Understanding Embryo Donation and What is involved in the known embryo donation process?

Before Miracles Waiting was formed in 2004, donors and recipients had to rely on donation through their IVF clinic or an agency, or find a match themselves by searching the Internet or through word of mouth. After, the Miracles Waiting website was created, families/individuals could then place an ad/profile in the donor or recipient listings, then search through the listings to find a match. When they locate someone that they think might be a fit, they simply e-mail them and wait for their response. Once contact has been made, the donors and recipients together will determine if a match has been made. Miracles Waiting is not responsible for matching donors and recipients; rather we provide a repository of profiles, creating a mechanism for contact between donors and recipients.

A number of important elements need to be considered early on in the known embryo donation process if the recipient does not plan to travel to the donors’ clinic for the transfer. The recipients must do some homework on their end to determine:

• if their clinic will accept embryos from another clinic for transfer
• whether their clinic will perform a frozen embryo transfer (FET) using embryos from a known donor
• what testing or screening procedures will be required of themselves and the donors
• any other criteria to accept the embryos and perform the transfer
• what paperwork is required by the receiving clinic, and the timeframe required to process paperwork

Ideally, the recipients will have researched these questions and feel confident that their clinic is willing to work with known donor embryos prior to reaching an agreement with a donor couple.

Once an agreement has been reached between the donors and recipients, it will need to be formalized in a legal contract. These contracts can be as simple or as complicated as you see fit. The main criteria are that they meet the requirements of the donors, recipients, sending and receiving clinics and any applicable state or federal laws. Click here for more information on embryo donation agreements. Click here for examples of contracts others have used.

Important Note: Laws vary so it is important for a lawyer, knowledgeable in donor law, to review the contract to make sure that it is legal and binding. If the embryos will be transferred across state or country lines, the attorney should have knowledge of the laws in both localities.

Once the contract has been agreed upon, it is executed. A common way to handle this when the parties live in distant locations is for the donors to sign and notarize two original copies and mail them to the recipients, who countersign and notarize both originals. One original is then returned to the donors. Typically, the sending and receiving clinics will each require a copy of the fully executed contract, but most clinics will accept photocopies of the original document.

The donors will instruct their clinic to ship the embryos to the recipients’ clinic. The recipients can proceed with the embryo transfer procedure once the shipment has been completed. The American Society for Reproductive Medicine recommends that you wait at least three months between signing the consent form to donate and the actual donation, and some clinics may require such a waiting period.

What is involved in the Frozen Embryo Transfer process?

The Frozen Embryo Transfer (FET) process using donor embryos is the same as the FET process using your own embryos. This is referred to as Donor Frozen Embryo Transfer (DFET). The procedure can be performed during a medicated or unmedicated cycle. Some clinics prefer to do a mock cycle first to ensure that you will respond appropriately to any medications used, and that they can insert the catheter through the cervix without incident. A mock cycle is a chance to see how your body responds; no embryos are used during the simulated transfer. Once the cycle is underway, and the lining of the uterus is at an acceptable level, the embryos will be thawed and transferred. A beta test will be done 10 – 14 days after the transfer.

What type of testing, screening and other criteria is generally required for donors and recipients?

Before donated cryopreserved embryos created after May 25, 2005 can be transferred to the recipient, federal law now requires that, if possible, an eligibility determination be made regarding the providers of the egg and sperm used to make the embryos. If the embryos have not been frozen (as occasionally occurs when patients undergoing IVF donate remaining embryos to another couple during their fresh cycle, rather than cryopreserving them), a donor eligibility determination is mandatory. [Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Donor Screening and Testing, and Related Labeling; Interim Final Rule]. The donor eligibility determination process focuses on screening and testing for “relevant communicable disease agents and diseases” (i.e., those which can be transmitted through use of a particular type of HCT/P).

Tests currently required for both male and female embryo donors are HIV-1, HIV-2, hepatitis B, hepatitis C, Treponema pallidum (the agent for syphilis), Chlamydia trachomatis and Neisseria gonorrhea. Female donors whose eggs were removed by non-vaginal laproscopy (rather than transvaginally) are exempt from the last two requirements. The screening process involves a review of medical history and test results, a physical examination, and a patient interview in which an evaluation of risk factors (including high-risk social behaviors) is made. In addition, donors are also screened for risk or evidence of human transmissible spongiform encephalopathy (e.g., Creutzfeldt-Jakob Disease). The list of diseases and agents that must be screened or tested for is subject to expansion in the future.

