Fertility drug could lead to 7% increase in live births after IVF, trial finds

A study of a new fertility drug has found that it can increase the chances of embryo implantation during IVF and lead to a 7% increase in live births.

The pill, known as OXO-001, is designed to work directly on the lining of the uterus to make it more receptive to the embryo that is implanted. The findings raise hope for patients who have experienced repeated implantation failures during successive rounds of IVF.

“We are very pleased with the results of this study, which highlight the potential of OXO-001 to become the first therapeutic treatment to increase embryo implantation success with a non-hormonal drug that uses a novel mechanism of action and acts directly on the endometrium,” said Dr. Ignasi Canals, Chief Scientific Officer at Oxolife, the Spanish biotech company behind the study, which will be presented on Monday in Amsterdam at the 40th Annual Meeting of the European Society of Human Reproduction and Embryology.

IVF success rates have steadily improved thanks to advances in egg collection, embryo culture, and selection of embryos most likely to produce a successful pregnancy. But less progress has been made in ensuring that the pregnancy continues after the embryo is transferred.

Implantation is a crucial milestone in pregnancy and involves a complex series of signalling between the embryo and the uterine wall. Oxolife has not revealed how OXO-001 works, other than to say that it “enables the expression of key molecules that allow the embryo to stop rolling (on the uterine surface), to penetrate and complete implantation”.

The latest study, conducted in 28 centres in Europe, included 96 women up to the age of 40 who underwent a single embryo transfer during fertility treatment. The trials were randomised and double-blind, with 42 women receiving a placebo and 54 receiving a daily dose of OXO-001. Treatment began one menstrual cycle before embryo transfer and continued for five weeks afterwards.

Those taking the drug had significantly higher rates of biochemical pregnancy compared to the placebo group (76% vs. 52%). The benefits continued to be seen in the rates of heartbeat detected at 10 weeks (46% for OXO-001, 36% for placebo) and for live births (43% vs. 36%).

The drug appeared to have no negative side effects and during the six-month follow-up the babies showed healthy development and there were no differences from the placebo group.

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

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

Prof Karen Sermon, Chair of ESHRE, said: “Despite continued developments in ovarian stimulation, embryo manipulation and culture, improvements in birth rates with medically assisted reproduction have 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.”