Sperm Motility Standards
The following are Cryobank’s specimen quality standards:
|Specimen Type||Total Motile Cells/ milliliter (TMC)||Clinical Use|
|IUI||10 million/vial||Washed vials, ready for intrauterine insemination (IUI)|
|ICI||10 million/vial||Ready for intracervical insemination (ICI) or can be washed for use in an IUI or IVF with/without ICSI|
|IVF||5 million/vial||Ready for ICI or can be washed for use in an IUI or IVF with/without ICSI|
|IUI ART||> 6 million/vial||Ready for IUI or can have post thaw processing and be used for IVF with/without ICSI|
|ICI ART||> 6 million/vial||Ready for ICI or can be washed for use in an IUI or IVF with/without ICSI|
Fairfax Cryobank has frozen donor sperm specimens specifically prepared for three types of procedures: direct intrauterine insemination (IUI and IUI ART are washed), intracervical insemination (ICI and ICI ART are unwashed) and In Vitro Fertilization following a post-thaw wash of all specimen types (IVF, ICI, ICI ART, IUI, and IUI ART). Our specimens have been frozen after the addition of a freeze medium containing a cryoprotectant that will protect the cells during the freezing and thawing process.
Fairfax Cryobank specimens are color-coded to indicate the preparation type. IUI/ IUI ART specimens are color-coded with an ORANGE cap, ICI/ICI ART specimens are color-coded with a RED cap, and IVF doses are color-coded with a WHITE cap.
IUI and IUI ART ready frozen donor sperm has been prepared by washing the fresh ejaculate to remove the seminal plasma prior to freezing.
ICI, ICI ART, and IVF specimens contain seminal plasma and require additional processing if used in procedures other than intracervical insemination.
IVF versus ART Vials:
Recently we have experienced a rise of questions regarding our IVF and ART prep vials. The popularity of the IVF vial has proven that an economical alternative to purchasing a full insemination dose is needed in IVF situations. Thus, in order to better serve this market, Fairfax Cryobank has decided to phase out the IVF prep vial and replace it with the ART prep vial. ART vials can be used exactly the same way that the IVF vials were being used, but the ART vial offers a couple of advantages over the IVF vial.
IVF vials: The word IVF implies that the vial is designed for IVF (in vitro fertilization), and therefore, at times is confused that it could only be used for that purpose, when in fact it can be used in any insemination procedure. Fairfax Cryobank produced IVF vials in response to feedback from clients who were looking for an economical alternative to purchasing our standard IUI and ICI vials, which contain 10 million total motile cells (TMC) per vial, and only needed donor sperm as a back-up in an IVF procedure with or without Intracytoplasmic Sperm Injection (ICSI).
The number of sperm cells needed in an IVF procedure with/without ICSI is considerably less than what is typically used for an ICI or IUI procedure. Although the IVF vial can be, and is used in ICI and IUI procedures, typically 2 vials are purchased to get a “full” complement of total motile cells, as the IVF vials contain only 5 million TMC per vial.
ART vials: The name ART better describes the potential uses of our NEW ART prep vial. ART means Assisted Reproductive Technology. All procedures that involve the use of insemination techniques fall under the ART designation and hence the NEW name.
There are two advantages to the NEW ART prep. First, Fairfax Cryobank ART vials come in two preparation types: ICI ART (unwashed) and IUI ART (pre-washed). Both the IUI ART, and ICI ART, can be used for all insemination types; however, post-thaw prep may be required. IVF procedures may require additional post-thaw preparation of specimens as well. Second, our ART vial contains more total motile cells than our IVF prep starting at a minimum of 6 million TMC and going up to > 10 million TMC per vial.
ART vial use: If used in an IUI procedure, the IUI ART does not require further preparation after being thawed. Both ICI ART and IUI ART vials can be used in IVF with/without ICSI, ICI, and IUI procedures but may require post-thaw processing. Going forward, we anticipate that the ART vial will be more popular than the IVF vial.
