Section III Consent Forms
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- Jerome Hensley
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1 Section III Consent Forms Please read the consents prior to your IVF consultation appointment. Most people have questions regarding the consent forms. Your questions will be addressed during the appointment. Please do not sign the consent forms prior to your appointment. ~ 19 ~
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3 Utah Center for Reproductive Medicine University of Utah Consent For Attempted In Vitro Fertilization and Implantation of Resulting Embryos 1.0 I, and my partner acknowledge that we have been unable to achieve a pregnancy because of one or more conditions impairing fertility, and acknowledge that we have considered or attempted therapies less costly and invasive than In-Vitro Fertilization. 2.0 We hereby express our desire to attempt pregnancy utilizing In Vitro Fertilization and embryo transfer. We acknowledge that this approach has been fully explained to us, and that the following is an outline of the steps and risks involved in this procedure. 2.1 Determination by standard infertility tests that we are suitable candidates for the procedure. These tests include special studies of the semen. It may also include special laboratory tests, ultrasounds, or other procedures for the woman. 2.2 Obtaining screening tests. These may include cervical cultures for Gonorrhea and Chlamydia, blood type and blood tests for determination of exposure to rubella virus (German measles), and when appropriate may also include serologic (blood) testing for hepatitis B virus, Hepatitis C virus, HTLV I and II viruses and HIV (the AIDS tests). Screening tests for thyroid function and for genetic conditions including cystic fibrosis, thalassemia, and sickle cell anemia or other conditions may be recommended. Tests to make sure the sperm can cause fertilization may be required, and tests to be sure the cavity of the uterus is normal are also routinely necessary. 2.3 Use of fertility drugs in an effort to produce the development of multiple eggs. We understand the risks and means of administration of these drugs and the need to adhere to a strict timing and dosage of these medications. 2.4 Ultrasound examinations and blood tests to assist in determining number of developing eggs and their readiness for retrieval. 2.5 Undergoing transvaginal ultrasound-guided aspiration of follicles to obtain eggs. This is a painful procedure requiring medication for deep sedation, and entails surgical risks to the woman. 2.6 Obtaining a semen specimen by either masturbation (fresh or frozen samples) or by testicular biopsy (fresh or frozen samples), and laboratory treatment of the sperm to prepare it for fertilization. 2.7 Causing fertilization of the eggs to occur by mixing the egg(s) and sperm together or by injecting sperm singly into the eggs (IntraCytoplasmic Sperm Injection, or ICSI ) if the sperm are deemed incapable of reliably fertilizing eggs without this measure. The decision to perform ICSI may arise during the consultation with the doctor, during the stimulation cycle or immediately after the retrieval of eggs. 2.8 Using high doses of the hormone progesterone to make sure the uterine environment is suitable for embryo implantation. Commonly this is by injection and these injections may be painful. ~ 21 ~
4 2.9 After fertilization, transferring the embryo into a different media for growth and observing the progress of each embryo After several cell divisions, transferring some embryo(s) into the uterus (usually between 3 and 6 days after fertilization). The number of embryos transferred depends upon the number and appearance of embryos at that time Possibly assisting the hatching of embryos by thinning the outer membrane of the embryo (zona pellucida) Obtaining blood samples after embryo transfer in an attempt to determine if pregnancy has occurred and is proceeding normally. 3.0 We understand that in the course of attempting in vitro fertilization and embryo transfer any of the following may occur and could prevent the establishment of a pregnancy: 3.1 Spontaneous ovulation before attempted retrieval or other factors may preclude success in obtaining eggs. 3.2 We may be counseled to terminate attempts to stimulate the ovaries for egg retrieval because of inadequate or excessive ovarian response to medications. Inadequate response may make proceeding with IVF futile. Excessive response may place the woman at risk for a severe illness resulting from ovarian hyperstimulation. 3.3 If eggs are obtained, they may not be normal. 3.4 Attempts to obtain sperm for fertilization may fail. 3.5 Fertilization may not occur. 3.6 Cleavage or cell division of the fertilized egg may not occur, even if ICSI was performed 3.7 The embryo(s) may not develop normally. 3.8 Transfer of embryos to the uterus may be technically impossible. 3.9 Implantation may not occur after the embryo is transferred to the uterus Laboratory complications could result in loss or damage to the fertilized egg or embryo Other unforeseen circumstances may prevent establishment of a pregnancy Ovarian hyperstimulation syndrome, (OHSS) may occur. Blood chemistry and fluid imbalances, abnormal clotting, and other events may be life-threatening consequences of OHSS. OHSS may require costly hospitalization for which insurance may not provide coverage. 4.0 We recognize that it is best to transfer no more than a few, or only one embryo to the uterus to avoid the severe risks of multiple pregnancies. The IVF treatment regimen and egg recovery by follicle ~ 22 ~
