I.V.F. UNIT ASSUTA Hospital Consent Form for I.V.F. Treatment I.V.F. Treatments are performed in cases of: Basic treatment includes:

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1 I.V.F. UNIT ASSUTA Hospital Consent Form for I.V.F. Treatment I.V.F. Treatments are performed in cases of: Obstruction and/or dysfunction of the fallopian tubes Annovulation Hormonal problems Abnormal semen analysis Immunological infertility Unexplained infertility Endometriosis Basic treatment includes: Oocyte collection from ovaries of the female Fertilization of oocytes with semen of the aforementioned partner Fertilized eggs are placed in the incubator for a period of one to seven days and are then returned to the woman s uterus vaginally and/or via fallopian tubes Chances for Success: The chances of successful treatment can change and are dependent upon the age of both partners, pathological status of the uterus, fallopian tubes, ovaries, uterine cavity, quality of semen, etc. It is not possible to determine the percentage success rate for each particular treatment but rather the range of success. It is impossible to know or promise prior to treatment that pregnancy will occur. Under the supposition that pregnancy will occur, it must be understood that spontaneous abortion remains a possibility in about 20% of the cases. In I.V.F. treatments which result in the birth of a child and/or children, birth defects, genetic abnormalities or any abnormality may occur to the same degree as in any pregnancy which occur via natural fertilization. Hormonal Treatment A correlation exists between the number of embryos that are transferred to the uterus and the chances of success. Therefore, an important goal is to attain as large a number of fertilizations as possible,. The use of hormonal therapy usually increase the chances for multiple oocytes production and therefore the opportunity to collect more eggs. As a result, the possibility increases of attaining more embryos. Some medications are used to simulate the ovaries, some to regulate or balance hormonal levels and others to repress the centers of the hypothalamic axis, which permits greater efficiency of treatment.

2 Implications of Hormonal Treatment Hormonal stimulation can sometimes lead to a condition known as ovarian hyperstimulation. In some, cases it presents itself with symptoms such as abdominal pain, lower abdominal swelling, vomiting, diarrhea, fever, elevated hematocrit, enlargement of the ovaries, and/or fluid accumulation in the abdominal cavity. Symptoms may vary due to severity of reaction. These symptoms can occur from three to four hours post ovum collection to at least ten days following embryo transfer. If a positive result for pregnancy is attained, symptoms can remain for a prolonged period of time. In most cases, however, rest and the intake of large amounts of fluids are sufficient to relieve these symptoms. Moderate or severe ovarian hyperstimulation are rare occurrences, but nevertheless it must be known that, in some cases (0.5%-5%), lung exudates or emboli phenomena can occur. Very rare complications include heart and/or kidney failure. There have been very rare reports of death, and torsion or rupture of the ovary. Recent medical journals have investigated the incidence of an increase of ovarian cancer as a result of hormonal treatments. Researchers continue to investigate this possibility, but report that it is too early at this point in time to determine if a direct linkage exists. In instances where medication is used to suppress ovarian activity, reactions similar to menopause can be present. In addition, cysts can develop whereby removal and/or detainment and/or cessation of treatment may be deemed necessary. Allergic reactions to hormonal therapy are rare but have been reported. It is if utmost importance that the patient reports any unusual reactions to treatment, to her/his physician as early as possible to assist in proper diagnosis and consequently appropriate treatment. Ultrasound and blood test Prior to commencement of treatment each and every patient is required to perform infectious screening tests. These tests include HIV, Hepatitis B and Hepatitis C, blood group and typing, etc. Results must be obtained prior to ovum collection. Vaginal ultrasound and/or blood tests for hormonal levels are used to assess development of follicles produced by the ovaries.

