Download consentimiento informado de la sociedad española de fertilidad

ARTIFICIAL INSEMINATION WITH PARTNER’S SEMEN
INFORMED CONSENT
SPANISH FERTILITY SOCIETY
Ms._________________________________________________________________________
an adult with identification number _________________, marital status ___________, and
Mr._________________________________________________________________________
an adult with identification number. _________________, marital status ___________, residing
in the city of ___________________________________, street_________________________
number _______ Postal Code _______________ Country ______________________, making
this
agreement
as
(married
couple/domestic
partners)____________________________________________________
I. What does it consist of?
Artificial insemination involves the introduction of sperm, previously treated in the laboratory, in
the cervix or into the uterine cavity of the woman in the next ovulation period.
II. When is it indicated?
 Reduction in the number or mobility of sperm, and / or sperm abnormalities.
 Difficulty of sperm penetration into the uterine cavity.
 Unknown cause of infertility or sterility.
 Ovulatory disorders.
 Other causes.
III. Procedure
Artificial insemination can be carried out during a natural menstruation cycle, or after a process
of ovarian stimulation cycle. The pregnancy rate is significantly higher in stimulated cycles than
for spontaneous.
Ovarian stimulation is performed by using drugs whose action is similar to that of certain
hormones that the woman produces. Medications used include a leaflet that the patient must
consult, with the possibility of requesting the hospital’s medical staff for any clarification. The
purpose of this treatment is to obtain one or more developing follicles, inside of which are the
eggs.
The process of ovarian stimulation is routinely monitored by vaginal ultrasound to report the
number and size of the developing follicles, sometimes supplemented with certain hormonal
measurements. After obtaining the proper development, other drugs are administered to
achieve the final maturation of the eggs and schedule the best time for insemination.
On the day indicated for insemination the man must come in to provide the semen sample,
which will be processed in order to select the best quality sperm.
Subsequently, the sperm is introduced into the uterus through a thin, flexible catheter. This
procedure is painless and requires no anaesthesia or hospitalization.
Once the insemination occurs a hormonal treatment may be suggested in order to facilitate the
possible pregnancy.
IV. Results
Results depend largely on the age of the woman and concurrent causes that have determined
the indication for treatment. According to the 2011 Registry of the Spanish Fertility Society the
pregnancy rate is 14% per cycle performed.
Signature of interested parties
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ARTIFICIAL INSEMINATION WITH PARTNER’S SPERM
V. Risks
The main risks of this therapeutic procedure are:
1) Multiple pregnancy: This is a serious complication that involves physical risks to the
mother and the foetus, especially when the pregnancy consists of more than two foetuses.
2) Ovarian hyperstimulation syndrome: Sometimes ovarian response to treatment is
excessive: a large number of follicles develop, ovarian size increases and the amount of
estradiol in the blood rises considerably. 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, the latter being rare (less than 2%); it is
characterized by accumulation of fluid in the abdomen and even in the chest, as well as
impaired renal 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 pregnancy
termination advisable.
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.
4) Other risks that may occur exceptionally:
- Infection of the woman’s genital tract. In extreme cases, this complication can
compromise a woman’s future fertility.
- Ovarian torsion, manifested by acute pelvic pain and whose treatment may be surgical.
- Specific risks that occur in the case of an older woman; advanced maternal age
increases the risk of complications both in pregnancy and in the offspring.
- Risk of disease transmission to offspring: In patients who are known carriers of genetic,
infectious or other disorders, the risk of transmitting these problems to offspring must be
evaluated individually before treatment with artificial insemination.
- When a pregnancy is achieved through artificial insemination, the risk of birth defects,
hereditary diseases and complications during pregnancy and childbirth seems to be
similar to that of the general population.
5) Psychological risks, derived from the characteristics of the treatment, waiting
periods and not knowing the results: Symptoms of psychological disorders such as
anxiety and depressive symptoms may occur in men as well as in 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 in response to the repeated failure of
the technique.
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.
VIII. General legal aspects of assisted reproduction
The legal framework governing assisted human reproduction is constituted mainly by Law
14/2006 of 26 May on assisted human reproductive technologies.
Signature of interested parties
2
ARTIFICIAL INSEMINATION WITH PARTNER’S SPERM
These techniques are aimed at solving the problems of human infertility, to facilitate procreation
when other treatments have been ruled out as inadequate or ineffective.
They can also be 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 they are strictly indicated.
They can only be carried out when there is reasonable prospect of success and does 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, after being previously and duly informed of their chances of success, as well as the
risks and conditions of such application.
The woman receiving the treatments may request their suspension at any time and her request
will be honoured.
The consent of the man (married or not) whose sperm will be used in the treatment must be
provided prior to the use of techniques, unless they were legally or de facto separated and this
fact is reliably recorded.
IX. Alternatives if the technique fails
If pregnancy is not achieved after performing a suitable number of artificial insemination cycles
(generally three to six cycles), 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.
Choose other fertility treatments such as artificial insemination or in vitro
fertilization.
Consider other alternatives
WE DECLARE:
1. It has been explained to us that due to our conjugal process of sterility or infertility or that of
one of the partners, it is appropriate to perform a treatment of artificial insemination.
2. At the doctor’s office we have stated that we do not suffer from congenital, hereditary or
transmissible infectious diseases that can lead to serious risk to the offspring.
3. According
to
the
medical
team,
the
indication
was
determined
by
___________________________ and the most suitable technique is the one that we
consent to herein, called artificial insemination with the partner’s semen
(…………..…cycles).
4. We understood the contents of this information and we had the opportunity to request
additional clarification about it.
WE AUTHORIZE,
The application of the treatment and control procedures necessary to undergo a process of
artificial insemination with the partner’s semen.
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.
According to the provisions of Organic Law 15/1999, on protection of personal data, personal and health data will be
recorded in a file owned by the centre __________________________________. They may be used and assigned
exclusively for the purposes of responsible action, enjoying the rights of access, rectification, cancellation and
opposition. All data derived from the process will be reflected in the corresponding medical history, which will be kept
on the premises of the institution to ensure proper conservation and recovery.
In__________ on the ___ day of ______________year ______
Physician signature (License no.
Signature of interested parties
)
Patient signature
3
Partner signature
ARTIFICIAL INSEMINATION WITH PARTNER’S SPERM
ANNEX for the REVOCATION of this consent
Mr./Ms._________________________________________________________,
an
adult,
bearer of national I.D./passport No._________________ and residing at street/plaza
_____________________________ in ________________________, hereby requests the
REVOCATION of the application of the assisted reproductive technology to which I am
submitting.
Signed. Mr./Ms. __________________________________________________________
Physician’s Signature:
Signature of interested parties
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