5 aspiration may yield several ova, and the number of embryos that will show potential for life on the day of embryo transfer will often be greater than the number of embryos that would be wise to place in the uterus. Some couples will prefer not to risk having created living embryos for which there is no intention for chance to become an infant. Therefore couples may choose to limit the number of eggs fertilized, though this will lower the chance of pregnancy. Therefore couples have the following choices regarding the number of eggs to be fertilized and the disposition of embryos not transferred during their cycle of IVF: A. limit fertilization to 3 ova, and transfer all resulting embryos to the uterus. B. Fertilize all ova obtained and transfer the best 1 to 3 embryos that result. If embryos remain the laboratory after transfer to the uterus has been completed, we request that they: 1. Be discarded 2. Donate them for research or other purposes. You would have to be contacted by the University of Utah, Utah Center for Reproductive Medicine and the Andrology Laboratory to sign consents for the specific type of research or donation proposed. If the Andrology Lab is unable to contact you, the lab will dispose of the embryos. 3. Undergo cryopreservation for the potential future intrauterine transfer (specific consent applies). 5. If pregnancy is successfully established, miscarriage, ectopic pregnancy, multiple pregnancies, stillbirth, congenital abnormalities (birth defects) and/or any other pregnancy complication may occur. Current science suggests that pregnancy complications such as low birth weight, and birth defects may be more common after IVF than spontaneous conception. I certify that my questions regarding these outcomes have been answered to my satisfaction. 6. We understand that insurance coverage for any or all of the above procedures may not be available, and that we will be personally responsible for all expenses incident to this treatment. 7.0 We are aware that on the basis of present information the chances for a pregnancy using IVF vary unpredictably for couples and acknowledge that no representations or guarantees that have been made to us with respect to whether the procedure will be successful, other than as stated herein, and that we have been fully informed of the risks associated with the procedure, which include the following: 7.1 Drawing of blood. 7.2 Bleeding and/or infection. 7.3 Risks associated with general and/or local anesthesia. 7.4 Ultrasound examination. 7.5 Pain and discomforts such as headache, nausea, and fatigue associated with hormonal changes, injections, enlargement of the ovaries, or other procedures. ~ 23 ~
6 7.6 Discomforts and risks associated with pregnancy, including possibilities of multiple gestation or birth defects. 7.7 Injury to internal structures resulting from transvaginal needle aspiration of ovarian cysts. This includes the risk of pelvic hemorrhage, infection, or damage to internal organs. Each of these may cause serious threat to health and may require hospitalization which may not be covered by health insurance. 7.8 Ovarian hyperstimulation syndrome. 7.9 Psychological distress, loss of sense of well-being, depression, and marital strain with, or without success in achieving pregnancy Other unforeseen physical, financial or psychological harms. 8.0 We have had the opportunity to ask unlimited questions about the participation in the IVF program, and our questions have been fully answered to our satisfaction. We acknowledge that our participation in the IVF program is voluntary. 9. We understand that the University of Utah will consider the information developed about us during this treatment as confidential. Medical data may be included in professional publications as long as our identity is concealed. 10. We acknowledge that this consent is revocable by either of us at any time, and if either the partner or patient withdraws consent, the consent as to both shall be deemed revoked. We acknowledge that our signatures and the consent they represent are our own free act, without coercion or misrepresentation of any kind. 11. We recognize that during the course of any of the procedures outlined above, unforeseen conditions may necessitate additional or different procedures than those set forth above. In that event, we therefore authorize and request our physician, his/her assistant or his/her designees to perform such procedures as are in the exercise of professional judgment necessary and desirable. We acknowledge by our signatures below that we have read the foregoing and that all questions pertaining thereto have been answered to our satisfaction, and acknowledge receipt of a copy of this consent form. PATIENT NAME: Signature: Date: PARTNER NAME: Signature: Date: PATIENT ADDRESS: WITNESS NAME: Signature: Date: ~ 24 ~
