Regulations governing egg and sperm donation in the USA

By (embryologist) and (fertility counselor).
Last Update: 09/15/2015

Gamete donation, either egg or sperm donation, is a reproductive option in the United States by which same-sex and heterosexual couples as well as singles can become parents.

It should be clear the the USA does not count on specific regulations governing sperm and egg donation but it varies from state to state, that is to say, each state has its own legislation in this regard.

However, the majority of the states proceed according to settled case-law, the guidelines provided by the American Society for Reproductive Medicine (ASRM) and other specialized organizations such as the FDA (Food and Drug Administration) and the AATB (American Association of Tissue Banks).

In the absence of express regulations governing egg and sperm donation, both intended parents and gamete donors are recommended to seek legal advice for the whole process, especially when it comes to drawing up contracts about paternity rights, financial obligations, and the chance to come into contact in the future.

Regarding the types of donation, different options are available depending on each state. However, types allowed at a general level are as follows:

  • Known donation, in which the recipient or recipients are the ones delivering the donor, usually a relative or a friend. In the case of egg donation, there is the possibility of choosing the donor from a sperm donor database provided by the agency or clinic. If this is the chosen option, then the recipient has the chance to meet her in person and get to know her.
  • Anonymous donation, either from a donor database or provided by the professional team at the agency or fertility clinic. In this arrangement, identity disclosure is an option as long as the sperm donor allows it under express authorization and the donor-conceived individual requests it.

Requirements to become a donor

Although there is controversy in this area, the overall opinion is that both anonymous and known donors must undergo a series of medical examinations and psychological assessments. Thus, every potential donor must meet a series of requirements, being the following the most important ones:

  • Staying healthy as well as not being a carrier of any genetic or infectious disease (HIV, hepatitis, herpes, siphilis, candidiasis…)
  • Being aged between 21 and 34 years old in the case of egg donation, and between 21 and 40 in the case of sperm donors.
  • Passing a thorough psychological assessment performed by mental health experts
  • Passing every medical examination required

Informed consents are essential in every sperm and egg donation arrangement. There should appear a confirmation by the donor assuring he or she does not suffer from any genetic or sexually-transmitted disease.

Besides, the donor should commit to inform about any risk factor or change in his or her health status.

Regarding egg donation, the importance of this consent becomes greater, since becoming an egg donor poses greater risks if compared to sperm donation because of the medication that has to be administered. Thus, it is important for the egg donor to know and put on record the risks and side effects derived from ovarian hyperstimulation and egg removal (follicular puncture).

Egg and sperm freezing

A very important guideline established by the ASRM in terms of donor sperm use has to do with cryopreservation. Using frozen donor sperm instead of fresh sperm is the recommended option. In addition, that sperm should not be used before 180 days (6 months) due to the window period of some viral infections such as the HIV.

After 6 months from performing the very first analysis of infections to the potential donor, the same study will be done again. Only in case the second analysis is negative, that is to say, when the donor is proved to be free from infectious diseases, the donor sperm will be qualified as viable to be used.

As for egg donation, the quarantine period may not be practical, since egg freezing is not as effective as sperm freezing and thus it may diminish their quality. It should be taken into account that sperm freezing also has an impact on sperm quality, but to a much lesser extent.

However, thanks to the latest egg freezing services, i.e. vitrification, egg features are only slightly affected. For this reason, it is becoming increasingly advisable to wait for 6 months before using the donor eggs, in particular until it has been confirmed that the potential donor is indeed free from infectious diseases.

In fact, today most donations are performed using frozen eggs, which erases the necessity of synchronization between the cycles of the donor and the recipient, a major disadvantage in the majority of the cases. Besides, it allows shared egg donation, which means that a single egg donor delivers her eggs to more than one recipient.

Although there is no specific provision within the USA which expressly concerns sperm donation and its requirements, the American Society for Reproductive Medicine (ASRM) and other related institutions recommend a limit of 25 live births per sperm donor within a population area of 850,000 inhabitants. This may rule out possible inbreeding problems in the future.

However, as stated earlier, these are just guidelines and therefore there is no set of mandatory rules. It is estimated that only 40% of live births are recorded. Therefore, it is likely that some donors, especially sperm donors, count on almost 100 genetic children.

As for sperm donation, certain sperm banks establish their own limits. For example, there is a sperm bank in California that limits sperm donation to 10 families per donor. Another sperm bank from the same state marks a maximum of 6 different women per donor. However, it should be clear that this is not an appropriate solution, since sperm donors may turn to another sperm banks once the limit has been reached.

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Authors and contributors

 Andrea Rodrigo
Andrea Rodrigo
B.Sc., M.Sc.
Embryologist
Bachelor's Degree in Biotechnology from the Polytechnic University of Valencia. Master's Degree in Biotechnology of Human Assisted Reproduction from the University of Valencia along with the Valencian Infertility Institute (IVI). Postgraduate course in Medical Genetics. More information about Andrea Rodrigo
 Sandra Fernández
Sandra Fernández
B.A., M.A.
Fertility Counselor
Bachelor of Arts in Translation and Interpreting (English, Spanish, Catalan, German) from the University of Valencia (UV) and Heriot-Watt University, Riccarton Campus (Edinburgh, UK). Postgraduate Course in Legal Translation from the University of Valencia. Specialist in Medical Translation, with several years of experience in the field of Assisted Reproduction. More information about Sandra Fernández

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