Frozen Donor Sperm Program
International Cryogenics' frozen sperm program was organized thirty years ago, and provides one of the highest quality services available to physicians and patients working in the field of infertility. Donors are selected and screened to provide very high quality specimens. All aspects of the sperm bank are continuously updated to provide the highest standards in quality control.
All donor specimens are quarantined for a minimum of six months. From the time the specimens are collected throughout the six month quarantine period, the donors undergo extensive screening and testing. Many of the tests are repeated numerous times prior to the release of the specimens for use.
We get most of our donors from the local medical schools, dental schools and medical residency programs or by referral from current donors or people associated with our facility. Many sperm banks strive to be the largest bank, with a long list of donors to select from. We feel it is more important to be selective in choosing our donors and provide high quality specimens that are thoroughly tested.
In the area of donor identity, special precautions are taken. A donor is given a code for identification of his specimens and his medical records. The actual name of the donor is never linked with his semen specimens or his records and would never be released for any reason. Our donor program is strictly anonymous; we do not offer donors that agree to have their identity released when the child reaches eighteen years of age. There are no records in our facility or in the physician's office linking the name of the donor with that of the recipient.
Careful tracking is done to monitor and limit the number of pregnancies per donor. Tracking sheets are sent to physicians with the shipment requesting follow-up information be supplied to inform us if a pregnancy occurred. If we don't receive these tracking sheets within a given time frame we continue to contact the physician until we obtain the requested information.
Donor Testing
International Cryogenics is one of the founding members of The American Association of Tissue Banks reproductive council (AATB). AATB sets the guidelines and standards of Tissue Banking in the United States.
The screening and evaluation of the donor is the most important aspect in the current art of semen banking. Accurate and complete records are kept on all donors. These records contain information on the donor's medical history, the medical history of three generations of his family, interviews, physicals plus the results of all testing the donor has completed. These records are permanently on file at our facility.
Donors are selected and screened to provide the highest quality specimens. Donors are tested on an ongoing basis with multiple blood and culture screenings, including HIV for AIDS, Hepatitis, Cystic Fibrosis, Karyotyping for chromosome abnormalities and many others. Extensive fertility studies including a complete semen analysis, osmotic membrane integrity testing, sperm antibody testing and egg penetration assays (when necessary) are performed to ensure the donor specimens meet our high standards. The tests and measurements that are used in completing all facets of the donor screening process are the most valid in use today.
A medical history is completed on the donor and three generations of his family. Donors must have a medical history free of medical conditions that have a probable genetic link. If there is any history in the female recipient's family for genetic birth disorders, which might put them at risk for producing a child with a congenital malformation, they should inform the physician prior to any insemination. With these standards there is less risk of genetic disease transmission by donor insemination than there is in the general population.
In addition to concerns about the health of the baby, many patients are concerned about the risk of acquiring a sexually transmitted disease such as AIDS from a donor insemination. Over the past 18 years very accurate tests have been developed which detect the presence of antibodies to HIV (the virus that causes AIDS). The test indicates if a person has been exposed to the virus, and has now formed antibodies. Each donor specimen is frozen and quarantined for a minimum of six months from the date of collection. During this quarantine period donors are tested numerous times for HIV and many other sexually transmitted diseases. The specimens are only released for use after the donor has tested negative six months after the initial date of collection. Donor insemination provides a safe alternative for patients dealing with infertility.
The American Association of Tissue Banks and ICI strongly recommend that the recipient and her partner be tested for HIV, Hepatitis and other sexually transmitted diseases prior to inseminations. This is for the protection of the unborn child.
Quality Extensive fertility studies are done on the donors prior to being accepted in our donor program. Each donor specimen is analyzed before and after it is frozen to ensure the highest quality specimens. The standard ICI vials contain a minimum of 20 million motile sperm. Washed IUI ready specimens are available on most of our donors and contain 10 million motile sperm. We also have ART specimens available that are suitable for use in Assisted Reproductive Technologies such as IVF or ICSI. ART ICI vials will have a minimum of 10 million motile sperm and ART IUI will have a minimum of 5 million motile sperm per vial.
