Evaluation of the Prevalence, Regional Phenotypic Variation, Comorbidities, Risk Factors, and Variations in Response to Different Therapeutic Modalities Among Indian Women: Proposal for the Indian Council of Medical Research–Polycystic Ovary Syndrome (ICMR–PCOS) Study

Abstract

Background There is scanty data in India on polycystic ovary syndrome (PCOS) from several small, undersized, convenience-based studies employing differing diagnostic criteria and reporting varied regional prevalence. It is difficult to draw clear-cut conclusions from these studies; therefore, the present multicentric, well-designed, large-scale representative countrywide epidemiological study on PCOS across India was conceived with the aim to generate the actual prevalence rates of PCOS in India with a total sample size of approximately 9000 individuals. Objective The primary objectives of the study are to estimate the national prevalence of PCOS in India and the burden of comorbidities and to compare the variation in efficacy of standard therapeutic modalities for metabolic dysfunction in women with PCOS. Methods This multicentric umbrella study consists of three different substudies. Substudy 1 will involve recruitment of women aged 18-40 years using a multistage sampling technique from randomly selected polling booths across urban and rural areas to estimate national prevalence, phenotypic variation, and risk factors among regions. Substudy 2 involves recruitment of subjects from the community pool of substudy 1 and the institutional pool for quantitation of comorbidities among women with PCOS. Substudy 3, an interventional part of the study, aims for comparison of variation in efficacies of common treatment modalities and will be conducted only at 2 centers. The eligible consenting women will be randomized in a 1:1 ratio into 2 arms through a blinding procedure. All these women will undergo clinical, biochemical, and hormonal assessment at baseline and at 3 and 6 months. The data generated will be analyzed using the reliable statistical software SPSS (version 26). Results The study is ongoing and is likely to be completed by April 2022. The data will be compiled and analyzed, and the results of the study will be disseminated through publications. Conclusions The Indian Council of Medical Research–PCOS study is the first of its kind attempting to provide accurate and comprehensive data on prevalence of PCOS in India. Trial Registration Clinical Trials Registry–India CTRI/2018/11/016252; ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=26366 International Registered Report Identifier (IRRID) DERR1-10.2196/23437

Pre‐polycystic ovary syndrome and polymenorrhoea as new facets of polycystic ovary syndrome (PCOS): Evidences from a single centre data set

“…In line with these objectives, the authors intend to continue monitoring and recruiting similar partial phenotypes in their ongoing phase‐II study, which is sponsored by the Indian Council of Medical Research and focuses on PCOS research 38 …”

Prevalence, Regional Variations, and Predictors of Overweight, Obesity, and Hypertension Among Healthy Reproductive-Age Indian Women: Nationwide Cross-Sectional Polycystic Ovary Syndrome Task Force Study

“…We used data from the ICMR-PCOS Task Force study conducted across representative regions of India [ 21 ]. The data were collected from both rural and urban areas in 6 geographical zones of the country.…”

“…The states and union territories were grouped into 6 geographical regions based on their sociocultural similarities, with a small change from the grouping ( Table 1 shows the composition of each zone). Details of the sample size and sampling plan are available in our published protocol in JMIR Research Protocols [ 21 ].…”

Normative range of various serum hormonal parameters among Indian women of reproductive age: ICMR-PCOS task force study outcome

“…The detailed protocol of the study participants is published elsewhere. 7 Briefly, this national cross-sectional study envisioned to estimate the burden, and associated risk factors of polycystic ovary syndrome (PCOS), recruited participants from 2018 to 2022 in six zones (North India, Northeast, South India, Eastern India, Central India, and Western India) spreading across the country, involving 10 regional centres that represent a majority of ethnic groups. The screening of the participants was done employing a uniform methodology using a pre-designed screening questionnaire, designed by the coordinating centre.…”