Consent for Pre-Implantation Genetic Diagnosis (PGD), Embryo Biopsy and Disposition Book Number Patient Name (Please print): Patient, IVFNE eivf Number: Partner Name (Please print, if applicable): Partner, IVFNE eivf Number: Please read the following consent carefully. This consent for Embryo Biopsy and PGD should be read in conjunction with the Assisted Reproduction Consent for Treatment book and consent for the IVF procedure that have been provided to you. By signing this consent, you are attesting to have become familiar with the material in the Consent for Treatment book and have been afforded the opportunity to have your questions and concerns addressed by your physician and nursing team. Patient and Partner (if applicable) must present PHOTO IDs and sign in the presence of an authorized representative of IVF New England (IVFNE). This consent must be signed by the Patient and Partner (if applicable) at each signature line noted for Patient and Partner. All sections must be signed by Patient and Partner (if applicable). If you and/or your partner are unable to sign the consent in the presence of an authorized IVFNE representative, the consent must be notarized utilizing the attached Notarization Form and returned to IVFNE. You should keep the Consent for Treatment book for your records. Introduction In choosing Pre-implantation Genetic Diagnosis (PGD) as part of your In Vitro Fertilization (IVF) treatment, you are consenting to and authorizing the removal (biopsy) of one or more cells from each appropriately developed embryo. PGD may be for the identification of a disease-causing gene mutation, chromosome copy number (aneuploidy), the presence of a structural abnormality of a chromosome, gender selection or combination of these applications. PGD requires a treatment process called IVF. Medications called gonadotropins are used to stimulate the development of multiple eggs within the ovary which are subsequently retrieved and united with sperm in the laboratory after which embryos are expected to develop. This process is described in depth in the IVF Consent Book and in a separate IVF consent form. If these embryos have developed appropriately, a biopsy will be Revised October 2014
performed on each embryo to obtain cells for genetic analysis and the specimen sent to an outside laboratory which specializes in this type of genetic testing. The type of analysis to be performed and testing accuracy will depend on the genetic condition of concern and the method of analysis. The risks of embryo biopsy, risks and benefits of PGD testing and a detailed description of the types of analytic techniques used for specific genetic conditions are discussed in depth in the PGD section of the IVF Consent Book. It is essential to review the PGD section of the Consent for Treatment book prior to signing this consent form. Please initial each of the following items as an acknowledgement of your understanding of each statement. PGD / PGD is not a perfect technology and has an inherent error rate of 1-5% depending on the nature of the test performed. It is strongly recommended to confirm fetal status with Chorionic Villus Sampling (CVS) or amniocentesis after pregnancy has been established following PGD. / It is possible that no suitable embryos may be available for transfer or cryopreservation either due to non-survival of the embryo(s) or genetic abnormalities of the embryo(s) that may be fatal or seriously impact the health of the child(ren). / An embryo that is determined to be genetically "unaffected" may not continue to develop into an embryo that implants and continues on to become a healthy pregnancy or live birth. There are other nongenetic factors which are necessary for appropriate embryo and fetal development. For this reason, the risk of miscarriage may be reduced but not eliminated with PGD testing. / Once the biopsy is performed, the PGD service is rendered even if the cycle is cancelled and/or there are no available embryos for transfer. There is no refund for PGD services once the biopsy has been performed. / It is strongly recommended that you discuss your upcoming cycle with IVFNE Financial Services as insurance coverage for PGD may vary depending on your health insurance plan benefits. / IVFNE counselors are available to discuss psychosocial issues that may be related to PGD testing. It is RSC policy that any couple planning to undergo PGD for gender selection has a one-time visit with an appropriate counselor. 2
