IN VITRO FERTILIZATION AND EMBRYO TRANSFER THERAPY
I/We, ________________________________ (woman, referred to herein
as "Patient") and _________________________________ (man, referred
to herein as "Spouse/Partner"), have elected to undergo in vitro fertilization
and embryo transfer (IVF) therapy at Georgia Reproductive Specialists (referred
to herein as GRS). We certify that the following statements represent our
understanding and acceptance of conditions, responsibilities and risks
involved in the use of IVF therapy.
SPERM SOURCE
I/We understand and agree that the following will be used as a source
for sperm for the IVF procedure:
_____ ______ Male Partner Fresh and/or Frozen (circle one or both
if applicable)
_____ ______ Anonymous sperm donor
_____ ______ Known donor sperm ___________________________
RISKS AND LIMITATIONS
I/We understand and agree to assume the risks involved in IVF therapy,
which include but are not limited to:
- Repeated blood sampling causing a risk of redness, small bruises, and,
to a lesser extent, infection or thrombosis.
- The utilization of fertility drugs to induce ovulation may impose certain
risks including physical as well as emotional pain or discomfort, blood
clotting, ovarian tumors/cancer and the related risks of ovarian hyperstimulation
syndrome, which can cause death.
- Material risks of egg retrieval procedure: DEATH, RESPIRATORY ARREST,
CARDIAC ARREST, BRAIN DAMAGE, DISFIGURING SCAR, PARAPLEGIA OR QUADRIPLEGIA,
PARALYSIS OR PARTIAL PARALYSIS, LOSS OF FUNCTION OF ANY LIMB OR ORGAN,
SEVERE LOSS OF BLOOD, ALLERGIC REACTION AND INFECTION. These are material
risks attendant to any surgical procedure. The specific physical risks
involved regarding surgical egg recovery from Patient's ovaries including
pain and discomfort, anesthetic complications, surgical complications
such as injury to the bowel, blood vessels, or other structures, bleeding,
and/or infection. Bleeding or other injuries or complications resulting
from the egg retrieval may require an invasive surgical procedure to correct
the complication. Any such complication or its correction could affect
future fertility.
- During the egg retrieval procedure, the physician/surgeon may become
aware of conditions or complications which were unforeseen or not known
before the start of the procedure. I therefore authorize and request the
physician/surgeon and such assistants or physicians as may be present
to perform such additional or different operations or procedures as are
necessary or appropriate in the exercise of professional judgment to treat,
cure or diagnose such conditions.
- There is a higher probability of a multiple gestation pregnancy (twin,
triplet, quadruplet) outcome using IVF.
- If pregnancy results from this procedure, there is a possibility of
complications from pregnancy and parturition or other adverse consequences.
The possibility of complications during pregnancy and parturition are
greater in the case of a multiple gestation pregnancy.
I/We acknowledge and agree that within the human population a certain percentage
(approximately 4%) of children are born with physical and/or mental defects
and that the occurrence of such defects is beyond the control of GRS Physicians
and Staff. We therefore agree that Georgia Reproductive Specialists, its
officers, directors, agents and employees including physicians and staff
do not assume responsibility for the physical or mental characteristics
of a child or children born as a result of IVF therapy.
I/We acknowledge and agree that our acceptance into the IVF program
and our continuing participation is within the sole discretion of GRS.
I/We understand that I/we can withdraw from the program at any time by
written notice to GRS without affecting the availability of other present
or future medical evaluations or treatments within GRS. GRS's physicians
may terminate IVF therapy when, in their best medical judgment, it is prudent
to do so. The physician in charge will consult with Patient and Spouse/Partner
prior to such termination and will discuss options for future therapy.
I/We acknowledge our understanding that many couples that require IVF
therapy may not be covered by medical insurance for some or all of this
treatment. I/We affirmatively represent I/we are financially able to pay
for this therapy and are responsible for all medical costs incurred during
our evaluation and treatment at GRS. I/We will promptly pay all charges,
which I/we may incur. I/We are aware that there will be charges I/we must
pay before the first medications are administered in any separate treatment
cycle. If I/we are found not to have third party insurance coverage for
IVF, I/we understand that attempting to obtain insurance reimbursement
for non-covered charges may constitute fraud. I/We agree not to submit
these bills for uncovered charges to our carrier for reimbursement.
I/We acknowledge and accept that GRS is a teaching facility and that
the IVF staff will include attending physicians, fellows, residents, interns,
scientists, technicians, nurses and medical students. I/We consent to allowing
GRS IVF staff or other medical personnel to observe laboratory procedures
or any other treatment or procedure performed on me or on my behalf. Furthermore,
it is possible that our participation in this program may aid in the development
of techniques that may help other infertile couples and/or may yield new
and useful information for medical science. Therefore, I/we consent to
the collection and publication of information and data and the making of
photographic and/or audiovisual tapes during the course of our IVF therapy
for use in advancing medical education and research. However, under no
circumstances will our identity be revealed.
