IN VITRO FERTILIZATION (ICSI) WITH PREIMPLANTATION GENETIC DIAGNOSIS (PGD) CONSENT DOCUMENT SPANISH FERTILITY SOCIETY

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1 IN VITRO FERTILIZATION (ICSI) WITH PREIMPLANTATION GENETIC DIAGNOSIS (PGD) CONSENT DOCUMENT SPANISH FERTILITY SOCIETY Ms. an adult with national I.D./passport no., marital status, and Mr. an adult with national I.D./passport no., marital status, residing in the city of, street number Postal Code Country, making this agreement as (married couple/domestic partner). I/WE DECLARE: 1) I/we are adults and have full capacity to act. 2) I/we hereby freely, knowingly and expressly give our written consent for the use of assisted reproductive technologies. 3) Having received, prior to this act, verbal and written information, the latter through the Information Document on In Vitro Fertilization with Preimplantation Genetic Diagnosis, which I/we have read, understood and signed. Accordingly, I/we have received information on the following issues: Information and advice on the assisted reproductive technologies in their biological, legal and ethical aspects. The indication, probability of success, risks, contraindications and complications of the proposed treatment. Only those embryos will be transferred with normal chromosome complement for chromosomes analysed. Embryos without conclusive genetic diagnosis or unbalanced diagnosis will be considered non-viable embryos with transfer discouraged. The medical indication for treatment is determined on my/our case: (check all that apply) Structural chromosomal abnormalities. Risk of transmission of disease linked to sex chromosomes (X or Y). Carrier of chromosomal translocation. Screening for aneuploidy or alterations in chromosome number. Risk of transmission of monogenic diseases. Other causes:. Possible risks that may result from a clinically inappropriate maternity age, both for women during treatment and pregnancy and for the offspring. The requirement to periodically renew or modify my/our consent with respect to the cryopreserved embryos and inform the centre of any change of address or personal circumstances that might affect their disposition (separation, death or incapacity of a spouse, etc.). Signature of interested parties 1

2 Information concerning the economic conditions of treatment. 4) That, according to the medical team, for my/our reproductive plan the appropriate treatment would be the assisted reproductive technology called: (IVF-PGD) and within the set of treatment alternatives, I/we understand that the most appropriate technique in our case is that to which we consent herein. 5) The medical team has also informed me/us of the following risks related to our personal circumstances:. In addition, I/we have been informed of the desirability of consulting the patient leaflet of the medications prescribed to learn more about the possible risks associated with their use, without prejudice to also request further clarifications from the medical team as deemed appropriate. 6) I/we acknowledge that at any time before the embryo transfer time, I/we can ask that the application of assisted reproductive technologies be suspended, and that this request must be honoured. 7) I/we authorize and I/we consent to the transfer of a maximum of (one, two or three) embryos. 8) Regarding the possibility of creating embryos that are not to be transferred to the uterus in the same cycle and based on our future reproductive plan: (check those which apply) I/we wish to generate ALL embryos possible as a consequence of the insemination or microinjection of all oocytes obtained, assuming the obligation to freeze viable embryos not transferred, and we consent to this. I/we wish to generate a LIMITED NUMBER of embryos, as a consequence of the insemination or microinjection of. (number) of oocytes, assuming the obligation to freeze viable embryos not transferred. The rest of the oocytes shall be: O Vitrified O Discarded I/we wish NONE OF THE EMBRYOS not to be transferred is generated, so that I/we authorize the insemination or microinjection of up to... (number) of oocytes. The rest of the oocytes shall be: O Vitrified O Discarded 9) That the disposition I/we wish for the potential oocytes and/or remaining frozen preembryos would be (check all that apply): Own use, namely use by the couple, the wife or, where appropriate, the female partner. Donation for reproductive purposes (if the woman is 35 years of age). Donation for research (based on a plan duly presented and authorized by the competent health authorities, following a favourable report by the competent authority and written consent of the couple or woman). Their removal from preservation without other use at the end of the maximum retention period (when the recipient does not meet the clinically appropriate requirements for assisted reproductive technology). I/we agree to come to the clinic to formalize the renewal or reassignment of cryopreserved materials (oocytes, sperm or embryos) and assume in any case the economic cost of the material cryopreserved for as long as it is placed in the centre. 10) I/we understand all the information that I/we consider appropriate and sufficient, provided by Dr.: 11) Likewise, in the doctor s office I/we stated: Signature of interested parties 2

3 I/we do not suffer from transmissible congenital, hereditary or infectious diseases with possible serious risk to offspring. I/we have not omitted or misrepresented any data of a legal or medical nature that might affect treatment or consequences. I/we agree to report to the centre any change of residence that could hinder communication if there are frozen embryos. And once duly informed, I/WE AUTHORIZE: The application of the treatment and control procedures necessary to undergo a process of In Vitro Fertilization (FIV)/Intracytoplasmic Sperm Injection (ICSI) with Preimplantation Genetic Diagnosis and embryo freezing, if applicable. 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. NOTE: The clinic will do everything possible to maintain the storage of cells/tissues in optimal conditions but shall not be responsible for the loss of viability of the same due to natural disasters or other emergencies that are beyond the control of the clinic. Please be informed that embryos could be transferred to an alternate location in case of an emergency (floods, riots, fire, violent situations or those involving firearms, terrorist threats/attacks, gas or other explosions, earthquakes, etc.). In on the of year 20 Signed.... Signed.... National I.D. no.... National I.D. no. Signed.... National I.D. no.... (Director of the CENTRE or representative) ANNEX for the spouse/partner or unmarried male: Mr., an adult, bearer of national I.D. no. hereby I consent that if I die before my reproductive material is in the womb of Ms., she may, in the 12 months following my death, become fertilized with it, and that the paternity of the child born will be mine. In on the of year Signed Mr./Ms. Physician s Signature Signature of interested parties 3

4 ANNEX for VARIATION of the disposition of cryopreserved embryos Ms., an adult, bearer of national I.D./passport no. and residing on street/plaza in, Mr., an adult, bearer of national I.D./passport no. and residing on street/plaza in, hereby request the change of disposition of our surplus/cryopreserved embryos and consent to the new disposition: O Use by the woman herself. O Donation for reproductive purposes (if the woman is 35 years). O Donation for research (based on a project presented and duly approved by the competent health authorities, following a favourable report by the competent authority and written consent of the couple or woman). O Cessation of preservation without further use once the maximum storage period has ended (when the recipient does not meet the appropriate requirements for assisted reproductive technology). 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. In on the of year Signed Ms. Signed Mr. Physician s Signature: Signature of interested parties 4

5 ANNEX for the REVOCATION of this consent Ms., an adult, bearer of national I.D./passport no. and residing at street/plaza in, hereby request the SUSPENSION of the application of the assisted reproductive technology to which I am submitting. Signed. Ms. Physician s Signature: Signature of interested parties 5