PGD (Preimplantation Genetic Diagnosis) Consent

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
Initial
Patient / Partner
_______ /_______ 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).
Initial
Patient / Partner
______ / _______ 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.
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EMBRYO BIOPSY
Initial
Patient / Partner
_______ / _______ 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.
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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:
Initial
Patient / Partner
_______ / _______ 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.
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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):
Initial
Patient / Partner
_______ / _______ 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: ________/_________/______________
Month
Day
Year
Date: ________/_________/__________
Month
Day
Year
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Patient - Type of Picture Identification
Driver’s License # __________
Expiration Date: _______/________/____________
Passport #: _________________
Expiration Date: ______/________/_____________
Other: _____________________
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: ______/______/___________
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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: _______________
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