New hope as first-of-its-kind fertility pill OXO-001 could increase the odds of IVF success
A NEW PILL could help boost the odds of successful IVF treatment, scientists say.
Initial trials showed “promising” results, with researchers saying the drug could lead to a 7 per cent increase in live births.
Researchers set out to test whether the drug – which is designed to act directly on the inner lining of the womb – can improve the implantation process during fertility treatment, making the womb more receptive to the embryo.
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.
Oxolife didn’t give specifics on the the pill works, only saying 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 new study found that the tablet boosted women’s odds of getting pregnant.
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.”
Ninety-six 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 – to be taken twice daily one menstrual cycle before the embryo transfer and for five weeks afterwards.
Researchers found “ongoing pregnancy rates” measured 10 weeks after embryo transfer were 46.3 per cent for patients treated with OXO-001 compared to 35.7 per cent for those given a placebo.
This is a “clinically significant finding”, according to the academics who presented 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 per cent for women who took OXO-001 compared to 35.7 per cent among those who took the placebo, according to the study, 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 women experienced mild to moderate symptoms.
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.
Dr Arbat said: “Ongoing pregnancy rates, measured 10 weeks after embryo transfer, were 46.3 per cent for patients treated with OXO-001 compared to 35.7 per cent 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 per cent is very good news for our patients, and hopefully this can be confirmed in larger patient groups.”
What you need to know about fertility and IVF
MORE than eight in 10 couples will get pregnant within a year if they're having regular unprotected sex.
For others, however, it may take longer.
It’s a good idea to see a GP if you have not conceived after a year of trying.
Women aged 36 and over, and anyone who’s already aware they may have fertility problems, should see their GP sooner, the NHS advises.
They can check for common causes of fertility problems and suggest treatments that could help.
Infertility is usually only diagnosed when a couple have not managed to conceive after a year of trying.
There are two types of infertility:
- Primary infertility – where someone who’s never conceived a child in the past has difficulty conceiving
- Secondary infertility – where someone has had one or more pregnancies in the past, but is having difficulty conceiving again
Treatments for infertility include medical treatments to make ovulation more regular, surgical procedures such as treatment for endometriosis, repair of the fallopian tubes, or removal of scarring within the womb, as well as assisted conception such as IVF.
What is IVF?
During vitro fertilisation (IVF), an egg is removed from the woman’s ovaries and fertilised with sperm in a laboratory.
The fertilised egg, called an embryo, is then returned to the woman’s womb to grow and develop.
It can be carried out using your eggs and your partner’s sperm, or eggs and sperm from donors.
Who can have IVF?
The National Institute for Health and Care Excellence (NICE) fertility guidelines recommend that IVF should be offered to women under the age of 43 who have been trying to get pregnant through regular unprotected sex for two years.
It’s also available to women who’ve had 12 cycles of artificial insemination, with at least six f these cycles using a method called intrauterine insemination (IUI).
What are the chances of success?
Younger women are more likely to have a successful pregnancy through IVF.
It isn’t usually recommended for women over the age of 42 because the chances of a successful pregnancy are thought to be too low.
In 2019, the percentage of IVF treatments that resulted in a live birth was:
- 32 per cent for women under 35
- 25 per cent for women aged 35 to 37
- 19 per cent for women aged 38 to 39
- 11 per cent for women aged 40 to 42
- 5 per cent for women aged 43 to 44
- 4 per cent for women aged over 44
Source: NHS
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 per cent 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.