Trial Title:
Novel Subtypes of Polycystic Ovary Syndrome
NCT ID:
NCT06124391
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Long-term follow-up
Description:
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.
Arm group label:
HA-PCOS
Arm group label:
LH-PCOS
Arm group label:
OB-PCOS
Arm group label:
SHBG-PCOS
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.
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.
Criteria for eligibility:
Study pop:
- 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.
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Penn State College of Medicine
Address:
City:
Hershey
Zip:
17033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Richard Legro
Email:
rsl1@psu.edu
Facility:
Name:
Hospital de Clinicas de Porto Alegre
Address:
City:
Porto Alegre
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Poli Spritzer
Email:
spritzer@ufrgs.br
Facility:
Name:
Chengdu Jinjiang Maternity and Child Health Hospital
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Zhou
Email:
linzhoucdjj@gmail.com
Facility:
Name:
Guangdong Second Provincial General Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xianghong Ou
Email:
ouxianghong@yahoo.com.cn
Facility:
Name:
Shandong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
Zi-jiang Chen
Phone:
86-531-85187856
Email:
chenzijiang@hotmail.com
Facility:
Name:
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Yun Sun
Email:
syun163@163.com
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Ye Tian
Email:
tianyesdu@126.com
Facility:
Name:
General Hospital of Ningxia Medical University
Address:
City:
Yinchuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Junli Zhao
Email:
zhaojunli6812@163.com
Facility:
Name:
National University Hospital, National University of Singapore
Address:
City:
Singapore
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Eu-Leong Yong
Email:
obgyel@nus.edu.sg
Facility:
Name:
Karolinska Institutet
Address:
City:
Solna
Zip:
17165
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Elisabet Stener-Victorin
Email:
elisabet.stener-victorin@ki.se
Facility:
Name:
Hacettepe University School of Medicine Hacettepe
Address:
City:
Ankara
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Bulent Yildiz
Email:
yildizbo@yahoo.com
Start date:
January 1, 2021
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Shandong University
Agency class:
Other
Source:
Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06124391
