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IN VITRO FERTILISATION OR INTRACITOPLASMATIC SPERM
INJECTION WITH EMBRYO TRANSFER AND EMBRYO
CRYOCONSERVATION (IVF/ICSI)
INFORMATION DOCUMENT
SPANISH FERTILITY SOCIETY
What does it consist of?
In Vitro fertilisation is a treatment that consists of medical and biological procedures in order to let the sperm fertilise the ova (oocytes/eggs) in a fluid medium in a laboratory and therefore obtain embryos that will be transferred into the uterus to achieve a pregnancy. In Vitro Fertilisation can be performed following two different procedures: conventional In Vitro Fertilisation (IVF), in which fertilisation occurs spontaneously by putting the ova and sperm together in a fluid medium in the laboratory and Intracitoplasmatic Sperm Injection (ICSI) in which fertilisation occurs by injecting a spermatozoon in each ovum (egg). From fertilisation, pre-embryos are obtained. These are cell groups resulting from the progressive division of the ovum (egg) since it is fertilised until 14 days later. In each reproductive cycle, only a certain number of pre-embryos can be generated so that, according to clinical criteria, a reasonable probability of reproductive success can be guaranteed in each case. A limited number (between 1 and 3) of the obtained pre-embryos will be transferred into the uterus to achieve a pregnancy. The remaining viable embryos, if any, will be frozen for legally established further use. When is it indicated?
It is most frequently indicated in these conditions: o Absence, obstruction or injuries in the fallopian tubes o Decrease in the number and/or mobility of the spermatozoa or increase in their o Severe or moderate endometriosis o Ovulation disorders o Failure of other treatments o Clinically inadequate age o Other Procedure
In Vitro Fertilisation or Intracitoplasmatic Sperm Injection usually begins with ovarian stimulation by using drugs whose effect is similar to that of certain hormones naturally produced by women. The medicaments that are used include an information leaflet that the patient must read and she can also ask the clinic’s staff about any doubts that may arise. The objective of the treatment is to induce the development of a number of follicles which contain the ova (eggs). In order to avoid spontaneous ovulation other hormonal drugs are also used. The ovarian stimulation process is usually monitored by blood tests to obtain counts of certain ovarian hormones and by ultrasound scans that show the number and size of the developing follicles. If they are adequately developed, other drugs are administered to achieve the final ripening of the eggs. Many of the medicaments that are used are injectable but they can be self-administered by the patient. The doses and administration instructions are adapted to each patient’s clinical characteristics and the response to the treatment can also vary. Occasionally, other drugs are used in combination. Ova are extracted by ovarian puncture and follicle aspiration under transvaginal ultrasound monitoring. This process does not involve hospitalisation but the use of anaesthetics and subsequent observation for a variable period of time are required. The eggs (oocytes) that have been obtained are prepared and classified in the laboratory. The number of eggs that are extracted from the puncture, their ripening phase and their quality cannot be precisely predicted. Once the eggs have been obtained, the laboratory will have spermatozoa from the patient’s partner or from an anonymous donor at its disposal when it is required. The semen is prepared in the laboratory in order to select the most adequate spermatozoa for the fertilisation process. If an In Vitro Fertilisation (IVF) is performed, the oocytes and the spermatozoa will be cultivated together in the laboratory under favourable conditions for spontaneous fecundation. If an Intracitoplasmatic Sperm Injection (ICSI) is performed, a spermatozoon will be injected into each ripe oocyte that has been previously retrieved. On the day after the IVF or ICSI has been performed, the number of fertilised oocytes or pre-embryos will be determined and during the following days of culture, the number and the quality of the developing pre-embryos will be assessed. These pre-embryos will be kept in the laboratory for 2 to 6 days and then the embryo transfer will take place. Embryo transfer consists of placing the embryos in the uterine cavity through the vagina. It is a process which requires neither hospitalisation nor any sort of anaesthetics. In order to favour embryo implantation a hormonal treatment is