STEPS AND CONSENT FOR IN-VITRO FERTILIZATION (IVF)

Transcription

1 I. EXPLANATION OF THE IVF CYCLE STEPS AND CONSENT FOR IN-VITRO FERTILIZATION (IVF) The following is a brief outline (not an in-depth explanation) of a routine In-Vitro Fertilization (IVF) cycle. IVF is a procedure used to treat fertility problems and assist in achieving pregnancy. During IVF, eggs are retrieved from the ovaries of a woman and fertilized in a laboratory by the sperm from a man. Either fresh or frozen eggs and/or sperm may be used. If embryos develop, then one or more of these resulting embryos may be transferred into the uterus of a woman where they might implant and possibly result in pregnancy. This procedure can be done using the intended parents eggs (egg provider), the intended parents sperm (sperm provider), known or anonymous donor eggs (egg donor), known or anonymous donor sperm (sperm donor), or known or anonymous donor embryos (embryo donor). In some cases, a gestational carrier (carrier) a woman who has one or more embryos transferred into her uterus without parental rights might be used. Other times, an intended parent may carry the child although her oocytes are not utilized (recipient). The entire cycle takes approximately three (3) weeks from start of stimulation until embryo transfer, and approximately 36 additional weeks for childbirth in case pregnancy is achieved. At any time the cycle may be adjusted and/or cancelled if any physician of the Fertility Center of Las Vegas (FCLV) finds it is medically necessary. The specific IVF procedure followed may change depending on whether fresh or frozen eggs and/or sperm are used and some steps specified below may not apply to all circumstances. The first step is to determine if an egg donor will be used. If an egg donor will be used, the first step is choosing the egg donor. The intended parents will receive profiles of potential anonymous egg donors from an IVF coordinator. Although FCLV assists in this decision, the choice is ultimately that of the intended parent/s and FCLV will not be held responsible for any future dissatisfaction. If possible, the intended parent/s should choose more than one donor because their first choice might not be available. The intended parent/s and any other person participating in this process will remain anonymous to the egg donor at all times just as the egg donor remains anonymous to the intended parents. The egg donor chosen will be contacted by FCLV and scheduled for appropriate examinations. Known donors will need to provide all pertinent medical information and undergo testing as well. The intended parent/s and a known egg donor are responsible for seeking independent legal assistance to complete all legal paperwork necessary for the donor to release ownership interests/parental rights in the egg/s provided. All legal paperwork must be completed before retrieval of the egg/s. If necessary, the egg donor/provider will then be placed on oral contraceptives to synchronize her schedule with the carrier. On the first day of the egg provider/donor s menses (period), she must call FCLV and schedule a blood test. On or before the third day of the egg provider/donor s cycle, she must attend an IVF consult with the IVF Coordinator. The IVF schedule will be reviewed with her at that time. From this point on, the egg provider/donor must use a barrier method of contraception. If an intended parent will be the sperm provider, then the sperm provider will need to schedule a semen analysis (if this has not already been done). Page 1 of 14 Initials: / / / Consent/Steps for IVF

