Inside Britain's Fertility Business Panorama

Can we trust everything Britain's multimillion pound fertility

industry tells us? These are doctors. We believe what doctors

tell us. This is a doctor that holds my happiness in his hands. How

effective are the treatments offered to thousands of couples by fertility

doctors? So many of them are not justified. It's just as simple as

that, they're not justified. Tonight on Panorama, we reveal major new

research showing there's little good scientific evidence some of those

treatments work. It was one of the worst examples I've ever seen in

health care. I can't understand how this has been allowed to happen in

the UK. We go under cover inside one of the UK's top fertility clinics.

We ask: Should Britain's fertility patients be better protected?

For about one in seven couples, infertility can be a private pain

that takes over their lives. Constant reminders. Constant guilt,

despair. There's always someone telling me every week they're

pregnant. I feel guilty because I couldn't give my husband the baby

that I wanted to. We got our babies, but I still feel like I'm an

infertile woman. I still have issues. That will never go away.

These people have all had fertility treatment. They've been hit by the

huge financial cost. I just found this receipt and that was for

?2,985. We spent about ?35,000. We don't have oodles of money coming

in. We spent something like ?45,000. I've worked at medical journal the

BMJ for a decade investigating the health industry. IVF, where an egg

and sperm are fused in a lab to try and make a baby, is an area of

growing interest. Over 50,000 women now have treatment annually. You can

get fertility treatment on the NHS, but what you can get depends on

where you live. So around 60% of all fertility treatment is done in the

private sector. On average, one in four attempts

results in a baby and chances get lower with age. Clinics sell extras

on top of IVF, they're supposed to increase your chances. They're known

as add-ones. -- add-ons. You can put your embryos in special devices, pay

for blood and genetic tests or have extra drugs. They don't always come

cheap. Kerry and Glyn Tomlinson have a little boy, Freddie. He was

conceived naturally, but only after a failed attempt at IVF on the NHS.

And three unsuccessful attempts at a private clinic. It cost ?23,000. IVF

cycles, it's got everything... Kerry's receipts show add-ons were a

big part of the cost. I had to have three of those, that was for one.

It's basically ?1,000. Yeah, yeah. The add-ons included tests and

treatments for problems with Kerry's immune system. Their doctor said

some people have high levels of immune cells that see an embryo as a

foreign body. So they attack it, stopping the pregnancy. Initially I

thought, oh, that sounds pretty serious. I didn't know I had

anything wrong with me. But he said, don't worry, he had treatment. The

add-on medicines would get rid of the extra immune cells or lower the

chance of them attack being.. I came away thinking, I'm with the right

person here. This is going to work. At the time, there was no convincing

evidence immune cells caused pregnancy failure and little

evidence to support the use of the add-on treatments. Kerry and Glyn

said their doctor didn't give thyme appreciation. We was being led to

believe this was giving a greater chance. Yeah. They were e-mailed a

document saying the treatments were experimental. It had a link to the

relevant medical opinion saying they had little evidence. But they say

face to face, their doctor was positive about the treatments.

Doctors have a really important duty to their patients. They have to tell

them about the benefits, harms and uncertainties of a treatment. It's

so patients can make the best possible decision. It's what you

call informed consent. Recently there's been further criticism of

immune treatments. The fertility regulator now says the theory behind

them has been widely discredited. So we decided to see what Kerry and

Glyn's doctor would tell us. He's the medical director at a clinic

with a roll call of celebrity clients. The Zita West Clinic in

London. This is Dr George Ndukwe. Two of our team are posing as a

couple. They tell him they've had three failed attempts with IVF in

the past. He wants to help them conceive. He

explains how problems with the immune system can stop you having a

baby. And he talks about specific cells in

the immune system called natural killer cells.

We showed the footage to Professor Ashley Moffett. She's spent her

career studying natural killer cells. They thinks their role has

been misunderstood by some doctors. Although they have been given the

name natural killer cells, they certainly don't kill the embryo.

They're not even in contact with the embryo. Dr Ndukwe wants to test our

couple to find out if they have high natural killer cell problems or

other problems that might prevent a pregnancy. If they do, one

suggestion is an add-on treatment, injections of a substance called

intralipid. Intralipid is a mixture of egg yolk

and soya oil. It's a nutritional supplement. Here, the idea is that

it will make the attacking cells less active. It's hard to understand

how intralipid came into use, because there's absolutely no

scientific rationale for using it at all. But Dr Ndukwe believes

intralipid works. He says one group of women, who'd had six failed

attempts at IVF, saw a massive jump in their pregnancy rates compared to

those who didn't use it. A five-fold increase.

So, from a 9% chance of getting pregnant without using intralipid,

to a 46% chance with it. Experts say he's basing this on very

low quality research. There's no good scientific evidence intralipids

help you have a baby. Dr Ndukwe can prescribe it if he thinks it could

help. But he should explain the back of good evidence and he doesn't.

The couple are sent for a variety of blood tests. The cost, ?2,000. When

it comes to those natural killer cells, Dr Moffett says these tests

are irrelevant. Blood is taken from the arm, but there are different

types of natural killer cells or NK cells. If you look at NK cells in

the blood, they're quite different than NK cells in the uterus. I don't

think this will provide any helpful information for the doctor. It's

like if you wanted to measure the number of black cabs in Trafalgar

Square, you do not measure the number of red mini cabs on the M25.