I/We understand and accept that we also have the following choices as
to the monitoring of embryo development. I/We authorize the GRS physicians
and/or staff involved in this procedure to: (please mark and place initials
of both patient and partner beside one choice)
_____ ______ I/We agree to attempt to inseminate all viable oocytes
(eggs).
_____ ______ If all viable oocytes (eggs) are not to be inseminated, I/we
agree to the insemination of ________ oocytes (eggs). The remainder will
be discarded and NOT inseminated.
I/We consent to the use and subsequent disposal of eggs or embryo(s)
that are judged to be not developing or viable, unfertilized eggs, and/or
eggs fertilized by too many sperm in approved research. In addition, I/we
consent to the disposal of or use of other cells, body tissue and fluids
that may have been obtained during the IVF process for research purposes.
I/We understand and accept that we also have the following choices as
to disposition of potentially viable embryos which are not used in our
IVF therapy and authorize the GRS physicians and/or staff involved in this
procedure to: (please mark and place initials of both patient and partner
beside one choice)
_____ ______ Cryopreserve (freeze) the embryo(s) for our use at a future
time. An additional consent form outlining additional requirements and
fees for cryopreservation must be signed if this option is selected.
_____ ______ Discard excess embryo(s) in a manner deemed appropriate by
the IVF team; selection of this option will necessitate further consultation
with the IVF staff.
_____ ______ Donate the embryo(s) to another infertile woman. We recognize
that donated embryo(s) will be frozen for storage. This option is only
possible if we complete additional medical and genetic screening. We consent
that GRS may dispose of the donated embryo(s) in a manner deemed appropriate
by GRS if a suitable woman cannot be identified to receive them.
_____ ______ Use the embryo(s) in research projects permitted under the
policies of Georgia Reproductive Specialists policies and applicable legal
requirements.
ASSISTED HATCHING
_____ ______ I/We understand that during
the final course of embryo development prior to embryo transfer, it may
be deemed appropriate by the IVF laboratory staff that my/our embryos might
benefit from Assisted Hatching of the outer shell of the embryo (Zona
Pellucida). This procedure will be undertaken at the discretion of
our lab team. We do/do not consent to assisted hatching when medically
indicated.
PREIMPLANTATION GENETIC DIAGNOSIS (PGD):
PURPOSE AND BACKGROUND
Currently, the only way to determine whether or not an embryo is affected
by a chromosomal or genetic disorder is to wait until pregnancy has begun
and then perform a prenatal test, such as chronic villus sampling (CVS)
or amniocentesis. These procedures involve sampling fetal cells from within
the uterus during the first trimester or second trimester of pregnancy.
The cells are then analyzed to determine whether a chromosomal anomaly,
or an inherited disorder is present in the developing fetus. If a disorder
is detected, parents face the difficult choice as to whether they should
continue or terminate the pregnancy. The purpose of preimplantation genetic
diagnosis (PGD) is to identify affected embryos at a very early stage,
and prevent them from implanting in the uterus. The effect of such a procedure
is to increase the probability that embryos that implant and form a pregnancy
will be unaffected by chromosomal anomalies, or the specific disease tested.
PGD is not yet considered to be a standard technique, and consequently
it is strongly recommended that patients who become pregnant following
PGD still undergo prenatal testing using CVS or amniocentesis. Prenatal
testing will reveal whether the PGD was correct, and confirm whether or
not the fetus is normal.
You are referred initially to the general options below, and then subsequently
to the detailed Consent Form appropriate for each form of screening as
provided by the Diagnostic Laboratory undertaking the screening of your
embryo's cells.
(The ONE box of three below applicable for your clinical situation
should be marked.)
PGD OF ANEUPLOIDY
The purpose of this procedure is to select and transfer into the uterus
only embryos that do not have recognizable chromosomal abnormalities.
Chromosomes are structures found in the center or nucleus of cells.
A human typically has 46 chromosomes or 23 pairs. We receive 23 chromosomes
from the sperm and 23 from the egg. Chromosomes missing chromosome(s) [a
state referred to as aneuploidy] can result in failure of implantation
of an embryo, pregnancy loss, and other conditions such as infertility
and Down's syndrome. PGD of aneuploidy is being offered to patients undergoing
in-vitro fertilization (IVF) who are generally 35 years old or older. Patients
in this age group are at increased risk of miscarriage or birth defects.
PGD may reduce these risks. PGD of aneuploidy may also assist the embryologists
to select embryos more likely to result in a pregnancy. PGD of aneuploidy
may also be used for patients of all ages who have unexplained failure
to conceive despite several IVF cycles. Other patients who may benefit
are patients with a history of miscarriage, especially when testing reveals
no clear explanation. Patients who have had an aneuploid pregnancy in the
past may also want to consider PGD of aneuploidy.
