Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 13, 2020
Date Accepted: Jan 6, 2021
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Methodological Details of ICMR-Polycystic ovary syndrome (PCOS) multicentric Phase I study: Evaluation of prevalence, regional phenotypic variation, co-morbidities, risk factors and the variations in response to different therapeutic modalities
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 reported 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 conceived with the aim to generate the actual prevalence rates of PCOS in India with a total sample size of ~10000 individuals.
Objective:
The primary objectives of the study are to determine the national prevalence in India. The additional objectives of the study are to estimate the burden of comorbidities among subjects and compare the variation in efficacy of standard therapeutic modalities for metabolic dysfunction in PCOS women
Methods:
This multicentric umbrella study consisted of three different sub-studies. The Sub-study I 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 estimation of national prevalence, phenotypic variation and risk factors among regions. Sub-study II involves recruitment of subjects from community pool of sub-study I and the institutional pool for quantitation of co-morbidities among women with PCOS. Sub-study III, an interventional part of the study, aimed for ccomparison of variation in efficacies of common treatment modalities will be conducted only at two centers. The eligible consenting women will be randomized in 1:1 ratio into two arms through a blinding procedure. All these women will undergo clinical, biochemical, hormonal assessment at baseline, at 3rd and 6th month. The data generated will be analyzed using the reliable statistical software SPPSS-26 version.
Results:
The study is ongoing, and is likely to get completed by 2021. The data will be compiled, analyzed and the results of the study will be disseminated through publications
Conclusions:
The ICMR–PCOS study is the first of its kind attempting to provide accurate and comprehensive data on prevalence of PCOS in India. Clinical Trial: This largest well-designed study addressing epidemiological aspects of PCOS was approved by Institutional ethics committees and is registered vide No. CTRI/2018/11/016252
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