Dr Ndukwe said these tests and treats are only relevant to a

minority of their patients. His and other clinics' data strongly support

the effectiveness of them, helping hundreds of couples where others

don't work. They aim to give patients the information needed to

make informed choices. He said the intralipid rates he quoted were not

intended to predict the likelihood of success, many different factors

are at work. Add-ons are becoming a bigger part of the IVF business.

Lots of clinics make big claims about add-ons and say they'll

increase your chance of success, but some critics say these claims are

not backed up by good evidence. Professor Robert Winston was unof

the UK's pioneering fertility doctors. He thinks most add-ons are

unnecessary. So many of them are not justified, it's just as simple as

that. They're not justified. They think they're giving the patient

hope. In my view, that's completely the wrong way to do this. They says

there's not good scientific evidence most add-ons improve your chances.

We need evidence-based medicine, based on good, rational trials with

that treatment. They've not been done. Until they're done, I'm not

prepared to accept that those treatments are necessary. We wanted

to find out how good the evidence is behind add-on treatments. We

approached Oxford University and the Centre for Evidence Based Medicine.

The academics here are among the best in the world at assessing

medical evidence. Welcome. They've spent a year researching it for us.

They've done a comprehensive study on the claims and evidence behind 27

add-on treatments. Here's all the different ones here, I can show you.

Professor Carl Heneghan's team started the way most patients do,

researching online. They found lots of positive claims for these add-ons

on clinic websites. Here, for instance, it will make a statement,

this allows a team to optimise your chance after chiefing the pregnancy.

-- of achieving. The team searched over 70 websites in which they found

almost 300 claims. Carl Heneghan is shocked at how little evidence was

quoted. It was one of the worst examples I've ever seen in health

care. It's worse than all the advertising products. The first

thing you'd expect is that anything that makes a claim for an

intervention would be backed up by some evidence. Cosmetics, they have

to say, like, this product was tested on 100 women. Correct. So

they went looking for what evidence there is to see how far it shows

these treatments boost your chances of having a baby. Their results are

surprising. 26 of the 27 don't have good scientific evidence they can

increase your chances of a baby. And there's a question mark over the

evidence for the one that does. So you are saying only one had any

evidence or reasonable quality evidence of having any benefit on

live births? That is exactly what I'm saying. Some of these treatments

are of no benefit to you whatsoever. And some of them are harmful. I

can't understand how this has been allowed to happen in the UK. To be

sure an add-on helps the team says you need to do high quality studies.

The best are randomised controlled trials, where patients are randomly

assigned to groups and given a treatment or an alternative like a

placebo. A trial is the most fair test we have over which treatment

works best. It's the gold standard. We can be confident when we've done

a randomised trial, if something works, we've excluded all other

explanations. Before medicines are approved, they have to undergo large

clinical trials. But many add-ons don't require the same high quality

level of evidence before use. So patients have to trust what their

doctor tells them about the effects. You look into what I can spend money

on all research to make this better, fixed the problem. You have someone

at the top of their field and they'd tell you you need to try this. As a

layperson, you're not going to ask, where is your evidence? I would have

taken anything offered. To me, it made sense in my head. Well

conducted trials matter because they can reveal problems with the

treatment. This Dutch scientist has concerns about one of the most

expensive add-ons around. This is our clean room, where we perform

IBF. It involves screening embryos to detect abnormalities which might

prevent them implanting. It is called PGS, pre-implanting genetic

screening. Nowhere in the Netherlands is offering PGS because

we see no proof of this technology. In the UK and elsewhere, a version

of PGS was offered for a decade before randomised trials work done.

Then Ndukwe did the first trial and found it could reduce your chances

of a baby. -- then Sebastiaan Mastenbroek. It sounded a very

promising technique. It significantly lowered the pregnancy

success. We did not expect that. More accurate versions are offered.

Some charge up to ?3000. Some initial research appears promising.

They have not been shown yet in robust trials to improve your

chances of a baby. At the moment, PGS has not been shown to improve

live birth rate. It has been shown to worsen outcomes. You can pay for

this privately Tamara and it will cost a few thousand pounds. Until

trials currently show otherwise, clinics are expected to tell

patients better evidence is needed. You would hope they tell you that up

front, but how many do? It is November last year and I am at a

fertility fair in London where dozens of clinics from the UK and

abroad pitch for new customers. I choose a team clinics at random. I

say I have been trying to get pregnant for a year and want IVF. I

ask if embryo screening, known as PGS, could be a helpful add-on. Are

there good results with PGS? Start from a number of clinics appear

positive. It is quite successful. I speak to 18 clinics. Five suggest

it could be helpful. Eights say they would only offer it to women over 40

or those who have had repeated IVF failures. There is no good

scientific evidence it helps those women have a baby. Only five give me

the full picture. Some think clinics should wait for

the results of the current trials on PGS before offering it in case, as

with the first version, they show a negative effect. I am actually

surprised that again PGS, a costly procedure is introduced into routine

practice. If anyone wants to offer it, they should at least acknowledge

there is no evidence of Sanjay to the current claims. It has been

three weeks since our undercover couples saw Doctor Ndukwe when he

suggested the add-ons supplement, Intralipid. You would expect this

document to say Intralipid is unproven. It does not. It says it is

investigation. It is not clear what that means. Now, our undercover

couple is back for the results of their ?2000 blood tests for issues

including natural killer cell levels.