2 For a fresh cycle, any carrier/recipient must be scheduled to synchronize her cycle with the egg donor/provider s cycle. The carrier/recipient must contact the IVF coordinator on the first day of her menses to begin the birth control pill to synchronize her cycle with the egg provider/donor s cycle. The carrier/recipient and the egg provider/donor s cycles are then synchronized using oral contraceptives, human chorionic gonadotropin (hcg) or GnRH agonist (such as leuprolide acetate), estradiol, and progesterone. Oral contraceptives help start the ovarian suppression process and are continued as needed. hcg and/or GnRH agonist are used to induce final maturation of the eggs before they are collected from the ovaries, and estradiol and progesterone are used to prepare the uterine environment of the carrier/recipient At the time of signing all IVF documents/consents, all participants requiring medication will need to let the IVF Coordinator know the pharmacy they will be using. All of the prescriptions will be either called in at this time, faxed, and/or will be given in written form. NO MEDICATIONS ARE TO BE TAKEN UNTIL INSTRUCTED TO DO SO BY FCLV. The carrier/recipient will be scheduled for a blood test, trial transfer, sonohysterogram, and will receive instructions as to self-injection of any required medications (if applicable). Following every blood test, the carrier/recipient will receive a call from FCLV with instructions. If FCLV does not contact the carrier/recipient by 4:30 PM on the following day, please call FCLV. The egg provider/donor will typically require controlled ovarian stimulation. During controlled ovarian stimulation, a drug called FSH is injected to stimulate the ovaries to develop multiple follicles. FSH is the hormone that causes follicles to develop in natural cycles. This FSH may be supplemented by another drug called clomiphene citrate. Clomiphene citrate causes the pituitary gland to release more FSH. In order to prevent premature ovulation, another drug may be used. This will usually be a GnRH antagonist (such as ganirelix acetate or cetrotide). The egg provider/donor will be scheduled for multiple ultrasound examinations and blood tests to monitor her progress. Adjustments may be given in medication dosage. During follicular development, ultrasound monitoring is used to determine the quantity and size of the follicles. The size indicates the probability of obtaining mature, high quality oocytes. These injections are given daily in the hip, thigh, or abdomen for as long as necessary, typically lasting 9-12 days. The egg provider/donor will be seen at FCLV as needed for blood tests and/or ultrasounds. These appointments are typically scheduled in the morning. The carrier/recipient will be given estradiol supplements in the form of pills, patches, or injections during the same time the egg provider/donor is undergoing ovarian stimulation. She will then have ultrasounds and/or blood tests to check the development of her endometrial lining. Once the follicles are mature, the egg provider/donor will receive an injection of hcg or GnRH agonist, or possibly both. This injection stimulates final maturation of the eggs and will prepare the follicles for retrieval. It is very important that this injection is taken exactly at the time instructed by FCLV. The egg provider/donor will have a blood test and examination the next day. The retrieval will be performed approximately hours following the hcg/gnrh agonist injection. This procedure is performed under transvaginal ultrasound guidance. If insufficient oocytes are obtained at this time, the cycle may be cancelled. The retrieval of eggs is conducted at FCLV. The egg Page 2 of 14 Initials: / / / Consent/Steps for IVF

3 provider/donor will be under sedation and the procedure takes approximately minutes. Recovery time will be approximately one (1) hour at FCLV. The egg provider/donor will begin antibiotics that evening. During the egg provider/donor s procedure, the known sperm provider/donor (if applicable) will be required to give a semen sample at a specified time on the day of oocyte retrieval. The sperm provider/donor should ejaculate no less than 48 hours prior to the day of oocyte retrieval. In the event frozen sperm is used from a different agency, the sperm will be shipped to the Shapiro Reproductive Institute LTD, doing business as The Fertility Center of Las Vegas, where it will be stored. Just prior to use in the fertilization process, the specimen will be thawed at FCLV. The sperm specimen collected, either fresh or thawed, and examined under a microscope to determine the number of motile sperm. The carrier/recipient will be contacted by phone forty-eight (48) hours in advance of the oocyte retrieval. The carrier/recipient will then begin progesterone injections once daily starting the evening of oocyte retrieval. The eggs will be inseminated on the day of the oocyte retrieval. Insemination is typically by intracytoplasmic sperm injection (ICSI). An FCLV physician will call the intended parent/s the following morning with fertilization results. If the fertilization is unsuccessful, the cycle will be cancelled. Following fertilization, normal embryos may develop and begin to divide. The embryos are grown in specialized growth media for 3-7 days. If apparently viable embryos form, then one or more of these embryos may be then transferred to the uterus at the appropriate time. If no embryos develop or if none appear viable, the cycle will be cancelled. The embryo transfer is 3-7 days (typically 5-6 days) following the egg retrieval. This procedure does not require anesthesia. This procedure normally takes minutes followed by rest in the recovery room for approximately one (1) hour. Before leaving FCLV, the carrier/recipient will be given bed rest instructions and a schedule of follow-up blood testing appointments. Pregnancy tests will be conducted on various days up to 10 days after embryo transfer. If the pregnancy test is positive, FCLV will typically monitor the pregnancy until approximately 10 weeks of gestational age. FCLV will then refer the parent or recipient/carrier to an obstetric specialist physician from whom the intended parents and/or carrier/recipient will choose to complete the pregnancy term. FCLV will not be responsible for the costs of obstetric care, including pregnancy monitoring, childbirth, or any complications. It is the responsibility of the intended parents and/or the carrier to determine whether their obstetric care is covered under their insurance. If the test is negative, the carrier/recipient will receive instructions. The intended parents will then be scheduled for a consultation with an FCLV physician to discuss ongoing treatment. II. EXPLANATION OF IVF PROCEDURES Trial Embryo Transfer for carriers/recipients Page 3 of 14 Initials: / / / Consent/Steps for IVF