EMBRYO BIOPSY / Embryo biopsy may have a negative effect on the embryo s development. If embryos arrest or develop abnormally, no embryo transfer will occur regardless of the embryo s genetic status. / Contamination of biopsy specimens with extraneous DNA affects less than 5% of cells tested during PGD. If a biopsy specimen is affected by contamination, the genetic analysis of the embryo from which it is derived will be reported as inconclusive. / It is possible that there may be no embryos suitable for biopsy, in which case the embryo biopsy procedure may not be done. / Depending on the purpose of the PGD, if there are very few embryos suitable for biopsy, there is the option not to proceed with biopsy for PGD. Rather, these embryos may be cryopreserved to accumulate a reasonable number before proceeding with embryo biopsy in a subsequent IVF cycle. / The embryo biopsy specimen will be sent to a laboratory specializing in genetic analysis for PGD testing. IVF New England will use packaging materials in accordance with the policies and procedures established by IVFNE to transport the biopsied specimen to the PGD laboratory. I/We acknowledge that IVFNE is not responsible for the handling, transportation or condition of the biopsied specimen once it is no longer in the possession and control of IVFNE. 3
EMBRYO DISPOSITION Please INITIAL (BOTH PARTNERS) EACH SECTION below to indicate your understanding of the following elements of PGD treatment you agree to undertake in your upcoming treatment cycle. We understand the situations described below are possible: / Genetically Inconclusive Embryos: It is possible that a biopsied embryo will have an inconclusive result where the genetic status of the embryo cannot be confirmed. Whether or not to transfer, cryopreserve or discard these embryos will be a decision made between you and your physician. / Genetically Affected embryos refers to those embryos that are considered positive for the evaluated disease, condition or undesired gender. I/We understand that all embryos reported as being affected will be discarded according to IVF New England standard procedures or donated for research (Separate consent required). / Genetically Unaffected Embryos refers to those embryos that are considered negative for the evaluated disease, condition or are of the desired gender. These embryos are candidates for transfer, cryopreservation (separate consent required in the IVF consent form) or other disposition. 4
THE FOLLOWING TWO SECTIONS ARE ONLY FOR PATIENTS WHOSE PGD IS FOR DETECTION OF A SINGLE GENE MUTATION: For PGD patients undergoing testing for single gene mutations for a recessive disease, please initial your understanding of the following and indicate your preference for disposition. / Carrier embryos are those embryos which contain one normal and one abnormal copy of the gene of the disease of concern or when a condition is X-Linked, a female may carry a normal copy of the gene on one X chromosome and an abnormal copy of the gene on her other X chromosome. In most cases, these embryos will not manifest the disease (depending on the particular disease) but will be at an increased risk of passing the abnormal copy of the gene on to their future children. In most cases, these carrier embryos are considered candidates for embryo transfer since they are not likely to be affected by the disease. I/We have had the opportunity to discuss the risks of transferring carrier embryos with my physician and/or genetic counselor, and I/we request that these embryos be: (Please choose ONE option): / Transferred and/or cryopreserved OR / Discarded or donated for research (separate consent required) I/We have read the IVFNE Consent for Treatment book and reviewed the information in this consent for PGD, Embryo Biopsy and Embryo Disposition with my physician. I/We have been provided with adequate opportunity by my physician and nursing team to address our questions about PGD, embryo biopsy and embryo disposition. Patient signature Partner signature (if applicable) Date: / / Date: / / Month Day Year Month Day Year 5
Patient - Type of Picture Identification Driver s License # Passport #: Other: Expiration Date: / / Expiration Date: / / Date: / / Picture Identification(s) Confirmed on Date: / / Witness - Print Name and Title Witness Signature Partner (if applicable) - Type of Picture Identification Driver s License # Passport #: Other: Expiration Date: / / Expiration Date: / / Date: / / Picture Identification(s) Confirmed on Date: / / Witness - Print Name and Title Witness Signature PHYSICIAN ATTESTATION The above mentioned patient and partner (if applicable) have been informed and counseled by me and others regarding the risks and benefits of the relevant treatment options, including non-treatment. The patient and partner (if applicable) expressed understanding of the information presented during the discussion. Physician Signature: Date: / / 6
Notarization Form This form must be completed for consents signed outside the Practice Patient name (please print): State of County of I certify that I know or have satisfactory evidence that is the person who appeared before me, and said person acknowledged that he/she signed this instrument and acknowledged it to be his/her free and voluntary act for the uses and purposes mentioned in the instrument. Dated Notary Signature Title My appointment expires: Partner name (please print if applicable): State of County of I certify that I know or have satisfactory evidence that is the person who appeared before me, and said person acknowledged that he/she signed this instrument and acknowledged it to be his/her free and voluntary act for the uses and purposes mentioned in the instrument. Dated Notary Signature Title My appointment expires: 7