Hey there! If you’re thinking about starting a surrogacy journey with your own eggs, embryos, or semen, it’s super important to be aware of the rules regarding human cells and tissues when using a Gestational Carrier (or Surrogate) in the U.S. Here at Pacific Fertility Center Los Angeles (PFCLA), we have over 30 years of experience helping people like you on this journey. With our in-house surrogacy agency, Hatch, we’re here to help you every step of the way!
In this post, we’ll break down the requirements for using human cells and tissues donated from abroad for surrogacy in the U.S. It’s vital to know this information, especially if you are an international patient or Intended Parent (IP) planning to donate or use frozen eggs, embryos, or semen. Many clinics and labs outside the U.S. may not meet the necessary regulatory standards or hold the right certifications, which can complicate the process.
The U.S. Food and Drug Administration (FDA) regulates human cells and tissues intended for implantation or transfer into a human recipient. These regulations apply whether the cells and tissues are already frozen abroad or are planned for donation in the future. There are different rules for those carrying the pregnancy themselves versus those utilizing a Surrogate, so we’ll focus on the latter.
Requirements for Human Cells and Tissues in Surrogacy
To comply with FDA regulations, any clinic or lab must assess donor eligibility before handling human cells or tissues. Here’s what generally needs to happen:
- Risk Factor Screening: This includes a physical exam and a review of the donor’s medical history and relevant social behaviors to minimize the risk of spreading communicable diseases. This must all be done within six months of collecting the cells or tissues.
- Infectious Disease Testing: Specimens from reproductive donors must be tested for infectious diseases, including HIV, Hepatitis B and C, Syphilis, Chlamydia, and Gonorrhea. Male sperm donors also need testing for HTLV and Cytomegalovirus. It’s crucial that these tests are performed using FDA-approved methods, which many foreign clinics may not have.
- FDA Registration: The clinics and labs involved must be registered with the FDA and must list their human cells and tissues within five days of starting operations, renewing their registration annually. This applies to any establishment outside the U.S. that plans to import cells and tissues.
For more information, you can check out the FDA website to find registered establishments.
Exemptions to the FDA Regulations
While these regulations are in place to protect recipients, there are some exemptions, including:
- Cells and tissues created for the donor’s personal use
- Reproductive cells donated by a partner for reproductive use
- Cryopreserved eggs or sperm originally intended for personal use that later become available for surrogacy
- Case-by-case exemptions granted by the FDA
These exceptions can be important if partners wish to use previously created embryos after discovering issues with carrying a pregnancy to term.
As a side note, if you’re interested in navigating paid parental leave as an LGBTQ+ parent, check out this other blog post for some helpful insights.
Summary
In summary, understanding the FDA’s requirements for using human cells and tissues in surrogacy is crucial, especially for international patients. Following the steps for screening, testing, and registration can ensure that your surrogacy journey goes smoothly. There are also exemptions worth exploring that can offer more flexibility. For those looking to gather more information, Healthline provides excellent resources on pregnancy and home insemination, and if you’re considering at-home procedures, Make a Mom offers a comprehensive kit to help you out.