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 In Vitro Fertilization and Embryo Transfer Consent


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:

  1. Repeated blood sampling causing a risk of redness, small bruises, and, to a lesser extent, infection or thrombosis.

     

  2. 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.

     

  3. 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.

     

  4. 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.

     

  5. There is a higher probability of a multiple gestation pregnancy (twin, triplet, quadruplet) outcome using IVF.

     

  6. 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.

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Patient Date
_________________________________________________________
Partner Date
_________________________________________________________
Notary Public/Witness' Signature Date