Eastern Siberia PCOS Epidemiology & Phenotype Study
Condition: PCOS
Study type: Observational

Summary: 
      This multicenter, institution-based, cross-sectional study evaluates the prevalence of
      polycystic ovary syndrome (PCOS) and PCOS phenotype in Eastern Siberia - the unique region of
      the Russian Federation with a multi-raced population living in similar geographic and
      socio-economic conditions for centuries. Therefore, the investigators considered this
      population optimal for epidemiological research.
    

Detailed description: 
      Polycystic Ovarian Syndrome (PCOS) has a high prevalence and is a significant reproductive,
      metabolic, and psychosocial disorder. Several studies have demonstrated that PCOS affects
      from 6% (defined by NIH 1990 criteria) to 19.5% (under Rotterdam 2003 criteria) of
      reproductive-aged women (Jalilian et al., 2015; Bozdag et al., 2016). The prevalence of PCOS
      and its symptoms may vary according to geography and race/ethnicity (Huang et al., 2016; Ding
      et al., 2017). Clinical studies indicate variations in the presence and severity of PCOS and
      its clinical symptoms: hirsutism, obesity, insulin resistance by race and ethnicity.
      Unfortunately, there is a lack of data on the prevalence of PCOS and its phenotype in many
      geographic regions, in particular, in one of the largest countries in the world, Russia.

      Objectives: To determine the prevalence of PCOS and the PCOS phenotypes in unselected
      (medically unbiased) premenopausal women in the Eastern Siberia region.

      Study design and population: this is the multicenter, institution-based, cross-sectional
      Eastern Siberia PCOS Epidemiology & Phenotype (ESPEP) Study, conducted in Irkutsk Region and
      the Burjat Republic (Russia) during 2016-2019 yrs. ESPEP included premenopausal women aged 18
      to 44 yrs, Caucasians, Asians, or those of mixed-race, recruited during an obligatory early
      medical employment assessment, and provided written informed consent. The study is approved
      by the Institutional Ethics Committee of the Scientific Center for Family Health a Human
      Reproduction (Irkutsk, Russian Federation).

      Methods. Subjects are evaluated consecutively, including questionnaires, anthropometry, and
      vital signs, gynecological examination, modified Ferriman-Gallway (mF-G) scoring, pelvic
      ultrasound, and blood sampling. For PCOS diagnosis the investigators use the Rotterdam (2003)
      criteria. Serum samples are analyzed for total testosterone (TT) using LC-MS/MS. DHEAS, sex
      hormone-binding globulin (SHBG), prolactin, TSH, and 17-OHP are assessed by ELISA. Free
      Androgen Index (FAI) is calculated (i.e. [TT/SHBG] x 100). The upper normal limit (UNL) for
      the mF-G score is determined using a 2k-cluster analysis in the total study population. The
      upper normal limits (UNL) for TT, FAI, and DHEAS are determined from the 98th percentiles for
      these parameters in )women, identified as the "super-controls". Pelvic ultrasound (U/S) is
      performed by 3 experienced specialists with the appropriate intra/inter-observer variations,
      using Mindray М7 (MINDRAY, China), a transvaginal probe (5,0-8,0 МHz) or transabdominal probe
      (2,5-5,0 MHz). Ovarian volume is determined by the following formula: length x width x height
      x 0,523.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        An unselected women from Eastern Siberia aged 18 to 44 years, Caucasians, Asians, or women
        of mixed race, recruited in Irkutsk Region and the Burjat Republic (Russia) during an
        obligatory early medical employment assessment in 2016-2019.
      
Biospecimen description: 
      The investigators obtain blood for DNA extraction at the screening visit. Blood is sent to an
      SC FHHRP facility where DNA is extracted and stored for future analyses.
    
Keywords: PCOS; phenotype; Eastern Siberia; Epidemiology; prevalence; hyperandrogenism; mF-G score; PCOM; unselected population