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IVF ‘breakthrough’ treatment

Pioneering use of the first oral medication of its kind in IVF treatment is showing remarkable trial results 

ObsEva, which develops reproductive health treatments, has reported trial results of a therapy with the potential to increase in vitro fertilisation (IVF) success rates by more than
10 per cent.

The reported findings are said to represent the biggest innovation in the field in 20 years and are one of many examples of small niche companies producing some of healthcare’s biggest advances. Many of these focus on some of the areas with great unmet need that large companies often ignore.

In fertility treatment, timing can be everything and the same is true of new companies

In fertility treatment, timing can be everything and the same is true of new companies. ObsEva was founded in 2012 as demand for reproductive healthcare was rising rapidly. Vast numbers of Western women were delaying having children to pursue their careers and then in 2015 China suspended its one-child-per-
couple policy.

Worldwide, the annual number of treatment cycles for assisted reproduction technology is estimated to have risen within the last decade from 1.6 million to 2.4 million. In China it is reported to be more than 800,000 a year.

Unfortunately for couples seeking fertility aid, quantity in demand does not equate to quality of outcome. The World Health Organization has estimated that only one in four infertility treatments end with a “take-home” baby.

ObEva’s founder and chief executive Dr Ernest Loumaye wants to fill what is for all too many women a therapeutic vacuum. He is a dedicated gynaecologist whose prime interest is looking after patients. But he felt that reproductive health had been left far behind in the biotech revolution.

As a clinician he was limited in what he could do. Wanting to develop innovative treatments, he moved into the pharmaceutical industry. Twelve years ago, he founded and was chief executive of another successful company, PregLem, which was sold in 2010 before the launch in Europe of its lead medicine.

ObsEva’s pipeline also includes a novel hormone-based therapy to treat both endometriosis, a common, painful condition that can cause infertility and pain during sex, and uterine fibroids, causing non-cancerous growths in and around the womb, heavy menstrual bleeding that may result in anaemia and other possible symptoms, including a frequent need to urinate.

Q&A

Founder and chief executive Dr Ernest Loumaye tells of the exciting trial results from ObsEva’s pioneering use of the first oral medication of its kind – nolasiban – in IVF treatment

What’s so special about the results you’ve just reported? 

Imagine 100 women undergoing in vitro fertilisation receiving nolasiban and another 100 patients receiving a placebo: our results show that 46 women in the first group may be able ultimately to go home with a baby compared with only 35 in the second. This 11 per cent difference represents a fantastic result in our view. In gynaecology, a 5 per cent increase in positive outcomes is considered a breakthrough – we more than doubled that threshold in this clinical trial.

What is nolasiban? 

An oral treatment to prevent expulsion of the embryo from the womb. It is taken four hours before “embryo transfer” – the implanting of the embryo in the uterus or womb.

How many patients were in the trial? 

There were 778 from 41 European fertility clinics.

How does nolasiban work? 

Nolasiban has a quietening or blocking effect on oxytocin, a naturally occurring hormone. It’s known as the “love hormone” because it is released during orgasm and can generate feelings of peace. But calling it the love hormone is a bit like calling a computer a writing tool. It also stimulates the uterus or womb to contract to begin childbirth. Contractions also occur during IVF as the embryo is being implanted. Rapid rises in contractions can expel the embryo from the womb and prevent pregnancy. Nolasiban also – and we believe this may be critical – increases blood flow in the womb and womb lining.

Is there any way to identify women who are prone to these problematic uterine contractions? 

That’s a very good question. Our nolasiban studies have focused on two groups: women with high contraction rates and those with low contractions. We found no clear relationship between any reduction in contractions and pregnancy outcomes. And so we didn’t measure contractions in the latest trial. We just enrolled women undergoing either their first or second IVF treatment cycle. The results confirmed that it’s not necessary to measure contractions to achieve a benefit. They also suggest that increased blood flow may be the real benefit. Blood flow is a critical factor in embryo implantation.

The study has also shone a very bright light on the ongoing controversy over the best time for embryo transfer. Is it best when the embryo is three days old and comprising four to eight cells or when it is five days old and made up of 70 to 100 cells? 

We tested both three and five-day embryo transfers. Overall, comparing nolasiban with placebo, we showed a relative increase in ongoing pregnancy rates of 25 per cent; with day-five transfers, we saw a larger effect of 32 per cent which we consider to be a highly meaningful result. The day-three alone data resulted in a 14 per cent improvement.

So there may be a strong case for making five-day transfers and nolasiban a routine part of IVF treatment? 

We believe so, but before we can answer this question, we await the data from women in the trial giving birth in the final quarter of this year and for the six-month follow-up after birth. We’re optimistic that the birth outcomes may be consistent with pregnancy rates because most miscarriages occur within the first 12 weeks of pregnancy.

Have you a final message for patients and clinicians?

There is a very simple, but critical, message. Nolasiban has the potential to increase pregnancy rates while reducing the number of multiple births. Although single-embryo transfers are now generally recommended, it is still often standard practice in the United States and some European countries to implant two embryos to increase the likelihood of having a baby. But our clinical trial results indicate that a single-embryo transfer plus nolasiban can result in a clinical pregnancy rate that is similar to what has been historically achieved with double-embryo transfer and thereby potentially avoiding risks of multiple pregnancy. This is of major importance both in terms of avoiding the health risks for both mother and baby, and for the considerable financial costs related to multiple births.

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