Development and Clinical Application of ApoC3 Protein as a Predictive Biomarker for Insulin Resistance in Polycystic Ovary Syndrome

Official record

Identifier

NCT07739953

Recruiting locations

country

China

Interventions studied

observational study

Lead sponsor

Guangdong Women and Children Hospital

Target enrolment

200 participants

Study type

OBSERVATIONAL

Phase

Not provided in the official record

Status

Active, not recruiting

First posted

Jul 31, 2026

Last updated on the registry

Jul 31, 2026

Age

16 Years – 45 Years

Sex

FEMALE

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

I. 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.

II. Inclusion and Exclusion Criteria

1. PCOS with Insulin Resistance (PCOS-IR)

   Inclusion Criteria:

   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).

   Exclusion Criteria:

   Other endocrine disorders; Medication effects; Severe systemic diseases; Special physiological conditions (e.g., pregnancy, lactation); Poor sample quality.
2. PCOS without Insulin Resistance (PCOS-non-IR)

Inclusion Criteria:

Meets the PCOS diagnostic criteria (as above), with HOMA-IR \< 2.5 and no glucose metabolism abnormalities.

Exclusion Criteria: Same as above.