FDA Regulations for Known Sperm Donors

Before we asked my brother-in-law to be our donor, we had a meeting with the donor coordinator at our fertility clinic. We learned a little about donor sperm and donor embryos.

When we got home I did my own research about the regulations, specifically about FDA regulations about known donor sperm. The major areas of regulation are:
– quarantine period
– communicable disease testing
– genetic testing
– psychological evaluation
– FDA registered facilities

The rules for sperm donation are very similar for anonymous donors and known donors, but there is one major difference that is critical. That rule is about the sperm quarantine period.

I’ll start with that rule because knowing it might help you get started on building your family 6 months sooner!

Quarantine Period

The FDA does NOT require the 6 month quarantine for sperm from a known donor (also called a directed donor). They only require “7 day testing” which is blood testing for communicable diseases like HIV within 7 days of semen donation. If the results come back all clear, then the sperm can be used immediately.

For random donors the FDA requires a six month quarantine of the sperm. More specifically, they require the donor to have blood testing for communicable diseases like HIV within 7 days of donation, then a quarantine of the donation for 6 months (sitting frozen in a tank at the clinic laboratory), and then retesting the donor’s blood at the 6 month mark for communicable diseases. If the results of both sets of blood work are all clear, then the frozen sperm can be removed from quarantine and shipped to you. When you’re shopping for sperm at a sperm bank all of these steps have already been completed and you don’t have to wait.

Even though the FDA doesn’t require the 6 month quarantine for directed donors, the ASRM (American Society of Reproductive Medicine) recommends it. Each clinic can set their own policies and procedures for directed donor sperm (the FDA requires each clinic to write their own set of these rules) for whether to follow the FDA minimum guidelines for 7 day testing or to follow the ASRM recommendation of 6 month quarantine, or to choose something in between.

If you’re at all worried about transmission of HIV or other STDs from your donor, you should have a frank conversation with them. Ask about prior testing, sexual lifestyle, dangerous conditions in their workplace (ex. police officers come in contact with people from all walks of life), etc. If you’re still not satisfied but you don’t want to wait 6 more months, it is generally accepted that IVF w/ ICSI can be done with virtually no chance of transmission of HIV from donor to mother. You should discuss this with your doctor.

Communicable Disease Testing

The FDA requires all donors, anonymous and directed, to be tested for the following:

– HIV 1 and 2
– Hepatitis B and C
– Treponema pallidum (syphilis)
– Human T-lymphotropic virus, type I and II
– Cytomegalovirus
– Chlamydia trachomatis
– Neisseria gonorrhea

Genetic Testing

The FDA doesn’t require ANY genetic testing at all for either directed donors or random donors. They are only concerned about communicable diseases. Depending on your genetic heritage, your clinic might require or highly recommend some genetic testing of you or your directed donor before proceeding. When choosing sperm from an anonymous donor at a sperm bank, the testing will be done already.

Psychological Evaluation

The FDA does not require a psychological evaluation for the donor or the recipient, they only care about communicable diseases. However, the ASRM recommends a psychological evaluation for both anonymous and directed sperm donors. They do not specify that an evaluation is recommended for the recipient couple, but I personally highly recommend it.

FDA Registered Clinic

In order to do the testing above, collect the sperm, freeze it, and then ship it to you, a clinic MUST be registered with the FDA to perform each individual step.

If you’re wondering what steps your clinic is registered to perform, the FDA has a handy search tool you can use to find out. We used this tool to find a clinic near my brother-in-law that was more convenient than traveling to a sperm bank to get all of this done. The bonus is that it is MUCH less expensive ($1,300 vs $4,000!) to use his local clinic instead of the sperm bank in California.

The steps are:

1. Screen – asking donor questions about lifestyle, medical history, etc. to determine if he has risk factors for communicable diseases
2. Test – testing donor blood samples for communicable diseases
3. Recover – collecting the semen
4. Process – testing of the semen or freezing it
5. Label – identification of the samples to prevent mix-ups
6. Store – controlling storage areas and storage conditions like temperature
7. Package – shipping containers must be designed to prevent contamination of the tissue
8. Distribute – determining when tissue should be able to be shipped, required shipping environment, etc.

I have done a fair amount of research on the FDA regulations. I’m not an expert by any means, but if you’re having trouble navigating the waters or you’re just starting, I’ll be happy to help you any way I can. Just leave a comment with your questions!

For your reference, here are several links to look at for more information.

