A national trial aiming to reduce pregnancy loss for women with Polycystic Ovary Syndrome at the Women’s Hospital
It’s National Gynaecological Awareness Month and we wanted to shed light on a clinical trial supported by our Women’s Hospital in partnership with the University of Birmingham, aiming to reduce pregnancy loss and increase chances of conception for women with Polycystic Ovary Syndrome (PCOS). PCOS is a condition affecting 1 in 10 women across the UK, often resulting in reduced fertility and an excess of male hormones.
The ‘LOCI’ trial investigates the efficacy of ‘Letrozole verse Clomifene’ or ‘Letrozole and Metformin verse Clomifene and Metformin’. These drugs are typically used in ‘ovulation induction’, encouraging the release of eggs (ova), improving the chances of conception for women with Polycystic Ovary Syndrome (PCOS) trying to get pregnant.
The University of Birmingham aims to recruit 2,100 women across the UK, including women from our Birmingham Women’s Hospital - reaching out to women with anovulatory (irregular periods) PCOS, between the ages of 18 to 43 years old. The drugs will be tested against each other to see which is most effective in increasing gestational birth rates, and the most cost-effective regimen out of the possible drug combinations (Clomifene or Letrozole, with or without metformin).
Lee Priest from the Tommy’s National Centre for Miscarriage Research and National Clinical Coordinator for the trial, shared: “The trial will not only help us to support women with Polycystic Ovary Syndrome but it will also help us to identify the most cost-effective method for ovulation induction. We have recruited over 850 women and look forward to recruiting many more to reach our target and improve the care and efficacy of fertility treatment for women with PCOS.”
Professor Arri Coomarasamy, Chief Investigator of the trial, said “Various small trials have attempted to determine which of the two main ovulation induction drugs (Clomifene and Letrozole) offers women the best chance of live birth while also maximising safety. Yet, the evidence remains insufficient to draw conclusions confidently. LOCI is the largest trial ever conducted in this field, and we hope it will make a meaningful contribution to women’s health”.
Clomifene has been used since the 1960s to induce ovulation in women with PCOS, while Letrozole has become available more recently. Although both drugs appear to offer benefit in inducing ovulation, it remains unclear which of the two is best to improve the chance of live birth.
Metformin is another ovulation induction agent and can be combined with Clomifene or Letrozole, although the extent of its benefits remain unclear. The LOCI trial aims to clarify how to maximise treatment effectiveness using these drugs to better support women with PCOS.
We are proud to be participating in the trial and want to say a big thank you to our clinical leads for taking the time to speak with us about the intervention. Stay tuned for the results of the LOCI trial and how this may go on to support women with Polycystic Ovary Syndrome.