Sims IVF Patient Consents Consent to undergo an IVF/ICSI Treatment Cycle
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Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Sims IVF Patient Consents
Consent to undergo an IVF/ICSI Treatment
Cycle
Patient Name: _____________________________
Partner Name: _____________________________
Chart Number: _____________________________
Page 1 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Table of Contents
Introduction to Consents.......................................................................................................................... 3
How should we complete the forms? ................................................................................................ 3
Where can we get further information? ........................................................................................... 3
General Consents ....................................................................................................................................... 4
Data Protection ........................................................................................................................................... 5
Requirements ............................................................................................................................................... 5
Screening .................................................................................................................................................. 5
Consents ................................................................................................................................................... 5
Treatments ................................................................................................................................................... 6
What does treatment include? ............................................................................................................ 6
How long does treatment take? .......................................................................................................... 6
Counselling ................................................................................................................................................... 7
IVF ................................................................................................................................................................... 7
ICSI............................................................................................................................................................. 8
IMSI ............................................................................................................................................................ 9
Medication ................................................................................................................................................. 10
Sedation ................................................................................................................................................. 11
The Effect of Male Partner’s Age on Fertility ................................................................................ 11
Cleavage & Blastocyst ......................................................................................................................... 12
Collection of Sperm ............................................................................................................................ 13
Oocyte Retrieval.................................................................................................................................. 14
Cryopreservation of Oocytes ............................................................................................................... 15
Culture and Manipulation of Embryos ............................................................................................ 16
Consents ................................................................................................................................................ 16
Eeva ......................................................................................................................................................... 17
Embryo Transfer / Elective Freeze .................................................................................................. 18
Freezing and Thawing of Embryos ................................................................................................... 19
Special Circumstances ............................................................................................................................. 21
In the Event of Divorce or Legal Separation. ....................................................................................... 23
Risks ............................................................................................................................................................ 24
The effect of pre-existing conditions .............................................................................................. 24
General Risk ......................................................................................................................................... 25
Multiple Pregnancy .............................................................................................................................. 26
Pregnancy ................................................................................................................................................... 27
Obstetric Ultrasound .............................................................................................................................. 28
Dignity and Respect at Work Policy.................................................................................................... 29
Comprehension of Consent Agreement........................................................................................ 31
Page 2 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Introduction to Consents
Why are we required to sign consents?
Fertility Treatment is a complex area, involving many different issues; particularly when
considering treatment, risk, and the creation and storage of embryos. The purpose of the
consent forms is to make certain you:
are aware of what is involved in the process;
ensure that you have considered all potential outcomes and complications; and
confirm that you have made the necessary decisions regarding the future of the
embryos created.
This consent form will supersede any previous consent form you have signed in Sims IVF so
please give it your full consideration.
How should we complete the forms?
The consent booklet has been divided into sections to make it easier to follow. Each section
provides instructions for completing it correctly. We recommend that you and your partner
give yourselves plenty of time to complete the consents, so that there is time for you to reflect
on the implications and to seek further information or advice if necessary.
Follow the instructions in the booklet carefully, remembering to sign and date where
requested. The final signature must be witnessed by a Sims IVF staff member and will take
place in the clinic.
How long is this agreement valid for?
This Agreement becomes effective when signed by you and Sims IVF. It is valid for a
maximum of one year from the effective date. If any terms in this agreement change you will
be notified by Sims IVF.
Where can we get further information?
We understand that the consent forms deal with issues with which you may not be familiar.
We have some online resources available through our website, www.sims.ie, which may be of
assistance. Should you have any further questions please feel free to contact Sims IVF. Sims
IVF is not qualified to provide legal advice. You are also free to seek outside professional
advice.
This consent was written in compliance with the Children and Family Relationships Bill 2015
which is expected to become law. Sims IVF may be required, by future legislation, to vary
these arrangements and that Sims IVF can give no guarantee that the arrangements defined in
this consent form will continue indefinitely into the future.
Page 3 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
General Consents
We request that Sims IVF provide us with treatment using assisted reproductive
technology, including in vitro fertilisation.
The nature of this treatment has been explained to us by a Sims IVF Clinician
We have had all our questions answered to our satisfaction
We understand that Sims IVF Clinicians may terminate IVF therapy if, in their judgement,
it is appropriate to do so.
We acknowledge and accept that Sims IVF provides teaching facilities and that the IVF
staff may include attending clinicians, fellows, scientists, technicians, nurses and medical
students. We consent to allowing Sims IVF staff or other medical personnel to observe
laboratory procedures performed on our behalf. Sims IVF staff or other medical
personnel may observe other treatment or procedures performed on me or on my
behalf unless we object to this at the time of the treatment or procedure.
We also understand that while every attempt will be made to complete our treatment
as originally planned, we acknowledge that differing response to medication (or other
factors) may make this impossible e.g. our planned embryo transfer for day 5 may have
to be carried out on day 2 or 3. We understand that this is just one of many possible
alterations to our treatment regime.