PGD OF TRANSLOCATION
The purpose is to select and transfer to the uterus only those embryos
that appear to be chromosomally normal with respect to a known translocation
in either partner.
Chromosomes are string-like structures found in the center of the cell,
the nucleus. Chromosomes contain genes that are made of DNA. Therefore
our inherited information is housed on the chromosomes. A translocation
is a change in chromosome structure in which chromosomes are attached to
each other, or pieces of different chromosomes have been interchanged.
An individual with a translocation is unaffected if there is no extra or
missing chromosome material, and if the break in the chromosome did not
disrupt gene function. If there is no additional or missing chromosomal
material, the translocation is considered "balanced". A translocation is
"unbalanced" if there is extra or missing material. Individuals with balanced
translocations typically have no medical issues though some do have fertility
problems. The concern with having a balanced translocation is that, though
the individual is healthy, the egg or sperm of that individual can have
an unbalanced chromosome make-up that leads to the resultant embryo or
pregnancy being unbalanced. The presence of an unbalanced translocation
can lead to an embryo not implanting, a pregnancy being lost, or a child
being born with mental or physical problems. Patients who have a translocation,
particularly when they have experience infertility, repeat miscarriage,
and/or birth of an afflicted child, may want to consider PGD of their embryos
for the presence of that specific translocation.
PGD OF GENE DISORDERS
PGD can be performed for almost any single gene disorder that is autosomal
recessive, autosomal dominant, or X-linked inheritance, as long as the
mutation or mutations have been previously identified, and that the method
of detection for the gene disorder can be used on a single cell taken from
your embryo.
PGD for single gene disorders relies on a process called the polymerase
chain reaction (PCR). The detection of mutations that cause single gene
disorders requires analysis of DNA from the individual being tested. In
the case of PGD only one cell (and therefore one copy of the genome) is
available for testing. There is insufficient genetic material from one
cell to allow direct analysis and consequently the DNA must be amplified
before it can be tested. For the purpose of DNA amplification, PCR is employed.
PCR is an enzymatic method that permits amplification of specified fragments
of DNA. In most diagnostic cases the fragment amplified encompasses the
mutation site, allowing the subsequent detection of any disease causing
variants of the DNA it contains. Patients who have a specific gene disorder,
particularly when they have experienced, infertility, repeat miscarriage,
and/or birth of an afflicted child, may want to consider PGD for that gene
disorder.
INTRAUTERINE INSEMINATION
I/We understand that intrauterine insemination may be recommended by the
physician to possibly achieve pregnancy after the IVF cycle has been canceled.
We understand that the male's sperm will be separated from the seminal
fluid and concentrated in order to enhance their fertility potential. These
concentrated sperm will then be placed directly into the women's uterus.
The risks associated with this procedure include but are not limited to
uterine bleeding, spotting, gastrointestinal upset, and pelvic infection.
We understand that within the normal population a certain percentage of
children are born with physical or mental defects. We hereby release GRS
and their directors, employees, or consultants from any responsibility
or liability if a child is conceived during an intrauterine insemination
cycle is born with physical or mental defects. We understand that this
may not be applicable depending on our diagnosis.
COMPREHENSION OF CONSENT AGREEMENT
I/We have read and understand this document and additional information
provided. I/We have discussed this document and additional information
with Dr.___________________, who has provided us ample opportunity to ask
any questions regarding IVF therapy and who has answered our questions
to our satisfaction. I/We acknowledge that no guarantee or assurance has
been made to the results that may be obtained. I/We further acknowledge
that this document is by no means a complete record of our conversations
with GRS physician(s), faculty and staff and are satisfied that I/we are
sufficiently advised and informed to make this decision.
CONSENT
I/We, understand and accept the conditions, risks and limitations of participating
in the GRS IVF program. We therefore voluntarily consent to undergo the
procedures associated with this therapy. I/We are 18 years of age or older.
RELEASE
I/We agree to absolve, release, indemnify, protect and hold harmless Georgia
Reproductive Specialists, its officers, directors, agents and employees
from any and all liability for any adverse outcome, however remote, arising
from IVF therapy including but not limited to complications related to
the IVF therapy, complications related to pregnancy and/or childbirth,
and/or the birth of a physically or mentally deficient child. Additionally
I/we release, discharge and hold harmless Georgia Reproductive Specialists,
its officers, directors, agents and employees from any and all liability
in connection with subsequent disputes arising between patient and spouse/partner
or any other third party in connection with the control and/or disposition
of any fertilized eggs or embryos in existence as a result of this therapy,
or the custody and/or support of any child(ren) born as a result of this
therapy.
_________________________________________________________
_________________________________________________________
_________________________________________________________
| Notary Public/Witness' Signature |
Date |