Complete FDA regulations
Regulations in easy to read format of Q&A
California Cryobank Directed Donor Information
Fairfax Cryobank Directed Donor Information
Xytex Directed Donor Information
ASRM Donor Guidelines
Search for FDA registered clinic


8 thoughts on “FDA Regulations for Known Sperm Donors

  1. Hi Mrs. E! I didn’t really know where it would be appropriate to post this…actually ideally I wanted to send to you via PM and you decide whether/where to post on your blog, but didn’t see that option to contact you. Anyhooo….I read this article a few days ago, and then woke up this morning, thinking I needed to share it with other ladies a) dealing with a diagnosis of azoospermia & feeling the need to figure out why and b) anyone that hopes to become pregnant, which is I think all of us reading this.

    Here is the original article with lots of evidence that toxic chemicals called phthalates are responsible for infertility, especially in males, and examples of the kinds of products that contain these:

    Also, I clicked on one of the citation links in the article (the word ‘perfume’ in the second paragraph – since I am a perfume lover), and also was very interested in this report from in 2002:

    Many of the studies cited in these articles were done back around the time my husband was born in the early 80’s. After reading about this, I have a very strong suspicion that his condition could have been caused by being exposed to these while in utero, and/or soon after birth. You will read that there’s very strong evidence these cause developmental problems with the functionality of a male’s reproductive organs.

    We’ve struggled for a long time to understand what has caused his condition. I don’t know about any of you but for us, knowing WHY would have been so comforting….at least that’s what we think. It’s not going to make a difference for anyone already going through this, other than just making you feel better knowing this might be the reason, but for anyone who has not yet become pregnant, please strongly consider this evidence and make the necessary changes before you do so. Hope this made sense, I don’t have a lot of time right now to edit for clarity 🙂

    • I will respond to this soon in a new post – thanks so much for bringing it up!

      Sneak preview: We got Mr.E tested for BPA, Phthalates, triclosan, etc. prior to doing the mTESE. He was positive for all of them but his levels were about the same as the rest of the population. I do believe they’re on to something here regarding conditions in utero. More to follow in a new post!

  2. Hi there,
    I see that this post is years ago but I’m desperately hoping that you can afford a wee bit of time to reply. I have a directed donor, and legal paperwork. We were going about things the old turkey baster method & I conceived identical twins. I miscarried in the 2nd trimester. I was considering using a sperm bank to do IVF or and IUI in order to move the process along, I turned 36 this fall. The nearest sperm bank (Xytex) to us has just closed down their known donor program and the travel and cost of sending my donor to a sperm bank is incredibly prohibitive. My fertility clinic led me to believe that the only way for them to use sperm for either of these procedures was for the donor to go to a sperm bank. Do you mind to share more of how you were able to get your brother in law to a lab that would do this for you? I’m pretty scared and devastated. Any information you might be willing to share about how to make this more manageable would be a real help. The main problem is getting my donor to a sperm bank to give samples – it involves him getting out of work, leaving his family & foregoing pay to fly to a place and stay for a week of all which I would foot the bill for – but it’s a bigger problem for him to find time to travel. Thank you so much for your time & graciousness.

    • As I recall, the FDA rules for known or directed donors are much less stringent than for anonymous (sperm bank) donors. The *clinic* may have more stringent rules though and that is actually one of the problems we ran into.

      I had to sort of talk our clinic into doing this for us. They essentially created their known donor program for us. So, just because they say no now, don’t give up! Keep talking, you may just change someone’s mind.

      You should be able to use the link to find an FDA approved clinic in your area that can do the necessary testing for known donors. Let me know if you need more help!

      Oh and yes we did pay for my BILs travel expenses for his trips to do the donation and testing, and for the meeting with the reproductive psychologist. Makes everything more expensive, but once you get these sperm donations, it can theoretically be a one time thing if you do IVF. If you want to do IUIs, paying for travel etc is probably still cheaper than IVF.

      • Thank you for your help & answers. Our clinic will not help us on this so it means we will likely be turning to an unknown donor. This makes me want to scream & cry, but there’s nothing for it. It seems ridiculous that it is harder & more expensive to use a known donor because of the red tape & unwillingness of fertility clinics. I don’t think we can afford to send our donor to an out of state bank & have him donate 3 times for potentially nonviable samples. It’s my understanding that he can only donate 3 times at most within a week period. Then they have to see if the sample will survive the freeze/thaw process first – meaning they might not even make it. Then there’s the quarantine. We planned to do IUI but my understanding there is that it can take up to 4 tries – and if he only produces a couple viable samples we could have paid $10K to still be nowhere, and need to send him to a bank to try it all over & spend $$ again. As you well know, this has been a heartbreaking problem. Thank you for your time, information and sharing your journey. It’s been a hard road & your blog has been comforting.

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