Egg and sperm donors donating after May 25, 2005 must also undergo a donor eligibility determination, which automatically applies to any embryos created. (If remaining embryos are later donated, no additional testing would be required of the egg or sperm donor, although the original donor eligibility requirements for sperm donors are more extensive than for egg and embryo donors). If frozen donor sperm collected prior to May 25, 2005 was used to create embryos after May 25, 2005, there is no requirement for a donor eligibility determination to be performed on the sperm donor. The majority of sperm banks have been testing and screening donors for most relevant communicable diseases for many years.

A potential donor is deemed ineligible to donate if either the testing or screening indicates the presence of a communicable disease or risk factor.  In a known donation, it is possible for recipients to receive embryos from donors who have completed the testing and screening process and been deemed ineligible to donate. In such cases, the recipients should be prepared to sign a legal waiver acknowledging informed consent, and accepting all responsibility. Check with your clinic for details as to any exceptions they will allow. Similarly, if a donor eligibility determination cannot be made (for example, if a donors refuses to be tested or is dead), both known and anonymous donations can still proceed with the informed consent of the recipients after they have been informed that an eligibility determination regarding the donors was not made.

Federal law does not require that any attempt be made to conduct a donor eligibility determination on donors of embryos created prior to May 25, 2005.  However, clinics may have uniform policies for all embryo donors, so potential donors should be prepared to undergo the related testing and screening. Donor screening for heritable diseases may also be required.

The requirements for recipients vary from clinic to clinic. Testing for sexually communicable diseases is common practice, along with a medical records review. Recipient women generally undergo an assessment of any potential obstacles to achieving a pregnancy via frozen embryo transfer. This most often involves hormone testing and imaging techniques to evaluate the uterus (such as a hysterinsalpingogram or hysteroscopy). Some clinics utilize Doppler ultrasound to measure blood flow to the womb. A pap smear may also be required. Requirements for any given patient will depend on what tests have already been performed, when they were performed, and the doctor and clinic used. A mammogram may be required of women over the age of 40 (or those over 35 who have not had a previous pregnancy). Women over the age of 45 may also have to undergo additional tests to evaluate them for any special health risks associated with pregnancy and childbirth.  These may include a treadmill stress test, diabetes screening, blood chemistry workup and platelet count, thyroid testing, and/or chest x-rays.  Depending on the history and risk factors associated with a particular patient, additional blood tests or an endometrial biopsy may also be performed.

Many clinics require that donors and/or recipients meet with a psychologist who specializes in infertility and donor issues to ensure that they are fully informed and in agreement. The psychologist’s role is not necessarily to evaluate donors and recipients, per se, but more to help them explore the issues and their thoughts and feelings regarding the donation of embryos or the use of donor embryos. Some clinics do not require counseling, but do require that both partners be present for a consultation, or require some other evidence that they are both fully informed and in agreement (such as a signed document of informed consent from the spouse of the recipient female).

Are donors paid for the embryos?

The law regarding direct compensation for embryos has not yet been defined in all states; it is illegal in some locations, and specifically allowed by the law in others. However, it is possible that payment for embryo donation could be construed as constituting undue influence or coercion or may be interpreted as a violation of other state laws. The practice guidelines of the American Society for Reproductive Medicine (ASRM) and the ethics guidelines of the American Medical Association (AMA) clearly recommend against the sale of embryos. Donors and recipients would be well advised to seek legal guidance from an attorney specializing in third party assisted reproduction regarding the applicable laws in the states where both parties reside.

Donation is, by definition, an altruistic act. Donors should not expect payment for any portion of the personal medical expenses incurred during their own fertility treatment that resulted in the creation of the embryos, but  recipients routinely assume responsibility for any additional costs related to the donation itself. Recipients normally reimburse donors for legal fees, embryo shipping, any current embryo storage fees, the costs of any medical or psychological screening or retesting of the donors in conjunction with the donation, and any other expenses involved in the transaction. The recipients should incur responsibility for the related fees even if there are no embryos to transfer after the thaw.

What are the costs associated with embryo donation for the recipients?

