Download OCUMENTO DE INFORMACIÓN DE FECUNDACIÓN IN VITRO O

IN VITRO FERTILIZATION OR INTRACYTOPLASMIC SPERM
INJECTION (IVF/ICSI) AND EMBRYO CRYOPRESERVATION
INFORMATION DOCUMENT
SPANISH FERTILITY SOCIETY
I. What does it consist of?
In Vitro Fertilization is a treatment that consists of medical and biological procedures to
facilitate attachment of eggs (oocytes) and sperm in the lab, and obtain embryos to be
introduced into the uterus to achieve pregnancy.
In Vitro Fertilization can be performed by two different methods: conventional In Vitro
Fertilization or IVF, in which the egg and sperm unite spontaneously in the laboratory; and
Intracytoplasmic Sperm Injection or ICSI, in which fertilization is done by injecting a single
sperm into each egg.
Fertilization produces embryos, which are the group of cells resulting from the progressive
cleavage of the ovum from fertilization up to 14 days later. Only a number of embryos should be
generated in each reproductive cycle, which, according to clinical criteria, ensures a reasonable
chance of reproductive success of each case.
A limited number (between 1 and 3) of the embryos obtained will be transferred to the uterus for
gestation. The remaining viable embryos, if any, will be frozen, destined for the purposes
established by law.
II. When is it indicated?
The most common indications are:
 Impairment of fertility:
- Tubal absence, obstruction or injury.
- Reduction in sperm number and/or motility or increased morphological alterations of
the sperm.
- Moderate or severe endometriosis.
- Ovulation disorders.
- Failure of other treatments.
- Advanced age.
- Others.
 Pre-implantation genetic diagnosis.
III. Procedure
In Vitro Fertilization and Intracytoplasmic Sperm Injection usually start with ovarian
stimulation using drugs whose action is similar to that of certain hormones produced by the
woman. Medications used include a leaflet that the patient must consult with the possibility of
asking the centre’s medical staff for any clarification. The purpose of this treatment is to obtain
the development of several follicles, inside of which are the eggs. In order to prevent
spontaneous ovulation other drugs with hormonal action are associated.
The process of ovarian stimulation is usually controlled with analysis of blood levels of
certain ovarian hormones and/or vaginal ultrasound reporting the number and size of the
developing follicles. After obtaining the proper size of the follicles that are developed, other
drugs are administered to achieve the final maturation of the eggs.
Many of the drugs used are injectable, and presentation allows self-administration by the
patient. Dosages and dosing schedules are tailored to the clinical characteristics of each
patient, and the response to treatment may be variable (normal or expected, high or low).
Occasionally they are used in association with other types of drugs.
The eggs are extracted by ultrasound-guided puncture of ovaries and aspiration of the
follicles through the vagina. This procedure is usually performed on an outpatient basis and
requires anaesthesia and subsequent observation for a variable period.
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IN VITRO FERTILIZATION OR SPERM INJECTON AND FREEZING OF EMBRYOS
The eggs (oocytes) obtained are prepared and classified in the laboratory. The number of eggs
that are removed in the puncture, their maturity and quality cannot be predicted with accuracy,
and may include not obtaining any eggs or their not being viable.
After obtaining the eggs, the laboratory must have the sperm from the partner, or from an
anonymous donor, as the case may be. Semen is prepared in the laboratory in order to select
the most suitable sperm for fertilization.
If In Vitro Fertilization (IVF) is performed, eggs and sperm are cultivated in the laboratory
together under favourable conditions for spontaneous union (fertilization).
If Intracytoplasmic Sperm Injection (ICSI) is performed, a sperm is injected into each of the
mature eggs that have been recovered.
The day after the IVF or ICSI the number of fertilized eggs will be determined and in the
successive days of cultivation the number and quality of embryos that continue their
development will be assessed. The embryos are kept in the laboratory for a period of 2-6 days
after which the transfer and/or freezing in some cases will occur.
Embryo transfer involves the deposition of embryos into the uterine cavity through the vagina.
It is an outpatient procedure that usually requires no anaesthesia or hospital admission. In order
to promote embryo implantation hormonal treatment is also prescribed.
The number of embryos transferred to the uterus cannot be more than three in a cycle, by legal
mandate. The biomedical team will give patients the information necessary to decide the
number of embryos to be transferred, in order to become pregnant and if possible to avoid
multiple gestation.
Finally, if there are any remaining viable embryos from a cycle of In Vitro Fertilization these
are preserved by freezing. Possible targets of cryopreserved embryos are detailed in the
legal information section of this information document (Section VIII).
In some cases, the usual techniques of IVF and ICSI may be supplemented with other
procedures on gametes or embryos to improve the ability of embryo implantation (assisted
hatching, removal of fragments, etc.).
IV. Results
The factors that determine the probability of pregnancy are: the age of the patient, the cause of
infertility, the number of oocytes obtained and that of final good quality embryos obtained.
However, it must be remembered that not all patients starting treatment achieve the adequate
follicular development to be submitted to puncture, and not all patients with ovarian puncture
have embryo transfer, since in some cases there is failure in obtaining eggs, in fertilization or in
early embryonic development.
The IVF/ICSI Registry of the Spanish Fertility Society for 2011 cited pregnancy rates of 28.6%
per cycle started, 31.7% by puncture and 37.7% by transfer.
Failure necessitates discussion with the healthcare team whether to undertake new treatments.
In addition, surplus embryos can be obtained, suitable for preserving by freezing, taking into
account that only those with biological characteristics of feasibility will be frozen.
Of these frozen embryos, 50-70% survive after thawing and are valid for transfer to the uterine
cavity. The pregnancy rate per transfer of frozen embryos in the 2011 IVF/ICSI Registry of the
Spanish Fertility Society is 28.1% by thawing and 31.4% by transfer.
V. Risks
The main risks of this therapeutic procedure are:
1) Multiple pregnancy: The risk of multiple pregnancy is related to the woman's age, the
number of embryos transferred to the uterus and the quality of them. In young patients and
with good quality embryos, the most advisable course of action is to transfer one or two
embryos in the first attempts. The transfer of three embryos is usually indicated in older
patients without good quality embryos, or when there was failure with previous transfers of
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IN VITRO FERTILIZATION OR SPERM INJECTON AND FREEZING OF EMBRYOS
fewer embryos. The 2011 Registry of the Spanish Fertility Society shows the multiple
pregnancy rate to be 23.7% with fresh embryos and 16.2% with frozen.
The gestation of two or more foetuses poses an increase of medical risks for the mother
and children, such as increasing the pregnancy pathology, prematurity, low birth weight and
severe neonatal complications. The severity of this complication increases in direct
proportion to the number of foetuses.
Multiple gestation is also accompanied by an increase in social, economic and work
difficulties for parents.
2) Ovarian hyperstimulation syndrome: Sometimes ovarian response to treatment is
excessive, a large number of follicles develop, and ovarian size increases. Furthermore, the
development of this syndrome is directly related to drug administration needed for the final
maturation of oocytes (HCG) and achieving pregnancy.
It is classified as mild, moderate and severe, this last being exceptional (less than 2%) and
is characterized by accumulation of fluid in the abdomen and even in the chest, as well as
impaired kidney and/or liver function. In critical cases it may be associated with respiratory
failure or coagulation disorders.
It may require hospitalization and medical-surgical treatment and only rarely is it advisable
to terminate the pregnancy.
3) Ectopic pregnancy. This involves the implantation of the embryo outside the womb, usually
in the fallopian tubes. Exceptionally it can coexist with a pregnancy located in the uterus. It
occurs in 3% of cases.
4) Miscarriage: The incidence of miscarriage is slightly higher than that observed in
spontaneous pregnancies (18.1% with fresh embryos and 30.5% with frozen in the 2011
SFS Registry).
5) Advanced age, smoking and significant body weight changes increase the risk of
complications during treatment, pregnancy and for the offspring. These conditions require
adaptations in the treatment necessary for ovarian stimulation and reduce success rates.
6) Birth defects and chromosomal abnormalities of children: Current data suggest that
children born in IVF/ICSI may be at slightly increased risk for congenital and chromosomal
anomalies; research has yet to pinpoint the cause of this increase. Thus it may be advisable
to perform prenatal diagnostic procedures such as ultrasound, amniocentesis or chorionic
biopsy.
7) Psychological risks. Symptoms of psychological disorders such as anxiety and depressive
symptoms may occur in both the man and the women. Difficulties may arise in the
relationship (sexual and emotional) conditioned by the treatment, the waiting periods and
the unpredictability of results.
8) Anaesthesia risks detailed in specific informed consent.
9) Other risks and complications that may occur exceptionally:
a)
b)
c)
d)
e)
f)
g)
h)
Adverse reactions or intolerance to medication.
Peritoneal infection.
Complications of follicular puncture:
Severe bleeding from accidental puncture of blood vessels or the ovary itself.
Puncture of an intestinal loop or other organs.
Ovarian torsion.
Pain, functional disability or incapacity.
Cancellation of ovarian stimulation due to absence of or inadequate follicular
development or excessive response to treatments.
Failure to obtain eggs in the puncture.
Failure to carry out the transfer:
 Egg not suitable for fertilization.
 Absence of fertilization.
 Normal or viable embryos not obtained.
 Physical impossibility of transfer due to anatomic abnormalities of the uterus.
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IN VITRO FERTILIZATION OR SPERM INJECTON AND FREEZING OF EMBRYOS
VI. Personalized risks:
Medical, social and occupational characteristics of each patient may lead to a modification of
the general risks or appearance of specific risks. In this case they would be:
____________________________________________________________________________
VII. Financial information (if applicable)
The prices charged in this centre are detailed in the attached budget, indicating the impossibility
of previously computing the exact total cost because treatments vary for each patient and
particularly depend on the response to ovarian stimulation of each woman.
The economic cost of maintaining the cryopreserved materials (oocytes, sperm or
embryos) shall be borne by patients, whatever the decision on their disposition and
during the time that they are deposited at the Centre.
VIII. Legal aspects of assisted reproduction
1.- General
The legal framework governing assisted human reproduction is constituted mainly by Law
14/2006 on Assisted Human Reproductive Technologies.
Assisted reproductive technologies are aimed to solving the problems of human infertility, to
facilitate procreation when other treatments have been ruled out as inadequate or ineffective.
They are also used in the prevention and treatment of diseases of genetic or hereditary origin,
where possible recourse to them comes with sufficient diagnostic and therapeutic guarantees
and is strictly indicated.
They can only be carried out when there is reasonable prospect of success and they do not
involve a serious risk to the physical or mental health of the woman or the possible offspring;
and always in older women, with full capacity to act, regardless of marital status and sexual
orientation, with subjects duly informed beforehand of their chances of success, as well as the
risks and conditions of such application.
The woman receiving the techniques may ask for them to be suspended at any time prior to
completion of embryo transfer, and her request must be honoured.
When the woman is married, the procedure will usually require the husband's consent, unless
they were legally or de facto separated and this is reliably recorded. For an unmarried couple,
male consent is required if his sperm is used in the treatment and consent voluntary in the use
of donor sperm. In the latter case, if consent is given prior to the use of techniques, such
consent will determine the paternal parentage of future offspring.
An unmarried woman, widow or a woman who is separated legally or de facto may be a
recipient or user of assisted reproduction in a personal capacity, using sperm from a donor,
provided she is over 18, has full capacity to act and has given her written consent in a free,
conscious and explicit manner, and does not present medical contraindications for this
procedure.
2.- Information for the case of use of gametes or embryos from donor
The donation of gametes and embryos is a free, formal, confidential contract between the donor
and the authorized centre. The gamete bank as well as the donor records and activity of the
centres must ensure the confidentiality of donors’ identity data.
Notwithstanding the foregoing, the recipient and the children born are entitled to obtain general
information about the donors, which does not include their identity. Also in extraordinary
circumstances encompassing a certain danger to the life or health of the child, or where
appropriate in accordance with criminal procedural law, the identity of the donor may be
revealed, in restriction and without ever modifying the previously established parentage.
The choice of donors can only be made by the medical team applying the technique, and in no
case at the request of the recipient or partner. Notwithstanding the foregoing, in any case the
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medical team should seek the greatest possible phenotypic and immunological similarity with
the recipient woman.
Donors of genetic material used must be at least 18 years of age, be in good mental and
physical health and possess full capacity to act. His psychophysical state must meet the
requirements of a mandatory study protocol for donors, including phenotypic and psychological
characteristics and clinical conditions and laboratory tests necessary to demonstrate that he is
not suffering from genetic, hereditary or infectious diseases that are transmissible to offspring.
Neither the parenting woman nor her spouse, when they have given their formal, prior and
express consent a given fertilization with contribution from a donor or donors, may challenge the
paternity of the child born as a result of such fertilization, which is considered legally their own
for all purposes. The same applies in these cases to an unmarried man who has signed the
informed consent prior to the use of the techniques.
3.- On the fate of remaining embryos that are cryopreserved
Remaining viable embryos from an IVF cycle are cryopreserved in liquid nitrogen, as not all
embryos transferred are suitable for freezing. The subsequent fate of frozen embryos can be:
a)
b)
c)
d)
The use by the woman herself or, as the case may be, her female partner.
Donation for reproductive purposes.
Donation for research purposes.
Termination of its conservation without other use.
a) Use by the woman herself or her spouse may be made at any time while the woman
meets the clinically appropriate requirements to perform assisted reproductive technology
(which is the maximum retention period). If the couple is separated, if she wants to use them for
personal reproduction she would have to have the consent of ex-husband for the new transfer
to be carried out, since the children would be both of theirs.
b) Donation for reproductive purposes can be carried out if the woman was not older
than 35 when the freezing occurred and the embryos can be donated to infertile couples or
women who need them. The donation is voluntary, free, anonymous and altruistic and
requires prior specific written consent and updated serology. Recipients and the children
born are entitled to obtain general information about the donors, which does not include their
identity. In extraordinary circumstances that entail a certain danger to life or health of the child,
or where appropriate in accordance with the criminal procedural law, the identity of the donor
may be revealed, in restriction and without ever modifying the previously established parentage.
c) In donation for research purposes the embryos are transferred altruistically for biomedical
research projects in specifically authorized health care facilities and for specific projects that are
also authorized. The effective exercise of this option will lead to the signing of an additional and
specific consent that explains the research goals to be pursued and their implications.
d) Cessation of conservation without other use, which in the case of cryopreserved embryos
and oocytes will only be applicable after the maximum retention period set by law in the
absence of the selection of one of the destinations mentioned in the previous sections. The
cryopreservation of oocytes, ovarian tissue and surplus embryos may be extended until such
time as it is considered by the attending physicians, with the assent of independent specialists
outside the institution involved, that the recipient does not meet the clinical requirements for the
use of assisted reproductive technologies.
4.- Obligation renewal of consent regarding cryopreserved embryos
At least every two years the parenting woman or partner will be asked for a renewal or
amendment of consent. If the parenting woman or partner stops signing the periodic renewal
of consent, after two consecutive requests from the facility by reliable means (burofax with
return receipt, registered letter with return receipt, telegram with acknowledgment of receipt,
notarized letter, etc.) embryos will be at the disposal of this centre, which may use them for
any of the purposes mentioned in paragraph 3, maintaining the requirements of confidentiality
and anonymity as well as the absence of payment and profit.
5. Regarding the possibility of having a posthumous child
In case of death of the man, parentage is only legally determined if his reproductive material
was located in the uterus of the woman at the date of death, unless the husband or the man not
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IN VITRO FERTILIZATION OR SPERM INJECTON AND FREEZING OF EMBRYOS
bound by marriage had consented in the informed consent of the techniques, in a deed, will or
advance directive, that his reproductive material could be used in the twelve months following
his death to impregnate his wife. This consent may be revoked at any time prior to the
completion of the techniques.
The law governing reproduction also provides that the consent of the deceased male is
understood to have been given for the post mortem insemination of his wife (whether he is
married or in an unmarried partnership), when the latter has been subjected to a process of
assisted reproduction already begun for the transfer of an embryo made prior to the date of the
husband’s death.
From the medical standpoint, it is considered starting treatment when the patient receives the
first dose of medication necessary for the procedure.
IX. Alternatives if the technique fails
If pregnancy was not achieved after one or more attempts at in vitro fertilization or
intracytoplasmic sperm injection, you might want to adopt, after due reflection, one of the
following alternatives:
-
Begin treatment again.
Perform supplementary studies.
Apply modifications to the technique used.
Conduct a pre-implantation genetic diagnosis (PGD).
Perform new treatments with donated gametes (eggs and/or sperm).
Use donated embryos.
Give up the assisted reproduction treatments.
The contents of this document reflect the current state of knowledge, and therefore are subject to change if new
findings or scientific progress so warrant.
In ______________________ on the ______ day of __________________year ___________
Physician signature (License no.
)
Patient signature
Partner Signature
National ID No.:………………………
National ID No.:……………………….
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