prescribed. The maximum number of pre-embryos that can be legally transferred into the uterus in one cycle is three. Patients will be advised by the medical team as to deciding how many pre-embryos should be transferred in order to achieve a pregnancy but also to avoid a multiple one. Finally, if after an In Vitro Fertilisation treatment remaining viable pre-embryos exist, these will be cryoconserved. The possible future uses of the cryoconserved pre-embryos are stated in the legal information section of this document (section VIII) In some cases, the usual reproduction techniques can be complemented with other procedures on gametes or embryos in order to improve the embryo implantation capacity (assisted hatching, fragments extraction.). The factors that determine pregnancy probability are: the sterility cause, the patient’s age, the number of oocytes obtained and the final number of good quality embryos. However, it must be taken into account that not all patients that initiate the treatment achieve the adequate follicular development to undergo puncture, and from those who do some do not finally achieve embryo transfer as in some cases there can be some failures in the oocyte obtaining process, the fertilisation or in the early development of the embryo. For this reason, the results of the treatment can be expressed in number of pregnancies over initiated cycles, over cycles with follicular puncture or over cycles with embryo transfer. The IVF/ICSI Register of the Spanish Fertility Society in 2005 refers pregnancy rates of 30.1% per initiated cycle, 33.9% per puncture and 38.1% per transfer. 80% of pregnancies are achieved during the first three IVF/ICSI cycles with satisfactory embryo transfer. Therefore, repetitive failure makes it necessary to discuss with the medical staff the advisability of starting more treatments. Between 40% and 60% of the patients obtain adequate embryos to be cryoconserved, taking into account that only those which are biologically viable will be frozen. From these frozen embryos, 50% to 70% will survive after defrosting and they will be adequate to be transferred into the uterine cavity. The pregnancy rate by frozen embryo transfer in the Register of the Spanish Fertility Society in 2005 is 21.1% per defrosting and 25.7% per transfer. The main risks derived from this therapeutic treatment are: 1. Multiple pregnancy: The risk of multiple pregnancy depends on the age of the patient, the number of embryos transferred into the uterus and their quality. In young patients and with good quality embryos, the most recommendable policy is to transfer fewer than three embryos in the first attempts. The transfer of three embryos is indicated for older patients without good quality embryos or in cases of failure in previous transfers of fewer embryos. In the Register of the Spanish Fertility Society in 2005 the multiple pregnancy rate is 26.1% using fresh embryos and 18.2% using frozen embryos. Pregnancies with two or more foetuses involve an increase of medical risks for the mother and for the children such as pregnancy pathologies, prematurity, low weight at birth and serious neonatal complications. The severity of these complications increases proportionally with the number of foetuses. Multiple pregnancies also bring about an increase of the social, economic and professional difficulties for the parents. 2. Ovarian hyperstimulation syndrome: Sometimes, the ovarian response to the treatment is excessive, a great amount of follicles develop, the ovaries are enlarged and there is a considerable increase of the amount of estradiol in the patient’s blood. The development of this syndrome is related to the administration of the necessary drug for the final ripening of the oocytes (HCG) and for the achievement of the pregnancy. Symptoms are set in three categories: mild, moderate and severe, being the latter unusual (below 2%) and include accumulation of fluids in the abdomen and even in the thorax together with disorders in both renal and hepatic functions. In critical cases, it can cause respiratory failure and coagulation disorders. Hospitalisation and medical/surgical treatment may be required and only in exceptional cases will the interruption of the pregnancy be recommended. 3. Ectopic pregnancy: The embryo implants outside the uterus, usually in the fallopian tubes. Only in exceptional cases can it coexist with a pregnancy implanted in the uterus. It occurs in 3% of cases. 4. Miscarriage: The incidence of miscarriages is slightly superior to that of spontaneous pregnancies (15.5% using fresh embryos and 30.1% using frozen embryos, according to the Register of the Spanish Fertility Society in 2005) . 