Novel Subtypes of Polycystic Ovary Syndrome

Last updated: November 28, 2023
Sponsor: Shandong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polycystic Ovarian Syndrome

Reproductive Health

Treatment

Long-term follow-up

Clinical Study ID

NCT06124391
PCOS-Subtypes
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria: Patients with congenital adrenal hyperplasias, androgen-secreting tumours, or Cushing'ssyndrome) will be excluded.

Study Design

Total Participants: 50000
Treatment Group(s): 1
Primary Treatment: Long-term follow-up
Phase:
Study Start date:
January 01, 2021
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre,
    Brazil

    Active - Recruiting

  • Chengdu Jinjiang Maternity and Child Health Hospital

    Chengdu,
    China

    Active - Recruiting

  • Guangdong Second Provincial General Hospital

    Guangzhou,
    China

    Active - Recruiting

  • Shandong University

    Jinan, 250012
    China

    Active - Recruiting

  • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai,
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin,
    China

    Active - Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan,
    China

    Active - Recruiting

  • Oulu University Hospital

    Oulu,
    Finland

    Site Not Available

  • National University Hospital, National University of Singapore

    Singapore,
    Singapore

    Active - Recruiting

  • Karolinska Institutet

    Solna, 17165
    Sweden

    Active - Recruiting

  • Hacettepe University School of Medicine Hacettepe

    Ankara,
    Turkey

    Active - Recruiting

  • Penn State College of Medicine

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

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