Third Party Reproduction

October 8, 2010Carole 1 Comment »

Third party reproduction is an umbrella term that covers using donated sperm, egg, or embryo or  “loaner” uterus to conceive and take home a baby. This option is rarely a first choice and is often the last resort before adoption or deciding to go on without children. As with much of reproductive biology, third party reproduction brings with it a lot of issues that an individual or couple going down this road should think about. There are various strings attached to third party reproduction including regulatory limitations and legal and social implications of this choice.

Historically speaking, “traditional” surrogacy (in which a woman is inseminated and produces a child for another) and sperm donation were the only options available. Traditional surrogacy in which the surrogates egg is used fell out of favor after the infamous Baby M case in which a traditional surrogate changed her mind about giving her biological child to the biological father and his wife ((the intended mother) at the delivery. This case thrust the issues of surrogacy into the public spotlight. Gestational surrogacy has become preferred because the surrogate only donates her uterus and has no genetic link to the child, making issues of parentage somewhat simpler. However, a judge in New Jersey declared a gestational surrogate with no genetic link to twins she carried their legal mother. The twins were created from donor egg and the sperm from a gay male couple who were legally married. It is unclear whether this bias in favor of the gestational mother was due in part to bias against homosexual couples. In any case, it highlights the legal minefield that may arise from using third party reproduction. Click on “download pdf ” to read the article “Baby Mama Drama: Parentage in the Era of Gestational Surrogacy“, which provides a fascinating review of the history and legal cases that affect the use of gestational surrogacy.

Since there are no federal laws regulating parentage in cases of gestational surrogacy, state laws, when they exist, regulate the use of surrogates. Some states have banned surrogacy or fail to recognize surrogate contacts as legally binding. A state-by-state guide to laws on gestational surrogacy can be reviewed here. Anyone considering entering into a gestational surrogacy arrangement (intended parents or surrogate) should get independent legal advice to avoid legal problems.

With the advent of IVF, eggs, sperm, embryos and uterus from various individuals can be combined to produce a child. This article “IVF twins born with five parents” describes a complex arrangement in which after IVF with donor egg failed, the mother of an infertile couple accepted a donor embryo transfer and carried the pregnancy to term for her daughter and son-in-law. According to the article, the resultant twins had five parents: two biological parents who created the embryo, the grandmother who carried the pregnancy and the couple themselves who formally adopted the twins since they had no genetic link to the children.

Even sperm donation, the oldest form of third party reproduction is not without various implications and issues. A previous post ” Who’s my daddy? The issues of sperm donation” , discusses the medical and personal questions that may arise from using anonymous versus known sperm donors. Donor conceived children have created donor sibling registries to find their half-siblings who share the same donor and sometimes, the donor himself.

Mechanics of Third Party Reproduction: The FDA’s interest in preventing the transmission of communicable diseases. What federal regulations exist to limit who may donate sperm, eggs or embryos? On May 25, 2005, the FDA published donor eligibility rules that regulate the use of donor gametes for the sole purpose of preventing the transmission of certain sexually transmitted diseases from donor to recipient. Interestingly, surrogacy is not regulated by the FDA because surrogates are considered recipients of the donated eggs, sperm or embryo and so are the parties to be protected from the donors. The FDA does not consider the fetus to be in need of protection from a possibly infected uterine environment, which is ludicrous from the reproductive medicine perspective because a healthy baby is the end goal. Fortunately, most physicians who participate in surrogacy arrangements insist that the surrogates also undergo screening and testing to rule out significant obstetric health issues before starting a pregnancy.

It is important to understand that these FDA regulations were not developed specifically for reproductive donors. In fact, reproductive donors were added on almost as an after thought and so some aspects of the law were not applied to reproductive tissues. The law was designed to regulate the donation of other bodily tissues such as skin, heart valves, corneas, bones, cartilage and various and sundry parts that are usually acquired from a cadaver and sold by agencies that sell human parts to hospitals. The American Society of Reproductive Medicine (ASRM), the Society for Assisted Reproductive Technology (SART) and other interested parties  such as Resolve, a infertility support and advocacy group gave the FDA feedback about the evolving regulation which resulted in modification of the rules in recognition of some unique aspects of reproductive tissue donation. For instance, FDA inspectors are not permitted to remove “samples” of embryos from liquid nitrogen tanks in IVF clinics they inspect to test for disease.

