Advice on treatment add-ons

It is sometimes difficult as a patient in a fertility clinic to know whether it is worth paying for some or any of the add-on treatments you may be offered. Now, the Human Fertilisation and Embryology Authority (HFEA), which regulates IVF clinics in the UK, and 10 of the leading professional and patient fertility groups, have agreed how treatment add-ons should be offered ethically in clinical practice in the UK in a consensus statement published today.

It’s published in response to growing evidence of add-ons being offered to patients, without conclusive evidence to date that any of them increase the chance of a pregnancy, and the fact that many patients feel they must do anything to improve the possibility of success. The aim is to create a culture change among fertility professionals in the UK.

Sally Cheshire CBE, Chair of the HFEA, said “We welcome the introduction of new treatments that could increase the chances of success, however, we want to see responsible innovation. Fertility treatment add-ons are being offered to more patients by clinics and we know many patients are asking for these add-ons and paying for them if they have private treatment. It’s crucial that clinics are transparent about the add-on treatments they offer, including the potential costs, to ensure patients know exactly whether they are likely to increase their chance of having a baby. That is why we’ve been working with professional groups such as the British Fertility Society to decide how unproven treatments into clinical practice should be correctly and ethically introduced, which is a vital step towards a more transparent approach in fertility services. We are now expecting clinics to provide information about treatment add-ons to patients, including what evidence there is of effectiveness.”

Alongside the principles for clinics, the HFEA has also published information on the most commonly offered add-ons, with a traffic light rating system, to help patients better understand the effectiveness of treatments they might consider.

Sally adds: “It’s crucial that patients inform themselves about the add-ons they may be offered, so that they can ask the right questions, and make the right choices, when choosing what treatment to have. We’ve produced ‘traffic light’ rated information on our website that keeps them up-to-date with the latest evidence on each of the most commonly offered add-ons.”

Jason Kasraie, Chair of the Association of Clinical Embryologists, said “We support greater transparency in the sector with regard to treatment add-ons. Whilst it is important that we work to ensure patients always receive the latest treatments and have access to new technologies in order to maximise their chance of treatment success, it is also essential that we ensure patients are fully informed and that only procedures or technologies that are evidence based are used.”

Key principles of the consensus statement are:

  • Clinics should only offer treatment add-ons where more than one high quality study demonstrates a treatment add-on to be safe and effective.
  • Clinics should stop offering the treatment add-on to patients if concerns are raised regarding safety or effectiveness.
  • Patients must be clearly informed of the experimental nature of any treatment add-on which is offered, where there is no robust evidence of its safety and/or effectiveness
  • Patients should not be charged extra to take part in a clinical trial.

The General Medical Council, has welcomed the statement. Chief Executive, Charlie Massey said: “We welcome this consensus statement, which will help protect fertility patients from poor practice and feeling pressure to accept additional, unproven extras. Patients deserve to have the best available evidence so they can make informed decisions, in partnership with doctors. It’s vital that doctors innovate responsibly and place patient safety first and foremost. Our guidance on consent sets out how doctors should work with patients to make decisions together about care and treatment options. Doctors working in the fertility sector must ensure that patients have information about the options available to them, including risks and available evidence, as well as any potential benefits.”

You can read the statement here and find out more about the HFEA’s traffic light system for add-ons here 

Could you be a lay examiner?

The Royal College of Obstetricians & Gynaecologists (RCOG) exams department is recruiting a new pool of Lay Examiners. The Membership Exam (MRCOG), for hospital doctors wishing to specialise in obstetrics and gynaecology, consists of a Part 1 written examination, Part 2 written examination, and Part 3 examination which is a role-play style Clinical Assessment involving multiple tasks. The new pool of examiners will build the capacity the College has to examine Part 3 as there is a growing number of doctors applying for the exam.

Part 3 aims to assess candidates’ ability to apply core clinical and communication skills in the context of the skills, knowledge, attitudes and competencies as defined in the MRCOG curriculum. For this, candidates are examined by Clinical Examiners alongside Lay Examiners. How doctors effectively communicate with and support their patients to understand their health and the choices they have is a crucial part of their role and the care they provide. Lay Examiners are responsible for assessing these skills.

Exams take place several times a year in London. This is a paid opportunity, remunerated at a fee of £125 per day of examining, excluding training days and the briefing session held the day before the examination. Travel is organised and paid for by the College and accommodation is provided for Lay Examiners who cannot travel to and from the College daily, on the days of examinations.

This is the second time the RCOG has recruited Lay Examiners. The College did so two years ago when Lay Examiners were first introduced into the Part 3, and they have since been successfully examining.

You can read the full role description, requirements and application process on web page below.

The closing date for applications is Wednesday 5th September, with a selection and training day scheduled for 25th September.

https://www.rcog.org.uk/en/about-us/get-involved-with-our-work/rcog-roles/part-3-mrcog-lay-examiners/

IVF funding situation is “shocking”

The latest figures released by Fertility Fairness earlier this week about funding for IVF treatment have been described as “shocking” by the President of the Royal College of Obstetricians and Gynaecologists, Professor Lesley Regan.

Commenting on the fact that so few clinical commissioning groups (CCGs) are currently following national guidance and that the number which have completely removed NHS IVF has almost doubled in the last year, Professor Regan said “These figures are shocking and it’s very disappointing to see even fewer CCGs following NICE guidance and providing full access to NHS fertility treatment. Current access to treatment is a postcode lottery and these health inequalities people face are unacceptable. Infertility can have a devastating effect on people’s lives, causing distress, depression, and the breakdown of relationships. IVF treatment is cost-effective and should be available on the NHS. The RCOG is committed to working with UK commissioners and healthcare providers to support them in following NICE Fertility Guidelines.”

Are you interested in equality and diversity?

If the promotion of equality and diversity is something you feel passionate about, you may be interested in the opportunity to join the Royal College of Obstetricians and Gynaecologists (RCOG) Equality and Diversity Committee. The RCOG is looking for doctors and lay members to join the committee which was set up in 2014 to monitor the way the College works.

This is a voluntary role and involves joining four two hour meetings a year which are held by video conference and take place on weekday afternoons. If it’s something you think may be of interest to you, you can find more details here about the Committee and what is involved

 

Could you help shape training for doctors of the future?

There’s a very exciting opportunity to help inform the new curriculum for specialist doctors who are training in gynaecology and obstetrics. The Royal College of Obstetricians and Gynaecologists is looking for a range of people to join a new public insight group to help identify the communication skills and clinical knowledge that doctors need to give the best possible care.

The curriculum is updated every so often to ensure that new evidence or technology is taken into account, and the RCOG is committed to involving people who use services in all aspects of their work. Although the expertise of experienced doctors is vital, it is just as important to involve service users to hear what knowledge and skills they feel specialists of tomorrow should have.

The Public Insight Group will aim to include people from across the UK with a variety of needs and experiences. It may also include representation from individuals who have particular understanding of the needs of specific communities and can represent the experiences and needs of those groups effectively. There will be a core group of around 20 people who will meet face-to-face for an initial workshop session. After this, the group will be coordinated mainly by email as the new curriculum develops.

A wider consultation group will bring a broader pool of views into the project. This group will only be involved by email. Both the core and the wider group will play a crucial role in informing the new curriculum over the next year. Both groups will be communicated with regularly to gain insight and feedback will be given to members about how the new curriculum is progressing.

For more details about what is involved and to see whether this is something you may be interested in, see here 

Expert opinion on treatment add-ons

If you’ve been unsure who to believe about fertility proline_level_measurement_in_eurasian_national_universitytreatment add-ons, you may be interested in some impartial and expert advice in two new scientific opinion papers published by the Royal College of Obstetricians and Gynaecologists (RCOG). They call for more high quality research into the role of natural killer cells in fertility and the effect of endometrial scratching on pregnancy outcomes.

Scientific Impact Papers (SIP), are up-to-date reviews of emerging or controversial scientific issues. The first paper looks at the role of uterine natural killer (uNK) cells, how they are measured, the role of testing and the evidence behind any links to improving implantation rates and early placental development. The paper clarifies that uNK cells are completely different from peripheral blood natural killer cells (which you would be testing in the blood tests some fertility clinics currently offer).

The paper makes it clear that there is no evidence to offer routine tests for NK cells as part of fertility treatment or testing, and that there is uncertainty about how NK cells are measured and reported. The paper says that treatment for raised levels with intravenous immunoglobulin (IVIg)  is not supported by the current evidence and, since it may have serious adverse effects, should not be used..

The second opinion paper explores the effect of endometrial scratch on pregnancy outcomes in women who have experienced recurrent miscarriage and recurrent implantation failure.

Endometrial scratch is a procedure which is hypothesised to help embryos implant more successfully after IVF/ICSI and involves scratching the lining of the womb.

Several studies have examined the impact of endometrial scratch in the cycle preceding an IVF treatment cycle in women with recurrent implantation failure, which appear to provide convincing evidence of benefit of superficial endometrial scratch in improving the implantation rate in this group of women. However, the effect of this treatment on pregnancy outcomes in women who have experienced recurrent miscarriage or those undergoing their first IVF cycle is uncertain.

Professor Adam Balen, Chair of the British Fertility Society (BFS) and spokesperson for the RCOG, said: “These two papers look at the current available evidence which exists and give much-needed guidance to both healthcare professionals and the public on these two topics. It is important that patients receive full information about treatments, the current evidence for benefit and whether there are any side effects or risks associated with it.”

Mr Mostafa Metwally, Vice Chair of the RCOG’s Scientific Advisory Committee added: “There is currently no convincing evidence that uterine natural killer cells are the cause of reproductive failure. Despite this, a number of women are requesting and being offered analysis of either peripheral blood or uterine killer cells and the value of these measurements remains controversial. Current evidence suggests that endometrial scratch may benefit women with recurrent implantation failure and therefore defining the optimal number of previously failed embryo transfer cycles needs to be evaluated in large cohort randomised prospective clinical trials.We still do not understand the mechanism by which endometrial trauma may lead to improvements in IVF outcomes in women and further studies are needed looking specifically at its success among women undergoing their first IVF cycle.”

The papers are available here:

The Role of Natural Killer Cells in Human Fertility

Local Endometrial Trauma (Endometrial Scratch): A Treatment Strategy to Improve Implantation Rates

Have you been affected by miscarriage?

If you have been affected by miscarriage, would you be able to help by completing a survey about priority setting around miscarriage? The link to the survey itself is here but if you are interested in reading more about it, this may be helpful from one of the lay members who has been sitting on the group leading the project.  The aim is to improve the care and treatment for women who experience miscarriage and those affected by it, and to set the priorities for research that will make the biggest difference.

Woman who have had a miscarriage themselves and their partners, family members, friends and colleagues are invited to complete the survey along with professionals involved  in caring for women who have experienced miscarriage and professional bodies, patient groups, charities and other organisations involved with miscarriage.

RCOG Women’s Voices

I’m really delighted to be able to let you know that I’ve been appointed as the first Women’s Voices Lead at the Royal College of Obstetricians and Gynaecologists – you can find out more about that here and about the Women’s Voices Involvement Panel itself here. I think it’s a really exciting time at the RCOG where there is a genuine commitment to listen to women’s voices – but do read more on the website and let me know what you think!

Reproductive immunology

Natural_killer_cellIf you look on fertility websites, you’ll often find people discussing reproductive immunology or their NK cell tests and results. What’s often not clear from the discussions is the fact that the reason many fertility specialists don’t offer this kind of treatment is because they don’t believe there is any scientific evidence to back up the theories.

This picture above is apparently an NK cell – I can’t imagine they are quite that purple in colour, but it gives them just the kind of slightly sinister look that the name conjures up. In fact, as Dr Norman Shreeve from Cambridge University explains in the latest edition of the BioNews online newsletter, the name is misleading as the cells play a key role in early pregnancy,

If you’re thinking of looking into having your NK cells tested, or taking some of the treatments currently offered in this field, you should first read the information on the HFEA website and a scientific impact paper on the subject from the Royal College of Obstetricians and Gynaecologists which is more complex but also concludes that there is little evidence to support the use of these treatments and that their use should be restricted to research trials.

What the experts have to say on reproductive immunology

If you are considering having immune tests or treatments along with your fertility treatment, it is important to have looked into this properly. You will find vast amounts of information about this online, some of it written by people who currently offer the treatment. More and more patients consider having NK cell testing along with other assessments, but not all are aware of the views of leading professionals in the field.

The things it is really worth reading about this are first, a Scientific Impact Paper from the Royal College of Obstetricians and Gynaecologists, which is the professional body for gynaecologists, including fertility specialists, in the UK. The other is the Human Fertilisation and Embryology Authority’s information for patients about reproductive immunology. These give an evidence-based view from professional experts and will give a good basis on which to make any decision about immune tests and treatments.