Eastern Siberia PCOS Epidemiology & Phenotype Study

NCT ID: NCT05194384

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1148 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-03
• Study Completion Date: 2019-12-31

Brief 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.

Conditions

PCOS

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems

OTHER

Sponsor Role: lead

Responsible Party

Larisa Suturina

The Head of the Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larisa V Suturina, PhD, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems. Irkutsk, Russia

Daria V Lizneva, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai, New York, NY, USA

Frank Stanczyk, PhD, Prof

Role: STUDY_CHAIR

Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

Richard S Legro, MD,Prof

Role: STUDY_CHAIR

Hershey Medical Center, Penn State College of Medicine, Penn State University, Hershey, PA, USA

Bulent O Yildiz, PhD, MD, Prof

Role: STUDY_CHAIR

Hacettepe University School of Medicine, Hacettepe, Ankara, Turkey

Ricardo Azziz, PhD, MD, Prof

Role: STUDY_CHAIR

School of Public Health, University at Albany, SUNY, Albany, and School of Medicine, University of Alabama at Birmingham, Birmingham, USA

Locations

Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems

Irkutsk, Irkutsk Oblast, Russia

Countries

Russia

References

Jalilian A, Kiani F, Sayehmiri F, Sayehmiri K, Khodaee Z, Akbari M. Prevalence of polycystic ovary syndrome and its associated complications in Iranian women: A meta-analysis. Iran J Reprod Med. 2015 Oct;13(10):591-604.

Reference Type: BACKGROUND

PMID: 26644787 (View on PubMed)

Bozdag G, Mumusoglu S, Zengin D, Karabulut E, Yildiz BO. The prevalence and phenotypic features of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod. 2016 Dec;31(12):2841-2855. doi: 10.1093/humrep/dew218. Epub 2016 Sep 22.

Reference Type: BACKGROUND

PMID: 27664216 (View on PubMed)

Huang Z, Yong EL. Ethnic differences: Is there an Asian phenotype for polycystic ovarian syndrome? Best Pract Res Clin Obstet Gynaecol. 2016 Nov;37:46-55. doi: 10.1016/j.bpobgyn.2016.04.001. Epub 2016 May 18.

Reference Type: BACKGROUND

PMID: 27289337 (View on PubMed)

Ding T, Hardiman PJ, Petersen I, Wang FF, Qu F, Baio G. The prevalence of polycystic ovary syndrome in reproductive-aged women of different ethnicity: a systematic review and meta-analysis. Oncotarget. 2017 Jul 12;8(56):96351-96358. doi: 10.18632/oncotarget.19180. eCollection 2017 Nov 10.

Reference Type: BACKGROUND

PMID: 29221211 (View on PubMed)

Lazareva L, Suturina L, Atalyan A, Danusevich I, Nadelyaeva I, Belenkaya L, Egorova I, Ievleva K, Babaeva N, Lizneva D, Legro RS, Azziz R. Ovarian Morphology in Non-Hirsute, Normo-Androgenic, Eumenorrheic Premenopausal Women from a Multi-Ethnic Unselected Siberian Population. Diagnostics (Basel). 2024 Mar 22;14(7):673. doi: 10.3390/diagnostics14070673.

Reference Type: DERIVED

PMID: 38611586 (View on PubMed)

Suturina L, Lizneva D, Atalyan A, Lazareva L, Belskikh A, Bairova T, Sholokhov L, Rashidova M, Danusevich I, Nadeliaeva I, Belenkaya L, Darzhaev Z, Sharifulin E, Belkova N, Igumnov I, Trofimova T, Khomyakova A, Ievleva K, Babaeva N, Egorova I, Salimova M, Yildiz BO, Legro RS, Stanczyk FZ, Azziz R. Establishing Normative Values to Determine the Prevalence of Biochemical Hyperandrogenism in Premenopausal Women of Different Ethnicities from Eastern Siberia. Diagnostics (Basel). 2022 Dec 22;13(1):33. doi: 10.3390/diagnostics13010033.

Reference Type: DERIVED

PMID: 36611327 (View on PubMed)

Other Identifiers

16

Identifier Type: -

Identifier Source: org_study_id