FDA Regulations
Beginning May 25, 2005 all laboratories that collect, freeze and store human reproductive tissues are required to comply with FDA rules. These regulations are specified in 21 CFR (code of Federal Regulations) part 1271. The regulations consist of three parts: Registrations Final Rule, Donor Eligibility Final Rule, Current Good Tissue Practices Final Rule.
The two rules that apply to reproductive tissue banks are:
The Registration Final Rule
The Donor Eligibility Final Rule
These rules are designed to ensure the safety of transplanted human cells and tissues.
International Cryogenics has always maintained the highest standards in the testing and screening of our donors and is continuing to implement these standards in compliance with the new FDA regulations. International Cryogenics has been registered with the FDA since 2001. Donor specimens processed prior to May 25, 2005 are not subject to the new FDA rules. Specimens that were shipped to physicians prior to May 25, 2005 are not required to have the updated documentation required by the new FDA regulations. All specimens shipped after May 25, 2005 will include a summary of records of all sexually transmitted disease testing performed on the donor and an interpretation of those records.
Copies of the new FDA Rules are available on the FDA website (www.fda.gov) or by calling the FDA 1-800-835-4709.
Donor Tests
Our sperm bank performs the following tests on all our donors:
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HIV 1 & 2 Antibody
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| HTLV 1 & 2 Antibody |
| Hepatitis B Surface Antigen |
| Hepatitis B core Antibody |
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Hepatitis C Antibody
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HIV 1 NAT ,HCV,(current donors as of 5/25/05)
HBV NAT (current donors as of 7/20/09)
CMV (Cytomegalovirus) IgG / IgM / PCR
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| RPR (Syphilis) |
| Karyotyping (chromosome analysis) |
| Cystic Fibrosis |
| Blood Chemistry Testing |
| CBC (complete blood count) |
| Chlamydia PCR |
| Gonorrhea Culture |
| Multiple Andrology Testing |
| Sperm Antigen Antibody Studies |
| *Tay-Sachs |
| *Sickle Cell |
| *Thalassemia |
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*Breast Cancer Gene testing (BRAC 1&2)
* Egg Penetration Assay
* Ashkenazi Jewish Panel (Canaran Disease,Gaucher Disease, Fanconi Anemia, Niemann-Pick Disease)
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| * Indicates tests are performed when applicable |
Making the Decision to Undergo Donor Insemination
We strongly recommend patients be counseled regarding the decision to undergo Therapeutic Donor Insemination. We hope the following information is helpful in making this decision.
There are over 5,000 babies born each year in United States who have been conceived by artificial insemination with donor sperm, also referred to as TDI (Therapeutic Donor Insemination). It was first performed in the United States in 1884 and was surrounded by much secrecy. Over 100 years later, most people still do not know much about this procedure. There are medical, psychological, religious and legal issues, which need to be considered; yet many couples thinking about TDI don't have the necessary information in order to make a well-informed decision.
People decide to choose Therapeutic Donor Insemination for many reasons. The major reason for choosing this procedure is male infertility, due to either the total absence of sperm (Azoospermia) or severe problems with their sperm, the count, motility, or morphology (shape). A man may have chosen sterilization through vasectomy and not wish to undergo the reversal surgery, which isn't always successful. He may have been exposed to radiation or chemotherapy for an illness such as cancer. Some may choose TDI to avoid transmitting a genetic disease such as Huntington's Chorea or Tay-Sachs.
The decision to go with TDI can be utilized when a woman is concerned about "the biological time clock". Women may consider going TDI due to the desire to have a child but not a relationship with the biological father.
There are distinct advantages to Therapeutic Donor Insemination. A couple can go through a pregnancy together knowing that they are providing the kind of prenatal care and protection that they want for their baby. They have the opportunity to prepare for childbirth and participate in labor and delivery together. They can be with the baby from the moment of birth. They know the genetic background of the mother and the donor, and there is a good likelihood of family resemblance.
