New Delhi: India’s apex health research institute, ICMR, will conduct a study to assess the effectiveness of two polycystic ovarian syndrome (PCOS) drugs in improving fertility and birth outcomes in women suffering from the ovarian condition. The drugs recommended by experts for this purpose are metformin and inositol which are used in the treatment of the condition.
ICMR has recently invited Expression of Interest (EOI): “Conducting a multi-centre randomized controlled trial to evaluate the efficacy of metformin vs inositol in improving fertility and birth outcomes in PCOS women”.
Polycystic ovary syndrome (PCOS) is a complex disorder ranging from mild to severe disturbances in reproductive, endocrine, and metabolic functions, with core features including irregular menstrual periods (anovulation), hyperandrogenism, insulin resistance, and abnormal gonadotropin secretion.
Infertility rates among women with PCOS are high, varying between 70 to 80 percent, ICMR said in an EoI document.
In addition, PCOS women have been found to have an increased prevalence of pregnancy complications and less favorable pregnancy outcomes (live birth, miscarriage, pregnancy rate) compared with women without PCOS, it states.
In modern practice, metformin and inositol are widely used to treat PCOS.
“However, the available evidence on the efficacy of these two drugs in terms of improvement in fertility and other related outcomes is insufficient,” the ICMR said in a document.
A Finnish study suggests that, compared to placebo, metformin improved pregnancy rates, live birth rates and ovulation rates in the population studied, the document said.
However, a Cochrane review with meta-analysis including three other small studies reported that compared with placebo, metformin may have only a marginal benefit for live birth rate outcome.
Furthermore, very limited data are available globally on the efficacy of inositol for PCOS women, particularly for birth outcomes and cycle regulation.
“Evidence on the efficacy of both metformin and inositol in the Indian context is almost non-existent. To address the knowledge gap and generate evidence on the management of PCOS to improve birth outcomes in the Indian context, the current ICMR call is being proposed,” the document said.
ICMR seeks to partner with interested researchers to develop a multicenter randomized controlled trial for the management of PCOS in Indian women.
Selected researchers will be invited to join the research team and will collaborate to develop a complete research proposal and roll out a multi-centre research project to be coordinated by ICMR.
The research question is “In women with polycystic ovary syndrome (PCOS), how does inositol fare compared to metformin in terms of efficacy and safety on outcomes including pregnancy conception, regularization of the menstrual cycle, and improvement in endocrinological and metabolic parameters?”
