Novel Subtypes of Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06124391
• Other study ID #: PCOS-Subtypes
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: November 2023
• Source: Shandong University
• Contact: Zi-jiang Chen
• Phone: 86-531-85187856
• Email: chenzijiang[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre
China	Chengdu Jinjiang Maternity and Child Health Hospital	Chengdu
China	Guangdong Second Provincial General Hospital	Guangzhou
China	Shandong University	Jinan
China	Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai
China	Tianjin Medical University General Hospital	Tianjin
China	General Hospital of Ningxia Medical University	Yinchuan
Singapore	National University Hospital, National University of Singapore	Singapore
Sweden	Karolinska Institutet	Solna
Turkey	Hacettepe University School of Medicine Hacettepe	Ankara
United States	Penn State College of Medicine	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Countries where clinical trial is conducted

United States,  Brazil,  China,  Singapore,  Sweden,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistence of PCOS Diagnosis	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.
Primary	Changes in PCOS Subtype	Tracking if patients have transitioned between different PCOS subtypes at the follow-up.	At the 6.5-year follow-up visit.
Primary	Body Mass Index	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.
Primary	Non-Alcoholic Fatty Liver Disease (NAFLD)	NAFLD will be assessed using abdominal ultrasound.	At the 6.5-year follow-up visit.
Primary	Hypertension	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.
Primary	Type 2 Diabetes Mellitus (T2DM)	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.
Primary	Dyslipidemia	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.
Primary	Total live birth rate	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.
Primary	Clinical pregnancy rate	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.
Primary	Pregnancy loss rate	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.
Primary	Maternal and neonatal complications	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.