Eastern Siberia PCOS Epidemiology & Phenotype Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Eastern Siberia PCOS Epidemiology & Phenotype Study (ESPEP Study)

Conditions
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PCOS

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent form Willing to comply with all study procedures and be available for the duration of the study Female Aged 18 to 44 All races and ethnic backgrounds Exclusion criteria: Current pregnancy or lactation History of hysterectomy, bilateral oophorectomy, endometrial ablation, uterine artery embolization Current or previous (within 3 months) hormonal medications or insulin-sensitizers intake Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study Unwillingness to participate or difficulty understanding the consent processes or the study objectives and requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of PCOS (overall and by race) in unselected (medically unbiased) women from Eastern Siberia ages 18 to 44 years | PCOS is defined in women ages 18-44 years by the Rotterdam 2003 criteria/ Two of three features, including oligo- or anovulation (OA), clinical and/or biochemical signs of hyperandrogenism (HA), and polycystic ovarian morphology (PCOM), is required, after exclusion of related disorders. Exclusion of related disorders includes uncompensated thyroid dysfunction, uncompensated hyperprolactinemia and 21-hydroxylase deficient non-classic congenital adrenal hyperplasia (NC-CAH). | March 2016-December 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The distribution of PCOS phenotypes among the women diagnosed with PCOS in the above objective, overall and by race. | PCOS subphenotypes are defined based on the combination of clinical and biochemical PCOS features in women aged 18-44 years as follows: Phenotype A - clinical and/or biochemical hyperandrogenism (HA) and oligo-anovulation (OA)/menstrual dysfunction (MD), and polycystic ovarian morphology (PCOM); B - HA and OA/MD; C - HA and PCOM; and D - OA/MD and PCOM. | March 2016-December 2019 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, phenotype, Eastern Siberia, Epidemiology, prevalence, hyperandrogenism, mF-G score, PCOM, unselected population