Frequently Asked Questions
How does Cryobiology recruit sperm donors?
What viral, baseline, and sexually transmitted testing is performed on semen donors?
What genetic testing is routinely performed?
Are all donors completely anonymous?
Do you quarantine samples prior to release?
What is the difference between prewashed and ICI vials?
How many sperm cells are provided in each vial?
What is your replacement policy?
What information about the donors is available to me?
How do I proceed with choosing a donor?
What if I want the Medical History on every donor for in which I am interested?
What other services do you provide for choosing donors?
What do I need to place an order?
How are the vials shipped?
Can you ship directly to my home?
Can I pick up my order from the lab?
What is the limit for the number of pregnancies established by one donor?
How do I ensure the same donor will be available for future use?
What are the Sperm Banking Background Fundamentals?
Glossary
How does Cryobiology recruit sperm donors?
Cryobiology advertises for donors on local college campuses. Donors are initially screened for sperm count and cryosurvival of sperm cells. If the donor has acceptable results, a family health history is obtained and reviewed by a genetic counselor. Tests for viral and sexually transmitted diseases are initiated and, the donor undergoes a physical. Once all testing and screening is completed and results are appropriate, he can begin collecting specimens for potential sale. Less than 10% of all potential donors are accepted into the sperm donor program and fewer are actually ever released for sale. The process is extremely thorough and selective. Please see www.Becoming a Donor.com for more information.
What viral, baseline, and sexually transmitted disease testing is performed on semen donors?
Once donors are accepted into the program, a routine CBC and Hemoglobin Electrophoresis are performed to screen for blood disorders. Viral antibody testing includes HIV 1 and 2, HTLV-I and II, Hepatitis B, Hepatitis C, Cytomegalovirus, and Syphilis. Follow-up NAT (nucleic acid test) or DNA based tests are performed for HIV I and Hepatitis C. Urine is analyzed for Chlamydia and Gonorrhea. All testing is performed at minimum 3 month intervals. Repeat semen samples are quarantined at least 180 days and the donor is re-tested prior to release of vials for sale.
What genetic testing is routinely performed?
We perform cystic fibrosis carrier testing on all donors as well as karyotyping (chromosomal analysis). Additionally, donors with Jewish, French Canadian, or Cajun backgrounds are tested for Tay Sachs disease. Donors with Jewish backgrounds are further screened for Canavans Disease and Familial Dysautonomia. All donors accepted since 1999 have been screened for blood disorders such as Thalassemia and Sickle Cell Anemia via CBC and Hemoglobin Electrophoresis. Please contact Cryobiology if you are a carrier or have concerns about any of those conditions so that we can confirm appropriate testing for your situation has been preformed.
Are all donors completely anonymous?
Currently, all Cryobiology donors are completely anonymous. We do have a number of donors in the program who have agreed to contact from potential offspring in the future. However, no formal program has been established to date. We are working on creating such a program, but do not have the details worked out just yet. We do not want to mislead you by stating that such a program exists, but there are donors who have expressed such interest. Please call the office for details.
Do you quarantine samples prior to release?
All samples are quarantined a minimum of 180 days and the donor is then re-tested for required viral and sexually transmitted diseases. Upon receipt of acceptable results, samples are released for sale. Most samples released have been quarantined longer than the 180 day minimum and donors have had multiple test panels performed.
What is the difference between IUI and ICI vials?
IUI= IntraUterine Insemination ICI= IntraCervical Insemination The difference between IUI and ICI vials is that ICI vials contain seminal fluid while IUI vials do not. If your physician is performing an intrauterine insemination, all seminal fluid must be removed from the sample using a wash process prior to the insemination. The wash can be performed on the frozen sample after a vial is thawed just before the insemination (as is done with ICI vials) or before the vial is frozen (as is done with IUI vials). Regardless of when the sample is washed, the process is required before an IUI can occur. During natural intercourse, semen is deposited at the base of the cervix. The cervix acts as a natural filter, eliminating all seminal fluid so that only sperm cells enter the uterus. The wash process accomplishes the same thing. When the cervix is bypassed during an intrauterine insemination, only sperm cells are introduced into the uterus.
How many sperm cells are provided in each vial?