5. Age, smoking and important alterations of the bodyweight increase the risk of complications during the treatment, the pregnancy and for descendants. They also require necessary treatments to be adapted and reduce the success rate. 6. Genetic defects and chromosomal alterations of the children: current data suggest that in children born from IVF/ICSI the risk of genetic and chromosomal anomalies can slightly increase. The causes of this increase have not yet been established. For this reason, it is recommendable to apply prenatal diagnostic techniques such as ultrasound scan, amniocentesis or chorionic villus biopsy. 7. Psychological risks: Psychological disorders may appear with anxiety and depression symptoms, both in men and women. In some cases, difficulties may arise in the couple’s relationship (sexual and emotional) and they can experience high levels of anxiety both during the waiting period between the application of the technique and the prospective achievement of the pregnancy and in case of repetitive failures of the technique. 8. Risks derived from the use of anaesthetics. This will be stated in the specific informed 9. Other risks and complications that can exceptionally occur: a. Adverse reactions or intolerance to medication. b. Peritoneal infection. c. Complications of the follicular puncture: i. Serious haemorrhage because of accidental puncture of a blood vessel ii. Puncture of an intestine loop or other structures d. Ovarian torsion e. Suspension of the ovarian stimulation due to absence or inadequate follicular development or to excessive response to the treatment f. Impossibility to obtain oocytes from the puncture g. Impossibility of transfer because of: i. Immature oocytes inadequate to be inseminated iii. Impossibility to obtain normal viable embryos iv. Physical impossibility for the transfer due to anatomical alteration of Personal risks:
Each patient’s medical, social or professional circumstances may imply a variation of the general risks or the appearance of specific ones. Price information
Our prices are specified in the attached estimate but patients must bear in mind that it is impossible to specify the exact final cost, as treatments vary significantly depending on the patient and especially on the respond to the ovarian stimulation of each particular woman. The patients are responsible for the economic cost of keeping the embryos cryoconserved, regardless of their decision as to their future use. Legal aspects in relation to assisted reproduction
The legal framework that regulates assisted human reproduction is specified in the Law 14/2006 of 26 of May on assisted human reproduction techniques (Ley 14/2006 de 26 de mayo sobre técnicas de reproducción humana asistida). The main objective of these techniques is to provide a solution for human sterility problems in order to facilitate procreation when other treatments have been rejected because they have proved to be unsuccessful or inadequate. They can also be used to prevent and treat genetic or hereditary disorders when they can be applied with sufficient diagnostic a therapeutic guarantees and are strictly indicated. They can only be performed in the existence of a reasonable possibility of success and when they do not entail any serious risks for the physical or mental health of the woman or her possible descendants. Also, women, regardless of their marital status or sexual orientation, must be of legal age, have full legal operative ability and must have been previously and adequately informed about their possibilities of success as well as their risks and conditions of application. The recipient woman can at any moment ask for the suspension of these assisted reproduction techniques, and this petition has to be attended. In cases of married women, the husband’s consent to the treatment is required unless they are separated either legally or de facto and so is duly stated. In cases of common-law couples, the male partner’s consent will be obligatory if his sperm is used in the treatment and voluntary if the semen sample is obtained from a donor. In this last case, if the consent is given before the application of the techniques it will establish the paternal filiation of the future descendants. Single women, widows and separated women, either legally or de facto, can individually undergo assisted reproduction techniques using semen samples from a donor as long as they are over 18 years of age, have full legal operative ability and they have expressed their written consent in a totally free and conscious manner. 