We understand that assisted reproduction is not always successful and that no
guarantees can be given that pregnancy will occur.
We understand that it is our responsibility to inform Sims IVF in the event that our
address or contact details change.
We understand it is our responsibility to inform Sims IVF if our relationship changes, or
if we want to postpone or cancel treatment.
We understand that some of the treatments outlined; assisted hatching, ICSI, IMSI or egg
freezing, are elective procedures that may or may not be recommended for us. They
have been included in this consent so that if one or more of these procedures are
required and suggested we can proceed without delaying our treatment. Signing
the consent for these procedures does not mean they are a part of your
treatment or that you are entitled to undergo them.
Please sign to state that you have read and understood the above consents and wish
to proceed.
Patient Signature:______________________ Date:_________
Partner Signature:________________________ Date:_________
Page 4 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Data Protection
Sims IVF takes its obligations to process all patient data in a safe, secure manner. In order
to keep your information as secure as possible we have confidentiality agreements in place
with all our testing facilities. We only transfer information required to facilitate your
treatment.
Requirements
Screening
We screen all of our patients for HIV, Hepatitis B, and Hepatitis C, in accordance with EU
regulations. This enables us to store any excess embryos for future use in a container with
other couples who have also been similarly screened. The screening process reduces but
does not eliminate the risk of cross contamination for you and your embryos. Cross
contamination from other patients has never happened in any IVF lab to our knowledge;
screening is a precautionary measure to further reduce the risk.
Consents
We understand that it is our responsibility to inform the medical staff if we are at
increased risk of Zika Virus, Malaria, West Nile Virus, Q-Virus, Dengue Virus or any
other communicable diseases before commencing treatment. We understand that it is
our responsibility to check our personal risk based on our travel history and current
advice issued by the Health Protection Surveillance Centre www.hpsc.ie and the
European Centre for Disease Prevention and Control www.ecdc.europa.eu
We understand that infectious screening blood test results are required before
treatment can be started and we consent to these being carried out, and to any additional
testing requested by the clinician on the basis of our medical history or social, ethnical
or environmental influences.
We understand that treatment will only proceed if all infectious screening blood tests,
including Hepatitis B Core and Hepatitis C antibodies are negative. Treatment may need
to be postponed if the test results are unclear.
We understand that this policy is carried out in order to minimize the risk of cross
contamination between couples attending for treatment (together with the risk to any
children born arising from such treatment).
We understand that folic acid supplements are recommended during fertility treatment,
smoking is not advised, herbal preparations are not advised, caffeine is not advised, and we
should be up to date with general medical matters such as breast screening, pap smears, and
rubella immunisation. Please sign to state that you have read and understood the above
consents and wish to proceed.
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
Page 5 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Treatments
What does treatment include?
Treatment considered as part of the IVF procedure include, but are not limited to:
The use of medications see section, “Medications”;
The use of monitoring including laboratory blood tests and ultrasound;
Collection of sperm;
Oocyte (egg) retrieval;
Fertilisation in the laboratory by IVF or ICSI/IMSI
Culture and manipulation of embryos;
Freezing and thawing of embryos;
Transfer of embryo(s);
Pregnancy and monitoring of pregnancy.
How long does treatment take?
In general, there is a one to two month run in period, so if the first day of your period is in
(say) April, your treatment will be two months later, that is, in June. During this time you will
be prescribed medications. These timings and taking of medications may vary depending on
the treatment protocol you are engaged with.
All treatment takes place on our premises and the time you actually need to be here for is the
two weeks of stimulation and the week of collecting the eggs and transferring the embryos.
Monitoring Protocol
Treatment will be closely monitored throughout by Sims IVF medical staff. This monitoring
will include frequent blood drawing, transvaginal scans and telephone consultations. There may
be some discomfort in undergoing tests and fertility treatment.
It is impossible to estimate the possibility of success relating to tests undertaken. This
uncertainty or the possibility of a negative outcome may cause some individuals psychological
or emotional distress. Repeated blood sampling may cause redness, small bruising and may
carry the risk of infection or thrombosis.Please sign to confirm you have read and understood
the requirements of treatment and monitoring and are happy to proceed
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
Page 6 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Counselling
Sims IVF offers a range of counselling services. This is booked directly through reception.
Counselling available includes; Therapeutic Counselling for individuals or couples,
Counselling if a patient experiences a negative outcome and/or Implications Counselling, for
patients requiring the use of donor sperm or donor eggs (mandatory).
Please sign to confirm you have read and understood the availability of Counselling
and wish to proceed.
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
IVF
The term “in vitro fertilisation” - (IVF), literally means fertilisation “in glass” and refers to the
process where a woman’s eggs are fertilised outside of her body in the laboratory. The
resulting embryos are then transferred back into the uterus a few days later.
The four general steps involved in an IVF cycle are:
stimulation of the ovaries to encourage development and maturation of the eggs;
retrieval of the eggs;
fertilisation of the eggs and culture of the embryos; and
transfer of the embryos back into the uterus.
