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Ovarian Tissue Freezing For Fertility Preservation In Post-Menarchal Girls Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen: A Study By The National Physicians Cooperative of the Oncofertility Consortium At [INSTITUTION]
This consent describes a study being done at [INSTITUTION]. Research studies help us learn more about conditions and possible new treatments.Research studies are voluntary, which means that it is your choice whether or not to allow your child to participate in the study. The study staff will also explain the study to you and answer any questions that you may have before you make a decision.
WHY IS THIS STUDY BEING DONE?
You are invited to have your child take part in this study because she will be treated with chemotherapy and/or radiation that will likely affect her ovaries and cause her to become infertile (unable to become pregnant) or she will have one or both of her ovaries removed to treat or prevent her medical condition.
The ovaries are reproductive glands found only in women. These glands are located in the pelvis (hip area).The ovaries produce eggs and female hormones. During each monthly menstrual cycle, an egg is released from one ovary. This study seeks to find out if removing an ovary in adolescents and children who have not reached puberty, and who are about to undergo chemotherapy and/or radiation may preserve, or keep, their ability to have children in the future. The ovary tissue that is removed will also be used to do research for better ways to store themand use them in the future.
Participation in this study is completely voluntary. You can choose to allow your child to take part. If you agree to allow her to take part in this study, your child will have one of her two ovaries removed by surgery before having her chemotherapy and / or radiation therapy.
This study has two parts. The removal of the ovarian tissue, and the storage of the ovarian tissue. A special process called Ovarian Tissue Cryopreservation will be used to store the removed ovarian tissue. This special kind of freezing is a special method that is used to try to prevent the eggs from being damaged, and to keep them frozen for a long time. The frozen tissue will be available to you and your daughter to be used at a later time, of your choosing.
Also, we would also like to ask your permission to store some of your child’s tissue for use in future research studies that will study better ways to store tissue like this, and better ways to use them in the future.
However, if your child has been previously treated with chemotherapy that is considered likely to cause infertility, she will be required, as part of this study, to donate no more than 20% of her ovarian tissue to this future research before it is stored for her own use.
If your child has not been previously treated, thereare two options for how your child’s ovarian tissue would be used in this study:
- Option A:With this option, the tissue will be split between storage for her own use in the future and storage for future research. The majority, 80%, of the tissue would be frozen for your child’s own use. The lesser amount, 20%, would be used for the future research.
- Option B:With this option, all, 100%, of your child’s ovarian tissue will be frozen for your child’s own use in the future.
If you decide to have your child take part in this study and she has not been treated with chemotherapy, you will need to choose Option A or Option B for storageof your child’s tissue. Later in this permission form, you will indicate which option you choose.
At the present time, freezing of ovarian tissue is considered experimental. Also, the implantation of the thawed tissue to restore fertility is considered experimental. In order to use the tissue at a later time, the implantation will need to be performed as part of another research program. This may change in the future. Your child will determine in the future how and at what institution she wishes to use her own tissue to attempt a pregnancy.
If you agree to all your child to take part, your child will undergo surgery to remove the ovarian tissue. This will require your child to be under general anesthesia (completely asleep) during that surgery. The surgeon who will perform this study will go over the surgery procedures an options and will ask you to sign a separate consent form for the surgery and anesthesia.
A description of this clinical trial will be available on as required by U.S. Law. This website will not include information that can identify your child. At most, the website will include a summary of the results. You can search this website at any time.
WHAT IS INVOLVED IN THE STUDY AND HOW LONG WILL MY CHILD BE IN THE STUDY?
Tests and Procedures before Surgery:
Before your child begins this study, your child will have tests and procedures done by her oncologist or pediatric surgeon to confirm that she is eligible for this study.She will also be checked by her oncologist and the surgeon to determine if surgery is safe for her. They will also check to see if her medical condition would make it difficult to remove an ovary. If this is the case, your child’s oncologist and surgeon will discuss with you all available options.
Your child will also be checked by an anesthesiologist. If the anesthesiologist thinks that it is unsafe for your child to have anesthesia, then she will not be allowed to take part in the study.