What diseases does the FDA consider relevant? All tissue donors must be tested for HIV-1, HIV-2, hepatitis B, hepatitis C, and Treponema pallidum (Syphilis) . Donors of viable, leukocyte-rich cells and tissue ( semen and ovrian tissue) are also tested for HTLV-I and II and Cytomegalovirus (CMV). CMV is unusual because although testing is required, it is not considered “relevant” and each screening agency is given some latitude in how it deals with positive test results. Approximately half the population has antibodies to CMV, suggesting a previous exposure but not necessarily an active infection.  For reproductive donors specifically, screening and testing for Chlamydia trachomatis and Neisseria gonorrhea are also required.

Registration and Inspection of Screening/Testing Facilities. The FDA requires that any facility or agency who is in the business of screening donors must be registered with the FDA as a donor “screening facility”. Likewise, labs that act as testing facilities to determine donor eligibility must also be registered with the FDA. This allows the FDA to identify these facilities for  unannounced inspection to see if they are in compliance with federal regulations. The FDA has a three step process it requires facilities to perform for acceptance of individuals as donors. Your RE’s clinic,  if they find and screen donors themselves, are expected to register with the FDA. Donor matching agencies, if they perform donor screening are expected to register with the FDA. Commercial sperm banks who enroll and screen donors are expected to register with the FDA. In the old days, it was not unusual for physicians to identify a group of medical students or even fellow doctors who would serve as fresh sperm donors without any rigorous screening. In large part, regulation of sperm donation specifically and donor eligibility laws in general  are in response to the old ways sperm donation was performed and the advent of AIDs in 1985. You can read about the history of sperm donation and how AIDs changed public awareness and practices to do with sperm donation on California Cryobanks website.

What the FDA requires: A three step process for determining donor eligibility.

Screening through examination of medical records and social risk factor questionnaires to evaluate the donors risk of current infection. Although testing is not yet required due to the lack of adequate clinical tests, the FDA does require screening questions to rule out sepsis and exposure to West Nile Virus. You can download a pdf document of a sample questionnaire here. Anyone who has ever donated blood will recognize many of the questions dealing with social risk factors such as the potential donor’s history of engaging in gay sex, injection drug use, incarceration in prison and  travel to countries with a high prevalence of mad cow disease or AIDS.

Screening through a physical exam to rule out signs of infection. At some point, medical personnel are expected to examine the potential donor and look for physical signs of active infection or high risk behavior. The physician is expected to look for signs such as vaginal discharges, genital or anal warts, prison tatoos or needle tracks which could indicate the person is at higher risk for acquiring the diseases the FDA has deemed relevant.

Testing blood and urine for signs of active infection with any of the diseases of interest to the FDA. The FDA defines which test kits must be used for screening as opposed to diagnostic testing and the time frame relevant to donation (within 7 days of recovery for sperm and within 30 days of egg retrieval). If the wrong test kit is used, if the testing facility is not registered with the FDA or if the time frame is wrong, a donor is automatically disqualified and the donor gametes can not legally be used.

If the donor passes all three stages of screening and testing, they are deemed eligible to donate and their sperm or eggs can be used to create embryos for IVF.

The FDA has made a distinction between “Known” Versus “Unknown” donors. Although ALL donors are expected to go through the three steps (unless they flunk out after step one or two) , and are deemed either eligible to donate or ineligible to donate based on the results of the the three step process, the recipient’s relationship to the donor affects whether the recipient is allowed to to use an ineligible  donor. If the donor is anonymous and found ineligible to donate, they can’t donate. No exceptions. If the donor is someone the recipient knows or is related to (a friend or family member) and their known donor is found ineligible, the recipient can, in some instances, use the donor and accept gametes from them. The FDA will not interfere with the use of these gametes from an ineligible known donor as long as rules about labeling and informing the treating physician are followed. The FDA requires that the screening and testing facility inform the physician that the donor is ineligible to donate based on the screening/testing process. It’s up to the doctor to inform the recipient (his patient) that some screening results or test results suggests some risk (ranging from negligible to high) of infection exists. The FDA will not interfere with use of this donor if the medical records show that proper labeling and communication about the disease risk occurred.

