A Directed Donor is an individual who stores sperm for a designated recipient who is not his intimate spouse or partner. A Known Donor is a directed donor whose recipient has chosen to waive the recommended six-month quarantine of the donor’s semen samples. Those individuals who wish to do Personal Storage will need to go through the same processes, screenings and testings that the Directed Donors complete.
At the Seattle Sperm Bank (SSB), we encourage recipients to be involved in the directed donor screening process from the very first visit in order to ensure clear communication between all parties. The recipient is welcome to come to the initial screening process to both learn about the process and see the lab. When the recipient lives in another state, it’s important that she consult by phone with SSB. The recipient and donor will have joint decisions to make regarding the donor’s screening, how many visits he should make, and whether to wash his semen samples for intrauterine insemination (IUI) prior to storage.
First Step for Directed Donors:
Every directed donor must schedule a semen analysis and test thaw appointment with SSB prior to storing sperm. At this appointment, the donor provides an ejaculate for evaluation only; the ejaculate is not stored and can not be used for insemination. Our lab will perform a complete semen analysis on the sample, freeze it, and thaw it a day later to access how well the donor’s sperm survives freezing (anywhere from 50% to 80% of sperm die in the freezing and thawing process).
Donor Screening Requirements:
SSB follows FDA regulations, which impose strict screening requirements on all donors who store semen samples in order to reduce the risk of passing on communicable diseases through insemination. We require that the donor completes testing for communicable diseases through our own lab, and we will collect blood, urine, and semen samples to accomplish this. We also require directed donors to complete a social medical questionnaire, a medical examination (which must include a genital exam for indications of sexually transmissible infections), urinalysis, and blood testing (blood type and Rh factor, STD screen, CBC). Genetic testing for for Directed Donors is optional.
Deciding How Many Visits a Donor Should Make:
The more visits a donor is able to make, the more samples will be available for insemination attempts, which can increase the chances of conception. An average ejaculate yields between 1 and 2 vials of semen (vials are one mL (cc) if ICI and .5 mL if IUI). Most women insemination with 1+ vials per cycle attempt, and a post thaw sperm count of 20 million motile sperm per cc would be optimal to increase the chances of conception. However, there are many variables that we can discuss with you that you can then discuss with your medical provider.
Why SSB Recommends a Six Month Quarantine of Donor Semen Samples:
The Food and Drug Administration, the Centers for Disease control and Prevention, the American Association of Tissue Banks, and the American Society for Reproductive Medicine all recommend a sixmonth quarantine of donor semen samples followed by a repeat blood testing of the donor. The quarantine period is designed to cover the window period between the time an individual is infected with HIV and the time he or she develops HIV-specific antibodies that are detectable on a blood test. When donors are tested for the presence of HIV antibodies at the beginning of the storage process and then again six months after providing their last sample, recipients can have greater confidence that the samples are free from HIV and other infectious organisms. The ‘Known Donor’ Option: Waiving the Six Month Quarantine: As a licensed sperm bank, SSB follows New York State Department of health regulations for Tissue Banks. According to these regulations, ‘If the semen to be released originates from a directed donor, the recipient may be given the opportunity to waive the quarantine period in writing after being advised by the sperm bank director, his/her designee, or the physician performing the insemination of the risks involved in doing so.’ We strongly encourage all recipients to consult with a medical professional regarding the risks involved in waiving the quarantine period. Some clinics will not work with sperm samples that have not been quarantined. If the recipients waives the quarantine period, her donor will be designated a ‘known donor’, and she must sign a waiver assuming any risks of using semen samples that have not been quarantined.
Release of Donor Samples:
A directed donor’s semen samples are releasable only after SSB receives the results of his six-month blood draw; this blood draw must be done six months (180 days) after the last semen sample is provided. Therefore, we recommend grouping storage visits within the shortest time period possible so we can release all samples at once and the donor and recipient can avoid the expense of repeating exit blood draws. If storage visits extend over a period longer then three months, the directed donor must repeat all the initial testing for sexually transmissible infections. This is another argument for expediting the storage process.
A known donor’s samples are releasable immediately after the two week collection window is complete (including exam, blood work and questionnaire); this generally takes around one month. If his storage visits extend over a period longer then two weeks, the known donor must repeat all the initial testing for sexually transmissible infections. Once samples are releasable, the recipient should call to arrange for their retrieval; there is a release/waiver form to fill out for both the recipient and the medical professional. Donors sign a HIPAA form to release medical records collected by SSB to both the recipient and the medical professional prior to shipment. Recipients can either pick up samples at the SSB lab or make arrangements to have the samples shipped.
Legal Considerations for Directed Donors:
We recommend that recipients using directed donors consult with a lawyer to create a written donor-recipient contract. The National Center for Lesbian Rights (1.800.528.6257) is a useful resource as you go about doing this.