7 UTAH CENTER FOR REPRODUCTIVE MEDICINE UNIVERSITY OF UTAH CRYOPRESERVATION CONSENT 1. Definitions: As used in this Consent, the following definitions shall apply: (a) CRYOPRESERVATION is preservation by freezing. In this case, cryopreservation refers to the preservation by freezing of human embryos. (b) An EMBRYO is a fertilized egg, or ovum, that has divided to form a small number of cells. (c) IN-VITRO FERTILIZATION or IVF refers to the processes whereby egg growth is followed or stimulated in a woman, the eggs are obtained from her ovaries, then fertilized by sperm in the laboratory, and the resulting embryos placed in her uterus. 2. Cryopreservation of Embryos. We, the undersigned, as a couple, (hereinafter sometimes referred to as we ) understand that as a result of our participation in the in vitro fertilization (IVF) program more embryos may form than our physicians may recommend to be placed back during the IVF cycle. Accordingly, we desire that these surplus embryos be cryo-preserved so that they may be placed in the uterus in some later cycle for the purpose of establishing pregnancy. 3. Absence of Guarantee. We understand that there is no guarantee that the embryos will survive the cryopreservation, or that pregnancy will be achieved utilizing this process. We understand that mechanical failures may occur at any point during the process resulting in loss of the embryos. 4. Change of Decision. We understand that we have the right at any time in the future to change any decision about embryo use or disposal, as indicated in this document, by advising the University of Utah IVF program in writing with the notarized signatures of both partners. In the event of death of either of us or divorce, the use or disposal of such embryos shall be in accordance with the applicable provisions of paragraph Implantation of Cryo-preserved Embryos. We understand that when we and our physician have determined that the cryopreserved embryos are to be placed in the patient s uterus, they will be thawed and placed in the uterus in a controlled ovarian cycle. We understand that before thawing the cryopreserved embryos, we will have the opportunity to discuss and approve the strategy regarding how many embryos may be thawed with the staff of the Utah Center for Reproductive Medicine. The goal will be to obtain an optimal quantity and quality of viable embryos for subsequent transfer into the uterus. The thawing strategy will depend upon the number and condition of embryos cryopreserved, and other pertinent infertility factors. Also, we understand that only ~ 25 ~
8 embryos considered to be potentially viable by the medical team, using reasonable medical judgment, will be transferred. Placement of the embryos to the uterus requires a normal uterine lining and close synchronization to the normal process of ovulation. Such synchronizations may require monitoring by frequent blood or urine testing and ultrasound examinations, and the embryos will only be thawed and so placed if the conditions are determined to be adequate by our physician. 7. Procedures in the Event a Pregnancy is Achieved. There are neither present indications of a significant increase in the rate of anomalies among infants born after successful uterine transfer of cryopreserved embryos, nor any indication of increased abnormalities after cryopreservation from extensive experience in animals. Nevertheless, it is not possible to know whether information in the future may find some evidence of harm from cryopreservation. We accept this risk of abnormality in the child so conceived through that embryo cryopreservation process. 8. Costs for Initial Freezing and Annual Maintenance Fees. Cryopreservation of human embryos is an intricate and time-consuming process. We understand that it is our responsibility to pay the costs of freezing and pay semi-annually for continued storage. We understand there also is a fee for thawing embryos prior to transfer. (1) We agree to inform the University of Utah IVF program of any change in our address occurring while we have cryopreserved embryos in storage at the University of Utah. We further agree that if any of these payments remain unpaid for more than one year, the embryos will be: (a) Donated for research or other purposes. You would have to be contacted by the University of Utah Center for Reproductive Medicine and the Andrology Laboratory to sign consents for the specific type of research or donation proposed. If the Andrology Lab is unable to contact you, the lab will dispose of the embryos. (b) Disposed of (2) Costs may increase at any time due to changes in costs of supplies, equipment, techniques, or other factors 9. Management and Disposal of Cryopreserved Embryos. We hereby express our wishes in relation to the management and disposal of our cryopreserved embryos in the following situations: (1) In the event of death of the partner, we wish our embryos to be: (select desired option) (a) desires. Placed in the uterus of our surviving female partner, if she so ~ 26 ~
9 (b) Donated for research or other purposes if the patient so desires. You would have to be contacted by the University of Utah, Utah Center for Reproductive Medicine and the Andrology Laboratory to sign consents for the specific type of research or donation proposed. If the Andrology Lab is unable to contact you, the lab will dispose of the embryos. (c) Disposed of However, it is understood that the surviving patient has the right following the partner s death, to forego any or all of the above. In the event of the death of the patient, we wish our embryos to be: (a) In the event the partner establishes a new relationship, we wish our embryos be placed in the new female partner s uterus if they desire: (b) In the event my partner establishes a new relationship after my death and they do not desire transfer of the embryos they are to be: (i) Donated for research or other purposes. You would have to be contacted by the University of Utah, Utah Center for Reproductive Medicine and the Andrology Laboratory to sign consents for the specific type of research or donation proposed. If the Andrology Lab is unable to contact you, the lab will dispose of the embryos. (ii) Disposed of (c) Disposed of (d) Donated for research or other purposes. Your surviving partner would have to be contacted by the University of Utah, Utah Center for Reproductive Medicine and the Andrology Laboratory to sign consents for the specific type of research or donation proposed. If the Andrology Lab is unable to contact you, the lab will dispose of the embryos. ~ 27 ~