4 In addition to evaluating the uterus for abnormalities, FCLV may also evaluate the shape and length of the cervix and uterus by performing a trial embryo transfer under ultrasound guidance. This procedure is performed with the same equipment and technique used for the actual embryo transfer. During the trial transfer we will take measurements and make notes that we can refer to during the actual embryo transfer. If problems are encountered during the trial transfer we can make the necessary changes to ensure the best embryo transfer possible. Sonohysterogram for carriers/recipients It is important to have an evaluation of the uterine cavity before proceeding with an IVF cycle. A sonohysterogram is an office-based test for uterine abnormalities that might interfere with pregnancy. This test involves no radiation. Compared to a regular ultrasound, a sonohysterogram is better at detecting abnormalities on the inside walls of the uterus because it involves infusing sterile fluid inside the uterus. This way, the walls of uterus separate from each other and any abnormalities may be more readily resolved. Typically, a catheter is placed in the cervical canal or uterine cavity and held in place by inflating a balloon at the tip. Transvaginal or abdominal ultrasound is then used to visualize the uterus while fluid is injected through the catheter into the uterine cavity. This fluid may be water, saline (salt-water), or special fluid designed to be seen during ultrasound. The risks associated with this procedure are infection, bleeding, trauma and allergic reactions. A risk of infection is present as bacteria normally present in the vagina may be inadvertently transferred into the abdominal cavity by the catheter. These bacteria may cause an infection of the uterus, fallopian tubes, ovaries, or other intra-abdominal organs. Treatment of infections could require the use of oral or intravenous antibiotics. Severe infections occasionally require surgery to remove infected tissue. Bleeding may occur as small amounts of blood loss are common during this procedure and may result from trauma related to catheter placement or irritation of the uterine lining. Occasionally, dilation of the cervical canal to assist with catheter placement may cause some bleeding. The most serious risk is trauma to the cervix. Manipulation of the cervix to assist with catheter placement can result in damage to the cervix, uterus, fallopian tubes or adjacent structures. Trauma may require additional treatments such as surgery to repair damage. There is also a risk of allergic reaction. Before placing the catheter into the uterus, the cervix is cleaned with iodine. Iodine may cause an allergic reaction in susceptible individuals. Possible Side effects are uterine cramps, uterine/ vaginal bleeding, dizziness, lightheadedness, nausea or vomiting. Embryo Transfer The embryo transfer requires no sedation. The embryo transfer catheter is loaded with one or more embryos and the physician passes it through the cervical opening into the uterine cavity. Abdominal ultrasound is used simultaneously to ensure the catheter tip advances to the proper location. The embryo(s) is/are then "transferred" (released from the catheter) to into the uterine cavity. The catheter is then slowly withdrawn and checked under a microscope for any retained embryos. If an embryo is retained in the catheter, the transfer procedure may be repeated. III. ALTERNATIVE TREATMENTS Page 4 of 14 Initials: / / / Consent/Steps for IVF

5 The alternative to IVF as an intended parent is to continue to attempt to expand a family through alternative infertility treatments, adoption, or not having a child altogether. There is no obligation to undergo IVF even if a physician recommends it. The risks, benefits, and alternatives of IVF should be discussed thoroughly with a physician. A prospective gestational carrier may elect to not participate as a gestational carrier. ***IT IS IMPORTANT TO READ ALL INFORMATION IN THIS DOCUMENT CAREFULLY AND HAVE ALL QUESTIONS ANSWERED BEFORE SIGNING THE CONSENT BELOW. /// /// /// IV. DECISION AND CONSENT REGARDING OOCYTES (EGGS) I/We, the intended parent/s and have chosen to: obtain one or more eggs from an anonymous egg donor chosen from the donor bank maintained by FCLV for use under IVF treatment. obtain one or more eggs from an anonymous egg donor chosen from a third party donor bank for use under IVF treatment. obtain one or more eggs from a directed/known egg donor, (name of donor), for use under IVF treatment. obtain one or more eggs from one or both of the intended parents, and (name or names of the egg provider/s), for use under IVF treatment. I/We authorize the physicians and their designees at FCLV to perform the procedures associated with oocyte retrieval, fertilization, culture, assessment, and embryo transfer as deemed appropriate by the physicians and their designees. I/We understand that pregnancy, childbirth, and delivery endure the same type of complications that arise as with a child conceived by sexual intercourse. I/We, the intended parents, understand it is also possible the resulting child or children could be born abnormal, possess undesirable traits or hereditary tendencies, or have any of the other problems or disabilities of children conceived by sexual intercourse. Page 5 of 14 Initials: / / / Consent/Steps for IVF

