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ICMR to Evaluate Metformin and Inositol for PCOS Treatment in Multi-Center Trial

• The ICMR is initiating a multi-center, randomized controlled trial to compare metformin and inositol for improving fertility and birth outcomes in women with PCOS. • Current evidence on the efficacy of metformin and inositol for improving fertility in PCOS patients is insufficient, especially regarding birth outcomes and cycle regulation. • The trial aims to address the knowledge gap and generate evidence specific to the Indian context regarding the management of PCOS and improving birth outcomes. • Researchers will assess the efficacy and safety of inositol compared to metformin on pregnancy conception, menstrual cycle regulation, and endocrinological and metabolic parameters.

The Indian Council of Medical Research (ICMR) is set to conduct a multi-center study to assess the effectiveness of metformin and inositol in enhancing fertility and birth outcomes for women with Polycystic Ovarian Syndrome (PCOS). This randomized controlled trial seeks to address the limited evidence on these commonly used treatments, particularly within the Indian population.

Addressing a Critical Need in PCOS Treatment

PCOS is a complex condition characterized by reproductive, endocrine, and metabolic disruptions, including irregular menstrual periods, hyperandrogenism, insulin resistance, and abnormal gonadotropin secretion. Infertility rates among women with PCOS range from 70% to 80%, and they face increased risks of pregnancy complications and less favorable outcomes.
While metformin and inositol are widely used to manage PCOS, the ICMR notes that current evidence supporting their efficacy in improving fertility and related outcomes is lacking. A Finnish study suggested metformin improved pregnancy, live birth, and ovulation rates compared to placebo. However, a Cochrane review indicated only marginal benefits for live birth rates.

Trial Design and Objectives

The ICMR has invited expressions of interest for a multi-center randomized controlled trial comparing metformin and inositol. The primary research question is: "Among women with Polycystic Ovary Syndrome (PCOS), how does inositol in comparison to metformin work in terms of efficacy and safety on outcomes including pregnancy conception, menstrual cycle regularisation, and improvement in endocrinological and metabolic parameters?"
This trial aims to provide robust evidence on the efficacy of both metformin and inositol in the Indian context, where data is currently scarce. Selected researchers will collaborate with the ICMR to develop a comprehensive research proposal and implement the multi-center project.

Implications for PCOS Management

By generating evidence specific to the Indian population, this ICMR-led trial has the potential to refine PCOS management strategies and improve fertility outcomes for affected women. The study will provide valuable insights into the comparative effectiveness of metformin and inositol, informing clinical practice and addressing a significant unmet need in PCOS treatment.
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Reference News

[1]
ICMR to study efficacy of Metformin, Inositol in PCOS treatment - The Economic Times
m.economictimes.com · Oct 6, 2024

ICMR to study efficacy of Metformin and Inositol in improving fertility and birth outcomes among PCOS women, as current ...

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