Everything you ever wanted to know about donor sperm, but were afraid to ask!

Printer-friendly version

As of June, 1996 semen for assisted conception has been classified by Health Canada in the same category as drugs and therefore falls under the authority of the Food and Drugs Act (FDA)(1,5). Under this law it is now necessary to adhere to the regulations governing the processing and distribution of semen samples as outlined in the Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations) document (2). 

Regulations governing the procurement, processing and distribution of donor semen for assisted conception have endured many transformations since 1986 when the question regarding guidelines on donor insemination was raised at the Annual General Meeting of the Canadian Fertility and Andrology Society (CFAS) held in Toronto.

At that time, it was determined that the published guidelines of the American Fertility Society (now the American Society for Reproductive Medicine (ASRM)) were "in a number of ways, either inappropriate for Canada, insufficient, or, in one or two specific matters, incorrect "(3). Consequently, Canadian guidelines were developed by the CFAS and they were approved by the Board of Directors and the general membership in October, 1988.

The guidelines were again re-vised in 1992, 1996 and 2000 (3). The 2000 revision expand-ed the donor selection criteria and the testing requirements for transmissible diseases, specifically outlining the conditions that had to be met in order to distribute semen samples processed prior to March 14 2000 (i.e. the date the CFAS 2000 Guidelines became effective) (4,5).The CFAS 2000 guidelines were then converted into the Technical Requirements for Therapeutic Donor Insemination (the Directive) by Health Canada and became effective on July 27, 2000 (4,5).  

Over the past few years Health Canada has issued Guidance (1), Clarification (4,6), and Inspection Strategy (7) documents to assist semen processors and distributors in understanding the Regulations. Canada now has very stringent screening and testing requirements of semen donors.

To ensure public safety, what factors should be considered when choosing donor sperm?

Has the semen establishment (clinic, physician’s office, semen bank) undergone regular inspection by Health Canada and are the semen samples compliant with the semen regulations?

Health Canada schedules inspections on a yearly basis or once every 2 to 4 years depending on the activity of the semen establishment (5). Semen samples must be checked to ensure that they satisfy the regulations prior to their distribution for use in the treatment of women undergoing donor insemination (2).

What are the requirements to become a sperm donor? Can anyone be a donor?

All prospective donors must complete an extensive questionnaire, pass a physical examination, satisfy the rigorous standards for semen analysis, have a risk-free medical and family history, and undergo infectious disease and genetic disease testing (8). Only about 3-5 % of prospective candidates eventually satisfy all these requirements to be accepted as sperm donors (9).

What are some of the tests the donors must undergo?

Donors must have blood tests for HIV1 & 2, HTLV 1 & 2, Hepatitis B & C, Syphilis, Cytomegalovirus, and their semen samples must be tested for Chlamydia, Gonorrhea and general microbiological organisms. All semen samples must be placed in quarantine by freezing them for a minimum of 180 days to allow for repeat screening and testing before they can be released for distribution (8,10).

Are other tests performed inaddition to those specified in the semen regulations?

Additional tests that are performed include chromosomal analysis, testing for Cystic Fibrosis carrier status, Alpha -1 antitrypsin deficiency carrier status (S & Z mutations), Human Papilloma (HPV) virus, and Herpes simplex virus types 1 & 2. However, not all sperm banks perform these additional tests.

Are state of the art testing methods used to detect infectious diseases?

Test kits used for screening or detecting infectious diseases must be approved or licensed under the Canadian Medical Devices Regulations or must be as effective as those specified by Health Canada in the Technical Requirements for Therapeutic Donor Insemination (the Directive) document (8). Testing labs may employ cutting edge technology such as polymerase chain reaction (PCR) which detects a genetic copy of the virus in the cells (9).

Are ethnic donors (eg. Jewish, African, Chinese Mediterranean) tested for conditions specific to their ancestry?

Donors of French Canadian ancestry may be tested for carrier status for Tay Sachs, while donors of Jewish descent may be tested for Tay Sachs, Canavan, Gaucher, Breast & Ovarian Cancer (BRCA-1) gene mutations and Niemann-Pick carrier status. Donors of African descent may be tested for sickle cell anemia and other hemoglobinopathies while Asian, Middle Eastern and Mediterranean donors may be tested for Thalassemia.