Consents
We understand that there is a small risk that all of the eggs collected will fail to
fertilise during IVF treatment and that this may be due to either a sperm or egg factor.
We understand that there is a remote risk of failure of eggs to fertilise through any
number of means including but not limited to accidents, mechanical breakdown of
equipment, loss of power, human error, or natural or man made catastrophic events
and that Sims IVF will not be liable for any failure that occurs.
Please sign to confirm you have read and understood the requirements of IVF and
wish to proceed.
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
Page 7 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Please Note: You may not be having an ICSI cycle, but we ask all patients to consent to ICSI so
that, in the event ICSI is necessary to improve your chances of fertilisation our embryology staff can
proceed. Signing this consent does not entitle you to, nor oblige you to have ICSI.
ICSI
ICSI is where we take an individual egg and an individual sperm and insert individual sperm
into that egg straight through the shell on the outside of the egg to increase the chance of
fertilisation. Normally, we transfer embryos either on day three or day five.
Consents
We understand that the embryology staff may need to carry out micromanipulation
Intracytoplasmic Sperm Injection (ICSI) on the day of egg collection if the sperm sample
is such that it is deemed necessary.
We understand that one important cause of azoospermia (i.e. no sperm in the ejaculate)
is Congenital Bilateral Absence of the Vas Deference (CBAVD), which is where the tubes
that carry sperm from the testis to the penis are both missing. We understand that men
with this condition may carry the gene for cystic fibrosis and therefore should consider
genetic testing and counselling before proceeding with ICSI.
We understand that parents (male and female) who require ICSI have a slightly increased
risk of having (and therefore passing on) chromosomal abnormalities. We understand
that men who need ICSI during IVF may have certain gene abnormalities (e.g. deletions
on the Y chromosome) which can be passed from father to son. We understand that
these risks therefore arise in most cases from the underlying risks of inheritance.
Please sign to confirm you have read and understood the requirements of ICSI and
wish to proceed
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
Page 8 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Please Note: Unless your clinician has specifically discussed IMSI with you, and you
have decided to proceed with IMSI you do not need to sign this page.
IMSI
Intracytoplasmic morphologically selected sperm injection (IMSI) is a variation of ICSI that
uses a higher-powered microscope to select sperm. IMSI uses a high power light microscope
(enhanced by digital imaging) to magnify the sperm sample over 6000 times. This allows the
embryologist to detect subtle structural alterations in sperm that a normal microscope could
not detect. Sperm are then selected which have the most normally-shaped nuclei.
Some studies suggest that using this technique selects better quality sperm and results in
higher pregnancy rates and lower miscarriage rates compared to ICSI.
Consents
We understand that the use of IMSI is limited by the resources needed to carry out the
technique. IMSI takes a minimum of 60 minutes - and may take up to 240 minutes. It can
also require two embryologists to analyse the same sample simultaneously to minimise
the subjective nature of the sperm evaluation. Due to the requirements of IMSI it may
not be available on the day of treatment.
We understand that one important cause of azoospermia (i.e. no sperm in the ejaculate)
is Congenital Bilateral Absence of the Vas Deference (CBAVD), which is where the tubes
that carry sperm from the testis to the penis are both missing. We understand that men
with this condition may carry the gene for cystic fibrosis and therefore should consider
genetic testing and counselling before proceeding with IMSI.
We understand that parents (male and female) who require IMSI have a slightly increased
risk of having (and therefore passing on) chromosomal abnormalities. We understand
that men who need IMSI during IVF may have certain gene abnormalities (e.g. deletions
on the Y chromosome) which can be passed from father to son. We understand that
these risks therefore arise in most cases from the underlying risks of inheritance.
We understand that whilst every effort will be made to ensure IMSI takes place when
scheduled, due to the nature of the process and its requirements for resources, it is not
possible to guarantee IMSI will take place
Please sign to confirm you have read and understood the requirements of IMSI and
wish to proceed.
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:________
Page 9 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Medication
Medication required for fertility treatment can include the contraceptive pill, down-regulating
agents - by injection or nasal spray, ovulation induction agents, luteal support, immunotherapy
including Clexane, aspirin and prednisolone, insulin sensitising agents, antibiotics or other
indicated treatment.
What medications do I take?
From the point of view of medications, the standard regimen involves getting control of your
cycle by using the contraceptive pill for two weeks, followed by down regulation in the form
of an injection or nasal sniff over the following two weeks which turns your hormones off.
Finally there is approximately 12 days of injections to stimulate the ovaries.
What are some of the possible side effects?
Although there is no evidence to show that the drugs used to stimulate the ovaries during IVF
cause ovarian cancer, ovarian tumors have been linked to the prolonged use of fertility drugs
in some studies. Bruising, discomfort, or infection may occur as a result of subcutaneous or
intramuscular injection.