6 I/We understand that in some cases, the birth of a child might also produce psychological problems for the intended parent/s and for the child. I/We understand FCLV makes no guarantees as to the results of this procedure and the failure of oocyte retrieval; failure of embryos to develop; failure to attain pregnancy; complications of or resulting from pregnancy; ectopic pregnancy; miscarriage; complications of or resulting from childbirth; multiple pregnancy and multiple childbirth; pre-term delivery; infection; disease; and/or the birth of one or more abnormal children. If applicable, I/we shall/have select/ed a donor with physical and mental characteristics compatible with mine/ours and release FCLV from any liability arising out of our choice of the oocyte donor. I/We understand that any oocyte donor is evaluated by responses to questionnaires and/or laboratory indices to eliminate, within the limits of the information available, congenital or infectious diseases. However, I/we understand that despite testing, it is possible for the carrier/recipient or child to acquire an infectious disease, including but not limited to AIDS, hepatitis, or other infectious disease, and for such disease to be further communicated. If applicable, I/we assume responsibility for the costs incurred by FCLV of screening potential donors for congenital and infectious diseases, for payment of compensation to the donor, and all costs of ovarian stimulation, oocyte aspiration, in-vitro fertilization, and embryo transfer. I/We also assume responsibility for any expenses in monitoring ovulation for precise timing of embryo replacement. I/We understand that, if through no fault of the donor (e.g. unexpected illness, poor response to ovarian stimulation), the oocyte donation fails, I/we will still be responsible for all expenses incurred and services provided by FCLV. I/We further agree and consent that, at FCLV s option, they may elect to inseminate no more than twenty (20) fresh mature oocytes. In this case, any mature oocytes beyond the total number that are inseminated may be cryopreserved for potential later use, or donated as indicated in my/our Consent for Embryo Cryopreservation and Subsequent Disposition. I/We have read and fully understand the above information. I/We have been given the opportunity to have my/our questions answered by both the physician and the staff regarding the above procedure. I /We understand the risks associated with providing oocytes for use in an IVF procedure and would like to use donor oocytes despite these risks. I/We realize that not having this treatment is an option. I/We understand following all physician and staff instructions is imperative to the success of this procedure. I/We have reviewed all of these matters with our physician, and our questions have been answered. SPECIFIC CONSENT FOR USE OF ANONYMOUS OOCYTE DONOR I/We understand the identity of the anonymous donor will be kept strictly confidential to the best of FCLV s ability. However, I/We understand there is no 100% guarantee this information will not be discovered in the future through accidental disclosure and/or statutory requirements or court order. I/We understand my/our identity will also be kept strictly confidential from the donor in the same manner. Page 6 of 14 Initials: / / / Consent/Steps for IVF

7 I/We understand the anonymous oocyte donor has waived and disclaimed any interests in any offspring born from the use of the donated oocyte and has consented not to attempt to discover the identity of persons who receive or result from the oocytes. I/We agree never to attempt to discover the identity of the donor. I/We further agree to waive all rights I/we might have under any applicable law to see or copy, either in person or through a representative, records concerning the donor that may be kept by the physician or facility supplying frozen oocytes, and understand that at some point all records and information concerning the donor may be destroyed to protect her identity. /// /// /// SPECIFIC CONSENT FOR USE OF KNOWN/INTENDED OOCYTE DONOR I/We have contracted with the known/intended oocyte donor to waive and disclaim any rights to the oocyte and to any offspring born of the use of her oocyte. I/We understand I/we are responsible for all costs associated with the screening of the oocytes for relevant communicable diseases. V. DECISION AND CONSENT REGARDING SPERM I/We, the intended parent/s and have chosen to: use anonymous sperm provided to FCLV from a sperm bank for use under IVF treatment. obtain sperm from a directed/known sperm donor, (name of donor), for use under IVF treatment. obtain sperm from one or both of the intended parents as a sperm provider, and (name or names of the provider/s), for use under IVF treatment. I/We authorize the physicians and their designees at FCLV to perform the procedures associated with sperm retrieval, use in fertilization, culture, assessment, and embryo transfer as deemed appropriate by the physicians and their designees. Page 7 of 14 Initials: / / / Consent/Steps for IVF