REGISTER OF AVAILABLE DONORS

What information about the donor does it contain?

Information about the donor’s ethnicity, height, weight, hair and eye colour, blood type, education, occupation and interest should be available (9). Most semen banks will have a donor register or catalogue with this information available on their website for easy viewing and downloading.

Beyond the basic information, is additional information available about the donors and their families?

Most donors have provided extensive medical and personal profiles in addition to childhood photos, audio CDs, donor essay, photo donor likeness and personality profiles. This additional information is usually available at a cost ranging from $10.00 - $150.00. Photo matching may be an option if there is a person you want the donor to resemble. Actual adult photographs and videos of the donors cannot be provided in order to protect the identity of the donor as required by the Semen Regulations. It is the responsibility of the semen bank or fertility clinic to protect the confidentiality of the donor.

Does the semen bank have an adequate inventory of samples for the donors listed in the register?

Nothing can be more frustrating than spending hours selecting a particular donor only to find that his samples are no longer available. To avoid this situation, semen banks try to maintain up to date inventory records. It is important that samples are acquired in advance, especially if you are planning to have another pregnancy using the same donor.

How do I order samples?

Depending on the setup in your physician’s office or clinic, orders can be submitted by fax or e-mail by you or the clinic staff. Delivery is usually a set day of the week but can be arranged overnight by courier.

WASHED & UNWASHED SAMPLES

What is the difference between washed and unwashed samples?

Seminal plasma contains prostaglandin hormones which can cause uterine cramping. In washed samples, the prostaglandins are removed prior to cryopreservation. These samples can then be used for either intrauterine insemination (IUI) or intracervical insemination (ICI) when thawed. Unwashed samples do not have the seminal plasma removed prior to freezing and if not washed after thawing can only be used for intracervical insemination.

INTRACERVICAL AND INTRAUTERINE INSEMINATION

What is the difference between intracervical and intrauterine insemination?

In an intracervical insemination, the thawed semen sample is drawn up into a catheter and deposited around the cervix (opening to the uterus). In an intrauterine insemination, the washed sperm sample is transferred into the uterus by means of a catheter directly through the cervix.

SAMPLE QUALITY GUARANTEE

Is sperm quality guaranteed?

Most semen banks will guarantee that the sperm samples will have a minimum of 35% motility and at least 10 million motile sperm in the thawed sample. This is more than adequate to achieve pregnancy.

What are the costs for unwashed and washed samples?

The costs for unwashed samples range from $225.00 - $350.00 and for washed samples they range from $275.00 - $400.00. Shipping costs are in the range of $50.00 - $200.00, and handling charges are typically $25.00 per order. GST is applicable to all shipping and handling charges, but not for donor sperm which is zero-rated.

REFUND POLICY AND PROCEDURE

Is there a refund/replacement policy and under what conditions would a refund or replacement sample be issued?

Most sperm banks have a sample quality guarantee and would refund the cost for or replace a sperm sample that falls below this quality level providing the thawing and semen assessment instructions have been followed by the physician’s office or clinic. The refund procedure may require a written request from the physician or clinic as well as information about the quality of the thawed sample.

How easily can information on the donor be accessed?

Most semen distributors have web sites and brochures that contain information about their company and their donors. Updated donor registry information (catalogue) can be viewed and downloaded in the privacy of your home. Toll-free phone and fax lines make it easier to fax orders or contact the distributor without having to incur additional costs.

What is the typical pregnancy rate with donor sperm?

Pregnancy rates using cryopreserved donor sperm is in the range of 9 – 20% per cycle. (9,12) and are not only dependent on the individual but also the clinic. The clinic statistics should be evaluated before proceeding with treatment.Factors that affect pregnancy rates include maternal age or other infertility factors, timing of ovulation, sperm source (bank) and semen quality (13,14).

Is there a limit to the number of babies that can be conceived from one donor within a geographical area?