Although studies show that IVF overall confers no extra risk, fertility drugs used to induce
ovulation may impose certain risks including physical and emotional pain or discomfort, blood
clotting, and the related risks of ovarian hyper-stimulation syndrome including pain and
distension of the abdomen, nausea and vomiting, difficulty in breathing, a blood clot in an artery
or vein (which can occasionally travel to the lungs), stroke or, in extreme cases, death.
What are some of the risks associated with the medications?
The pill could give you some breast tenderness, and there are small risks, particularly of clots
in the legs or the lungs (especially for smokers over 35). The risks associated with the down
regulation are mostly related to the effect on mood and flushes, in other words, the mini
menopause for the 10 to 14 days while you are on the treatment and this may affect your
mood. The third aspect is stimulation which carries the rare but possible risk of ovarian
hyperstimulation syndrome. This will be discussed in more detail later on.
There are other medications that we give, some of which can cause the patient to develop an
allergic reaction or other problems. In particular the codeine given before egg collection can
cause some nausea. The normal procedure for collecting the eggs is carried out under what is
called conscious sedation. Most of the patients do not remember the procedure occurring but
do sometimes speak or chat during the procedure. The drugs that are normally used are
Cyclomorph (pain relief and anti-emetic) and Hypnovel (which is a version of Valium) to sedate
you. It is important that you make your clinician or a Sims IVF staff member aware of any
allergies you have.
Hyperstimulation is a serious risk, particularly for patients with polycystic ovaries. There are
means of managing this which include (a) cycle cancellation, (b) withholding the HCG / LH
injection, called “coasting”, (c) not transferring the embryos, i.e., elective freeze, (d) draining
the fluid that accumulates and (e) hospital admission. In the vast majority of cases, this settles
down either conservatively or sometimes with these above steps being required.
Please sign to confirm you have read and understood the requirements of medications
and wish to proceed.
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
Page 10 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Sedation
Sedation is generally administered for egg retrieval, but for certain patients it may be
recommended for embryo transfer, SIS or other procedures, by their clinician, based on their
medical history or previous experiences.
Consent
We understand that the purpose of sedation is to more comfortably receive necessary
care.
We understand that sedation may be administered orally or intravenously.
We understand that sedation is a drug induced state of reduced awareness and decreased
ability to respond. We understand we will be able to respond during the procedure and
that our ability to respond normally returns when the effects of the sedative wear off.
We understand that there are risks and limitations associated with all forms of sedation.
These risks include the possibility of inadequate levels of sedation initially, or an atypical
response to the sedative administered.
We understand that it is our responsibility to inform the treating clinician of any allergies
or abnormal reaction to medications before sedation is administered.
Please sign to confirm you have read and understood the requirements of sedation
and wish to proceed.
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
The Effect of Male Partner’s Age on Fertility
It is common knowledge that women’s fertility declines after the age of 35. It is however less
well known that men over 40 also have significantly lower fertility than younger men. We will
provide advice and guidance that may improve age related male fertility factors, such as
supplements or lifestyle changes, if requested.
Consents
We understand that the likelihood of fathering a child is reduced for older men.
We are aware that there is an increased risk of miscarriage and, rarely, of specific
associated conditions such as autism or dwarfism.
Please sign to confirm you have read and understood the information regarding male
fertility
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
Page 11 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Please Note: Blastocyst Transfer may not be part of your treatment, but we ask all patients to
consent to Blastocyst Transfer so that, in the event your clinician recommends a change to your
treatment plan we can proceed. Signing this consent does not automatically entitle you to blastocyst
transfer.
Cleavage & Blastocyst
We have a choice of transferring embryos back into the uterus at two different times; the
cleavage stage (day 2 or 3 post fertilisation) or the blastocyst stage (day 5 or 6).
The advantage of waiting until the blastocyst stage allows us to select the embryos to transfer
back to you and maximise your chance of pregnancy. However, there is a risk that your
embryos may not survive until the blastocyst stage in the lab. Another option is to use a
closed incubator system that aims to predict on day 3 which embryos will most likely progress
to the blastocyst stage and therefore allow us to transfer your best embryos at an earlier
stage.
Your clinician will discuss the optimal time for transfer with you, based on your own
circumstances, number of available embryos, previous cycles of IVF/ICSI, and your wishes. Any
plans that are made regarding timing of transfer may change depending on your circumstances
and at your clinician’s discretion.
Any embryos not transferred back will be cultured to the blastocyst stage and then, if suitable,
frozen for future use by you.
Please sign to confirm you have read and understood blastocyst culture and wish to
proceed.
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
Page 12 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Collection of Sperm
There are three possible sources for sperm; (A) fresh or frozen sperm donated by the male
partner, (B) anonymous donor sperm or (C) identifiable donor sperm. In the case of (A), the
husband/partner will be asked to attend for surgical sperm retrieval or to provide a semen
sample by masturbation on the day of the egg recovery. There is always a risk that there will
be no fresh sperm available on the day of retrieval due to inability to collect, no sperm in the
sample, etc.
If you wish to freeze a sperm sample prior to the cycle you must inform a member of the Sims
nursing or embryology staff well in advance of the treatment cycle.
Consent
Please read the options carefully and select the one with which you wish to proceed.
In relation to the sperm used for our treatment we wish to proceed with
(please tick the appropriate box)
Husband/Partner fresh or frozen sperm
Anonymous donor sperm
Identifiable donor sperm
We understand that Sims IVF will seek to maintain the arrangements covered in this
consent form. However, we also understand that Sims IVF may be required, by future
legislation, to vary these arrangements and that Sims IVF can give no guarantee that the
arrangements defined in this consent form will continue indefinitely into the future.
We understand that if we require advice about the legal rights and liabilities arising out of
participation in a donor sperm treatment cycle or about the legal status of any child born
from donated sperm, we should seek legal advice
Please sign to confirm you have read and understood the information regarding sperm
collection and have selected the option above most suited to you.
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
Page 13 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Oocyte Retrieval
There are risks of bleeding and infection as with all surgical procedures, however these risks
are low. The risk of bleeding is 1 in 500, which is a 99.8% likelihood of there being no problems.
In particular, when the needle is put in at the ovary, you can get bleeding from the wall of
vagina or even from a blood vessel inside the abdomen or the bladder or the bowel being
damaged as well. Although, these are very unusual, they can and do sometimes happen.
Consents
We understand that egg retrieval is performed by a surgical procedure under local
analgesia with sedation in which a needle is inserted through the wall of the vagina using
ultrasound control.
We understand that sometimes no eggs will be retrieved
We are aware of the material risks of the egg retrieval procedure which include death,
respiratory arrest, cardiac arrest, brain damage, disfiguring scar, paraplegia or
quadriplegia, paralysis or partial paralysis, loss of function of any limb or organ, severe
loss of blood, allergic reaction or infection. We understand these are the material risks
attendant on any surgical procedure.
We understand the specific physical risks specific to surgical egg recovery from the
patient’s ovaries include pain, infection and discomfort; untoward reaction to analgesia
or anesthesia; surgical complications such as pain, infection, bleeding or injury to the
pelvic organs, blood vessels or other structures.
We understand that bleeding or other injuries or complications resulting from the egg
retrieval (such as damage to bladder, bowel, or a blood vessel) may require an invasive
surgical procedure to correct the complication and that any such complication or its
correction could affect future fertility.
During the egg retrieval procedure, the clinician may become aware of conditions or
complications which were unforeseen or not known before the start of the procedure.
We therefore authorize and request the clinician and such additional clinicians as may be
present to perform such additional or different operative procedures as are necessary
or appropriate in the exercise of professional judgement to treat, cure or diagnose such
conditions.
Please sign to confirm you have read and understood the requirements of oocyte
retrieval and wish to proceed.
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
Page 14 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Cryopreservation of Oocytes
In the event that there is difficulty in obtaining a sperm sample suitable for treatment on the
day of egg retrieval you have the option to freeze your eggs for use at a later date. The eggs
will be frozen, and thawed for use when you are ready to proceed.
Please read the options below and select the one you wish to proceed with.
You can only select one option
I give my consent to the cryopreservation of any viable oocytes not used for fertilization
I understand that the oocytes will be kept frozen for one year free of charge. After that
an annual storage fee will apply.
I understand that no assurance can be given by Sims IVF that the stored oocytes will
survive the subsequent thawing process or be suitable for fertilisation.
I understand that Sims IVF cannot accept responsibility for any damage that might occur
to oocytes as a result of the freezing/ storage/ thawing process or any abnormality, or
diseases occurring in a child born as a result of fertility treatment in which freezing has
taken place.
I understand that Sims IVF cannot guarantee that all samples in the liquid nitrogen bank
are free from infectious agents.
I understand that there is a remote risk of loss of oocytes through any number of means
including but not limited to accidents, mechanical breakdown of equipment, loss of
power, human error, or natural or man made catastrophic events and that Sims IVF will
not be liable for any loss of oocytes that occurs.
I understand that no stored oocyte can be removed from the storage facility at Sims IVF
without our written consent.
I understand that in the event of my death any oocytes frozen at Sims will be discarded.
Or
I do not give my consent to the cryopreservation of any oocytes not used for fertilization
I understand that if oocytes retrieved from my ovaries and there is no suitable sperm
to fertilise them they will be discarded.
I understand that once the oocytes will not be available for any future treatment.
I understand that I am authorising Sims IVF to discard all oocytes retrieved from me.
Please sign to confirm you have read and understood the requirements of
cryopreservation and wish to proceed.
Patient Signature:______________ Date:_________
Page 15 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Please Note: You may not require Assisted Hatching, but we ask all patients to consent to
Assisted Hatching so that, in the event Assisted Hatching is necessary to improve your chances of
fertilisation, our embryology staff can proceed.
Culture and Manipulation of Embryos
Assisted hatching is automatic for all patients over 35 years, and will also be offered to selected
patients. The shell around the embryo may be too hard and can impede the “hatching” of the
blastocyst out of the shell. A small cut is made in the shell to aid this process. It is usually
offered to older patients, or patients with a high FSH level. There is a small risk of identical
twins with this procedure, of the order of 3%-5%.
Consents
We understand that assisted hatching is a laboratory procedure that may be required to
help the embryo “hatch” out of its shell.
We understand that embryology staff may consider it necessary to carry out assisted
hatching on the day of embryo transfer.
We understand that sometimes none of the embryos will develop properly, with no
transfer taking place
Please sign to confirm you have read and understood the requirements of the culture and
manipulation of embryos and wish to proceed.
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
Page 16 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Please Note: Eeva may not be part of your treatment, but we ask all patients to consent to Eeva
so that, in the event your clinician recommends a change to your treatment plan we can proceed.
Signing this consent does not automatically entitle you to Eeva.
Eeva
Eeva is a monitoring system that fits inside our incubators, and monitors the development of
the embryos. The way an embryo develops can help determine which has the most potential
to result in a successful pregnancy. Eeva monitors the embryos constantly and will make a
prediction of ‘High’, ‘Medium’, or ‘Low’ based on how the embryos developed. Eeva is only a
tool to assist our embryologists in picking the best embryos for transfer, not as a substitute
for their knowledge and experience.
Consents
We understand that Eeva is a camera monitoring system that fits inside the incubators. It
does not interact with our embryos, and does not expose them to anything that could
be potentially harmful.
We understand Eeva allows the embryos to be monitored without taking them out of the
incubator, so actually reduces any potential risks.
We understand that Eeva is an adjunct tool used for gathering further information on
embryo development. It is used in addition to the embryologist’s judgement of your
best embryos based on their morphology (their size and shape).
We understand that while the odds of success with an Eeva ‘High’ embryo are increased,
an embryo classed as ‘Low’ can also go on to result in a successful pregnancy
We understand the Eeva ‘Low’ embryos are still viable embryos and if not used they
will be cryopreserved.
We understand Eeva may not always be able to make a prediction. If this occurs we will
be refunded the cost of Eeva, but will not receive any discount on the cost of the cycle
Please sign to confirm you have read and understood the requirements of Eeva and wish to proceed.
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
Page 17 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Embryo Transfer / Elective Freeze
We understand that embryos are transferred into the womb by means of a small catheter
which is inserted through the vagina and the neck of the womb.
We understand that there is a risk of bleeding from pelvic organs as a result of embryo
transfer into the womb.
We understand that the embryos may not implant.
We understand that the number of embryos to be transferred will be decided by the
clinician on the day of transfer.
We understand that while our guidelines advise transfer of a maximum of two embryos
for patients under 38 years of age that other medical factors are taken into consideration
including a history of previous IVF failure as well as the number and quality of available
embryos on the day of transfer.
We understand that in some cases it may not be possible to proceed with a fresh embryo
transfer procedure in the case of OHSS or other medically significant factors. This is
called an elective freeze procedure where all suitable embryos are frozen for future use.
This decision will normally be medically directed. The costs associated with this are
available on the Sims IVF website.
We understand that we may also request an elective freeze for personal reasons (non-
medically directed elective freeze). In this event we must notify the treating doctor and
laboratory of our intention in this regard and that we will be charged in accordance with
the Sims IVF pricelist
Please sign to confirm you have read and understood the requirements of embryo
transfer and wish to proceed.
Female Patient Signature:______________ Date:________
Male Partner Signature:________________ Date:_________
Page 18 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Freezing and Thawing of Embryos
Consent
We understand and accept that viable embryos that are not used in our IVF treatment
will be frozen (cryopreserved) for our use at a future time.
We understand that embryos may be frozen at any stage between the one-cell (pro-
nuclear) stage and blastocyst stage, depending on individual circumstances, and at the
discretion of the embryology laboratory staff.
We understand that all reasonable precautions are taken to reduce the risk of infectious
contamination between stored human tissue (sperm, eggs, and/or embryos).
We understand that the associated risk of infection from known (or unknown organisms)
is extremely low but that no guarantee of absolute safety can be provided and we accept
this negligible risk.
We understand that cryopreservation does not guarantee that embryos will subsequently
survive the thawing process and that there is a possibility that after thawing there will be
no viable embryos available for embryo transfer.
We understand and accept that there is an additional charge associated with embryo
freezing and that we are liable for payment of this charge if we have any embryos
suitable for freezing.
Please sign to confirm you have read and understood the requirements of the freezing
and thawing of embryos and wish to proceed.
Patient Signature:______________ Date:________
Partner Signature:________________ Date:_________
Page 19 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Cryopreservation Consent
We give our consent to the cryopreservation of any embryos, not transferred, that have
resulted from our IVF/ICSI treatment. We understand that this means we consent to all of
the following:
We understand that not all embryos are suitable for freezing and that there are,
sometimes no spare embryos suitable for freeze-storage.
We understand that no assurance can be given by Sims IVF that the stored embryos will
survive the subsequent thawing process or be suitable for transfer.
We understand that Sims IVF cannot accept responsibility for any damage that might
occur to embryos as a result of the freezing/ storage/ thawing process or any abnormality,
or diseases occurring in a child born as a result of fertility treatment in which freezing
has taken place.
We understand that Sims IVF cannot guarantee that all samples in the liquid nitrogen
bank are free from infectious agents.
We understand that there is a remote risk of loss of embryos through any number of
means including but not limited to accidents, mechanical breakdown of equipment, loss
of power, human error or natural or manmade catastrophic events, and that Sims IVF
will not be liable for any loss of embryos that occurs.
We understand that no stored embryo can be removed from the storage facility at Sims
IVF without our written consent.
We understand that, in the event of a disagreement between us, it is our individual
responsibility to notify Sims IVF in writing if we do not wish the other partner to have
access to the embryos.
We understand that we will be charged an additional fee on top of our treatment fee for
embryo freezing and storage. The additional fee includes up to one year of storage. An
annual storage fee will apply thereafter.
Please sign to confirm you have read and understood the requirements of
cryopreservation and wish to proceed.
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
Page 20 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Special Circumstances
We understand that at all times the embryos belong to us, Sims IVF is merely acting as a
storage facility. Because of this we must indicate our intentions for the embryos in the event
of death or divorce. Either party may change or withdraw their consent at any time by
contacting Sims IVF in writing.
Sims IVF does not guarantee treatment involving the posthumous use of embryos or gametes,
but can release the embryos for treatment elsewhere, provided that appropriate consent is
given.
Section to be completed by Patient:
Please read the options carefully. This is the option you wish to be followed in the event of your
death or mental incapacitation.
Answer yes or no for all options
You must answer yes to at least one option
You can answer yes to as many of the options as you choose
In the event of my death or mental incapacitation Yes No
(a) My partner shall have the right to use the embryos for
treatment with a future partner
(b) My partner may donate the embryos to Sims IVF for training
purposes should a program become available.
(c) Sims IVF may release the embryos into the care of my
partner, after which they would have no responsibility for the
embryos.
Signature of patient: ______________ Date: __________________
Section to be completed by Partner:
Please read the options carefully. This is the option you wish to be followed in the event of your
death or mental incapacitation.
Answer yes or no for all options
You must answer yes to at least one option
You can answer yes to as many of the options as you choose
In the event of my death or mental incapacitation Yes No
(a) My partner shall have the right to use the embryos for future
treatment
(b) My partner may donate the embryos to Sims IVF for training
purposes should a program become available.
(c) Sims IVF may release the embryos into the care of my
partner, after which they would have no responsibility for the
embryos.
Page 21 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Signature of partner: ______________ Date:__________________
Section to be completed by Both Parties
Please read the options carefully. This is the option you wish to be followed in the even that both of
you are dead or mentally incapacitated.
Answer yes or no for all options
You must answer yes to at least one option
You can only answer yes to one option
In the event of our death or mental incapacitation Yes No
(a) We donate the embryos to Sims IVF to be used for training
purposes should a program become available.
(b) Sims IVF may release the embryos into the care of a person
nominated by us, after which they would have no
responsibility for the embryos.
Signature of patient: ______________ Date:__________________
Signature of partner: ______________ Date:__________________
Page 22 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
In the Event of Divorce or Legal Separation.
Please read the options carefully and select the one with which you wish to proceed. Both the patient
and their partner must consent. Please read the Important Notes sections carefully before
completing this section. Either party may change or withdraw their consent at any time by
contacting Sims IVF in writing
Please complete Section 1 and Section 2
In Section 1 You may choose to say yes to one option only
Section 1 Yes No
1 Partner _______________________obtains sole ownership of the
embryos (Block Capitals)
2 The couple retain joint ownership of the embryos
In Section 2 You may answer yes or no for all options
You must answer yes to at least one option
Section 2 Yes No
(a) The person(s) we selected in Section 1 shall have the right to use the
embryos for future treatment.
(b) This person(s) we selected in Section 1 may donate the embryos to
Sims IVF to be used for training purposes should a program become
available.
(c) Sims IVF may release the embryos into the care of the person(s) we
selected in Section 1, after which Sims IVF would have no responsibility
for the embryos.
Signature of patient: ______________ Date:__________________
Signature of partner: ______________ Date:__________________
Page 23 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Risks
Failure is a possible outcome of all treatment, and unfortunately, we cannot take that risk away
from you. The only guarantee that we can give you is that we will of course do our best to
make it a successful outcome in your case. Sims IVF will not be liable for any failure that occurs.
Failure to achieve pregnancy may occur as a result of difficulties with any of the steps described
above. These difficulties may include but are not limited to:
Sub-optimal follicular development may lead to cancellation of the cycle;
The ovaries may be inaccessible during egg retrieval;
No eggs may be retrieved;
The eggs may be abnormal;
Fertilization may not occur;
Fertilization may be abnormal;
Embryo development may fail or may be abnormal;
Embryo transfer may be difficult or may not be possible;
Implantation of the embryo in the womb may not occur;
There is a remote risk of failure through any number of means including but not limited
to accidents, mechanical breakdown of equipment, loss of power, human error, or natural
or man-made catastrophic events
Natural or man-made disaster may make key personnel or services unavailable.
The effect of pre-existing conditions
There are some common specific conditions which can affect what happens during a
treatment cycle including endometriosis, diminished ovarian reserve, uterine fibroids and
polycystic ovaries.
Endometriosis arises when the lining of the womb (endometrium) grows outside the
womb – often on the surface of the pelvic organs or inside the ovaries themselves.
Among other things, patients undergoing IVF who have endometriosis have a tendency
to have (a) less eggs, (b) reduced egg quality, (c) a reduced chance of being pregnant, (d)
a lower chance of embryo implantation, (e) an increased risk of infection after the eggs
are collected, and (f) can develop severe pain in the tummy (“peritonism”) from leaking
“chocolate” cysts of one or both ovaries after egg collection.
Patients with diminished ovarian reserve are usually recognised by the presence of low
AMH, an elevated blood level of FSH in the early days of a period (second or third day).
They also have a tendency to have fewer eggs, reduced egg quality, and a reduced chance
of being pregnant.
Fibroids are benign muscle swellings that are unlikely to affect treatment unless they
occupy and distort the interior cavity of the womb (uterus).
Polycystic ovaries can cause the ovary to over-respond to stimulation. This condition is
covered in the following section on medications.
Please sign to confirm you have read and understood the risks involved and wish to
proceed.
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
Page 24 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
General Risk
Infection is also a risk and it is estimated in the literature at about 1 in 250 which is 4 in
a 1000, (a 99.6% likelihood of not happening). This is also very rare in our hands and we
do give prophylactic antibiotics to further reduce that risk.
There has been one death in Ireland from ovarian hyperstimulation, although the risk in
the international experience of death from hyperstimulation is estimated between 1 in
50,000. The most important factor is to exclude polycystic ovaries, particularly in the
younger patient and this is normally done with vaginal ultrasound, which you will have
repeated on a number of occasions. If you have any concerns in this regard, please discuss
it either with one of the other clinicians or nurses. We will happily go through this in
detail with you.
There is a rare risk of torsion, which is in the region of 1 in 5000, and this is particularly
the case in any situation where the ovary is enlarged. It is a rare occurrence and if it did
happen you would have severe pain on the side of the ovary that is affected. Sometimes,
the ovary can be untwisted where it twists on its blood supply but in some situations the
ovary has to be removed. You would know that torsion was occurring and would require
admission to hospital as an emergency.
There is always a risk of miscarriage no matter how you conceive and the risk in IVF is a
little bit higher than the normal population, i.e., somewhere in the range of 29% compared
to 25% from the general population. Indeed, of every three pregnancies that our patients
have, one is lost through either miscarriage or ectopic pregnancy.
Ectopic pregnancy itself is a risk to women no matter how they conceive, in the region
of 1 in a 100, although this can go up to 3% risk if there is a history of tubal disease. In
ectopic pregnancies, the pregnancy grows outside the uterus, usually in the fallopian tube,
and can cause a risk of serious bleeding and emergency admission. However, we normally
pick this up quite early because we scan patients early to confirm that any pregnancy is
in the uterus and proceeding normally.
A rare type of ectopic pregnancy called “Heterotopic pregnancy” can occur in as many
as 1 in 100 couples who conceive through IVF. This is when one embryo implants in the
uterus and another embryo implants elsewhere as an ectopic pregnancy.
Patients undergoing IVF have an increased risk of clots developing in their circulation.
There is always the risk of an abandoned cycle whereby we stimulate the patient for
superovulation, i.e., producing as many follicles as possible but the patient does not
respond. This is the other end of the spectrum from hyperstimulation.
There is a risk of failed fertilisation. This is where we obtain eggs and mix them with
sperm in the normal way but the sperm fail to fertilise the eggs. This does not mean the
end of the process; ICSI is still a viable treatment option.
In rare instances equipment malfunction or technical error may occur and result in
sperm, egg or embryo loss.
Please sign to confirm you have read and understood the risks involved and wish
to proceed.
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
Page 25 of 32Sims IVF Form No. PT-CONS-056
Revision No. 05 Effective Date 07.02.17
IVF Information & Consent Form – Sims IVF Dublin
Multiple Pregnancy
Multiple pregnancy is one of the most important complications of IVF treatment. Our
incidence of twins is in the region of 25%, our risk of triplets is less than 1%. However,
these rates vary. This is a significant issue for you as it can be associated with increased
risks of death and disability for the infants.
The particular risk is of preterm labour, which is associated with blindness, deafness,
and intellectual disability.
Please sign to confirm you have read and understood the risks involved with multiple
pregnancies and wish to proceed.
Patient Signature:______________ Date:_________
Partner Signature:________________ Date:_________
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