Cryobiology, Inc. guarantees approximately 30 million motile cells per ml with approximately 40% forward progression for ICI vials, which are a full 1 ml volume. For prewashed vials, the volume is 0.5 ml and contains approximately 20 million motile cells per ml with approximately 50% forward progression. The guarantees are stated as approximations due to variation in methodology used to perform analysis at different laboratories. There will always be differences in counting and analysis between technicians. The guarantees are approximations to be used to ensure good quality samples are received. Two or 3 points in either direction will not significantly increase or decrease the chance of establishing a pregnancy.
What is your replacement policy?
If a vial is significantly below our guarantee, Cryobiology, Inc. requires that the patient or the laboratory performing the analysis contact us as soon as possible. A copy of the formal lab report will be requested for review by our Quality Assurance department. A decision will then be made whether the vial will be replaced upon the patient's next cycle pending pregnancy results for the current cycle. If the pregnancy test is positive, no replacement will occur. CRYOBIOLOGY DOES NOT REFUND THE COST OF VIALS OR SHIPPING. We will only replace an inadequate vial for the next cycle. Shipping costs are not included for replacement vials.
What information about the donors is available to me?
The information on the Donor List, the Donor Profile, the Donor's Medical History, and In Your Own Words essays are available to you for all donors. Additionally, donor silhouettes, audio interviews, baby photos, and current photos are available on those donors who have given Cryobiology consent to release those items.
All Cryobiology donors are anonymous. Any information released about an anonymous donor is non- identifying. The donor profile is a physical description of the donor and is created by Cryobiology staff. It also includes a short summary of the donor's personality and interests. Additionally, we offer a copy of the donor's medical health history. This three- generation family health history is completed by the donor upon acceptance into the donor program and is updated periodically while he continues to participate. The In Your Own Words essay offered for each donoor is photocopied (includes the donor's handwriting) so that written expressions can be evaluated in addition to the medical information. Some donors choose to allow additional information such as baby photos, audio interviews, and silhouettes to provide more non-identifying information about themselves. Donors are not required to participate in release of this information however. Some donors are very open about their donation and agree to release current photos of themselves and also possibly be contacted when offspring reach 18 years of age. Just as each donor is unique in physical characteristics, they are also unique in release of information.
All donors sign a consent form upon acceptance into the program, which waives any rights or responsibility to children born to patients who use their sperm. Patient data, established pregnancies, miscarriages, birth information or any other tangible information concerning patients is never released to a donor unless by mutual consent of the donor and offspring.
How do I proceed with choosing a donor?
You can proceed however you feel most comfortable. Our system is designed so that you can first use the Donor Search to narrow the list of donors which meet your blood type or ethnicity requirements. You can then review the Donor Profile of each selection for additional physical details. From the profiles, you should be able to narrow your choice and then request the Medical History, In Your Own Words, and/or additional information (silhouette, audio, photos) the donor has agreed to release on each of them. Your final decision can be based upon that review. See Choosing a Donor for additional information.
What if I want the Medical History and additional information on every donor in whom I am interested?
You can purchase as many Medical Histories, Photos, Silhouettes, and Audios as you like. There is no limit.
What other services do you provide to help me choose a donor?
We offer Photo Matching Services in addition to the self-serve information available. If you send in multiple photos of the person or people you want to match a donor to and a short physical description of the traits most important to you, we can suggest donors for you to consider. You can do this instead of the initial match yourself or in conjunction with a system you have initiated. We can also comment on how well, in our opinion, you matched a certain person. Please include a Photo Match form with each photo match request as well as the required fee (see form).
What do I need to place an order?
You open an account when you call to place the order or place your first order online. You must be under the direct care of a physician. However, we do not have any forms or consents for you or the physician to complete. When you place the order, please have the donor number, the number of vials you are ordering, the date the order needs to arrive at the physician's office, and a form of payment. Alternatively, your physician's office can place your order and Cryobiology will bill the physician. It is best to check with your physician's office for their ordering protocol prior to placing your first order.
How are the vials shipped?
Vials are shipped in specially designed shipping containers, or tanks, which hold the temperature of nitrogen vapor (at least -130 degrees Celsius). This vapor keeps the vials frozen at an appropriate temperature prior to use. The shipping tanks undergo routine quality control measures to help ensure they are able to maintain this temperature for up to 7 days. Shipping tanks are shipped via Courier next day delivery. Please be aware that despite all precautionary measures and reputable courier use, thawing does occasionally occur and shipments can be lost. Plan accordingly when ordering specimens.
