PCOSNCT05194384
Eastern Siberia PCOS Epidemiology & Phenotype Study
An observational study of PCOS, run by Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- PCOS
- How many people
- 1,148 participants
- Where
- 1 siteRussia
- Study dates
- 3 Apr 2016to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems
Irkutsk, Irkutsk Oblast, 664003
About this study
Official title: Eastern Siberia PCOS Epidemiology & Phenotype Study (ESPEP Study)
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.
Read the 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
- Keywords
- PCOS, phenotype, Eastern Siberia, Epidemiology, prevalence, hyperandrogenism, mF-G score, PCOM, unselected population
- Medical subject headings
- Hyperandrogenism
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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.
Measured: March 2016-December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start3 Apr 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, University of Southern California, Penn State University, Hacettepe University, University of Alabama at Birmingham
- Responsible party
- Principal investigator, Larisa Suturina, Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems
- Investigators
- Larisa V Suturina, PhD, MD, Prof, Principal investigator, Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems. Irkutsk, RussiaDaria V Lizneva, PhD, MD, Principal investigator, Icahn School of Medicine at Mount Sinai, New York, NY, USAFrank Stanczyk, PhD, Prof, Study chair, Keck School of Medicine, University of Southern California, Los Angeles, CA, USARichard S Legro, MD,Prof, Study chair, Hershey Medical Center, Penn State College of Medicine, Penn State University, Hershey, PA, USABulent O Yildiz, PhD, MD, Prof, Study chair, Hacettepe University School of Medicine, Hacettepe, Ankara, TurkeyRicardo Azziz, PhD, MD, Prof, Study chair, School of Public Health, University at Albany, SUNY, Albany, and School of Medicine, University of Alabama at Birmingham, Birmingham, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194384
- Sponsor's protocol ID
- 16
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 26644787Bozdag 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.
PubMed 27664216Huang 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.
PubMed 27289337Ding 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.
PubMed 29221211Lazareva 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.
PubMed 38611586Suturina 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.
PubMed 36611327
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eastern Siberia PCOS Epidemiology & Phenotype Study (ESPEP Study)
- ClinicalTrials.gov ID
- NCT05194384
- Acronym / sponsor ID
- 16
- Conditions
- PCOS
- Keywords
- PCOS, phenotype, Eastern Siberia, Epidemiology, prevalence, hyperandrogenism, mF-G score, PCOM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,148 participants (actual)
- Lead sponsor
- Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction ProblemsUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, University of Southern California, Penn State University, Hacettepe University, University of Alabama at Birmingham
- Study start
- 3 Apr 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of PCOS (overall and by race) in unselected (medically unbiased) women from Eastern Siberia ages 18 to 44 years
Time frame: March 2016-December 2019
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).
1 secondary outcome
The distribution of PCOS phenotypes among the women diagnosed with PCOS in the above objective, overall and by race.
Time frame: March 2016-December 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Background: PubMed 26644787Jalilian 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.
- Background: PubMed 27664216Bozdag 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.
- Background: PubMed 27289337Huang 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.
- Background: PubMed 29221211Ding 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.
- Derived from this study: PubMed 38611586Lazareva 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.
- Derived from this study: PubMed 36611327Suturina 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.
- Individual participant dataSharing planned: Yes. 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
Related trials for PCOS
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Not yet recruitingObservational study
Chinese Overweight/Obesity Cohort: Metabolic & Comorbidity Risks
Obesity & Overweight, Diabetes Mellitus, Type 2
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for PCOS
Polycystic Ovary Syndrome (PCOS), Polycystic Ovary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larisa V Suturina, PhD, MD, Prof principal investigator
Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems. Irkutsk, Russia
Daria V Lizneva, PhD, MD principal investigator
Icahn School of Medicine at Mount Sinai, New York, NY, USA
Frank Stanczyk, PhD, Prof study chair
Keck School of Medicine, University of Southern California, Los Angeles, CA, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCOS, run by Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of PCOS (overall and by race) in unselected (medically unbiased) women from Eastern Siberia ages 18 to 44 years (time frame: March 2016-December 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05194384, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.