Doctor Ndukwe says this means they need treatment. Among other things

he suggests two Intralipid infusions at nearly 200 man they go -- ?200 a

go and more if they get pregnant. I think it is very sad. These women

are being offered tests and therapies which are expensive. There

is no scientific rationale. Doctor Ndukwe should discuss the lack of

good scientific evidence for Intralipid. By the time he is asking

the couple to sign a consent form, he still has not said anything. Is

there anything else we need to know or is it all in here?

Halfway down, it finally reveals Intralipid is unproven. Our couple

leave. This barrister says this is not good enough to inform them

properly. Doctor Ndukwe needs to be equally clear about the pros and

cons of an add-on he is selling. Whether it is summoned selling DIY

material or a doctor offering a service in relation to IVF

treatment. Warts and all is the best approach. Then you can argue that if

you're patient signs, they truly have had all the information to

allow them to give informed consent. Doctor Ndukwe might be falling foul

of consumer protection legislation. A consumer court might well conclude

that what the doctor had done was a misleading act under these wrecked

relations. Doctor Ndukwe said the experience was a one-off. Patients

are sent a document. We were not sent it. He's says a part-time

worker was not sufficiently familiar with their routine. The document

saying Intralipid is investigation on now says unproven.

What I did not realise is getting pregnant is quite hard. Jessica

Hepburn campaigns to ensure fertility patients are better

informed. She spent ?70,000 on 11 failed attempts of fertility

treatment at different clinics. We remortgage our house, maxed out our

credit cards, borrowed money from family. You feel like you are not a

proper woman, you cannot do what every other woman seems to be able

to do. She says many patients feel powerless in consultations. You do

not want to complain or ask too many questions. These are doctors. We

believe what doctors tell us. This is a doctor who holds my happiness

in his hands. Often, it is difficult to know what to believe about an

add-on. Some clinics make big claims about the special incubator. It

takes photos of embryos every few minutes so clinics can watch them

grow. They say this helps them choose the best embryo. Some charge

hundreds of pounds to use it. Trials have been done. Together, they

suggest there is not enough evidence to prove success rates. Oxford

research questions why patients are charged. It is no different to what

is happening already. Couples are charged for this. They should not

be. It does not increase your chances. It does not increase your

chances of getting pregnant? No, it does not. So, why would you charge

for it? I'm off to find at Britain's biggest private clinic. Now we can

see it developing very fast. Some clinics charge nothing. Here it is

an extra ?775. You have probably 300 images over a 24-hour period. The

clinic has done its own big study from patient results. It is

currently published but they say it shows a big boost to a patient's

chances. Sceptics would say, you would find that because you are

charging over ?700. We have invested in this. We have studied it. We

believe it works. We are offering it at a price was we have to buy the

equipment and train the staff. There is a price for that like anything.

The team at Oxford questions such research. The clinic said it would

not offer the add-on if it did not believe the results. It says trials

are often impractical. Patients will not take part but they are often

expensive and take too long to do. Many of our patients do not have

time. If we evaluate it to the point where we believe we have enough

evidence to at least have a sensible discussion with a patient, it is

unlikely to do you harm but it has a possibility of doing new benefit,

then I believe the patient has a right to make a decision. It is

about the doctor giving the right information to the patient. It is up

to patients to decide. Clinics need to inform them sufficiently. I think

it is our responsibility to ensure that couples have full information,

provided we are not causing any harm. I do not think there is any

problem with giving patients information, discussing that we

don't know yet but there is an evidence -based developing. It is a

confusing area. Patients might look to the fertility regulator, the

Human Fertilisation and Embryology Authority for help. They licensed

clinics and offer information for patients. There is a sort of

confusion because you think this is the Government regulator, said they

are licensing this clinic that is offering a treatment they say is

unproven. It cannot be that bad, can it? They are licensing that clinic.

The regulator told us they have limited powers to stop clinics

offering add-ons or to control pricing. They publish information

for patients they can make informed decisions. Shouldn't they be doing

more? I think the HFEA has done a bad job at protecting patients. The

good job at insisting on high laboratory standards that bad at

anything they might consider beyond their remit. The HFEA declined to be

interviewed. They say they are concerned about the recent step

change in the use of add-ons. Next year they will launch a website with

more information about a wider range of add-ons. Some might ignore that

advice. Most of these patients paid for add-ons even when they were told

they were unproven. If someone said, if you cut of your hand, you will

have a baby, I think I would have done it. With all these add-on

treatments, it kept as going that there was still hope. Fertility

treatments need to be built on more than just hope. They should be

backed up by the strongest scientific evidence. When that is

not available, it is vital desperate patients can trust what their clinic

tells them.