The golden egg

But there’s a tightrope to walk between what is possible, what is ethical, and what is harmful. And in the murky, anxiety-ridden and highly lucrative world of fertility, there is always someone dancing along it – pushing the boundaries.

In August 2019, ProFaM, a new fertility clinic, burst into view offering a medical breakthrough it claimed could revolutionise the lives of half the world’s population – a procedure to preserve fertility and delay the menopause. ProFaM employees appeared on TV studio sofas to spread the news to women: no need to worry about running out of time to have a baby; no more hot flushes or fuzzy memory at the peak of your career.

But it prompted a fierce backlash from experts concerned about how safe or effective it actually is. While ovarian tissue freezing, the procedure that ProFaM offers, is not a new technique, ProFaM is offering it in a new way, to a new set of people, for a new purpose. Specifically, young, healthy women who probably wouldn’t be thinking about the menopause or extending their fertility for decades.

How did we end up here? The answer is – of course – bigger than ProFam: it’s about the commercialisation of fertility; the rise and rise of IVF; and the people who see a golden business opportunity. And it’s a story that starts with the CEO of ProFaM, Simon Fishel.

Birth of the wild west

In 1980, when Fishel was 27, he was on his way up the stairs in Cambridge University when he was stopped by a head of department, and given a warning: “You may have a brilliant research career ahead of you… don’t ruin it to go and work for the devil.”

The devil – or devils – were Robert Edwards, Patrick Steptoe and Jean Purdy. Two years earlier they had achieved a remarkable scientific breakthrough, arguably more important than the moon landing: the birth of Louise Brown, the first baby in the world born via in vitro fertilisation. The warning on the stairs didn’t work: Fishel went to join them as Deputy Scientific Director at Bourn Hall, the world’s first private IVF clinic.

But the team faced criticism from all angles. “We had to be a little bit gritty, a bit resilient because of the animosity all around,” Fishel says. IVF involves fertilising an egg outside the human body – and at the time it caused religious and social outrage. Even some within the scientific community thought creating life this way was immoral – or an attempt to “play God”.

In the 42 years since, over 8 million babies have been born globally by IVF – that’s about the same as the population of Switzerland. And it’s not just patient numbers that have ballooned: IVF is now 85 per cent more successful than it was in 1991, when the Human Fertilisation and Embryology Authority (or the HFEA) started to regulate the field. It’s transformed into a global marketplace expected to be worth nearly $40 billion by 2027.

And from those early years at Bourn Hall, Fishel is now the Founder and President of CARE Fertility, the UK’s most successful chain of private fertility clinics, and the CEO of ProFaM. It’s a transformation that echoes the path of the industry. And neither is without controversy.

Frustrated by regulation in the UK that prevented him from testing a new sperm micro-injection, in the late ’80s he went to work in Italy, with a maverick gynaecologist called Severino Antinori (in 2017, Antinori was sentenced to seven years in prison for forcibly removing a woman’s eggs at his Milan clinic).

According to Fishel, when he tried to end their working relationship a few years later, Antinori locked him in his clinic and returned hours later with a legal document stating he could not work for anyone else. When he refused to sign, Fishel alleges that Antinori pulled out a revolver and threatened to kill him. Fishel signed, and flew straight back to the UK. “I never went back [to Italy] for quite a long time. I kept looking over my shoulder, even in England, for men with black violin cases.”

In 1994, Antinori helped one of the oldest women in the world to carry a baby at 63. There’s always been a side of fertility science that has involved pushing the boundaries of social acceptability – it’s an industry that’s often referred to as a “Wild West”.

“I think what history will show is you need regulation, but you need permissive regulation,” Fishel says. “There can be rogue individuals in any sphere who want to push the boundaries beyond what I would say is the balance between cutting edge work and what is ethical.”

When asked if he’s ever pushed those kinds of boundaries, Fishel pauses. “I would hope I haven’t stretched the boundaries that will come back retrospectively to haunt me.” But he adds: “I don’t mind stretching them at a time if I believe I’m right. Even though somebody else has a different ethical view. If I believe with other colleagues that it’s the right thing to do for the patient, then I think we’ll have a go.”

A booming industry

A slew of breakthroughs in the ’90s – like new procedures to treat male infertility or reduce multiple births – meant the field was constantly changing and improving. At the same time, due to better access to contraception, better education and improved healthcare, fertility rates dropped. In 1974, the average woman in England had her first baby at 24 years old. In 1994 it was 26. By 2017, 29.

Interest in IVF has boomed. And it’s become hugely lucrative. In the late ’90s Simon Fishel set up CARE Fertility. In 2012, an investment fund called Bowmark Capital backed the buy-out of the fertility group for £60m. Last year it was bought by a private equity firm called SilverFleet, for an undisclosed sum.

