SpermCenter.com believes that the sperm banks matters almost as much as finding the right donor. To help educate yourself we have listed some of the issues and questions we believe are important below.
The FDA now requires that all donors be screened and tested for sexually transmitted diseases. These are referred to as “Relevant Communicable Diseases” or RCD.
The required tests are for the agents that cause HIV, HTLV, HBV, HCV, Chlamydia, Gonorrhea, Syphilis and CMV. This testing with the required six month quarantine and retesting have nearly eliminated the risk of acquiring an infection from donor sperm with one of these diseases.
There are two components in risk reduction, one is the infectious disease testing, the other is a required medical and social history of the donor which assists in identifying risk related behavior.
Both are considered essential in the management of the donor in order to reduce risk of infection. Testing alone is not adequate.
This is a very relevant and important issue for sperm banks and families with donor conceived children. However, there are significant barriers to making this happen. Essentially, a sperm donor can not be compelled to comply.
Their personal health information is protected by privacy laws.
The issues of how a sperm bank can obtain a donor's information, how it will be incorporated into the donor’s records and, not least, how will it be made available to you is still a hot area of discussion in the fertility industry.
FDA registration is required for all sperm banks and they are required to comply with FDA regulations. This became effective May 25, 2005. Sperm specimens, collected before that date, are not subject to the current FDA requirements. SpermCenter.com verifies the FDA registration of every sperm bank listed.
The FDA performs inspections to determine regulatory compliance. If serious deficiencies are found the facilities will be issued a warning letter ordering correction within a defined time period, or if more serious may order the sperm bank to cease operations immediately. The FDA does not issue licenses to sperm banks.
The only organization that inspects and accredits sperm banks is the American Association of Tissue Banks (AATB). Sperm banks are not required to have AATB accreditation.
It is strictly voluntary and the sperm bank has to pay substantial fees to maintain their accreditation. The AATB has developed a comprehensive set of standards that are more extensive than the FDA and nearly all state departments of health.
Accreditation by the AATB is granted only after an onsite inspection has determined that the bank is in compliance with its standards. This is a measure of quality.
New York Department of Health
The New York Department of Health has developed a comprehensive set of regulations and requires that all sperm banks that provide donor sperm to NY residents are inspected and have a current license by the Department of Health.
Their requirements are in many ways comparable the AATB standards. In the absence of AATB accreditation this is perhaps the best alternate measure of quality.
State Licenses Other Than New York
There are a number of other states that have licensing requirements. Some may require inspections while others only require payment of a licensing fee. In general it is difficult to determine what most of these licenses mean. In our opinion, unless there are published regulations and accompanied by an onsite inspection to determine compliance they have little value in assessing quality.
This refers to the Clinical Laboratory Improvement Act passed by Congress. CLIA regulations do not apply to sperm or other tissue banks. These regulations are aimed at diagnostic clinical laboratories.
Some states may require sperm banks to be CLIA licensed, but where they are required, the inspections are limited to clinical laboratory procedures and have very little value as a means to determine the quality of sperm banking procedures and practices.
The American Society for Reproductive Medicine (ASRM) publishes guidelines for sperm and egg donor programs.
It is important to point out that the ASRM does not perform inspections and it has no means of enforcing compliance with its guidelines. A statement that the sperm bank follows ASRM guidelines has very little value to the public because there is no way to verify compliance.
The best way to ship sperm is in liquid nitrogen vapor tank that is generally called a “dry shipper.” Dry ice is an option but it is not the preferred method because it does not completely arrest cell metabolism and will reduce the life expectancy of frozen sperm.
Sperm will stay viable in a nitrogen tank for at least seven days, even longer if the tank is fully charged. Most experts discourage using shipping tanks for storage and recommend transfer to a monitored liquid nitrogen storage tank designed for storage.
This is important information because it allows you to evaluate their reputation among medical professionals rather than having to rely on their claims.
This track record allows you measure their practices against their claims. Your relationship with your donor’s bank will be important for decades to come. Getting pregnant is just the beginning. The bank controls access to the donor and is the custodian of the donor’s records.
The longer a sperm bank has been in business, the more experience and customers they're likely to have. On our Sperm Banks search, we show the number of years each sperm bank has been in business. Choosing a sperm bank is a lot like finding a good doctor or lawyer.
Ask people you trust and try to find people that will be willing to share the basis for their opinions with you.
It is very important you report all pregnancies and births to the bank for a number of reasons. Banks need to monitor the relative fertility of the donor, be informed of the number of reported pregnancies and live births and of any adverse outcome such as birth defects and suspected genetic disorders.
Sometimes the first indication that the donor may be a carrier of a previously unsuspected genetic disease is from a report of a birth defect.
Limiting the number of pregnancies and or births
At present there are no laws or regulations that limit the number of pregnancies allowed from one donor. However medical professionals agree that the number of donor conceived children should be limited. The debate centers around what that number should be and how does the bank actually establish controls.
There are numerous sound reasons why limits need to be established.
We at SpermCenter recommend you ask the sperm bank what those limits are and how they actually control the number. This is important because many women either don’t report their pregnancy or may do so several years later.
In general the only way to control the number of donor offspring is to limit the number of donor specimens (vials or straws) distributed for insemination.
Most banks have established limits based upon the number of families with children by the donor rather than the actual number born. The limits reported range from 10 to 40 family units per donor. These limits are self imposed and are derived from published guidelines.