8 I/We understand that FCLV does not certify the absence of bacterial contamination. I/We understand that the specimen might not contain useable sperm. I/We understand FCLV does not guarantee the number or quality of the sperm collected. If applicable, I/we understand there are differences in the counting methodology utilized by a sperm bank and FCLV that could result in difficulty verifying a breach of the sperm bank s minimum guarantee policy. I/We understand the sperm bank may not grant the intended parents a free replacement specimen for use in a future cycle. I/We understand that due to the nature of timed insemination, a replacement specimen would be of little value for the specified cycle in question even if provided by the sperm bank. In the event of bacterial contamination or immotile sperm, I/we choose: TO HAVE a second specimen on standby in case the first specimen is deemed inadequate, and to pay the associated costs. OR NOT TO HAVE a second specimen on standby in case the first specimen is deemed inadequate. I/We understand that pregnancy, childbirth, and delivery endures the same type of complications that arise as with a child conceived by sexual intercourse. I/We, the intended parents, understand it is also possible the resulting child or children could be born abnormal, possess undesirable traits or hereditary tendencies, or have any of the other problems or disabilities of children conceived by sexual intercourse. I/We understand that in some cases, the birth of a child by this method might also produce psychological problems for the intended parent/s and for the child. I/We, the intended parents, shall/have choose/n a donor with physical and mental characteristics compatible with mine/ours and release FCLV from any liability arising out of our choice of the sperm donor. I/We understand this procedure may require multiple inseminations over a time period of many months and ultimately may not result in conception. I/We understand that any sperm donor is evaluated by responses to questionnaires and/or laboratory indices to eliminate, within the limits of the information available, congenital or infectious diseases. However, I/we understand that despite testing, it is possible for the carrier/recipient or child to acquire an infectious disease, including but not limited to AIDS, hepatitis, or other infectious disease, and for such disease to be further communicated to the carrier. I/We have read and fully understand the above information. I/We have been given the opportunity to have my/our questions answered by both the physician and the staff regarding the above procedure. I /We understand the risks associated with this procedure. I/We realize that not having this treatment is an option. Page 8 of 14 Initials: / / / Consent/Steps for IVF

9 I/We understand following all physician and staff instructions is imperative to the success of this procedure. I/We have reviewed all of these matters with our physician, and our questions have been answered. SPECIFIC CONSENT FOR USE OF ANONYMOUS SPERM DONOR I/We, the intended parents, understand the identity of the anonymous donor will be kept strictly confidential to the best of FCLV s ability. However, I/We understand there is no 100% guarantee this information will not be discovered in the future through accidental disclosure and/or statutory requirements or court order. I/We understand my/our identity will also be kept strictly confidential from the donor in the same manner. I/We understand the anonymous sperm donor has waived and disclaimed any interests in any offspring born from the use of the donated sperm and has consented not to attempt to discover the identity of persons who receive or result from the sperm. I/We, the intended parents, agree never to attempt to discover the identity of the donor. I/We further agree to waive all rights I/we might have under any applicable law to see or copy, either in person or through a representative, records concerning the donor that may be kept by the physician or facility supplying frozen semen, and understand that at some point all records and information concerning the donor may be destroyed to protect his identity. SPECIFIC CONSENT FOR USE OF KNOWN/INTENDED SPERM DONOR OR SEXUALLY INTIMATE PARTNER SPERM I/We, the intended parents, have contracted with the known/intended sperm donor to waive and disclaim any rights to the sperm and to any offspring born of the use of his sperm. I/We understand that pursuant to 21 CFR (l) and (q) a donor of reproductive cells or tissue (including semen, oocytes, and embryos to which the donor contributed the sperm or eggs) are generally required to be kept in quarantine for six (6) months so as to accurately identify the existence or nonexistence of relevant communicable diseases. I/We understand there is an exception for sexually intimate partner donors under which screening for relevant communicable diseases need not be performed at all. I/We understand there is also an exception for a directed donor who knows and is known by the recipient before donation under which retesting six (6) months after the date of donation of semen for relevant communicable diseases may be waived. However, I/We understand an initial screening must be conducted by FCLV at the time of initial collection. I/We understand the retesting of the semen at six (6) months after the date of donation may lead to the discovery of relevant communicable diseases that were otherwise not discovered during the first screening. I/We, the intended parents and gestational carrier (if applicable), hereby specifically identify our desires as follows: Page 9 of 14 Initials: / / / Consent/Steps for IVF

