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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. Signature of interested parties 1 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 Signature of interested parties 2 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. Signature of interested parties 3 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 Signature of interested parties 4 IN VITRO FERTILIZATION OR SPERM INJECTON AND FREEZING OF EMBRYOS 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 Signature of interested parties 5 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.:………………………. Signature of interested parties 6