Current generally recommended genetic testing
Genetic testing helps reduce risk for certain specific genetic disorders.
None of this eliminates risk.
For all donors:
Cystic Fibrosis mutations, Chromosome analysis (Karyotyping), Spinal Muscular Atrophy (SMA) mutations and hemoglobin evaluation for abnormal hemoglobins and thalassemia.
Donors of Ashkenazi Jewish origin:
Current recommendations include, Tay-Sachs disease, Canavan disease, Familial dysautonomia, Bloom syndrome, Fanconi anemia type C, Gaucher disease, mucolipidosis type IV and Nieman-Pick type A.
Recommended to have testing for Fragile X as well as the same diseases listed for sperm donors.
It is important to understan that the donor sperm recipient provides fully ½ of all the DNA of a child. Ideally the recipient should have genetic evaluation similar to that of the sperm donor.
There are also some diseases that are inherited solely from the mother. These are mitochondrial disorders. We humans inherit our mitochondria exclusively from our mothers.
If you know you are a carrier for a known genetic disease we strongly urge you to discuss this with the sperm bank before you choose a donor.
This is a very relevant and important issue for sperm banks and families with donor conceived children. While nearly ever one agrees that this is important there are significant barriers to making this happen. Donors can not be compelled to comply.
Their personal health information is protected by privacy laws. The issues of how a sperm bank can obtain the information, how it will be incorporated into the donor’s records and, not least, how will it be made available to you are all issues under hot debate in the fertility industry.
The AATB requires that every donor have a three generation medical and genetic history in order to properly evaluate risk of genetic diseases in donor conceived offspring.
This consists of the donor, any children he may have had, his parents with their brothers and sisters including their children and the donor’s maternal and paternal grandparents with their brothers and sisters. All of this information is provided by the donor.
Except in rare circumstances no documentation is provided. It is dependent upon the donor’s knowledge of his family’s history and what he has been told by his relatives.
To one degree or another it will always be incomplete, and on occasion, be inaccurate. The sperm bank is dependent upon the donor to provide this information which in turn it evaluates.
This is best performed by a trained and qualified genetics counselor, either face to face or by telephone or by similar methods.
To determine how healthy or at-risk a potential sperm donor may be. This consists of a through medical and family history and a complete physical examination by a qualified physician. Many sperm banks also perform a complete blood count, urinalysis and a general chemistry profile.
What accreditations, registrations and licenses do they have?
Sperm banks MUST be registered by the FDA. Its a requirement. If a bank isn't registered by the FDA, stay clear. Always call to double check a banks qualification if they don't list their registration or accreditations on their website.
Sperm banks may be accredited by the American Association of Tissue Banks (AATB), but this is voluntary.
They are required to be licensed by a state department of health under CLIA if they have a clinical laboratory.
In addition, the American Society for Reproductive Medicine (ASRM) publishes guidelines that most sperm banks follow.
We list each bank's accreditations on their bank profiles in the fertility professionals search.
What type of screening does the bank perform?
One of the most important things the sperm bank does is screen sperm donors and the sperm itself in order to reduce the risk from potentially harmful diseases.
In addition, sperm banks measure the sperm's motility.
Do all donors receive a physical exam that includes blood testing?
Does the bank review the donor's family medical history going back one or two generations?
Does the bank personally interview each donor?
Do they perform genetic screening or chromosomal analysis?
Does the bank track medical history?
Tracking the donor's medical history is extremely important. Suppose your donor comes down with a genetic disease after you've already had children using his sperm?
Your child could have the same disease. In certain cases, you might be able to use the information to take preventive action to protect your child.
It's extremely important to ask the bank: Do you track the donor's medicacl history and will you notify me of any changes?
Does the bank track pregnancies?
Tracking pregnancies is important for two reasons.
First, tracking pregnancies is the only way to know how many children have already been born from a particular donor. Unfortunately, tracking pregnancies is not always easy, because often women are so happy to be pregnant they don't report it to the sperm bank.
Second, it’s the only way the sperm bank can provide you with any new medical information that becomes available about the donor you used.
Does the bank limit the number of donor pregnancies?
There is no law limiting the number of pregnancies allowed from one donor, but medical professionals agree that the number should be kept low in order to avoid consanguineous complications among offspring conceived by the same donor.
Different sperm banks follow different guidelines to limit the number of pregnancies from a single donor.
How many years has the bank been in business?
The longer a sperm bank has been in business, the more experience and customers they're likely to have. On our Sperm Banks page, we show the number of years each sperm bank has been in business.
Does the bank perform a freeze test?
Some donors' semen freezes better than others'. The sperm bank should perform a freeze test to determine how well the semen freezes.
Does the bank ship using nitrogen?
Donor sperm must be frozen to a very cold temperature in order to preserve it for long periods of time. The best way to ship sperm is in a dry nitrogen vapor dewar (a tank kind of like a thermos that's charged with liquid nitrogen).
Sperm will stay viable in a nitrogen tank for at least seven days, even longer if the tank is fully charged. Some banks may offer dry ice as an option because it's cheaper, but most fertility specialists don't recommend this.
What kind of cryoprotectant does the bank use?
Sperm banks use a cryoprotectant to improve freezability. Some cryoprotectants can cause an allergic reaction which may be serious.
For example, egg yolk can cause allergic complications whereas glycerin is safer. Your doctor can recommend a bank whose procedures he/she is comfortable with.