Your child’s surgeon will decide what is appropriate for her medical condition. Typically, the surgery used to remove an ovary is done by laparoscopy. If your child is scheduled for another surgery already, the surgery to remove the ovary will be done at the same time if possible.
This pre-surgery assessment will be done while your child is in the hospital or in the pediatric oncology, surgery, or anesthesia clinic as an outpatient.
Surgery to Remove the Tissue:
This surgery will be done solely for research purposes.It is not required for the treatment of her cancer. If your child’s surgeon decides, she will have the ovary tissue removed by a surgery called a laparoscopy. Laparoscopy surgery is done under general anesthesia (your child will be asleep during the surgery) in the operating room.
A telescope-like instrument (a laparoscope) will be put into her belly through a small (about half an inch) cut just below her belly button.Two or three other cuts may be made to allow for other instruments to help remove one of her ovaries. The surgeon will then look at both ovaries before the removal of one. Both of your child’s ovaries must appear normal and be free of any masses in order to complete the surgery.The ovary that will be removed, will be chosen by the surgeon at the time of surgery.This type of surgery is likely to last for 30 to 45 minutes
If your child’s has a laparoscopy, it will be done as an outpatient procedure. It won’t require an overnight hospital stay. The recovery time before your child can do normal activities or start their scheduled chemotherapy and/or radiation therapy is about 2 to 3 days.Her total time spent in the hospital will be about half a day.
After surgery is complete, she will not have any further procedures as part of this study. She will be required to have check-ups with the surgeon to make sure she has fully recovered from the surgery. If her ovary is removed as part of another surgery, the hospital recovery time may be different that the time stated above. The surgeon will discuss the hospital and recovery time with you.
Tissue Analysis at the Lab:
After the surgery, a small piece of the removed ovary may be sent to the Pathology Laboratory and checked under a microscope. This will need to be done depending on your child’s current diagnosis.
The lab will look at the sample to check for cancer cells in the removed ovary. Sometimes the ovary can look healthy, but have a small amount of cancer that can only be seen under a microscope. If there are cancer cells in the ovary tissue, implanting them in your child at a later time to when she is trying to get pregnant, could cause the cancer to come back.
If the pathologists finds an something that is not normal, or cancer cells in the sample, they may request that all of the tissue taken during your child’s surgery be sent to them for a more detailed examination. If this occurs, there may be no tissue remaining for fertility preservation purposes. You and your child will receive a copy of the report from the Pathology lab about what was found when they looked at the sample under the microscope.
Tissue Storage and Use for Future Research:
If you choose to donate a portion of your child’s ovarian tissue to research, some of the ovarian tissue (never more than 20% of the total tissue taken) will be sent to an Oncofertility Consortium lab for research. This research may include studying how best to get usable eggs from the tissue.
The tissue reserved for research may also be studied before freezing. These studies will include looking at the number of eggs that are usable before and after the freezing and thawing process and looking at how effective the tissue freezing and storage process is. Research done on the ovarian tissue will not include fertilization of the eggs the tissue contains. The 20% of the tissue donated for research will not made available to you and your child to use.
We will not be able to give you any information about the tissue that was donated to research. The samples that are used in the research will completely de-identified. They will not have any information that can identify your child, such as her name or social security number. They will be labeled with an assigned code only. Only [PI NAME] and the [INSTITUTION] research team will keep the linking document for this code, and it will not be shared with others. Some health information about your child may be sent along with the samples, but this information will not have any identifiers. The researchers will not know that the samples came from your child.
Tissue Storage for You/Your Child’s Use in the Future:
The rest of the ovarian tissue (80% if you choose study Option A or 100% if you choose study Option B) will be stored for your child’s possible future use at an accredited long term storage facility called ReproTech, Ltd. (RTL), in St. Paul, MN (
You will be asked to sign a separate storage agreement with RTL that addresses the ownership, storage, shipping, and future disposition of your child’s samples.