As with most medical procedures, costs will vary depending on the individual patient, clinic used, and insurance coverage (if any). Some sample costs are given below, just for informational purposes:

• Retesting of donors for infectious diseases: $100 – $1,000
• Infectious disease screening of recipient: $100 – $1,000
• Legal contract: $500 – $2,500 (may vary greatly)
• Shipping of embryos: $500 – $1,000 (may vary greatly)
• Prescription drugs: $500 – $2,500 (may vary greatly)
• Blood work and ultrasounds: $500 – $3,000 (may vary greatly)
• Frozen Embryo Transfer: $1000 – $5,000+ (may vary greatly)

What medications are generally used by the recipient during a frozen embryo transfer?

The medications used will based on clinic protocols, and may be adjusted for an individual patient based on her body’s response to certain drugs and the outcome of prior cycles. Some clinics will perform a non-medicated cycle for patients who produce an adequate uterine lining without assistance, but medicated cycles are more common. In a non-medicated cycle, the embryos will be transferred to your uterus at the time during your normal cycle that conception and implantation would naturally occur. Many clinics perform medicated cycles to allow for more precise timing and control of the process. Consult with your clinic to determine which method they recommend, what drug protocol they use in the case of a medicated cycle, as well as any risks and side effects of medications prescribed. A typical medicated cycle may include the following medications:

• Antibiotics – used to fight off infection, generally taken around the time of transfer.
• Oral Contraceptives (birth control pills)- prevents ovulation, helps regulate the timing of the cycle, and helps to prevent cysts which may delay a cycle.
• Prenatal Vitamins & calcium supplement – ensures adequate intake of folic acid and other vitamins.
• Lupron (or other pituitary suppressor)- suppresses ovulation that could interfere with a frozen embryo transfer. Administered via injection.
• Baby Aspirin – helps increase blood flow to the endometrial lining.
• Estrogen Supplementation – develops the lining of the uterus. Administered via pill, patch, suppository or injection.
• Progesterone – supports the lining of the uterus and prepares it for implantation. Critical to the ongoing viability of a pregnancy conceived via FET.  Administered via injection or suppository.

What are my chances of success using donor frozen embryos?

A number of factors determine the success rates of frozen embryo transfers.  These include the quality of the embryos that are frozen, the stage of the embryos when they were frozen, and how well the embryos survive the thawing process.

Depending on the stage the embryos were in when they were frozen (at fertilization, day 3 or day 5), between 50-80% of the frozen embryos typically survive the thawing process and continue dividing. You should understand that there is a possibility that no embryos will survive. The overall chance of pregnancy with a FET is 20% – 25% per transfer. While this number may seem low, it still offers great hope for the thousands of infertile couples who may benefit from receiving donated embryos.

There is an increased risk of multiple births when multiple embryos are transferred to the uterus. You should discuss this risk and any concerns with your doctor prior to transferring embryos.

Are there any special risks to pregnancy resulting from embryo donation?

A pregnancy resulting from embryo donation has the same risks, to the baby and the recipient, as any other pregnancy with the additional consideration of the age and medical conditions of the donors. It is extremely important to be open with your obstetrician regarding details of your pregnancy as this information may affect the specific care received.

How do I get started?

We recommend that you learn as much as possible about embryo donation through the Miracles Waiting website. If you have not yet discussed this option with your clinic, contact them to discuss their embryo donation program and fee structure. You can also search our Professional Directory for information on available embryo donation programs and/or fertility clinics that may offer an embryo donation program. You may also want to discuss these options with a trained psychologist or counselor who specializes in fertility (specifically donor issues) and who also specializes in dealing with loss and grief. You may also want to join a support group to talk to people who are experiencing similar issues. For information on organizations and professionals who can provide emotional and mental health support, or for tips on coping, visit our Find Support Page. Once you have made the decision to donate embryos, or if you would like to receive embryos, you can become a member and sign up for the Miracles Waiting Embryo Donation Program at our members website.

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This page was written by the Miracles Waiting Team based on the personal experiences of individuals, and information gathered regarding the process of embryo donation in the United States. Nothing contained herein should be construed as constituting medical or legal advice. Miracles Waiting does not guarantee that all of the information provided herein is accurate or up-to-date. Furthermore, procedures and practices can vary greatly from clinic to clinic and state to state. For this reason, we suggest that you verify all of the information provided with your physician, attorney, or other applicable professional.