Novel Subtypes of Polycystic Ovary Syndrome

NCT06124391 | Unknown

• 1 other identifier: PCOS-Subtypes
• Study Type: observational
• Target: 50,000
• Locations: 6 countries
• Sites: 11

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (11)

• 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.

• 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.

• 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.

• Non-Alcoholic Fatty Liver Disease (NAFLD)

  NAFLD will be assessed using abdominal ultrasound.

  At the 6.5-year follow-up visit.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (4)

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

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

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

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

Interventions

Long-term follow-up OTHER

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.

HA-PCOS; LH-PCOS; OB-PCOS; SHBG-PCOS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• PCOS patients diagnosed using the Rotterdam criteria, which requires the presence of at least two of the following:
• Menstrual Irregularities: A menstrual cycle length of fewer than 21 days or more than 35 days, and/or fewer than eight cycles per year.
• 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.
• 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.

You may not qualify if:

• Patients with congenital adrenal hyperplasias, androgen-secreting tumours, or Cushing's syndrome) will be excluded.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (11)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

RECRUITING

Hospital de Clinicas de Porto Alegre

Porto Alegre, Brazil

RECRUITING

Chengdu Jinjiang Maternity and Child Health Hospital

Chengdu, China

RECRUITING

Guangdong Second Provincial General Hospital

Guangzhou, China

RECRUITING

Shandong University

Jinan, 250012, China

RECRUITING

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

Shanghai, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, China

RECRUITING

National University Hospital, National University of Singapore

Singapore, Singapore

RECRUITING

Karolinska Institutet

Solna, 17165, Sweden

RECRUITING

Hacettepe University School of Medicine Hacettepe

Ankara, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and plasma samples will be collected.

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Zi-jiang Chen

  Center for Reproductive Medicine, Shandong University

  STUDY CHAIR

Central Study Contacts

Zi-jiang Chen

CONTACT

86-531-85187856; chenzijiang@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academician

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 9, 2023
• Study Start: January 1, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); CN (6); BR (1); SG (1); US (1); TU (1)