Can you ship directly to my home?
We work only with patients who are under the care of a licensed physician. As such, we only ship directly to the physician's office unless a written request from the physician is provided specifically requesting that a shipment be delivered to your home. This request must state the donor number, the number and type of vials, your name, and the request to ship to your home. This must be on file before the order is released.
Shipping fees are as follows:
Courier Standard Overnight-delivery by 3:30 next business day $150
Courier Priority Overnight- delivery by 10am next business day $170
Courier Saturday- limited delivery area, call for availability $190
Courier First Morning- very limited delivery area, call for availability $210
Client tank pick up and return $20 - Required tank deposit (refundable)$850
Courier delivery (within Columbus only $65
International delivery- varies per shipment
Call for shipping services not listed.
Prices subject to change without prior notice.
Can I pick up my order from the lab?
You may pick up your order from the lab and deliver it directly to your physician's office. Again, the same documentation is applicable as when a shipment is delivered to your home. You must obtain a written request from the physician that the order be released to you. You can either take the vial or the processed (washed) specimen (if ICI vials were ordered). Again, if the vial is to be processed, it must clearly be stated on the physician's request. Alternatively, you can pick up the order in a shipping tank so that it can remain frozen until needed by the physician. This works well for inseminations which may be scheduled on the weekend. The physician can then thaw and prepare the sample accordingly. Whenever a tank is taken from the lab, you will be required to sign an acknowledgement of responsibility for care of the tank and pay a refundable deposit for the cost of the tank.
What is the limit for the number of pregnancies established by one donor?
We strongly encourage all physician offices to report pregnancies to us. We analyze this information quarterly to determine when a donor reaches 10 pregnancies in a certain geographical area, determined by population. At that point, the donor is no longer available for distribution in that area, except for sibling pregnancies.
How do I ensure the same donor will be available for future use?
The only way to ensure a donor will be available for future sibling pregnancies is to reserve vials and keep them in long term storage. In order to reserve vials, they must be purchased and the long term storage fee paid annually. Additional vials can be added to your inventory at any time with no additional storage fee. There is no limit to the number of vials stored. One storage fee covers all vials stored. When you no longer need the vials in long term storage, Cryobiology will purchase any unused vials, provided they have not left our storage facilities and the donor is still available on our donor list. If the donor is no longer available on the donor list, we will help you find a buyer for the vials by advertising them on the Donor List. You will receive a refund of your purchase price less a 20% restocking fee, when they are purchased. Please refer to the Services Offered (Storage) section of our website for additional details.
PLEASE REMEMBER THAT DONORS COLLECT SAMPLES FOR A LIMITED PERIOD OF TIME. ONCE ALL VIALS ARE SOLD, NO MORE WILL BE AVAILABLE!
Sperm Banking Background Fundamentals
The following background information on sperm banking was prepared by and agreed upon by the leading companies in the industry. It's purpose is to provide basic information about some of the key elements of a sperm bank's operations and influence further understanding by providing accurate and consistent information.
1. Regulations: Sperm banking, which includes the screening and testing of sperm donors, is an increasingly regulated activity. Effective on May 25, 2005, the U.S. Food and Drug Administration (FDA) commenced its regulation of reproductive tissue banks (21 CFR Part 1271). The FDA's regulatory focus includes standards for the screening and testing of donors and proper record keeping procedures. Since these regulations became effective, all major sperm banks have been audited for compliance by the FDA through on-site inspections. FDA inspections will be performed on a continuing basis.
In addition to federal regulation, most major sperm banks are also licensed and inspected by several states, particularly New York, California, and Maryland. Licensing by state agencies began as early as 1992.
Although not having the force of law, sperm banks also have conducted operations consistent with the guidelines and/or standards of professional organizations such as the American Society of Reproductive Medicine (ASRM) and the American Association of Tissue Banks (AATB).
Notwithstanding the regulatory oversight of government agencies and professional associations, most sperm banks have exercised self-regulation consistent with the highest medical and ethical standards. In fact, most major sperm banks were performing more than all the tests required by the FDA several years prior to the FDA's effective date, and with greater frequency than required by the FDA and other regulatory agencies.