Sperm banks rely on the physician or clinic using the sperm samples to provide pregnancy outcome information to them. While limitations to donor use is not addressed in the Semen Regulations, it is difficult to provide a precise number of donor offspring in a given population without first considering the population base from which the donor was recruited, as well as the geographical area served by the donor (11). The American Association for Reproductive Medicine guidelines suggest that limiting a single donor to no more than 25 births in a population of 800,000 would avoid an increased risk of inadvertent consanguineous conception (ie. offsprings from the same donor producing children) (11). This guideline may require modification if the recipient population represents an isolated subgroup or if the samples are distributed over a much wider geographical area (11).

Can I reserve samples for future sibling pregnancies?

Sperm bank inventory changes on a daily basis so if you are considering future pregnancies with the same donor it is prudent that you purchase units and have them stored either at the sperm bank or your doctor’s office or clinic. If the samples are stored at the sperm bank and are no longer needed, the sperm bank may refund you part of the purchase price. However, in most cases, once the samples have left the sperm bank they cannot be returned for a refund as there is no guarantee that the samples were properly stored.

Are there provisions in place to test the donors for diseases that may be identified in the future?

Semen banks may store serum, semen and DNA from the donor for future testing if required.

Is someone available to answer questions?

Semen banks should have knowledgeable staff to assist patients in making their final selection and be able to respond to their questions within 24 hrs.   As the regulations governing the procurement, processing and distribution of donor semen for assisted conception changes, there will be new factors to consider when selecting a sperm donor to be the biological father of your child. There should not be any questions that you are afraid to ask when making this important and emotional decision. Feeling comfortable with the sperm bank you have chosen, understanding the process you are undertaking, having available all the necessary information and dealing with knowledgeable sperm bank staff can make a seemingly overwhelming decision much easier.

Haimant Bissessar, B.Sc. is Vice-President of CAN-AM Cryo Services Corp., the Canadian distributor of Fairfax Cryobank donor sperm. Can-Am Cryo Services is located in Hamilton, Ontario.

1. Guidance on the Processing & Distribution of Semen for Assisted Conception Regulations - June 27th, 2001.
2. Processing & Distribution of Semen for Assisted Conception Regulations - December 1st 2000.
3. CFAS guidelines for Therapeutic Donor Insemination 1988, 1992, 1996 and 2000.
4. Therapeutic Products Program Guidance on the Donor Semen Special Access Programme December, 2000.
5. The Donor Special Access Programme (DSSAP) - December 2000.
6. Clarification of the Repeat Testing Requirements Specified in the “Health Canada Directive: Technical Requirements for Therapeutic Donor Insemination” - October 2001.
7. Inspection Strategy For Semen Establishments (POLICY 0023) - July 29th, 2002.
8. Health Canada Directive Technical Requirements for Therapeutic Donor Insemination - July 27th, 2000.
9. Hazelrigg, B. Donor Insemination: Sperm Banks Offer Many Choices. INCIID Insights, volume 1 issue 3, 2002.
10.  Guidance on Donor Semen Special Access Programme: Donor Semen Eligible for Special Access - November 27th, 2002.
11. Guidelines for sperm donation - The American Society for Reproductive Medicine. Fertility and Sterility, Volume 77, No. 6, SUPPL. 5, June 2002.
12.  Thyer A, Patton P, Burry K, et. al. Fecundity trends among sperm donors as a measure of donor performance. Fertil Steril 1999;71:891-5.
13. Carrell D, Cartmill D, Jones K, et.al. Prospective, randomized, blinded evaluation of donor semen quality provided by seven commercial sperm banks. Fertil Steril 2002;78:16-21.
14. Bissessar H, Cowan L, Neal Michael et. al. Reorganization of a donor insemination program. CFAS 2001 annual meeting.

http://www.outreachhealthservices.com - Website of the Canadian distributor for Xytex Corporation

http://www.repromedltd.com - Website of Reprodmed Ltd, a Canadian sperm bank.

http://www.canamcryo.com - Website of the Canadian distributor for Fairfax Cryobank

http://www.cfas.ca – Website of the Canadian Fertility and Andrology Society

http://www.asrm.com - Website of the American Society for Reproductive Medicine