10 I/We request FCLV perform the six (6) month retesting of the semen for relevant communicable diseases even if we qualify for an exception under federal law. OR I/We willfully and voluntarily waive the six (6) month screening of the sperm for communicable diseases because I/we have chosen to utilize the semen of a sexually intimate partner. OR I/We willfully and voluntarily waive the six (6) month screening of the sperm for communicable diseases because I/we have chosen to utilize the semen of a directed donor who I/we knew and who knew me/us at the time of donation. VI. DECISION AND CONSENT REGARDING A GESTATIONAL CARRIER I/We agree any embryo produced will be carried by a gestational carrier known to me/us, (name of gestational carrier). I/We agree any embryo produced will be carried by an intended parent, (name of intended parent). Specific Consent Required to be a Gestational Carrier I, agree and consent to be a gestational carrier at FCLV. This will include the transfer of embryos into my uterus. My intent is to give birth to a child or children for the intended parents, and. I understand there are risks associated with IVF, including but not limited to the risks associated with pregnancy and childbirth, and complications from pregnancy and childbirth. All complications and risks have been explained to me by the FCLV physician. I understand the egg provider/donor and the sperm provider/donor have been initially screened for infectious diseases by FCLV but there is still some risk of transmission of infectious disease from them to me. All of the risks associated with the transmission of infectious diseases have been explained to me by the physician. I willfully and voluntarily assume any and all risks associated with the IVF procedure, and agree to hold harmless and indemnify FCLV, any employees or assigns, including the physician should any complications arise. I agree FCLV and any other employees or assigns of FCLV have not provided any input regarding the contract between me and the intended parents. I agree that should any liability arise regarding the contract between us, I agree to hold harmless and indemnify FCLV, as well as any employees or assigns of FCLV for any liability associated with the gestational contract. I agree to undergo screening for infectious diseases, to have a physical examination including blood samples and a uterine examination, as well as a mental examination at FCLV or by a person/facility referred to me by FCLV. I understand following all physician and staff instructions is imperative to the success of this procedure. Page 10 of 14 Initials: / / / Consent/Steps for IVF

11 I agree to give FCLV complete and accurate information about my health and access to my complete health records. I will sign any and all appropriate forms to allow FCLV and the physician to obtain my medical information. I further agree to execute the necessary documents to effectuate open communication between FCLV, the physician, and the intended parents as to my progress in this procedure. I agree not to have sexual intercourse for at least one month prior to the planned embryo transfer date, and to promptly report to FCLV any changes in my health status prior to and after the embryo transfer date. I agree to make the appointments scheduled with FCLV or other designated doctor/physician referred to me by FCLV, and to take all medications and nutritional supplements as directed by the physicians and their designees at FCLV. If the embryo transfer results in me becoming pregnant, I agree to undergo pregnancy monitoring at FCLV. I further agree to see and be treated by an obstetric specialist at FCLV or referred to me by FCLV, and agreed upon by the intended parent/s. I agree to follow the specialist s instructions, attend all appointments, and take all medications or supplements as specified. I agree that, should a complication arise during pregnancy, I will take reasonable measures to save the pregnancy and achieve the birth of a healthy child, provided these measures do not place my own health in significant additional risk. I further authorize the physician and his/her designees to perform such procedures as are necessary, in the exercise of his/her professional judgment, to remedy unforeseen acute conditions that may be revealed during the course of the original treatment. I understand FCLV will not proceed with a transfer of the embryo unless and until legal clearance is received by FCLV from the legal counsel for each party. Consent for Gestational Carrier and Intended Parents We agree FCLV and any other employees or assigns of FCLV have not provided any input regarding the contract between us. We agree that should any liability arise regarding the contract between us, we agree to hold harmless and indemnify FCLV, as well as any employees or assigns of FCLV, for any liability associated with the gestational contract. We understand FCLV will not proceed with a transfer of the embryo to the gestational carrier unless and until legal clearance is received by FCLV from the legal counsel for each party. VII. GENERAL CONSENT FOR ALL PARTIES INVOLVED IN IVF PROCESS: I understand this document s purpose is to communicate information about the IVF Cycle along with disclosure of risks and alternative forms of treatments, including no treatment. I understand the informed consent documents cannot be considered all inclusive in defining other methods of care and risks and that the physician may provide us with additional or different information which is based on all the facts of our particular case and the current state of medical knowledge. I understand these informed consent documents are not intended to define or serve as the standard of medical care as such standards are Page 11 of 14 Initials: / / / Consent/Steps for IVF