2. Statistics: The popular press often cites the number of anonymous donor inseminated births per year at 30,000. Although no industry-wide statistics are maintained, an unpublished survey conducted by the AATB suggests that a more accurate figure would be 4,000 to 5,000 donor inseminated births per year. (This is calculated based on 1.5 vials per insemination, a 10% pregnancy rate per cycle, and a 20% spontaneous miscarriage rate.) By extrapolating this annual figure, the total number of anonymous donor inseminated births is estimated to be less than 130,000 over the last 30 years.
3. Limitations on Donor Distribution: All surveyed sperm banks use some type of standard to limit the number of births attributable to any one donor. Some use the actual number of births while others use the number of family units. For example, one standard used is the guideline of the ASRM, which is currently 25 births/donor per 800,000 (1 birth per 32,000) in a circumscribed population, i.e., the population surrounding the location where donor inseminated births are reported as occurring. Another method to limit the number of donor inseminated births is to establish an absolute number of births per donor, e.g., 10. Reports of a donor having many offspring should be viewed in the context of such births typically occurring throughout the nation, and not in a limited area. Notwithstanding the standard used to limit the number of births per donor, sperm banks do not limit the number of births within a family unit, thereby permitting full siblings via donor insemination.
4. Donor Information: As part of the screening process to determine donor eligibility, sperm banks gather a great deal of family (3 generations) and personal medical history. In addition, while donating, donors are given a physical examination every six months, and are also tested for a wide array of infectious diseases at least every six months. Most sperm banks also perform chromosome analysis (karyotype) and test for many common genetic diseases such as cystic fibrosis in the general population, and genetic conditions common to certain ethnic groups (e.g., sickle cell trait for African Americans). Donors are interviewed extensively to check for consistency and accuracy of reported information. In addition to the screening and testing of donors used to establish medical eligibility to donate, sperm banks also offer other "soft" information on its donors such as childhood photos, personality tests, audio interviews, staff impressions, and personal profiles. It has been said that the amount of medical and personal information on an anonymous donor greatly exceeds the knowledge most people have of a known partner.
5. Donor Anonymity: The maintenance of donor anonymity is essential to the availability and quality of donors. There are those who believe that the identity of all donors should be known, and such disclosure is, in fact, required in a number of countries such as the United Kingdom and Australia. But the consequence of this requirement has been a severe shortage of donors in those countries, since most donors do not want to be known. However, the industry is sensitive to the desire by some for "known" donors as an alternative to anonymous donors. Consequently, now most of the major sperm banks offer donors who have agreed to have their identities disclosed to their offspring at age eighteen. Interestingly, known donors are not selected disproportionately more than anonymous donors. Since it is clear that many want their donors to remain anonymous, sperm banks do not think it is wise to destroy the anonymous status for ALL donors. To do so would breach the contracts and representations made to donors and to those who selected an anonymous donor, and eliminate for a large segment of potential users of sperm donors, the much wanted option to select a forever anonymous donor.
GlossaryA | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z
Andrology- The study of male fertility/infertility.
Alpha and beta thalassemia - heritable, abnormal conditions of hemoglobin synthesis. These conditions occur in both the alpha and beta chains and are found most frequently in Asian and Mediterranean populations, respectively.
Artificial insemination - a procedure performed under a physician's direction whereby a prepared semen sample is placed into the uterus or cervix in an attempt to establish a pregnancy. Most commonly, a woman's sexually active partner or donor semen is used.
Audio interview - an audio recording of the donor's response to various questions. The recording allows potential recipients to hear the donor's voice and his reactions and responses to the questions.
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Client depositor - A male who freezes sperm for his own use in the future. A client depositor is not a donor.
Cryopreservation - the act of freezing and thawing.
Cryoprotectant - an additive to a processed semen sample which enhances the survival rate of the cells during cryopreservation. The most common cryoprotectant added to human semen is glycerol.
Cryoprotectant buffer - an additive to a processed semen sample which enhances the cell's ability to survive cryopreservation. The buffer "coats" the cells and protects them during cryopreservation and also acts as an energy source for the cells.
Cystic fibrosis - a hereditary condition in which the body produces an excess of thick mucus affecting the respiratory system and pancreas. Cystic fibrosis is the most common recessive genetic condition in Caucasian populations.