2. Information in relation with the use of donated gametes or embryos Gamete and pre-embryo donation is a costless, formal and confidential contract between the donor and the authorised clinic. Both gamete banks and clinics, in their donor and activity registers, must guarantee the confidentiality of donors’ identity and their data. However, recipient women and their children that may be born, have the right to obtain general information about the donors, except for their identity. Also, in very special circumstances that may entail life or health risks for the newborn or when acting according to the procedural criminal law, the identity of the donors may be revealed. This disclosure will be carried out in a restrictive manner and without modifying in any way the previously established filiation. Donor selection can only be conducted by the medical team that apply the technique and under no circumstance by the recipient woman/couple. However, the medical team will have to ensure the highest phenotypic and immunological similarity to the recipient woman. Donors from which the genetic material is obtained must be 18 or over, be physically and mentally healthy and have full legal operative ability. Donors’ physical and mental condition must fulfil the requirements of a mandatory protocol in order to evaluate donors. This includes phenotypic and psychological traits and also the necessary tests to verify that the donor does not suffer from any sort of genetic, hereditary or infectious disease transmissible to descendants. For this purpose, regulations in the Royal Decree 1301/2006 will be observed. Neither the recipient woman nor her husband, after having expressed their previous formal consent to a specific fertilisation with donor contribution, can contest the marital filiation of the child born from such fertilisation. This limitation will also affect heterosexual common-law couples who have signed the informed consent prior to the application of the technique. 3. Future use of remaining cryoconserved embryos Some of the remaining viable embryos from an In Vitro Fertilisation cycle are cryoconserved in liquid nitrogen, as not all untransferred embryos are adequate to be frozen. The future use of the cryoconserved embryos can be: a. To use them to fertilise their female owner, or if it is the case, her wife. b. To donate them for reproductive purposes c. To donate them for research purposes d. To stop their conservation without any further use. The use of these embryos by their female owner or her legal partner will only be possible if
the woman fulfils the clinically adequate requirements to perform the corresponding assisted
reproduction technique, which is determined by the maximum conservation period. In case of
separated/divorced couples, if the woman wishes to use these embryos for personal reproduction
purposes, she will have to obtain the former husband’s consent to the new embryo transfer, as
both will be the newborn’s legal parents.
In donations for reproductive purposes embryos are donated to sterile couples that need them.
The donation is voluntary, free of charge, anonymous and altruistic and a previous specific
written consent is required. Recipient women/couples and their children born from this
technique, have the right to obtain general information about the donor, except for his identity.
Also, in very special circumstances that may entail life or health risks for the newborn or when
acting according to the procedural criminal law, the identity of the donor may be revealed in a
restrictive manner and without modifying in any way the previously established filiation.
In donations for research purposes embryos are donated in an altruistic manner for
biomedical research projects to especially authorised centres carrying out authorised specific
projects. In this sort of donations an additional specific consent will have to be signed in which
the purposes and the implications of the corresponding specific research will be stated.
When couples decide to stop the conservation without any further use, in the case of
cryoconserved embryos and oocytes it will only be applicable when the maximum conservation
period established by law expires without having chosen any of the other future uses mentioned
above. The cryoconservation of remaining oocytes, ovarian tissue and embryos can be extended
until the medical staff decides with the help of a favourable report from external independent
specialists that the woman does not fulfil the clinically adequate requirements to perform the
corresponding assisted reproduction technique.
