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Novel Subtypes of Polycystic Ovary Syndrome

Recruiting
18 - 45 years of age
Female
Phase N/A

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Overview

To classify subtypes of Polycystic Ovary Syndrome (PCOS) using machine-learning algorithms, and compare the reproductive and metabolic characteristics and IVF outcomes across these identified subtypes.

Description

In this study, we've developed a machine-learning model to classify PCOS patients into four subtypes based on nine clinical characteristics.

The goal of this observational study is to:

  • Learn about different PCOS subtypes using our classification model.
  • Compare the reproductive and metabolic features of these subtypes.
  • Assess the outcomes of IVF among different PCOS subtypes.
  • Prospective 6.5-year follow-up data will be collected.

Participants will:

  • Undergo a telephone interview to gather details on:
    1. Current physical stats like height and weight.
    2. Reproductive history, including pregnancies and childbirths in recent years.
    3. Details about any IVF treatments.
    4. Current status of conditions such as PCOS, Type 2 Diabetes, hypertension, and dyslipidemia.
  • Be invited for a physical examination that includes:
    1. Measurements such as height, weight, blood pressure, and body circumferences.
    2. Laboratory tests for endocrine and metabolic conditions.
    3. Ultrasound scans of the ovaries and liver.

Eligibility

Inclusion Criteria:

  • PCOS patients diagnosed using the Rotterdam criteria, which requires the presence of at least two of the following:
    1. Menstrual Irregularities: A menstrual cycle length of fewer than 21 days or more than 35 days, and/or fewer than eight cycles per year.
    2. Hyperandrogenism: Defined either by an elevated total testosterone level (as per local laboratory criteria) or by a modified Ferriman-Gallwey (mFG) score of 5 or higher.
    3. Polycystic Ovaries on Ultrasound: Presence of 12 or more follicles measuring 2-9 mm in diameter in each ovary and/or an ovarian volume exceeding 10 mL.

Exclusion Criteria:

        Patients with congenital adrenal hyperplasias, androgen-secreting tumours, or Cushing's
        syndrome) will be excluded.

Study details

Polycystic Ovary Syndrome

NCT06124391

Shandong University

25 January 2024

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