July 21, 2024

A trial of a new fertility drug has shown that it increases the rate of embryo implantation during IVF and lead to a 7% increase in live births.

The pill, known as OXO-001, is designed to act directly on the uterine wall to make it more receptive to the embryo being implanted. The findings offer hope for patients who have experienced repeated implantation failures during successive rounds of IVF.

“We are delighted 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 agent using a novel mechanism of action that directly targets the endometrium work,” said Dr Ignasi Canals, chief scientific officer at Oxolife, the Spanish biotech company behind the trial, which is being presented at the European Society of Human. Reproduction and Embryology’s 40th annual meeting on Monday in Amsterdam.

Success rates in IVF have steadily improved thanks to advances in egg collection, the cultivation of embryos and the selection of those most likely to produce a successful pregnancy. But there has been less progress in ensuring that the pregnancy progresses once the embryo is transferred.

Implantation is a crucial milestone in pregnancy and involves a complicated sequence of signaling between the embryo and the uterus. Oxolife did not reveal how OXO-001 works, other than to say that it “enables the expression of key molecules that allow the embryo to stop rolling [across the womb’s surface]to invade and complete implantation”.

The latest study, carried out across 28 centers in Europe, involved 96 women aged up to 40 who underwent a single embryo transfer during fertility treatment. The trials are randomized and double-blind, with 42 women receiving placebo and 54 receiving a daily dose of OXO-001. Treatment started one menstrual cycle before the embryo transfer and continued for up to five weeks afterwards.

Those who took the drug had significantly higher rates of biochemical pregnancy compared to the placebo group (76% versus 52%). The benefits were still seen in the rate of heartbeat detected at 10 weeks (46% for OXO-001, 36% for placebo) and for live birth rates (43% v 36%).

The drug had no negative side effects and in the six-month follow-up, the babies had healthy development and showed no differences with the placebo.

Prof Richard Anderson, head of obstetrics and gynecology at the University of Edinburgh, who was not involved in the trial, said the results were impressive. “To get a 7% difference in live birth rate with a simple oral medication in live birth rate is very significant,” he said. “It looks very exciting and it raises the question of whether it will help natural conception.”

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The company is also investigating the potential for the same drug as a treatment for polycystic ovary syndrome.

Prof Karen Sermon, Chair of ESHRE, said: “Despite ongoing developments in ovarian stimulation, embryo manipulation and culture, the improvement in live birth rates in medically assisted reproduction has been incremental at best. A jump of almost 7% is very good news for our patients, and hopefully this can be confirmed in larger patient groups.”

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