4. Obligation to renew the consent regarding the cryoconservation of embryos Every two years, at least, the woman/couple will be asked to renew or modify her/their consent. If after having expired two consecutive conservation periods it is impossible to obtain form the woman/couple her/their renewed corresponding consent, having been previously required by the clinic in an irrefutable manner (certified fax with acknowledgment of receipt, certified letter with acknowledgment of receipt, telegram with acknowledgment of receipt, notarized letter, .) the embryos will be at the clinic’s disposal and they will be used for any of the uses stated in section 3, maintaining the established confidentiality and anonymity requirements and also their free-of-charge nature with no profit motive. 5. Regarding the possibility to have a posthumous child In case of death of the husband (or male partner, in common-law couples), the law indicates that the filiation will only be legally determined if the reproductive material is in the woman’s uterus prior to the husband’s (or male partner, in common-law couples) death, except in cases in which he has given his consent in the informed consent document of these techniques or in a notarially recorded deed or in his will or in a previous instructions document so that his reproductive material can be used within twelve months following his death to fertilise his female partner. This consent can be revoked at any time prior to the performance of the techniques. Also, the law establishes that the deceased husband’s (or male partner’s, in common-law couples) given consent to the post-mortem fertilisation of his wife will be understood when she has already started an assisted reproduction process that involves the transfer of embryos originated prior to the husband’s death. In medical terms, the treatment is considered to have started when the patient takes the first medication dose required for the treatment. Alternatives in case of failure of this technique
If after undergoing one or various treatment attempts of In Vitro Fertilisation or Intracitoplasmatic Sperm Injection, a pregnancy is not achieved, after serious consideration it may be recommendable to consider some of the following alternatives:  Restart the treatment  Perform complementary tests  Apply variations in the technique  Perform a Preimplantation Genetic Diagnosis (PGD)  Start new treatments with donated gametes (eggs and/or spermatozoa)  Use donated embryos  Desist from assisted reproduction treatments The content of this document reflects current knowledge and is therefore subject to alterations if new scientific discoveries and achievements advise otherwise. Place and date: ______________, ________________________________ Doctor ________________ Registration number ______________ Signatures __________ IN VITRO FERTILISATION OR INTRACITOPLASMATIC SPERM
INJECTION WITH EMBRYO TRANSFER AND EMBRYO
CRYOCONSERVATION (IVF/ICSI)
CONSENT DOCUMENT
SPANISH FERTILITY SOCIETY
Ms. _______________________________________________________________________ of legal age, DNI/Passport number ______________ marital status _______________, and Mr./Ms______________________________________________________________________ of legal age, DNI/Passport number ______________ marital status _________________, residing in __________________________________ address _________________________ _______________ postal code __________ country ________________________________ being present as (married couple, common-law couple, single woman) _________________ I/WE DECLARE:
1. I/We have full legal operative ability. 2. In this act, in a free, conscious and explicit manner I/we give my/our written consent to the use of assisted reproduction techniques (mark with a cross): 3. Before this act, I/we have been informed both orally and in writing through the Information document for the informed consent of in vitro fertilisation or
intracitoplasmatic
sperm
injection
with
embryo
transfer
and
embryo
cryoconservation, which I/we have read, understood and endorsed. Consequently, I/we
have been informed about:
 Information and advice about assisted reproduction techniques in their biological,
legal and ethical aspects. Also, when semen from a donor is used, I/we have received information about its use and especially about the legal relevance of the husband’s (or male partner’s, in common-law couples) signature in this informed consent in order to establish the paternal filiation of the prospective descendants.  The indication, procedure, probability of success, risks, contraindications, and complications of the proposed treatment.  The staff’s willingness to give further information about any aspect that has not  The further use of the possible viable pre-embryos that will remain cryoconserved in the embryo bank of the clinic and which have not been transferred into the uterus during the course of the treatment cycle.  The possible risks that can be derived from maternity at a clinically inadequate age, both for the mother during the treatment and pregnancy and for the descendants.  The obligation to periodically renew or modify my/our consent in regard to the cryoconserved pre-embryos, and to inform the clinic about any change of address or personal circumstance that may affect their further use (separation, death or acquired disability of one of the spouses, .)  Information related to the economic terms and conditions of the treatment. 4. That, according to the medical team, for my/our reproductive project, an assisted reproduction treatment using ____________________________________________ (IVF/ICSI) is required, and among the different available treatments, I/we have understood that this is the most adequate one and therefore in this act I/we give my/our consent to it. 5. To know that, at any moment before the embryo transfer, I/we can ask for the suspension of the assisted reproduction techniques, and that this petition has to be attended. 