Sexually intimate couples and embryo donation. Couples who are sexually intimate with each other and use IVF to create a baby are not considered “donors” in the eyes of the FDA at the time of the creation of the resulting embryos. If the same couple decides they would like to donate their excess embryos in cryostorage when they are done with treatment, they become egg and sperm “donors” that created an embryo in the eyes of the FDA. Some IVF programs have made the decision to test ALL their married/sexually intimate couples to comply with state laws or in anticipation of the possibility that the couple may want to donate their embryos later on.

Even though the couple’s donor status has changed, the FDA is as clear as mud about what it really expects IVF programs and agencies to do about it. The FDA has stated that it will most likely not interfere with embryo donation if the screening and testing is not performed for couples who originally were not obligated to undergo the screening. However, they strongly suggest that if it is possible to do late screening and testing on the donor couple (as required for egg and sperm donors)  before donating the embryo to a recipient, the FDA would like to see that. Some donor agencies and physician practices have interpreted this murky guidance differently. Some test every couple like a donor couple “just in case” they want to donate later which increases the expense for the couple. Others wait until the issue of embryo donation arises and “try” to screen and test the donor couple later. Interestingly, there has been no scientific evidence that a donated egg or embryo is capable of  infecting a recipient, yet we have these rigorous rules.

The down side of this sometimes overzealous regulation is that procedural failures in the donor eligibility process (using wrong test kit, wrong test lab, time frame errors) that are discovered too late can result in the creation of embryos that can not be legally used because they were produced from ineligible donors. In cases where the donor is probably not infectious and may even be later re-tested and found to be non-infectious may still not be used legally because testing must be completed before the donor donates and embryos are produced.  Programs and intended parents have petitioned the FDA to legally use embryos created from ineligible donors. Embryos can linger in this legal limbo for month or years while the FDA decides whether to allow the embryos to be used. Mistakes in donor eligibility determination are not trivial because the FDA can charge health care providers  with non-compliance, theoretically punishable with steep fines and even imprisonment. You can read warning letters issued to companies and health care providers that failed to follow FDA rules on the FDA website. Hopefully, you won’t find your RE there.

Genetic Issues? Couples considering the use of  donor gametes should understand that there is no federal regulation that requires donors be screened for ANY genetic diseases. The recent case of a sperm donor who fathered 24 children, nine of which inherited a fatal heart defect which killed one of the children at age 2 has resulted in calls for routine genetic screening. Many sperm banks and egg donor agencies already voluntarily ask the donor about their genetic disease risk when they take a three generation medical history.  Some donor agencies/banks perform genetic tests( if they are available) for genetic diseases that are common in certain ethnic groups (for example, Tay-Sachs disease in Ashkenazi Jews).  Although in principle, it would be great to be able to test donors to rule out genetic disease, the truth is we all carry some genetic mutations which could result in genetic disease in our children. Every time we create a child, we roll the genetic dice and wish for the best. Couples that know they are at risk for specific diseases based on knowledge of their family tree (another child or relative has the disease) can use preimplantation genetic diagnosis (PGD) to prevent future pregnancies using embryos that carry the genetic mutation. If you use an anonymous donor, there is usually no way to know what genetic disease they may carry except for what they know and care to reveal about their families genetic history. In the case of the sperm donor who donated sperm in his twenties, he was not diagnosed with the cardiac defect he passed on until he was in his forties and fathered children with his wife. He could not reveal what he did not know.

Social Considerations? Besides the medical considerations that arise from third party reproduction, there are social considerations. Should parents tell their donor-conceived children how they were conceived?  Should they tell their extended families? Should your child know that her Aunt Joan is really her biological mother? These are really hard questions that couples struggle with. If you google “raising donor conceived children”, you will find lots of studies, opinions, and advice about the topic. Most IVF programs strongly suggest and some require that couples who are considering donor gametes, donor embryo or a surrogacy undergo family counseling with a specialist who will bring up various issues so that the couple can try to think about and anticipate potential problems and decide whether third party reproduction is the way to go for them. In the turmoil and emotional roller coaster of infertility, it is sometimes a good idea to stop , take a deep breath, and realize that infertility is a temporary condition, parenting a child, on the other hand,  is a permanent condition.

© 2010, Carole. All rights reserved.

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