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...

Overview

Journal JMIR Res Protoc

Publisher JMIR Publications

Specialty General Medicine

Date 2021 Aug 27

PMID 34448720

Citations 5

Authors

Mohd Ashraf Ganie

Subhankar Chowdhury

Vanita Suri

Beena Joshi

Prasanta Kumar Bhattacharya

Sarita Agrawal

Neena Malhotra

Rakesh Sahay

Roya Rozati

Puthiyaveettil Khadar Jabbar

Vishnubhatla Sreenivas

Mukesh Sriwastva

Imtiyaz Ahmad Wani

Shalini Singh

Radhey Shyam Sharma

Affiliations

Soon will be listed here.

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.

Citing Articles

Prevalence, Phenotypes, and Comorbidities of Polycystic Ovary Syndrome Among Indian Women.

Ganie M, Chowdhury S, Malhotra N, Sahay R, Bhattacharya P, Agrawal S JAMA Netw Open. 2024; 7(10):e2440583.

PMID: 39441596 PMC: 11581580. DOI: 10.1001/jamanetworkopen.2024.40583.

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.

Ganie M, Chowdhury S, Suri V, Joshi B, Bhattacharya P, Agrawal S JMIR Public Health Surveill. 2023; 9:e43199.

PMID: 37672315 PMC: 10512112. DOI: 10.2196/43199.

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

Ganie M, Chowdhury S, Suri V, Joshi B, Bhattacharya P, Agrawal S Lancet Reg Health Southeast Asia. 2023; 15:100226.

PMID: 37614351 PMC: 10442974. DOI: 10.1016/j.lansea.2023.100226.

Variation in normative values of major clinical biochemistry analytes in healthy reproductive-age women in India: A subset of data from a National Indian Council of Medical Research-Polycystic Ovary Syndrome task force study.

Ganie M, Chowdhury S, Suri V, Joshi B, Bhattacharya P, Agarwal S Indian J Pharmacol. 2023; 55(2):76-88.

PMID: 37313933 PMC: 10335651. DOI: 10.4103/ijp.ijp_694_22.

Addressing Challenges During Community based Screening of Women for Polycystic Ovary Syndrome (PCOS): A Research Experience from Maharashtra, India before and During COVID Pandemic.

Hasan G, Shaikh S, Joshi B, Ganie M, Shukla A, Vadhan H Indian J Community Med. 2023; 48(1):167-171.

PMID: 37082412 PMC: 10112744. DOI: 10.4103/ijcm.ijcm_181_22.

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