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NCT06124391 | RECRUITING | Polycystic Ovary Syndrome

Novel Subtypes of Polycystic Ovary Syndrome
Sponsor:

Shandong University

Information provided by (Responsible Party):

Chen Z i-Jiang

Brief 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.

Condition or disease

Polycystic Ovary Syndrome

Intervention/treatment

Long-term follow-up

Detailed 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 50000 participants
Official Title : An Evidence-Based Novel Subtypes of Polycystic Ovary Syndrome and Their Association With Outcomes: a Large Cohort Study
Actual Study Start Date : 2021-01-01
Estimated Primary Completion Date : 2025-12-30
Estimated Study Completion Date : 2025-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
Criteria
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.
Novel Subtypes of Polycystic Ovary Syndrome

Location Details

NCT06124391

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Pennsylvania

Penn State College of Medicine

Hershey, Pennsylvania, United States, 17033

RECRUITING

Brazil,

Porto Alegre Clinical Hospital

Porto Alegre, Brazil,

RECRUITING

China,

Chengdu Jinjiang Maternity and Child Health Hospital

Chengdu, China,

RECRUITING

China,

Guangdong Second Provincial General Hospital

Guangzhou, China,

RECRUITING

China,

Shandong University

women, China, 250012

RECRUITING

China,

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

Shanghai, China,

RECRUITING

China,

Tianjin Medical University General Hospital

Tianjin, China,

RECRUITING

China,

General Hospital of Ningxia Medical University

Yinchuan, China,

RECRUITING

Singapore,

National University Hospital, National University of Singapore

Singapore, Singapore,

RECRUITING

Sweden,

Karolinska Institutet

Solna, Sweden, 17165

RECRUITING

Turkey,

Hacettepe University School of Medicine Hacettepe

Ankara, Turkey,