6. The medical staff has also informed me/us about the following risks related to my/our personal circumstances: ______________________________________ Also, I/we have been informed about the importance of reading the information leaflets in the prescribed medicaments to know the possible risks associated to their use in more detail and about the fact that I/we can also ask the staff about any doubts that may arise. 7. I/We authorise and consent to the transfer of a maximum of _____ (one, two or three) 8. As to the possibility to produce extra viable pre-embryos that will not be transferred  I/We assume the obligation to cryoconserve the remaining viable pre-embryos and I/we consent to it.  I/We do not wish to generate more pre-embryos than necessary and therefore I/we only authorise the insemination of maximum ________ oocytes. 9. If our possible remaining cryoconserved embryos are not used in the future for our common reproductive project, we would like them to be  Donated for reproductive purposes  Donated for research purposes  Not used for any other purposes and stop their conservation when its period 10. I/We have understood all the information given in a sufficient, comprehensible and adequate manner by Dr. ______________________________________________ 11. In the same way, in the medical consultation I/we have stated that:  I/we do not suffer from any transmissible genetic, hereditary or infectious disease that can constitute a serious risk for my/our possible descendants.  I/We haven’t omitted or falsified any medical or legal details that might affect the  I/We accept the commitment to inform the clinic about any change of personal circumstances (death, separation, divorce, .)  I/We have the obligation to inform the clinic about any change of address in case of I/We authorise:
The application of the treatment procedures and necessary controls to undergo an In vitro Fertilisation / Intracitoplasmatic Sperm Injection treatment, embryo transfer and embryo cryoconservation if the latter is necessary. The content of this document reflects current knowledge and is therefore subject to alterations if new scientific discoveries and achievements advise otherwise. Under Spanish Organic Law 15/1999 of 13 December on the Protection of Personal Data (Ley Organica 15/1999 de protección de datos de carácter personal), my/our personal and medical data will be registered in the file owned by ____________________________ and can only and exclusively be used or transferred in relation to the above professional assignment, keeping the right to access, modify or cancel them. All data derived from the process will be registered in my/our medical history which will be in the custody of GIREXX to ensure its correct conservation and recovery. Note: The clinic will do everything possible to keep the store of cells/tissues in optimal conditions but it takes no responsibility for the loss of their viability due to natural disasters or other emergencies beyond the clinic’s control. Your frozen embryos could be transferred to an alternative location in case of an emergency situation (floods, riots, fire, violent situations / weapons, terrorists threats or actions, gas or other explosions, earthquakes, etc.) Place and date: ______________, ________________________________ Doctor ________________ Registration number ______________ Signatures ___________ ANNEX for MALE PARTNER
Mr. _______________________________________________________________________ of legal age, DNI/Passport number ______________ in this act I state that if I die before my reproductive material finds itself in the uterus of Mrs. _____________________________ ___________________________________ , I consent to the fact that she can be fertilised with it within 12 months after my death and that the filiation of the new born is established Place and date: ______________, ________________________________ Doctor ________________ Registration number ______________ Signature ___________ ANNEX for VARIATION of the future use of the cryoconserved pre-
embryos
Ms. _______________________________________________________________________ of legal age, DNI/Passport number ________________________, residing in ___________ _________________ address _______________________________________________ postal code __________ country __________________________________________ and Mr. _______________________________________________________________________ of legal age, DNI/Passport number ________________________, residing in ___________ _________________ address _______________________________________________ postal code __________ country ____________________________________________ in this act I/we request the variation of the future use of our remaining cryoconserved pre-embryos and we consent to (use them to fertilise their female owner, donate them for reproductive purposes, donate them for research purposes, stop their conservation when its period expires) ____________________________________________________________________ Place and date: ______________, ________________________________ Doctor ________________ Registration number ______________ Signature ___________ ANNEX for REVOCATION of the present consent
Mr____________________________________________________________________ of legal age, DNI/Passport number ______________ residing in _____________________ address __________________________________________ postal code __________ country ___________________________________ in this act I request the REVOCATION of the application of the human reproduction technique that I am currently undergoing. Place and date: ______________, ________________________________ Doctor ________________ Registration number ______________ Signature __________

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