Clinical trial NCT06124391: Novel Subtypes of Polycystic Ovary Syndrome
Official title: An Evidence-Based Novel Subtypes of Polycystic Ovary Syndrome and Their Association With Outcomes: a Large Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 50000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Persistence of PCOS Diagnosis
timeFrame: At the 6.5-year follow-up visit.
measure: Changes in PCOS Subtype
timeFrame: At the 6.5-year follow-up visit.
measure: Body Mass Index
timeFrame: At the 6.5-year follow-up visit.
measure: Non-Alcoholic Fatty Liver Disease (NAFLD)
timeFrame: At the 6.5-year follow-up visit.
measure: Hypertension
timeFrame: At the 6.5-year follow-up visit.
measure: Type 2 Diabetes Mellitus (T2DM)
timeFrame: At the 6.5-year follow-up visit.
measure: Dyslipidemia
timeFrame: At the 6.5-year follow-up visit.
measure: Total live birth rate
timeFrame: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
measure: Clinical pregnancy rate
timeFrame: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
measure: Pregnancy loss rate
timeFrame: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
measure: Maternal and neonatal complications
timeFrame: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
city: Chengdu
country: China
facility: Chengdu Jinjiang Maternity and Child Health Hospital
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital
city: Jinan
country: China
facility: Shandong University
city: Shanghai
country: China
facility: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
city: Singapore
country: Singapore
facility: National University Hospital, National University of Singapore
city: Solna
country: Sweden
facility: Karolinska Institutet
city: Ankara
country: Turkey
facility: Hacettepe University School of Medicine Hacettepe
Study officials:
affiliation: Center for Reproductive Medicine, Shandong University
name: Zi-jiang Chen
role: STUDY_CHAIR
References: