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RECEIPT OF OOCYTES FOR REPRODUCTIVE PURPOSES
INFORMATION DOCUMENT
SPANISH FERTILITY SOCIETY
I. What does it consist of?
It is the process by which oocytes are received from a donor for reproductive purposes. These
oocytes are inseminated with sperm from the recipient's partner or a sperm donor. Generated
embryos are transferred into the uterus of the recipient woman to achieve pregnancy.
The receipt of oocytes is a secret and anonymous act whose intent is that the oocytes can be
used for assisted reproduction treatments in women in whom they are scientifically and clinically
indicated.
II. When is it indicated?
The most frequent indications are:
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Early ovarian failure, spontaneous or secondary to surgery, chemotherapy and
radiotherapy.
Gonadal dysgenesis and other genetic alterations of gametes.
Serious maternal genetic diseases with high risk of transmission and not susceptible to
prevention by other methods.
Previous failure of assisted reproduction due to repeatedly insufficient response to
ovarian stimulation.
Repeated failure of embryo implantation.
III. Procedures
The origin of donated oocytes can be:
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Oocytes from a donor subjected to a simultaneous process of ovarian stimulation or not at
receipt.
Frozen and subsequently donated oocytes.
The laboratory must have the sperm from the partner, or from an anonymous donor, when
pertinent. If in Vitro Fertilization (IVF) is performed, oocytes and sperm grown in the laboratory
under favourable conditions for fertilization. If Intracytoplasmic Sperm Injection (ICSI) is
performed, one sperm is injected into each mature oocytes that is retrieved.
The day after the IVF or ICSI the number of fertilized eggs or embryos will be determined.
The embryos will be kept in the laboratory for a period of 2-6 days after which the embryo
transfer will proceed. This process involves the deposition of embryos into the uterine cavity
through the vagina. It is an outpatient procedure that requires no anaesthesia or hospital
admission.
The recipient woman must undergo hormone treatment in order to properly prepare the uterus
for the implantation of embryos. Medications used include a leaflet that the patient must consult
with the possibility of asking the Centre’s medical staff for any clarification.
The number of embryos transferred to the uterus cannot exceed three in a cycle. The
biomedical team will provide patients with the information needed to decide the number of
embryos to be transferred, with the intention of obtaining pregnancy and avoiding possible
multiple gestation.
The usual reproductive technologies can be supplemented with other procedures on gametes or
embryos to improve the ability of embryo implantation (assisted hatching, removal of fragments,
etc.).
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RECEIPT OF OOCYTES FOR REPRODUCTIVE PURPOSES
IV. Results
Receiving donor oocyte is the most effective assisted reproductive technology, as it is based on
the use of gametes from young women without reproductive pathology, which therefore are of
high biological quality. The overall probability of pregnancy after four oocyte donation cycles can
reach 90%.
The IVF/ICSI Registry of the Spanish Fertility Society in 2011 reported pregnancy rates of
49.3% per cycle initiated and 53.2% per transfer.
On the other hand, a high number of cycles with receipt of donated oocyte achieved adequate
quality frozen embryos, whose subsequent transfer increases the overall pregnancy rate per
donation.
The possibility of pregnancy resulting from receiving donated oocytes depends critically on the
quality of embryos transferred.
However, it must be remembered that not all donors who initiate treatment achieve the
adequate follicular development to be submitted to puncture, and not all recipients who undergo
treatment achieve adequate endometrial preparation, which also affects the likelihood of
pregnancy.
V. Risks
The main risks of this therapeutic procedure are:
1) Multiple pregnancy: In receiving donated oocytes, the risk of multiple pregnancy is related
to the age of the donor, the number of embryos transferred to the uterus and their quality. In
young patients and with good quality embryos, the most advisable course of action is to
transfer fewer than three 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 fewer embryos.
The gestation of two or more foetuses increases medical risks for the mother and offspring,
such as increasing the pathology of pregnancy, 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) 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.
3) Miscarriage: The incidence of abortions is slightly higher than for the general population.
4) Advanced age, smoking and significant body weight changes increase the risk of
complications during treatment and pregnancy and for offspring.
5) 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.
6) Hypertensive states in pregnancy, preeclampsia and eclampsia.
7) Psychological risks. Symptoms of psychological disorders such as anxiety and depressive
symptoms may occur in both the man and the women. In some cases, there may be
difficulties in the relationship (sexual and emotional) and high levels of anxiety in the waiting
period between the application of the technique and the confirmation of the achievement or
otherwise of the pregnancy as well as to the repeated failure of the technique. Patients may
access, whenever necessary, emotional support through a clinical psychologist who is
expert in reproduction.
8) Impossibility of transfer due to:
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RECEIPT OF OOCYTES FOR REPRODUCTIVE PURPOSES
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Oocytes that are immature or unsuitable for insemination.
Absence of fertilization.
Normal or viable embryos not obtained.
Physical impossibility of transfer due to anatomic abnormalities of the uterus.
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:
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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
Law 14/2006 on Assisted Human Reproductive Technologies is the primary legal framework
governing assisted human reproduction. In addition, when gamete donors are involved,
European standards on quality and safety for the reproductive cells apply.
2.- Information for the case of use of gametes or embryos from donor
The donation of gametes and embryos is carried out after the prior signing of 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.
The recipient woman must understand that 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.
In any case the medical team should seek the greatest 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. Their 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 she 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.
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, provided that such disclosure is necessary to avoid
danger or achieve the legal purpose. This revelation will be restricted and does not involve in
any case the identity of donors, nor would it modify the previously established parentage.
3.- Disposition of surplus cryopreserved embryos
Surplus 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) Their use by the woman herself.
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RECEIPT OF OOCYTES FOR REPRODUCTIVE PURPOSES
b) Donation for reproductive purposes.
c) Donation for research purposes.
d) Termination of their preservation 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 and 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 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, and will
make specific reference also to the use of the technique or specific techniques to be applied
(Law 14/2007 on Biomedical Research).
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
the moment when 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 for 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
unmarried man 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 point of view, it is considered starting treatment when the patient receives the
first dose of medication necessary for the procedure.
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RECEIPT OF OOCYTES FOR REPRODUCTIVE PURPOSES
IX. Alternatives if the technique fails
If pregnancy is 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:
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Begin treatment again.
Perform supplementary studies.
Apply modifications to the technique used.
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 I.D. no.:……………… National I.D. no.:…………………
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