You will be responsible for the cost of the freezing of the tissuewhich is approximately $695, and the yearly storage fee of approximately $275. You will also be responsible for the costs of the initial shipping charges to RTL and any other charges, such as shipping the samples to another institution, at your request. Your child’s tissue will only be stored at [INSTITUTION] Lab for a short period after the freezing while shipment to RTL is arranged.
You and your child will have control over your child’s tissues and may use them as you and your child consider appropriate at the institution that your child chooses in the future. There is no limit to how long your child’s tissues may be stored at RTL, provided the storage fees are paid annually after the first year.
RTL has a financial assistance program in place for those who qualify and you will be provided with the information about this program if you want it, both before and after agreeing to your child’s participation in this study. You and your child may transfer your child’s tissues to another long-term storage facility at any time and at your own expense.
During the period your child’s tissue is stored, it is possible that technology for thawing stored ovarian tissues will advance. If such advances take place and are found to be safe, your child may request to thaw her tissue for re-implantation or egg recovery for in vitro fertilization to attempt pregnancy. At the time that your child wishes to use the tissue, your child’s stored tissue will be transferred by RTL to the facility of your child’s choice at her request and at her expense.
As part of your child’s participation in this study, you and your child will be updated on new options that become available to improve pregnancy outcomes with the use of frozen ovarian tissue and where those options are available.
It is also possible that technological advances to thaw the stored ovarian tissue may never occur and the tissue may not be usable. Although unlikely, it is also possible that thawing techniques may require approval by outside agencies (like the Food and Drug Administration) before they could be used to attempt a pregnancy.
Infectious Disease Testing:
The storage of tissue and later use is regulated by the Food and Drug Administration (FDA). Currently, the FDA requires that all tissue that is stored and later used be tested for certain infectious diseases. Also, the FDA requires that a blood sample be collected and stored with the tissue.
The tests for infectious diseases will include, but are not limited to, testing for HIV, Hepatitis B and C. The screening and tests that will be done are the same as those done on an anonymous tissue donor. This will also require a physical exam, answering questions about possible high risk behaviors, and blood tests. These tests may allow the tissue to be used by your child, or by another individual (such as a gestational carrier/surrogate), in the future. Your child’s ovarian tissue will be stored with tissue of the same infectious disease status.
Your child’s blood will be tested for HIV. HIV is the term used for the virus that produces HIV infection and may lead to AIDS. The Illinois AIDS Confidentiality Act is an Illinois law that sets up how HIV testing must be done and protects the confidentiality of information about someone’s HIV status. The study doctor will comply with this Illinois Law. If you have questions about this law, and what is required to be reported, please discuss them with your study doctor.
In addition, a sample of your child’s blood will be stored with her tissue to allow any additional future testing that may be required under federal regulations.Current FDA regulations are specific and must be performed on a blood sample taken within 7 days of tissue removal. If the FDA requires additional tests in the future, this stored blood might be used to perform those tests. It is also possible that federal regulations may change and it may not be possible to do the appropriate testing that will allow use of your daughter’s tissue in the future.
The blood samples can be drawn from your child’s central line if she has one in place. If she does not, then the blood will be drawn at a time that she is already scheduled to have blood taken for her regular care. About 2 tablespoons of blood will be drawn for the infectious disease testing.
Information to be Collected about Your Child:
As a part of this study, certain medical information will be collected and used. Medical information collected from your child’s medical chart include: Hormone levels where possible, diagnosis, past cancer treatment, if any, information from physical exams, planned treatment associated with high risk of sterility, how the ovary is collected, the time from surgery to start of chemotherapy or radiation, the cancer care outcome (remission, relapse or death) and reproductive or menstrual history before cancer diagnosis, during and after treatment. Some of this medical information will be stored with the samples for research, but they will not include any identifying information about your child.
Follow-up:
You and your child will be contacted once a year to answer questions, about a 10-minute phone call, to find out about how your child chose to use her own ovarian tissue within the past year and about your current attitudes and feelings on preserving fertility.
WHAT ARE THE POSSIBLE RISKS OR SIDE EFFECTS (BAD THINGS) OF THE STUDY?
Your child might experience some side effects and discomfort while taking part in this study. Those seen in the past include the following risks. Most of these are related to the general risks of surgery.