NCT05194384

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,148

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
Last Updated

February 7, 2022

Status Verified

January 1, 2022

Enrollment Period

1.7 years

First QC Date

January 4, 2022

Last Update Submit

January 23, 2022

Conditions

PCOS

Keywords

PCOSphenotypeEastern SiberiaEpidemiologyprevalencehyperandrogenismmF-G scorePCOMunselected population

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The distribution of PCOS phenotypes among the women diagnosed with PCOS in the above objective, overall and by race.

    March 2016-December 2019

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Irkutsk, Irkutsk Oblast, 664003, Russia

Location

Related Publications (6)

  • 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.

    PMID: 26644787BACKGROUND

  • 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.

    PMID: 27664216BACKGROUND

  • 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.

    PMID: 27289337BACKGROUND

  • 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.

    PMID: 29221211BACKGROUND

  • 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.

    PMID: 38611586DERIVED

  • 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.

    PMID: 36611327DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Hyperandrogenism

Condition Hierarchy (Ancestors)

46, XX Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAdrenogenital SyndromeMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System Diseases

Study Officials

  • Larisa V Suturina, PhD, MD, Prof

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

    PRINCIPAL INVESTIGATOR

  • Daria V Lizneva, PhD, MD

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

    PRINCIPAL INVESTIGATOR

  • Frank Stanczyk, PhD, Prof

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

    STUDY CHAIR

  • Richard S Legro, MD,Prof

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

    STUDY CHAIR

  • Bulent O Yildiz, PhD, MD, Prof

    Hacettepe University School of Medicine, Hacettepe, Ankara, Turkey

    STUDY CHAIR

  • Ricardo Azziz, PhD, MD, Prof

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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Head of the Department

Study Record Dates

First Submitted

January 4, 2022

First Posted

January 18, 2022

Study Start

April 3, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2019

Last Updated

February 7, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

For continued research, IPD data from the ESPEP study will be available to other researchers who have developed important research questions that can be answered by these valuable data. This data access policy applies to all individuals or organizations who would like to utilize data from the ESPEP Study. ESPEP study data may be requested by researchers from various institutions for research purposes only, by submitting an expression of interest (EoI), which should include brief information about a Project leader's name, institution, a title of the potential project, and ethical approval from the Ethics Committee, and a summary of the proposed project. IPD to be shared may include de-identified socio-demographic, clinical data, as well as lab tests results

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The data is currently available, without time limitations
Access Criteria
Requests for access to data will be reviewed by the Sponsor and the Steering Committee of the ESPEP study A Statement of Data Use and a Confidentiality Statement must be signed by any person associated with the project including those who present results, or whose name appears on a publication that is associated with the project. Data access will not be granted until these documents are signed. In signing the Statement of Data Use the lead researcher acknowledges responsibility for ensuring adequate facilities and resources to enable the project to progress in a reasonable manner. Full acknowledgment of the source of data used must be provided in any publications that arise from access to and use of the data as set out in the publication policy

Locations

RU(1)