Innovation and money often go hand in hand in medical science. It’s possible that this kind of development in the UK fertility industry – the improved success rates, the transformed lives – could never have come via the NHS.

But it’s a field that runs off emotion – hope, anxiety, fear. And as the business opportunities have increased, so have the opportunities for exploitation. It’s a potent combination in an area where the power dynamic of patient and doctor can go horrifically wrong. Take Jan Karbaat, the Dutch fertility doctor who used his own sperm to inseminate dozens of his patients without their knowledge – and may have secretly fathered up to 200 children.

And it’s not just rogue individuals. Fertility “add-ons” are reproductive technologies that can be added onto an IVF cycle but don’t necessarily have a large evidence base, Dr Lucy van de Wiel, a research associate at Cambridge University’s Reproductive Sociology Research Group, explains.

They’re part of an industry-wide faultline – and get to the heart of the tension between innovation, business and patient care. In fact, one of the HFEA’s big concerns at the moment is patients being mis-sold treatments. “Add-on” treatments are often new and innovative – but their success rates or safety are uncertain. The problem is how up-front clinics are about the benefits, and how much they charge patients who are often desperate and vulnerable.

CARE Fertility, the clinic group Fishel founded, is firmly on the side of innovation, and is known for offering patients add-ons.

These add-ons are at the sharp end of an industry gathering a lot of cash in investment.

Over the past five years global venture-capital investments in the fertility industry is cumulatively $2.2bn, Kamran Adle, an early stage tech investor with Octopus Ventures, says. In two years there’s been an almost 100 per cent year-on-year increase in investment – more than both cannabis tech or telemedicine.

From apps to surgeries and supplements, there’s an overwhelming number of options for people to choose from.

“There are companies that have fertility vans that drive around urban cities, where they offer free fertility tests,” says Dr van de Wiel. Whatever the result, these tests can act as a pathway to egg freezing. If your test is low, it’s an indication that you should freeze them now before it’s too late. If your test is high, then now is the best time to freeze them because they’re at their peak.

“What is the conflict of interest here?” van de Wiel asks. “Is this really to benefit women or is this to benefit the investors in the clinics? Or is it a win-win situation?”

It’s within this expansive – and expensive – realm of fertility that ProFaM landed in August last year. It was founded by four fertility experts, with Fishel as the CEO. CARE Fertility is a partner.

The offer is simple. A slice of ovarian tissue is taken during keyhole surgery, and then frozen and stored. It’s a technique that’s already used with young cancer patients: the tissue is full of eggs, and if you re-implant it near the fallopian tube it can be used to extend fertility, providing the possibility of conceiving children naturally later in life.

But ProFaM is expanding the market to healthy women. And it claims to be the first organisation in the world to offer young women ovarian tissue freezing to store their hormones to use in later life to postpone the menopause for up to 20 years. The same tissue slices can be re-implanted in the armpit – or somewhere else under the skin – and the hormones they produce could act as a type of natural hormone replacement therapy.

Some women might want to delay the menopause for social reasons, but Fishel says there’s also a medical argument. Women are living longer than ever before, but the average age of menopause is still 51. Post-menopausal women have a higher risk of health issues like heart disease or osteoporosis, and delaying the menopause can help reduce those risks. It could also save the NHS millions of pounds in treatment costs at the same time.

A moral maze

But not everyone is convinced. “When I hear about commercial companies starting to say ‘good news, we’re going to offer this’. I keep thinking, offer what?” asks Art Caplan, the Director of the Division of Medical Ethics at the NYU Grossman School of Medicine in New York City.

“A gigantic risk? With a gamble that you’d spend a fair amount of money, hoping that maybe something would happen? We really don’t understand what’s going on here at all.”

When ProFaM went public last year it had only carried out the procedure on 11 people. And many fertility experts have raised concerns about ProFaM bringing the technique to market at this point. They argue that while the procedure is potentially exciting, there are still lots of unknowns – particularly related to delaying the menopause.

Depending on who you speak to, there are lots of unanswered questions: from whether the tissue will increase the risk of certain cancers, to how long the tissue will last and how well it will work in older women. Even Claus Yding Andersen, a professor of human reproductive physiology at the University of Copenhagen and cryopreservation expert who has spearheaded the research in this area, says that it’s something that should be introduced with caution.

When asked about the backlash, Fishel says he does not believe that ovarian tissue freezing is experimental anymore or something that could cause harm to patients. The only area he believes is potentially experimental at this point is how well ovarian tissue fares compared to HRT.

And it’s never been more clear that we do need better menopause options. We’re in the middle of an HRT shortage – a treatment many women rely on – and the arsenal for women is limited. So if the women who have signed up for this know what they’re getting into, what’s the problem?

“Because medicine isn’t a restaurant,” says Art Caplan. “You don’t go in and order off the menu.”

