Eastern Siberia PCOS Epidemiology & Phenotype Study

PCOS Clinical Trial

Official title:

Eastern Siberia PCOS Epidemiology & Phenotype Study (ESPEP Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05194384
• Other study ID #: 16
• Status: Completed
• Start date: April 3, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2022
• Source: Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1148
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• PCOS

Locations

Country	Name	City	State
Russian Federation	Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems	Irkutsk	Irkutsk Region

Sponsors (6)

Lead Sponsor	Collaborator
Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems	Hacettepe University, School of Medicine, Icahn School of Medicine at Mount Sinai, Penn State University, University of Alabama at Birmingham, University of Southern California

Country where clinical trial is conducted

Russian Federation, 

References & Publications (4)

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. Epub 2016 Sep 22. Review. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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