Consent form for in vitro fertilization/assisted rerproduction
Consent for Assisted Hatching and Fragment Removal The ART Institute of Washington at Walter Reed Army Medical Center We, ________________________ and ___________________, understand that this consent gives the embryology team at The ART Institute of Washington at Walter Reed Army Medical Center permission to assess our embryos microscopically and determine whether assisted hatching with or without fragment removal will be performed on any of them. A – Initial studies and inclusion criteria We understand that the embryologists have performed assisted hatching and fragment removal in scientific studies involving infertile couples and have found this micromanipulation technique to be advantageous for some of the embryos, by promoting attachment to the uterus. It was found that certain patients and embryos benefited from the procedure, but whereas, others did not. We agree that the embryologists will study the embryos and determine the speed of their development. Some embryos may be selected for the procedure, whereas others will be left as is. We agree that the embryologists may remove debris and/or fragments (blebs released from the embryonic cells) from underneath the zona pellucida (clear layer of membrane surrounding the egg), which may otherwise interfere with the development of the embryo. We understand that this is only done when there are many fragments present or when their appearance suggests that they could interfere with normal growth. We understand that there are embryonic characteristics, which are used to determine whether assisted hatching can be safely applied to those embryos, selected for transfer. We also understand that certain aspects of the female partner’s history, such as age, basal FSH levels, previous IVF history and prior medical history may also be used to determine whether the embryos should undergo selective assisted hatching. Further experiences beyond those initial studies have confirmed the results of the published studies, which indicate enhanced pregnancy rates. We understand that the magnitude of the anticipated result varies from patient to patient and will depend on our specific circumstances. B – Description of procedure We understand that the procedure involves the use of the micromanipulator (a delicate instrument hat holds the egg) to pick up the embryo and another micromanipulator to deposit minute amounts of acidic solution onto a small area of the zona pellucida to create an opening. We also understand that by consenting to have selective assisted hatching performed, that our physicians will prescribe antibiotics for the female partner (Doxy 100ug BID) and corticosteroids (usually Medrol 16 mg per day orally day for four days), both beginning on the day of retrieval. These drugs are administered to protect the embryos from bacterial contamination and attack by immune cells. The role of these corticosteroids is not determined at this time and is considered optional. The IVF procedure will otherwise not deviate from the standard protocol. Embryo transfer may occur anywhere between three to seven days after retrieval. If for any reason our embryos need to be replaced prior to day three, the selective assisted hatching procedure can not be performed.
Assisted Hatching Consent Form Page 1 of 1 (version01/03/2000)
C – Potential drawbacks and risks The procedure may also involve the following risks or disadvantages as is only recommended in specific instances which will be discussed with us prior to the procedure being offered:
1. There is potential for harm to occur to our embryos during the hatching process.
Although damage to the embryos is exceedingly rare, single cells within the embryo may be damaged in less than 1% of cases. Information available at this time indicates that this does not appear to affect the overall developmental potential of the embryo.
2. The exact likelihood of success for a given embryo or patient cannot be predicted.
However, the implantation rate per embryo may rise. This rise in implantation rate raises the risk for multiple gestation.
3. Although unlikely, this technique may yield unknown risks to the baby or mother. The
holes in the zona may decrease its protective effect for the embryo. The higher implantation rates found in appropriately selected embryos which undergo selective assisted hatching indicate that the net effect is likely to be beneficial.
4. The micromanipulation itself may produce abnormal embryos or rarely, may cause
immediate degeneration of the embryos. Technical problems may make successful micromanipulation impossible in our case.
5. The corticosteroids given to the female partner are considered low dose. Over five
thousand patients have now been treated with this regimen in cycles where there was some zona manipulation. The only notable side effect has been the occurrence of vaginal yeast infection. Though none of the following effects have been reported to date in these thousands of cases, we nevertheless understand that these drugs may: mask signs of infection and new infections may occur during use; increase blood pressure, salt and water retention, and excretion of potassium and calcium, cause mood swings, insomnia, depression, psychotic manifestations, muscle weakness, impair wound healing, increase sweating, headache, vertigo, allergic reaction, loss of muscle mass, osteoporosis and abdominal distention, cause nausea, vomiting, diarrhea, loss of appetite, rashes, increase sensitivity to the sun, hypersensitivity reactions resulting in shock, blood disease including reduced platelets or fractured red cells which occur with anemia or bleeding.
6. The chances of having identical twins may be increased. Identical twins carry all the
risks of any multiple pregnancies, but may also have special risks. These include an increased risk for pre-term labor, small for-gestation-age babies, and umbilical cord accidents, which may lead to the demise of the developing fetus. So-called conjoint twins or triplets also known as Siamese twins are abnormal identical fetuses that can occur rarely after IVF and assisted hatching. In such cases, fetal reduction may be considered. This associated procedure can produce increased financial and emotional burdens.
7. Fragment removal may cause damage of one or two cells in less than 5% of cases. The
damage is usually done in embryos with very poor growth and excessive fragmentation or where the fragments are closely associated with the cells.
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We understand that our decision to have selective assisted hatching may be beneficial to us as the chance of pregnancy may increase. In our particular case, however, we understand that there is no guarantee that our embryos will receive any benefits from the procedure, or even that the procedure will be performed on any of our embryos. D – General policies The consents of the IVF, cryopreservation, ICSI, and oocyte donation consent forms apply to this consent as well. This consent form is being offered to all couples treated with IVF at The ART Institute of Washington at Walter Reed Army Medical Center. Any information obtained during this study and identified with you will remain confidential. The Food and Drug Administration (FDA) and The Center for Disease Control (CDC) in association with the Society for Assisted Reproduction (SART) may inspect the records. Your decision whether or not to have embryos frozen will not prejudice your future relations with The ART Institute of Washington at Walter Reed Army Medical Center and the treatment you now undergo in this institute. If you decide to participate, you are free to discontinue participation at any time. Your participation is voluntary and your refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled. In any event, it is understood that the Institute and its staff, as well as the partners must abide by any applicable federal, state, or local laws or regulations. We have been encouraged to ask questions and any that we have asked have been answered to our satisfaction. A member of the IVF team will answer future questions. __________________________
Assisted Hatching Consent Form Page 3 of 3 (version01/03/2000)
Ophthalmic Contract Visit Form To be completed by the PCT (References in brackets in bold italics are references to clauses of the model mandatory or additional services as appropriate) Voluntary information is highlighted with grey background shading Section A – All Contracts 1. Practice Details 1.1 Practice Name (66.3) 1.2 Contractor Name (If different)