The other problem, he explains, is that commerce should not be leading knowledge. “Especially commerce that spins it so that it’s like, ‘Hey, let’s do this for your birthday, or here’s a fun Christmas present. How about we preserve your tissues?’ Somehow I find that kind of marketing a little far away from the seriousness of the subject.” It’s worth pointing out that during media rounds last year, Simon Fishel mentioned plans to buy his then-22-year old daughter ProFaM for her 30th birthday.

What’s startling about the ProFaM offering is how young you have to be to do it. The optimal age to have the surgery is between 25 and 30. It’s something that has to be thought about and done in advance – a bit like a pension.

The company’s website takes a strong line. “The younger the better!” it claims. “Will you be ready?” it asks. There’s a sense that the anxiety of a generation has been turned into a marketing tool; that the women who cannot afford to do this – or simply do not want to – risk letting their future selves down.

Fishel accepts that might be the case, but argues that being forthright is necessary to get the message across. Birth rates are declining, he points out. “And society is going to struggle with those declining birth rates. Let alone your own individual needs.”

Women, he says, need to be empowered. ProFaM is not saying “you must do this” – but empowering women to make the choice. But it can be hard to navigate those choices when the people who are telling you about them are also selling them.

It’s always been that way, Fishel says. If the NHS started to offer ovarian tissue freezing, he would be delighted. “There’s not a single ProFaM Director that gets paid. We are not salaried… We just want to try to make sure that we can get something like this out there in the domain for it to work.”

Dr van de Wiel sees the whole conversation as part of a broader pattern. Egg freezing is the fastest growing form of fertility treatment in the UK, and Fishel is far from the only person encouraging young women to think about their fertility or the menopause in this way.

“I think ProFaM is an example of this broader trend of moving from reactive IVF to pro-active fertility management in relation to testing and egg freezing, and now ovarian cryopreservation,” van de Wiel explains. “And it’s a trend that has – not exclusively, but in many cases – a strong commercial component.”

The fertility market is expanding to include all women, no matter your fertility levels or family plans. “This was different 10 years ago, this was different for the previous generation,” van de Wiel says.

Do women even want to delay the menopause? The heated discussions when ProFaM went public last year display just how varied the answer is. There’s no one size fits all. But this is an expensive choice that needs to be made young: what if you never need to use it? Plus, there’s concern among some experts that the menopause is being medicalised: that it is becoming something to treat and to fear, rather than a physical process.

Others share the view that something like ProFaM – that re-imagines the path of reproductive biology – is disrupting nature. Women’s reproductive health is still a moral and political battleground.

“I think there’s a reason why Mother Nature basically switches fertility off before we’re about 50,” Elizabeth Howard, a speaker for Catholic Voices, a panel of laypeople who share the Catholic Church’s view on a range of current issues, says.

She’s donor-conceived herself, and her concerns about fertility preservation and the fertility industry centre around the rights of the child. She worries that children are at risk of being seen as a commodity instead of a gift, and that ethics haven’t caught up with the advances in medicine. “It’s really important for [society] to take a step back and look at the ethics overall and not just in terms of the intended parents for any sort of assisted fertility – but also for the children.”

Would Fishel help a woman in her 60s get pregnant? The short answer is no. In that instance ProFaM would only re-implant the tissue to provide hormone replacement, not fertility preservation. He doesn’t believe age determines good parenting but he wouldn’t want to contribute to creating medical problems or health risks. And anyway, it wouldn’t be his choice. It would be up to an ethics committee.

So: in the year since it went public with such fanfare, how many women have had the operation? And how many of those were healthy women – women who do not have any medical reason to go through an experimental operation?

The answer, it turns out, is none.

Although there are about 200 women on the ProFaM waiting list, no new operations have been carried out since August. Even before the pandemic, Fishel admits, the NHS hospital that was supposed to be working with ProFaM “were making it a bit difficult to get surgical opportunity” and so the company was forced to delay scheduled operations in order to find private surgical spaces. They’re hoping to restart things soon.

It means that it’s still only 11 women who have undergone the procedure. The whole thing feels a little “Emperor’s New Clothes”.

But the conversation around ProFaM also feels like a moment when all the separate elements in the story of fertility – the innovation, the risk, declining fertility rates, anxieties, hopes – are coming to a head.

The fertility industry has never been more complex than it is today. There have never been more options, more new ideas or companies. It’s a maze. On the one hand, it is clear – it’s positively transformed the lives of millions of women, millions of families. And it’s transformed the limits of what is possible for the human to do. It’s transformed the way we think about having babies, and who can have them, when.

On the other hand, it’s never been more apparent how murky it all is – how there is potential exploitation and manipulation. And at the heart of it are women – already under immense pressure to make decisions about a future that no one can predict for them.

* This article is an abridged version of the Tortoise Slow Newscast The golden egg. Listen here:

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