Clinical trial NCT05194384: Eastern Siberia PCOS Epidemiology & Phenotype Study
Official title: Eastern Siberia PCOS Epidemiology & Phenotype Study (ESPEP Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PCOS
Keywords: PCOS
phenotype
Eastern Siberia
Epidemiology
prevalence
hyperandrogenism
mF-G score
PCOM
unselected population
Lead sponsor: Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: University of Southern California
name: Penn State University
name: Hacettepe University
name: University of Alabama at Birmingham
First posted: 2022-01-18
Enrollment: 1148
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
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.

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.

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

Primary outcomes:
measure: The prevalence of PCOS (overall and by race) in unselected (medically unbiased) women from Eastern Siberia ages 18 to 44 years
timeFrame: March 2016-December 2019
Secondary outcomes:
measure: The distribution of PCOS phenotypes among the women diagnosed with PCOS in the above objective, overall and by race.
timeFrame: March 2016-December 2019
Other outcomes:
Locations:
city: Irkutsk
country: Russian Federation
facility: Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems
state: Irkutsk Region
Study officials:
affiliation: Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems. Irkutsk, Russia
name: Larisa V Suturina, PhD, MD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai, New York, NY, USA
name: Daria V Lizneva, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Keck School of Medicine, University of Southern California, Los Angeles, CA, USA
name: Frank Stanczyk, PhD, Prof
role: STUDY_CHAIR
affiliation: Hershey Medical Center, Penn State College of Medicine, Penn State University, Hershey, PA, USA
name: Richard S Legro, MD,Prof
role: STUDY_CHAIR
affiliation: Hacettepe University School of Medicine, Hacettepe, Ankara, Turkey
name: Bulent O Yildiz, PhD, MD, Prof
role: STUDY_CHAIR
affiliation: School of Public Health, University at Albany, SUNY, Albany, and School of Medicine, University of Alabama at Birmingham, Birmingham, USA
name: Ricardo Azziz, PhD, MD, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.