Cytomegalovirus - A virus in the same family of viruses as the herpes virus. Once exposed to CMV, the virus is always harbored in the body, either in an active or a dormant state. Symptoms, which are similar to a bad case of the flu or bronchitis- type symptoms, are often mild and overlooked in healthy individuals. Donors are tested for active or contagious states of the virus while participating in the program. If detected, samples are not released for sale. Physicians differ in opinions about the significance of CMV, therefore, recipients should consult their physician before proceeding with insemination.
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Directed donor - A donor who is known to the recipient and who directs his semen for use by a particular recipient.
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ICI - Intra-Cervical Insemination. An artificial insemination procedure whereby the processed semen sample is deposited at the base of the cervix. The premise is that cells will swim through the cervix and into the uterus. Sperm specimens containing seminal fluid can be inseminated intra- cervically because the cervix acts as a natural filter, removing the seminal fluid, which is seen as foreign to the uterine environment.
ICSI - Intra-Cytoplasmic Sperm Injection. An assisted reproductive technology procedure in which the superovulation and egg retrieval portion of an IVF procedure is performed first. Rather than allowing fertilization to occur by combining sperm and eggs in a petri dish as in IVF, a single sperm cell is injected into each egg to result in fertilization. ICSI is often used for males with compromised motility, which may prevent the sperm cell from penetrating an egg on it's own. Resulting embryos are cultured to a certain cell stage and then transferred as in an IVF procedure.
In your Own Words essay - A one page response to 4 essay questions required of all donors. We photocopy the page to allow potential recipients to see the donor's handwriting, spelling, etc. if those things are important in your decision-making process.
IUI - Intra-Uterine Insemination. An artificial insemination procedure whereby the processed semen sample is deposited directly into the uterus. Specimens used for IUI cannot contain seminal fluid and therefore must undergo a wash process to remove it either prior to cryopreservation or prior to the insemination.
IVF - In Vitro Fertilization. An assisted reproductive technology procedure in which the female is superovulated in order to produce multiple eggs in a single cycle. The eggs are retrieved just prior to natural ovulation and are fertilized by adding the male's sperm into the same petri dish in the laboratory. The resulting embryos are cultured until they reach a certain cell stage and then a number of the best embryos are transferred back into the uterus. Remaining embryos not transferred can be frozen for future cycles.
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Karyotype - an analysis of the chromosomes.
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Liquid nitrogen - the environment in which cryopreserved specimens are stored and shipped. The liquid phase of nitrogen is -196°C. Cryopreserved specimens are stored at this temperature in the laboratory. The vapor phase of nitrogen has a slightly higher temperature. Shipping tanks used to ship and deliver specimens maintain vapor temperature since the vapor phase facilitates shipping.
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Long Term Storage - Storage for one year or longer at Cryobiology.
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Medical health history - a three generation family health history of a donor. Typically includes the donor and his siblings, the donor's parents, aunts and uncles, and the donor's grandparents. The medical health history may contain information about other family members as well if it is known.
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NAT - Nucleic Acid Test-a test to detect the genetic material of a virus within the body. The advantage of NAT over traditional antibody tests is not having to wait for the body to produce antibodies to the virus prior to detection; NAT provides results much sooner after infection.
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Profile - a two page summary of the donor. The first page is a physical description of a donor including personality observations. The second page is an abbreviated medical health history. The profiles are created by Cryobiology staff.
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Seminal fluid - semen without the sperm cells. The fluid from accessory sex glands helps transport the sperm cells through the reproductive tract and provides some support to sperm cells. Seminal fluid is removed prior to intra-uterine inseminations.
Seroconversion - the act of converting from negative to positive on a blood test.
Sickle cell anemia - a heritable condition of the hemoglobin whereby the red blood cells take on a sickling shape instead of the characteristic round shape. The sickling shape prevents the red blood cell from carrying oxygen adequately. Sickle cell anemia is most prevalent in African American populations.
Silhouette - side view (profile) of a donor in black and white format. The silhouette is designed to provide an outline of the donor's facial features without sacrificing his anonymity.
Short Term Storage - Storage for no longer than 3 months at Cryobiology.
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Tay Sachs - a fatal metabolic disorder, hereditary in nature, which predominantly occurs in populations of Jewish descent, French Canadian, or Cajun ancestry.
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Vial - the container in which the semen sample is cryopreserved and stored. Each Cryobiology vial is labeled with the sperm bank name, the donor number and the date the semen sample was collected.