Questions about the health of babies conceived through donor insemination reveal yet another advantage to this choice: the rate of congenital birth defects in our nation is about 6% (half of these are considered "minor"). Studies have shown the incidence of birth defects in TDI babies to be less than 1%.
The secrecy aspect of donor insemination can be another difficult decision to make. Do you tell your friends and family that you are considering inseminations or that you conceived your pregnancy through donor inseminations? If you don't plan to tell your child that he or she was conceived through donor insemination, we recommend not telling anyone. This is not something that you want your child to accidentally hear from someone else. Whether to tell the child they were conceived through TDI is a very personal and sometimes difficult decision to make. Unlike adoption the biological father's identity would never be released to the recipient or the offspring.
Making one of the most difficult decisions of your life without the help of relatives and friends increases the anxiety of deciding to go the route of donor insemination. One solution that we have found to be helpful is for patients to seek a psychologist or counselor that is trained in this area. Patients can then have open discussions about their concerns and feelings regarding donor insemination.
Patients should be counseled about the completeness of the fertility evaluation, the prognosis, and deciding a reasonable time frame to keep trying. How long is realistic for you as a couple to keep trying to conceive? Generally it is thought that if a pregnancy has not occurred after 6 months to 1 year of well timed artificial inseminations with the husband's specimens, and in the absence of severe female infertility problems, it may be time to make a decision about what to do next. If the woman's age is a factor it may be advisable to shorten that time period, so that the option of invitro fertilization or donor inseminations can be explored.
Many couples have gone to a number of different doctors, endured numerous tests and assisted reproductive procedures such as sperm washing and intrauterine inseminations and IVF with the husband's sperm without success.
It seems like there is no end in sight as more time, effort and money are invested. The greater the vested interest, the harder it is to let go of your goal, even though you begin to feel maybe it would be a relief if you were told to stop.
When a couple is told they have little to no chance of conceiving a child without the aid of TDI it is a very emotional time. Do you accept the prognosis that there is little if any possibility of a pregnancy occurring with the husband's sperm specimen? It is even more difficult when the semen analysis is classified as sub-fertile which makes pregnancy unlikely, but not impossible, especially with the reproductive technology available today. If you are waiting to be told that a pregnancy with the husband's specimen is not possible, it may never happen. Waiting for such absolute terms can be a trap, because in medicine these terms are rarely used, as the human body can be very unpredictable.
A couple should not begin TDI immediately after learning that the husband has either an untreatable infertility problem or that treatment appears to be unsuccessful. Both husband and wife need time to absorb the shock and accept the fact that he will not be able to have a biological child. Grief can be expressed in many ways. Feelings of intense sadness, anger and loss of self-esteem are common. The wife is also struggling to deal with her reactions. She is feeling many of the same emotions and may feel guilty that she still has the possibility of conceiving and that she still wants a pregnancy. Infertility and the feelings that accompany it can be one of the most difficult times your marriage will endure.
TDI should not be consented to out of a sense of guilt caused by a spouse's pressure. It is advisable to consider all possible options of assisted reproduction prior to making a decision to go with TDI. Both partners need to be totally resolved that all options of conceiving as a couple have been exhausted. Acceptance does come. There will come a point when despite your doubts and fears, other ways of becoming a parent will begin to be acceptable to you. In order to accept the idea of fatherhood through TDI (as well as adoption) you need to separate the desire for a joint biological pregnancy from the desire for parenthood. How important is it for you to have a genetic link in order to love your baby? How do you define fatherhood? Is it planting the seed, or is a father someone that raises the child with daily love, support and nurturing.
In some cases the second child born to these couples will be the biological offspring of both husband and wife. This can be due to improved fertility in both the wife (full term pregnancy often improves fertility) and husband (sperm factors can improve over time for many reasons). When both husband and wife have impaired fertility, it makes obtaining a pregnancy very difficult. Often just improving on either male or female fertility factors makes the difference in obtaining a pregnancy.
