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A new tablet could help improve the odds of successful IVF treatment, scientists have said after initial trials showed “promising” results.
Researchers set out to test whether the drug, which has a direct effect on the inner lining of the womb, can improve the embryo implantation process during fertility treatment.
The pill, known as OXO-001 and created by Spanish biotech company Oxolife, is the first of its kind and had already gone through safety checks in early studies – known as pre-clinical trials.
The new study found the drug raised a woman’s odds of pregnancy.
Some 96 infertile women aged 40 and under who were receiving fertility treatment – either IVF or intracytoplasmic sperm injection (ICSI) with donor eggs – at 28 centres across Europe were enrolled in the study between September 2021 and January 2023.
They were either given a dummy drug, also known as a placebo, or OXO-001 – taken twice daily one menstrual cycle before the embryo transfer and five weeks after.
This is a clinically significant finding and we are excited to advance this promising treatment through the next phases of clinical development— Dr Agnes Arbat, Oxolife
Researchers found “ongoing pregnancy rates” measured 10 weeks after embryo transfer were 46.3% for patients treated with OXO-001 compared to 35.7% for those given a placebo.
This is a “clinically significant finding”, academics said presenting their study to the European Society of Human Reproduction and Embryology’s (ESHRE) 40th annual meeting in Amsterdam.
There was also a clinically meaningful increase in the number of mothers who went on to have a live birth, they said.
The live birth rate was 42.6% for women who took OXO-001 compared to 35.7% among those who took the placebo, according to the abstract, which is also being published in the journal Human Reproduction.
Side-effects were similar in both the placebo group and the group receiving the new treatment, with the most common being headaches, nausea, vomiting, gastrointestinal issues and dizziness – most of which were mild to moderate.
The drug will now be tested in a larger group of women in a study known as a phase three clinical trial, and will include women who are using their own eggs.
Oxolife chief executive Dr Agnes Arbat said: “Most rounds of IVF or ICSI still end in failure – many because a viable embryo does not implant.
“A simple-to-take pill that materially improves the chance of success would therefore be of huge benefit to those who want a baby. This proof-of-concept phase two study shows that hope is now a step closer.
“Ongoing pregnancy rates, measured 10 weeks after embryo transfer, were 46.3% for patients treated with OXO-001 compared to 35.7% for those given a placebo.
“This is a clinically significant finding, and we are excited to advance this promising treatment through the next phases of clinical development.
“This study was purposefully designed to include only women who used donor eggs so it could single out the true effect of OXO-001 on the endometrium. However, we believe OXO-001 has the potential to work equally well in those using their own eggs, and we are already planning a pivotal phase three clinical trial in this more extensive group to support product registration.”
Dr Ignasi Canals, chief scientific officer for Oxolife, added: “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.”
Commenting on the study, Professor Dr Karen Sermon, chair of ESHRE, said: “Despite continuous developments in ovarian stimulation, embryo manipulation and culture, improving live birth rates in medically assisted reproduction has been incremental at best.
“A jump of nearly 7% is very good news for our patients, and hopefully this can be confirmed in larger patient groups.”
It comes as a separate study presented to the the ESHRE meeting suggests women who are exposed to air pollution before starting IVF may have lower odds of a successful outcome.
Researchers studied data on air pollution levels and compared it to information on when women had their eggs collected during the IVF process.
They examined data concerning 1,835 patients in Perth, Australia, who underwent a total of 2,155 IVF cycles with frozen embryo transfers over an eight-year period.
The research team also looked at air pollution concentrations at four different time periods before the women had their eggs retrieved – 24 hours; two weeks; four weeks and three months.
Women exposed to the highest levels of a type of air pollution called PM10 in the two weeks before egg retrieval had 38% lower odds of a subsequent live birth compared to those exposed to the lowest levels of pollution.
The research team also found those exposed to PM2.5 in the three months prior to egg retrieval also had lower odds of live birth.