10 However, it is understood that the surviving partner has the right to forego any or all of the above options (2) In the event both members of the couple die, we wish that our embryos to be: (a) Disposed of (3) In the event of we cease to be a couple after the date of this document, we wish the embryos to be: (a) Donated for research or other purposes. You would have to be contacted by the University of Utah. Utah Center for Reproductive Medicine and the Andrology Laboratory to sign consents for the specific type of research or donation proposed. If the Andrology Laboratory is unable to contact you, the lab will dispose of the embryos. (b) Disposed of (c) Placed at the disposal of:, who shall have the right to make any lawful use of disposition of the same: (4) In the event the embryos are cryopreserved under the provisions of paragraphs No. 9 and there is failure to make payment for more than one year. we agree that the embryos may be either: (a) Donated for research or other purposes. You would have to be contacted by the University of Utah, Utah Center for Reproductive Medicine and the Andrology Laboratory to sign consents for the specific type of research or donation proposed. If the Andrology Lab is unable to contact you, the lab will dispose of the embryos. (b) Disposed of ~ 28 ~
11 (5) Any authorization for donation or disposal of our embryos, not elsewhere directed in this document, shall be in writing and have notarized signatures of both of us. 10. We understand that as of the date of this instrument the legal rights of members of a couple, or other parties, with regard to the use and disposition of human embryos resulting from IVF have not been statutorily or judicially determined by the State of Utah. Should it later be determined that any of the selected embryo uses or disposition outlined in this document is illegal, then such selected use or disposition shall be deemed null and void. In the event either member of the couple contests the legality of any provision of this document with the respect to the use or disposition of our embryos, the University of Utah will continue to preserve the frozen embryos at the expense of the contesting spouse, based upon the costs set forth in paragraph 7, and in the event of failure of the contesting spouse to make any payment due for more than one year, it is agreed that the said embryos may be disposed of by the University. 11. We understand that in any event the embryos will not be stored beyond the 50 th birthday of the wife, at which time the embryos will be: a. Donated for research or other purposes. You would have to be contacted by the University of Utah, Utah Center for Reproductive Medicine and the Andrology Laboratory to sign consents for the specific type of research or donation proposed. If the Andrology Lab is unable to contact you, the lab will dispose of the embryos. b. Disposed of 12. Surrogate Motherhood Program We understand that if the wife has a hysterectomy or change in the health of the uterus as to preclude pregnancy, the only known remaining alternative, other than donation or disposal of the embryos, would be to achieve pregnancy through a surrogate mother to carry the pregnancy and will abide by presently constituted Utah Statutes regarding surrogacy. In such event, we, the couple, will pay all costs related to the transfer. 13. Scientific Evidence. We understand that the University of Utah and the personnel involved in the IVF program are not obligated to proceed with embryo uterine placement if on the basis of scientific evidence the said University personnel, in their sole judgment, believe that the risks of proceeding outweigh the benefits. The University of Utah Hospital and the personnel operating the IVF program also reserve the right to terminate their participation in the human embryo cryopreservation project at any time. In the event of such termination, all reasonable efforts will be made to arrange for use, transfer or disposition of our embryos remaining in storage according to our wishes. In the absence of direction from us, the frozen embryos will be disposed of. ~ 29 ~
12 14. Donate to Outside Organization. We understand that if we choose to donate non screened embryos to an outside organization, there would be a reasonable processing and handling fee through the Andrology Lab. We understand that if we so choose to donate non-screened embryos to an outside organization, we will be responsible for all legal expenses involved with such donation. 15. Disposal Any disposal of our frozen embryos directed or authorized by this document shall be in accordance with the procedures then in effect at the University of Utah. 16. Additional Information. Should we require further information regarding our cryopreserved embryos, we can do so by calling the Andrology and IVF laboratory at (801) Our participation in the human embryo cryopreservation program will be kept in confidence to the extent required by law. 17. Receipt of Copy of Consent. We acknowledge receipt of a copy of this Consent document for our own records. We also acknowledge that our participation in the embryo cryopreservation program is voluntary. 18. Signature: We acknowledge by our signature below that we have read the foregoing and that all questions pertaining thereto have been answered to our satisfaction, and acknowledge receipt of a copy of this consent form. PATIENT NAME: Signature: Date: PARTNER NAME: Signature: Date: PATIENT ADDRESS: WITNESS NAME: Signature: Date: ~ 30 ~
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