Novel Subtypes of Polycystic Ovary Syndrome

November 28, 2023 updated by: Chen Zi-Jiang, Shandong University

An Evidence-Based Novel Subtypes of Polycystic Ovary Syndrome and Their Association With Outcomes: a Large Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • Porto Alegre, Brazil
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:
  • China
      • Chengdu, China
        • Recruiting
        • Chengdu Jinjiang Maternity and Child Health Hospital
        • Contact:
      • Guangzhou, China
      • Jinan, China, 250012
        • Recruiting
        • Shandong University
        • Contact:
      • Shanghai, China
        • Recruiting
        • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
      • Yinchuan, China
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National University Hospital, National University of Singapore
        • Contact:
  • Sweden
  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Hacettepe University School of Medicine Hacettepe
        • Contact:
  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  • Discovery cohort: Patients diagnosed with PCOS who sought care at the Center for Reproductive Medicine, Shandong University between December 2013 and June 2020.

  • The validation cohorts of this study consist of four populations.

    1. China Validation Cohort: Consists of patients from various regions in China, excluding Shandong.
    2. America Validation Cohort: Participants from the Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial.
    3. Singapore Validation Cohort.
    4. Europe Validation Cohort: Comprising patients from Turkey.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HA-PCOS
Patients were classified into each PCOS subtype based on our machine-learning classification model. The feature of the HA-PCOS group is hyperandrogenism.
Other: Long-term follow-up
Participants diagnosed with PCOS were not subjected to any specific intervention post-diagnosis. Instead, they were followed up after 6.5 years to assess various outcomes related to PCOS and associated conditions.
OB-PCOS
Patients were classified into each PCOS subtype based on our machine-learning classification model. The feature of the OB-PCOS group is overweight/obesity.
Other: Long-term follow-up
Participants diagnosed with PCOS were not subjected to any specific intervention post-diagnosis. Instead, they were followed up after 6.5 years to assess various outcomes related to PCOS and associated conditions.
SHBG-PCOS
Patients were classified into each PCOS subtype based on our machine-learning classification model. The feature of the SHBG-PCOS group is the high level of serum SHBG.
Other: Long-term follow-up
Participants diagnosed with PCOS were not subjected to any specific intervention post-diagnosis. Instead, they were followed up after 6.5 years to assess various outcomes related to PCOS and associated conditions.
LH-PCOS
Patients were classified into each PCOS subtype based on our machine-learning classification model. The feature of the LH-PCOS group is the high level of LH and AMH.
Other: Long-term follow-up
Participants diagnosed with PCOS were not subjected to any specific intervention post-diagnosis. Instead, they were followed up after 6.5 years to assess various outcomes related to PCOS and associated conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence of PCOS Diagnosis
Time Frame: At the 6.5-year follow-up visit.
Determining if patients still meet the Rotterdam criteria for a PCOS diagnosis at the follow-up. The hyperandrogenic, ovulatory, and polycystic ovarian conditions at the follow-up time will be assessed.
At the 6.5-year follow-up visit.
Changes in PCOS Subtype
Time Frame: At the 6.5-year follow-up visit.
Tracking if patients have transitioned between different PCOS subtypes at the follow-up.
At the 6.5-year follow-up visit.
Body Mass Index
Time Frame: At the 6.5-year follow-up visit.
Patients' weight (in kilograms) and height (in meters) will be collected and combined to report BMI in kg/m^2
At the 6.5-year follow-up visit.
Non-Alcoholic Fatty Liver Disease (NAFLD)
Time Frame: At the 6.5-year follow-up visit.
NAFLD will be assessed using abdominal ultrasound.
At the 6.5-year follow-up visit.
Hypertension
Time Frame: At the 6.5-year follow-up visit.
Blood pressure will be assessed, and we will determine if a patient has hypertension, defined as systolic blood pressure (SBP) ≥ 140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg.
At the 6.5-year follow-up visit.
Type 2 Diabetes Mellitus (T2DM)
Time Frame: At the 6.5-year follow-up visit.
Fasting glucose will be assessed, and we will determine if a patient has T2DM, defined as fasting glucose ≥ 7.0 mmol/l.
At the 6.5-year follow-up visit.
Dyslipidemia
Time Frame: At the 6.5-year follow-up visit.

Defined as the presence of any of the following abnormalities:

  • Total cholesterol ≥ 5.2 mmol/l
  • Triglycerides (TG) ≥ 1.7 mmol/l
  • High-density lipoprotein (HDL) < 1.0 mmol/l
  • Low-density lipoprotein (LDL) ≥ 3.35 mmol/l
At the 6.5-year follow-up visit.
Total live birth rate
Time Frame: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Live birth is defined as the delivery of any neonate with signs of life at ≥ 28 weeks of gestation.
From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Clinical pregnancy rate
Time Frame: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Clinical pregnancy is defined as the ultrasound confirmation of at least one intrauterine gestational sac.
From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Pregnancy loss rate
Time Frame: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Pregnancy loss is defined as pregnancies that eventuate in a spontaneous abortion or therapeutic abortion that occurred throughout pregnancy.
From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Maternal and neonatal complications
Time Frame: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Any maternal and neonatal complications, including gestational diabetes, preeclampsia, etc., will be collected.
From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Study Chair: Zi-jiang Chen, Center for Reproductive Medicine, Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

November 4, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCOS-Subtypes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polycystic Ovary Syndrome

Clinical Trials on Long-term follow-up

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe