13-03-23 - In Vitro Fertilisation

Question 1

Learning outcomes

Answer 1

• 1. to outline the procedure of in vitro fertilisation and when/why it might be used clinically
• 2. to describe some of the risks associated with IVF for both the mother and the child
• 4. to understand the role of the HFEA in regulating assisted reproduction in the UK
• 3. to outline the Scottish Government’s most recent (2016) recommendations for IVF on the NHS
• 5. to identify and discuss some of the ethical issues arising at key stages in the IVF process, mitochondrial transfer, and in surrogacy arrangements
• 6. to review 3 key assisted reproductive technology (ART) cases: Diane Blood, Natalie Evans, and Mr & Mrs A & B (note: these will be covered in the tutorial)

Question 2

What are 4 reasons for IVF?

Answer 2

• 4 reasons for IVF:

1) Infertility affecting male and/or female – most common reason

2) Chromosomal abnormality or inherited genetic disease – IVF combined with pre-implantation genetic diagnosis

3) Same-sex relationships

4) About to have cancer chemotherapy – wish to preserve eggs or embryos

Question 3

What does the term infertility mean?

What are 3 ways infertility has been described?

Answer 3

• The term infertility is used to describe people who have difficulties (or may find it impossible) to have children naturally
• 3 ways infertility has been described:
  1) A dysfunction (but not adisease)
  2) A socially constructeddisease
  3) A “terrible disease affecting our sexuality and well being” (Lord Winston)

Question 4

What 3 things should we consider in parenthood?

What are 4 different types of parents?

Answer 4

• 3 things we should consider in parenthood:
  1) Begetting
  2) Gestating
  3) Caring
• 4 different types of parents:
  1) Intentional parents
  2) Genetic parents
  3) Gestational mother
  4) Nurturing parents

Question 5

How many couples have difficulty in conceiving?

What % of couples will conceive naturally within a year if they have regular unprotected sex (every 2 or 3 days)?

How does NICE 2013 defined infertility?

How likely is it for couples who’ve been trying to conceive for more than 3 years the likelihood of getting pregnant naturally within the next year?

Answer 5

• ~ 1 in 7 couples may have difficulty conceiving
• ~ 84%of couples will conceive naturally within a year if they have regular unprotected sex (every 2 or 3 days).
• Infertility is defined (NICE 2013) as when “A woman of reproductive age who has not conceived after 1 year of unprotected vaginal sexual intercourse [in the absence of any known cause of infertility, should be offered further clinical assessment and investigation along with her partner]”
• Couples who’ve been trying to conceive for more than 3 years the likelihood of getting pregnant naturally within the next year is 25%or less.

Question 6

Causes of infertility.

What are 3 factors affecting a woman’s fertility?

2 factors affecting a man’s fertility?

Answer 6

• Causes of infertility
• 3 factors affecting a woman’s fertility:
  1) Abnormal ovulation (e.g. polycysticovary syndrome, early menopause)
  2) Damage to Fallopian tubes (e.g. surgery,PID)
  3) Endometriosis
• 2 factors affecting a man’s fertility:
  1) Low sperm count/quality
  2) Damage to testicles and/or failure to ejaculate

Question 7

What are 5 Assisted Reproductive Technologies to treat infertility?

Answer 7

• 5 Assisted Reproductive Technologies to treat infertility:
  1) Intrauterine insemination (IUI)
  2) In vitro fertilisation (IVF)
  3) IVF with intracytoplasmic sperminjection (ICSI)
  4) Use of donor sperm/eggs
  5) Surrogacy

Question 8

What are the 6 main stages of IVF?

Answer 8

• 6 main stages of IVF:

1) Suppressing your natural cycle

2) Helping your ovaries produce extra eggs

3) Monitoring your progress and maturing your eggs – ultrasound scans check development

4) Collecting the eggs – a needle is inserted through the vagina and into the ovaries to remove the eggs

5) Fertilising the eggs – the eggs are mixed with the sperm for a few days to allow them to be fertilised

6) Transferring the embryo(s) – 1 or 2 fertilised eggs (embryos) are placed into the womb

Question 9

What are 5 risks associated with IVF?

Answer 9

• 5 risks associated with IVF:

1) Side effects

2) Ovarian hyperstimulation syndrome
* Can occur thanks to superovulation in response to the drugs

3) Transfer of several embryos – multiple births
* Recommendation is for single embryo transfer

4) Ectopic pregnancy

5) Welfare of the child
* 1990: the need for a father
* 2008: the need for supportive parenting

Question 10

Why is supportive parenting considered in IVF?

Answer 10

• Supportive parenting is considered in IVF because a woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need for supportive parenting), and of any other child who may be affected by the birth.

Question 11

IVF on the NHS (England and Wales).

How does IVF treatment on the NHS vary in England and Wales?

Why is this?

What are 4 points of IBC criteria that need to be met for an individual to be considered for IVF?

How many cycles does NICE recommend should be on the NHS?

Answer 11

• The provision of IVF treatment varies across England and Wales, and often depends on local integrated care board policies (IBCs)
• ICBs may have additional criteria you need to meet before you can have IVF on the NHS
• 4 points of IBC criteria that need to be met for an individual to be considered for IVF:

1) Not having any children already, from both your current and any previous relationships

2) Being a healthy weight

3) Not smoking

4) Falling into a certain age range (for example, some ICBs only fund treatment for women under 35)

• Although NICE recommend up to 3 cycles of IVF should be offered on the NHS, some ICBs only offer 1 cycle, or only offer NHS-funded IVF in exceptional circumstances

Question 12

What are the guidelines for IVF treatment in Scotland (updated 2017, from 2013) – (in picture).

What are the 3 criteria for each?

Answer 12

Question 13

How successful is IVF?

What number were for women under 37?

How often is IVF privately funded?

How much does 1 cycle of IVF cost?

Answer 13

• 26.5% of IVF treatments, using own fresh eggs, successful
• 2/3 of the women were under 37:
• 32.8%: 18-34 yrs
• 29.5%: 35-37 yrs
• 21.8%: 38-29 yrs
• 13.7%: 40-42 yrs
• 4.9%: 43-44 yrs
• 2.0%: 45+ yrs
• 6/10 IVF cycles were privatelyfunded
• 1 cycle costs ~£3500

Question 14

What are 4 ways IVF is/was regulated?

What are 4 reasons IVF is regulated?

Answer 14

• 4 ways IVF is/was regulated:

1) 1978: First ‘test-tube’ baby – Louise Brown

2) Warnock Report 1984

3) Human Fertilisation and Embryology Authority (HFEA)
* Regulator and information provider
* Regulate:
* Treatment (inspect & licenseclinics)
* Research (licenses for human embryoresearch)

4) Human Fertilisation and EmbryologyAct 1990, 2008

• 4 reasons IVF is regulated:
  1) Risks
  2) Moral
  3) Ethics
  4) History

Question 15

What are 4 ethical issues associated with IVF?

Answer 15

• 4 ethical issues associated with IVF:
  1) Access
  2) Gametes
  3) Embryos
  4) Global

Question 16

Ethical issues in IVF: Access.

What 3 issues are raised?

Answer 16

• Ethical issues in IVF: Access

1) Equity of Access
* “NHS trusts across England and Wales are working to provide the same levels of service.” (NHS website)
* Additional criteria rules out couples from funding - way to allocate resources – but is it fair?
* Not all criteria related to factors that effect the efficacy of treatment – e.g. any children from current or previous relationships
* Some can pay for private treatment, for others unaffordable

2) Homosexual couples
* NHS Greater Glasgow and Clyde – very public case in 2009; at first NHS GGC said no, but then overturned that decision (now included in SGG2013)
* An NHS GGC spokeswoman said yesterday “treatment acceptance criteria” had at first been applied to the couple as they would have been to any other. She said: “As a couple, these two individuals are biologically incapable of conceiving and the board, therefore, initially took the view that the couple did not meet the necessary criteria to receive NHS-funded treatment. “The board has, however, reconsidered its position in light of other regulations, including the Human Fertilisation & Embryology Act 2008 and Equality Act (Sexual Orientation) regulations 2007, and has now decided to offer treatment to this couple.“ (The Scotsman, 26th February 2009)

3) Single women
* Case of Elizabeth Pearce (Ealing PCT)– using sperm bought from the US, and IVF funded by NHS
* Remember HFE Act 2008: “supportive parenting”
* Miss Pearce, who receives child tax credit and housing benefit, cited Articles 8 and 14 of the European Convention on Human Rights – the right to respect for family and private life and the prohibition of discrimination.
* She told the Mail: ‘I believe that it is my right as a woman to be a mother. The fact that I am single is irrelevant. (Daily Mail, 4th July 2011)

Question 17

Ethical issues in IVF: Gametes.

What are the 2 types of gametes?

What are ethical issues surrounding each type?

Answer 17

• Ethical issues in IVF: Gametes
• 2 types of gametes:

1) Frozen
* Must state how long and what happens in event of death
* Ceiling of £750 (HFEA, 2013)

2) Donated
* Is it okay to pay donors? In UK: “compensation”; not so elsewhere
* Should there be a limitto number of children created? – In the US: one man fathered 150 children; UK: limit = 10 families
* Should children be able to find out who their biological parents are? 2005: change in law
* Egg sharing is allowed

Question 18

Ethical issues in IVF: Embryos.

What 4 ways are embryos graded?

What are 4 questions associated with IVF embryos?

Answer 18

• Ethical issues in IVF: Gametes
• 4 ways are embryos graded:
  1) Use immediately
  2) Freeze
  3) Discard
  4) Research
• 4 questions associated with IVF embryos:

1) How many should be made?

2) How many should be implanted?

3) What do we do with those not used?

4) How does pre-implantation genetic diagnosis effect the making and use of embryos?

Question 19

Ethical issues in IVF: Global

Answer 19

• Ethical issues in IVF: Global
• Reproductive tourism:
  1) Cost differences
  2) Waiting lists
  3) Avoid legal restrictions

Question 20

What is IVF with mitochondrial replacement?

What does it involve?

What consultation took place regarding this technique?

What were the 4 considerations identified?

Answer 20

• IVF with mitochondrial replacement is a technique that allows those at risk of passing on certain mitochondrial conditions (carried on mtDNA) to avoid that risk
• It involves a pro-nuclear transfer or maternal spindle transfer
• HFEA held public consultation took place surrounding this technique
• 4 considerations identified:
  1) Modification of embryos and changing the germline
  2) Implications for identity and the status of the mitochondria donor
  3) General views on the permissibility of the techniques
  4) Licensing models and further regulatory issues

Question 21

Describe the IVF with mitochondrial replacement technique (in picture)

Answer 21

Question 22

IVF with mitochondrial replacement regulations

Answer 22

• IVF with mitochondrial replacement regulations:
• House of Commons: on Tuesday 3 February 2015 MPs voted by 382 to 128 to amend the Human Fertilisation and Embryology Act 2008 and allow mitochondrial donation.
• House of Lords: on Tuesday 24 February 2015 peers voted by 280 to 48 to allow mitochondrial donation to be licensed for use.
• HFEA: on15th December 2016, HFEA approved use of mitochondrial donation in certain, specific cases
• HFEA: 16th March 2017, approved first clinic application (Newcastle)
• HFEA: 10thOctober 2017, HFEA give guidance for clinics following 4th report on safety and efficacy (independent scientific panel)

Question 23

What are the 2 types of surrogacy?

What % of cases involve known surrogates?

In what % of cases do disputes arise? H

ow many surrogate arrangements/births are there a year in the UK?

Are surrogacy agreements enforceable?

Who is the legal mother in UK surrogacy?

What are 2 key reports surrounding surrogacy?

Answer 23

• 2 types of surrogacy:

1) Partial surrogacy: surrogate mother inseminates herself with commissioning father’s sperm

2) Full surrogacy (commissioning couple’s egg & sperm mixed in vitro and then transferred)

• 50% of surrogacy cases involve known surrogates
• Disputes arise in only ~5% of cases
• 100-180 surrogate arrangements/year in UK (50-80 births)
• Surrogacy agreements are not unlawful but they are unenforceable due to bodily autonomy (Surrogacy Act 1985)
• In UK surrogate mother is always the legal mother from birth (parental order or adoption required) (1990 amendment)
• 2 key reports surrounding surrogacy:
  1) Brazier Report
  2) Warnock Report