3 Ovum Collection and Fertilizations Ovum collection, in most cases, requires general anesthesia. Local anesthesia is rarely used. This procedure is performed by ultrasonically guided vaginal pick-up. Fertilization is performed in the laboratory under specific conditions, which enhances the fertilization process of the egg and sperm. Implications of Ovum Collection Ovum collection can cause discomfort and/or pain. Therefore, bed rest is essential for a minimum of three to four hours following treatment. Primary risks can result from the introduction of a needle to the area of the ovary. Bleeding and/or infection can occur. Pelvic infection is rare, but antibiotic therapy is usually sufficient in most cases. Light bleeding occurs with almost each and every ovum collection. Infrequently, bleeding can become heavy enough to require the administration of blood, operative procedures to terminate hemorrhage and/or removal of the ovary(ies) and/or uterus. Damage to the digestive tract is rare but nevertheless a possibility. Micromanipulation (ICSI) Intracytoplasmic Sperm Injection This procedure is performed in the laboratory that is utilized to attain the following: ICSI this procedure is performed when the quality of the sperm is poor and, therefore, natural fertilization would be impossible. Additionally, ICSI, is used when little or no fertilization has occurred in past treatments. Intracytoplasmic sperm injection is a process in which single sperm is injected into an egg by the use of sophisticated microsurgical equipment. Assisted Hatching (AHA, ASH) Assisted hatching is a technique, which involves manipulating the outer layer of the embryo. It is used to enhance the implantation of the embryo. Assisted hatching can be executed mechanically, chemically or with the assistance of a laser. A type of window or thinning is created on the outer lining of the embryo prior to the embryo transfer.

4 Implications of Micromanipulation These techniques are still considered experimental. To date, Researchers have not reported an increased risk for the newborn. The risks, if they do exist, will only be determine in the future. Consequently, it must be considered that men with low sperm counts or azospermia may be passing this genetic trait to male offspring. Incubation The fertilized eggs (embryos) are kept in incubators for a duration of one to seven days in order to maintain an optimal environment for their development. Transfer of Embryos The transfer of embryos can be completed by one or more of the following methods: Transfer directly to the uterus. The embryos are placed into a small thin plastic straw like tube and transferred to the uterus via the cervix two or three days after retrieval. In most cases, this procedure is performed without anesthetic of any kind. Transfer to the fallopian tubes (ZIFT). Tubal transfer is performed only if the fallopian tubes have been deemed healthy. If mechanical defects are present tubal transfers cannot be performed. In a natural fertilization cycle the development of embryos occurs within three to four days in the fallopian tubes. Chances for pregnancy increase if the fertilized eggs are transferred to the fallopian tubes, their natural environment. In most cases, this procedure is performed under general anesthesia and usually within twenty four hours after retrieval. Any operative procedure in which instruments are introduced into the body (such as GIFT, ZIFT or ovum retrieval) can raise the risk of infection. When laparoscopies are performed (ie ZIFT), CO 2 (carbon dioxide) is introduced into the abdominal cavity in order to perform this procedure. Shoulder or stomach pain can be anticipated shortly after completion that can last for a number of hours. One of the risks involved in laparoscopies in addition to general anesthesia is damage to the internal abdominal organs, such as: intestine, bladder, vascular system, all of which can require additional operative procedures for correction. In rare instances, death has been reported.

5 GIFT (Gamete Intrafallopian Transfer) Sperm and eggs are transferred to the fallopian tubes via laparoscopy on the day of ovum retrieval. TCTET (Trans Cervical Tubal Embryo Transfer) Embryos are transferred to the fallopian tubes within a thin plastic tube which is inserted through the cervix, and through the uterus. Implications of Anesthesia Administration of anesthesia is a relatively safe procedure, but can involve certain risks. Local anesthesia can cause allergic reactions to substances administered. The risks of epidural anesthesia can involve allergic reactions as well as nerve damage in very rare cases. Risks of general anesthesia can include damage to the teeth due to the introduction of an airway to the larynx, allergenic reactions of the different intensities to substances administered and, in very rare instances, death can occur. Therefore, the patient is urged to report any and all sensitivities to anesthetic substances prior to procedure. General anesthesia can pose a risk of aspiration as well, therefore, complete fasting is required six hours prior to administration. This can reduce the risk of aspiration considerably. Results of the preliminary laboratory tests are imperative prior to the administration of anesthesia. Cryopreservation This process can be completed only if good quality embryos remain following ovum transfer. Embryos, which are considered for cryopreservation, are those that will be used in additional treatment cycles, surrogacy, and those that need to be protected for a period of time until deemed suitable for use. The embryos are frozen at a temperature of minus 196 degrees celsius, in a strawlike cylinder or tube. The Ministry of Health permits embryos to be frozen for a period of five years. After five years, the couple is required to notify the hospital whether or not they are interested in continuing the cryopreservation process for an additional five years. The continuation of this process can occur only if signatures are obtained by both partners and the attending physician.

