A new fertility drug could be on the way after clinical trials demonstrated a 7 percent increase in live births among participants.
The treatment, known as OXO-001, is designed to improve embryo implantation during IVF by directly acting on the lining of the womb.
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Worldwide, one in six people will struggle with infertility in their lifetime, according to the World Health Organization. Every year, more than 3 million cycles of assisted reproduction treatments are performed around the world, with more than 750,000 babies born from the treatment, the European Society of Human Reproduction and Embryology (ESHRE) reports. However, each treatment cycle carries only a 40 percent success rate.
One of the leading causes of unsuccessful IVF is failed embryo implantation, and improving implantation success rates has remained a significant challenge.
"Despite continuous developments in ovarian stimulation, embryo manipulation and culture, improving live birth rates in medically assisted reproduction has been incremental at best," Karen Sermon, chair of ESHRE, said in a statement.
Now, scientists from the biotechnology company OXOLIFE have demonstrated that their drug OXO-001 may provide a solution.
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The Phase 2 clinical trial analyzed 96 women from across 28 European health centers under the age of 40. The women underwent a single embryo transfer with half of them receiving a daily dose of the OXO-001 treatment and the other half receiving a placebo. Treatment began one menstrual cycle before the embryo transfer cycle and continued until five weeks after the transfer.
When testing for early signs of pregnancy, the team found that 75.9 percent of the women in the OXO-001 group had become pregnant, compared to 52.4 percent of those in the placebo group. Most importantly, 42.6 of the women on the OXO-001 treatment had successful live births, compared to 35.7 percent of those on the placebo, representing a 7 percent increase overall.
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"From scientific societies, key opinion leaders, clinicians and patients, we know that an absolute increase of more than 5 percentage points in ongoing pregnancy is considered clinically meaningful," Agnès Arbat, CEO and CMO of OXOLIFE, said in a statement.
Sermon added: "A jump of nearly 7 percent is very good news for our patients, and hopefully this can be confirmed in larger patient groups."
The presence of side effects was roughly equal in both the treatment and placebo groups, with the most common being headaches, nausea, vomiting, gastrointestinal issues and dizziness. However, in most cases these were mild or moderate and there was no difference in the health of the babies born from the treatment at birth or during a six month follow-up.
"We are thrilled with the results of this trial, which highlight OXO-001's potential to become the first therapeutic treatment to increase embryo implantation success, with a non-hormonal drug using a new mechanism of action, acting directly on the endometrium," Ignasi Canals, CSO of OXOLIFE, said in a statement.
Arbat added: "We look forward to advancing this promising treatment through the next phases of clinical development."
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