12 determined on the basis of all the facts involved in an individual case and are subject to change as scientific knowledge and technology advance and as practice patterns evolve. I acknowledge I have the right to expect this procedure to be performed with not less than the customary standard of care and agree that the physician and/or FCLV shall be responsible only for acts of negligence on its part and the part of its employees, assigns, contractors, consultants and authorized agents. Otherwise, I shall refrain from bringing legal action of any kind and shall refrain from aiding or abetting anyone else from bringing legal action for or on account of any matter or thing that may arise out of the IVF procedure. I shall indemnify, hold harmless and release the physician and FCLV for attorney s fees, court costs, damages, judgments, or any other losses or expenses incurred by him, her or it with respect to any claim or legal action brought by any person resulting from the IVF procedure performed. I have read and fully understand the above information. I have been given the opportunity to have our questions answered by both the physician and the staff regarding the IVF procedure. I understand the risks associated with the IVF procedure and would like to proceed with this procedure despite these risks. I realize that not having this treatment is an option. I have reviewed all of these matters with the physician and my questions have been answered. I voluntarily and willfully entered into this agreement with the intent to participate in IVF at FCLV. LEGAL CLEARANCE: I/WE understand that FCLV is a medical clinic and they cannot/have not given any legal advice to any person signing herein. IVF is a legally complicated matter when it comes to parentage. All parties that participate in IVF are advised by FCLV to seek independent legal advice before proceeding with IVF to have all questions answered regarding the status of any/all parental rights and/or obligations. I/We, the intended parent/s, represent that my/our attorney has reviewed this form. I, the gestational carrier, represent that my attorney has reviewed this form. I, a known donor, represent that my attorney has reviewed this form. OR I/We, the intended parents, have had been advised and encouraged to have my/our attorney review this form and I/we voluntarily waive this right and consent to this procedure. I, the gestational carrier, have had been advised and encouraged to have my attorney review this form and I voluntarily waive this right and consent to this procedure. I, a known donor, have been advised and encouraged to have my attorney review this form and I voluntarily waive this right and consent to this procedure. Page 12 of 14 Initials: / / / Consent/Steps for IVF

13 IT HAS BEEN EXPLAINED TO ME IN A WAY THAT I UNDERSTAND: THE ABOVE TREATMENT OR PROCEDURE TO BE UNDERTAKEN THERE MAY BE ALTERNATIVE PROCEDURES OR METHODS OF TREATMENT THERE ARE KNOWN AND UNKNOWN RISKS TO THE PROCEDURE OR TREATMENT PROPOSED I/WE AM/ARE SATISFIED WITH THE EXPLANATION AND INFORMATION PROVIDED. I/WE WILLFULLY AND VOLUNTARILY CONSENT TO IVF. I/WE FURTHER CERTIFY THAT ALL BLANKS OR STATEMENTS REQUIRING COMPLETION IN THIS CONSENT WERE COMPLETED BEFORE I/WE SIGNED BELOW. STATE OF ) Intended Parent #1 Date )ss. COUNTY OF ) Intended Parent #1 Name (PRINT) SUBSCRIBED and SWORN to before me this day of, 2012 by. NOTARY PUBLIC STATE OF ) Intended Parent #2 Date )ss. COUNTY OF ) Intended Parent #2 Name (PRINT) SUBSCRIBED and SWORN to before me this day of, 2012 by. NOTARY PUBLIC STATE OF ) Known Oocyte Provider Date )ss. COUNTY OF ) Oocyte Provider Name (PRINT) SUBSCRIBED and SWORN to before me this day of, 2012 by. NOTARY PUBLIC Page 13 of 14 Initials: / / / Consent/Steps for IVF

14 STATE OF ) Known Sperm Provider Date )ss. COUNTY OF ) Sperm Provider Name (PRINT) SUBSCRIBED and SWORN to before me this day of, 2012 by. NOTARY PUBLIC STATE OF ) Gestational Carrier/Recipient Date )ss. COUNTY OF ) Gestational Carrier/Recipient Name (PRINT) SUBSCRIBED and SWORN to before me this day of, 2012 by. NOTARY PUBLIC End of Document Page 14 of 14 Initials: / / / Consent/Steps for IVF