6 Risks of Freezing Embryos The freezing process is successful in seventy five percent of the cases, the thawing process, fifty percent. Percentages of pregnancies from frozen embryos ranges from eight to sixteen percent. It is not known if there are long term implications resulting from frozen embryos, but many children have been born after freezing thawing without abnormalities. In vitro fertilization, technical failures can occur due to operative procedures, laboratory work and/or intricate technical processes. These procedures include mechanical and electronic equipment. Success of in vitro fertilization is dependent, in part, on the integrality of above mentioned procedures. Implications of Pregnancy and Multiple Births In about 20% of cases multiple embryos develop, (more than two), and fetal reduction is an option. Risks of reduction involve immediate or delayed abortion, infection of the uterus cavity, and/or early delivery. Multiple pregnancy itself can cause early, delayed or spontaneous abortion and premature birth that, in turn, can lead to a variety of complications. I/We female name in full passport oridentity # male name in full passport oridentity # declare that I/we were informed fully by physician (name of attending physician), about the complete course of treatment involving in vitro fertilization and are aware in full detail of the above agreement in its entirety, and consent to complete all procedures deemed necessary by the attending physician. Therefore, we are completely satisfied with the detailed explanations received from the physician about in vitro fertilization that I/we received in its entirety. I/we agree to execute the procedures that are required to promote success of the in vitro fertilization process. Signature: female male Doctor: Date:

7 CONSENT FORM FOR IN VITRO FERTILIZATION AND EMBRYO TRANSFER FROM EGG DONOR We, the undersigned husband ID # wife ID # Address state and agree to the following: Since medical tests on both of us have shown that we have no chance of conceiving with the woman s own ovum, and since the woman is not pregnant and it is our desire for the woman to conceive, we hereby authorize Dr. and his chosen staff to perform IVF utilizing donor eggs (thereafter, the donor) and the husband s sperm. We understand and agree that even though the fertilization and embryo transplant procedures may be performed a number of times at the discretion of the doctor, there is no guarantee that the woman will conceive as a result of the fertilization or that she will deliver a child. Furthermore, it has been explained to us and we understand that even if the woman conceives as a result of the egg donation there is a possibility of complications arising during pregnancy or birth. There is also a chance of delivering a child or children with poor health or emotional problems, abnormalities, hereditary abnormalities or any other deviation from normality as can occur in a spontaneous and ordinary pregnancy. We agree that the donor of the utilized eggs will be chosen by the said doctor at his own discretion and we will not be permitted to know now or later the identity of the donor, her qualities or any other detail related to her or her family. We agree to undergo all the necessary examinations and treatments required by the said doctor in order to enable the performance of IVF.

8 We hereby relinquish, together and each one separately, in name the of our inheritors, and our legal representatives and in the name of anyone representing us, the right to complain or sue for anything related to or resulting from the examinations and treatment that will be performed for IVF in respect to the donated egg, the donor or her personal qualities, hereditary qualities, spiritual and physical qualities, her origins or community of which she is a member, and also the child born (if born) his/her sex, external appearance, character, virtues, or health. The woman agrees and hereby declares that the child which will be born to her (if born) as a result of the IVF with donor egg will bear her name and will be considered her own child for any purpose and matter. In witness we hereby sign husband wife