development and Clinical Application of ApoC3 Protein as a Predictive Biomarker for Insulin Resistance in Polycystic Ovary Syndrome
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 28 Jul 2026
- Start date
- 1 Jun 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Guangdong Women and Children Hospital
- NCT number
- NCT07739953
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 Jun 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other endocrine disorders; Medication effects; Severe systemic diseases; Special physiological conditions (e.g., pregnancy, lactation); Poor sample quality.
Other
- PCOS without Insulin Resistance (PCOS-non-IR)
Who the study is looking for
- 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;
- 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.
Criteria the registry did not label
- Diagnostic Criteria
- The 2003 Rotterdam diagnostic criteria for PCOS jointly established by the European Society of Human Reproduction and Embryology (ESHRE) and the American Society for Reproductive Medicine (ASRM):
- Clinical and/or biochemical signs of hyperandrogenism; Oligo-ovulation or anovulation; Ultrasound findings: ovarian volume ≥ 10 mL, and/or \> 12 follicles with a diameter of 2-9 mm in a single section.
- A diagnosis of PCOS can be established when at least two of the following three criteria are met: ovarian dysfunction, hyperandrogenism, and polycystic ovarian morphology on ultrasound.
- Inclusion and Exclusion Criteria
- PCOS with Insulin Resistance (PCOS-IR)
Age in the registry: 16 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangdong Women and Children Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.