New Delhi: The Indian Council of Medical Research (ICMR), the nation’s leading body for biomedical research, has announced a significant study to assess the effectiveness of Metformin and Inositol in treating Polycystic Ovary Syndrome (PCOS). The research will specifically focus on how these medications impact fertility and pregnancy outcomes for women with PCOS. This condition, affecting millions of women across India, often presents significant hurdles to conception and healthy pregnancies.
The ICMR has issued an “expression of interest” (EOI), seeking collaboration with researchers to conduct a multi-center, randomized controlled trial. The aim is to rigorously compare Metformin and Inositol in improving fertility and birth outcomes for women diagnosed with PCOS.
PCOS is a multifaceted disorder characterized by hormonal imbalances that can lead to a range of health issues. These include irregular menstrual cycles, excess androgen production, insulin resistance, and abnormal gonadotropin secretion. The complexity of PCOS means that affected women experience varying degrees of severity, making effective treatment strategies crucial. The prevalence of infertility among women with PCOS is alarmingly high, ranging between 70% and 80%, according to the ICMR’s EOI document.
Furthermore, women with PCOS face increased risks of pregnancy complications and less favorable pregnancy outcomes, including higher rates of miscarriage and lower rates of live births, compared to women without PCOS. This underscores the urgency of finding effective interventions to improve reproductive health outcomes for this population.
While Metformin and Inositol are commonly used in PCOS treatment, the ICMR acknowledges that current scientific evidence regarding their true efficacy in improving fertility and related outcomes remains limited. “However, present evidence on the efficacy of these two drugs in terms of improvement in fertility and other related outcomes is insufficient,” the ICMR stated in its document.
One woman shared her experience on a PCOS support group forum, posting, “I tried Metformin for six months, and while it helped regulate my periods a bit, it didn’t get me pregnant. It raised more questions than answers,” highlighting the varied individual responses to these treatments.
Existing research presents a mixed picture. A Finnish study, as noted by the ICMR, suggested that Metformin improved pregnancy, live birth, and ovulation rates compared to a placebo. However, a Cochrane review, incorporating data from several smaller studies, indicated that Metformin might offer only a marginal benefit in terms of live birth rates. The data on Inositol’s effectiveness, particularly concerning birth outcomes and cycle regulation, is even scarcer on a global scale.
This lack of robust evidence is especially pronounced in the Indian context. “Evidence on the efficacy of both metformin and inositol in the Indian context is almost non-existent. To address the knowledge gap and to generate evidence on the management of PCOS for improving birth outcomes in the Indian context, the current ICMR call is being proposed,” the document explained. The ICMR aims to bridge this gap by generating evidence-based guidelines tailored to the Indian population, considering the unique genetic and environmental factors that may influence treatment outcomes.
The ICMR’s initiative seeks to establish a partnership with motivated researchers for a collaborative, multi-center, randomised controlled trial focused on PCOS management in Indian women. The selected researchers will join the ICMR research team to collaboratively formulate a detailed research proposal and implement the multi-center project, which will be overseen by the ICMR.
The core research question driving this initiative 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?”
The researchers are specifically interested to also study the underlying molecular mechanisms responsible for improvement in fertility and birth outcome.
The significance of this study cannot be overstated. By addressing the critical knowledge gap concerning the efficacy of Metformin and Inositol in the Indian population, the ICMR aims to provide clinicians with the evidence-based tools necessary to make informed treatment decisions, ultimately improving the reproductive health and well-being of countless women affected by PCOS across the country.
- Key objectives of the ICMR study:
- Evaluate the comparative efficacy of Metformin and Inositol in improving fertility outcomes.
- Assess the impact of these medications on pregnancy and live birth rates.
- Examine the effects on menstrual cycle regulation and hormonal imbalances.
- Provide evidence-based guidelines for PCOS management in the Indian context.
Reactions to the announcement on social media have been largely positive, with many women expressing hope that the study will lead to more effective and personalized treatment options. On X.com, one user wrote, “Finally, research focusing on *Indian* women with PCOS! So important.” Another comment on Facebook read, “About time! Hoping for real answers and better treatments.” Another insteresting post was from Instagram.