Processing, Packaging and Freezing:
All donor sperm specimens are produced onsite at the Fairfax Cryobank facility and tracked with a 3-part tracking label to verify the donor of origin. All specimens are processed using methods to provide protection from contamination of the specimen during processing.
Before freezing, a freezing media containing a cryoprotectant buffer is added to the specimens to protect the sperm cells and membranes during the freezing, storage, and thawing process. Fairfax Cryobank completes a bioassay test of each lot of freeze media to determine its suitability before use.
After processing, and addition of the freeze media, 0.5 ml aliquots of the specimen are packaged in individual vials for ICI and IUI-ready specimens; IVF specimens are processed with volumes of 0.5-1.0 ml aliquots. All vials are labeled with the unique donor number, freeze date, vial #, and a code for the facility of origin.
After freezing, the vials are stored at -196 degrees Centigrade in liquid nitrogen tanks for 6 months quarantine. The donor is subsequently retested for infectious disease before the specimens are released for use. The liquid nitrogen tanks are specifically designed with alarm systems for safety and security of the specimens.
More is Not Always Better
We all often fall into the societal pressure to accept that more or bigger is better, but that isn’t always the case. Sometimes there is an optimal amount, as is the case of the number of sperm required to achieve pregnancy through insemination.
At Fairfax Cryobank we have a specimen quality standard that all vials (ICI and IUI) will have a minimum of 10 million Total motile cells (TMC) per vial. We chose to put 10 million TMC per vial after careful consideration of data from laboratories at the Genetics & IVF Institute, our parent company founded in 1983, and extensive literature review.
Several studies demonstrate that when it comes to pregnancy rates, more is not always better. There is an observed plateau in pregnancy rates once the concentration of cells reaches 10 million. (Van Voorhis et al, 2001) & (Cressman et al, 1996).
We have carefully calculated what we believe to the optimal concentration of cells in the specimen for the ultimate goal of bringing home a healthy happy bundle of joy.
Specimen Quality Standard
Terms and conditions of the Fairfax Cryobank and Cryogenic Laboratories, Inc. (hereafter referred to as «Cryobank») Anonymous and ID Option specimen quality standard:
a. Sperm counts will vary 10-30% depending on the lab personnel and counting method. Laboratory variation is expected and taken into consideration when processing complaints. The possibility exists that sperm counts performed at other laboratories may be less than the stated specimen standards. Semen is not a homogenous or uniform mixture which adds to sample variability. A variation in count does not indicate the specimen is not suitable for insemination or that a pregnancy will not result if used for an insemination. Cryobank takes these variations into account when determining eligibility for refund or credit.
b. The physician/clinic must follow the Cryobank’s printed thaw procedures enclosed in each shipment. Thaw procedures may vary among specimen types.
c. Our specimen quality standard applies at the time of thaw and prior to any post thaw processing. Sperm cells will be lost in the process of washing a specimen. A pre-processing count must be taken to determine if the specimen meets the Specimen Quality Standard. If the physician’s office is not able to provide a pre-processing count and the specimen was washed and/or processed before use, you can expect the total motile cell (TMC) count to be less than the stated quality standard. We back our quality standard at the time of thaw only.
d. Specimens stored outside the Cryobank longer than 120 days are not eligible for refunds or credits. We do not have control over the storage and handling practices of outside laboratories or at other storage facilities.
e. Our shipping tanks will keep specimens frozen for 7 days. Physicians or laboratory personnel who receive our tanks containing specimens should check the tank upon arrival to be sure that the specimens arrive frozen. If you suspect that specimens have thawed, please call 1-800-338-8407 immediately and speak with a Client Services Representative. If the specimen arrives thawed, we will ship via FedEx Priority Overnight Service replacement specimens at no charge. If replacement specimens are shipped and not used, they can only be returned to the Cryobank for storage and are not eligible for any credit. If a replacement specimen is not available on your donor, a different donor you select of equal value may be substituted. If a specimen from a different donor is not an acceptable solution, you will be credited for the cost of the thawed specimens and the cost of shipping. Shipping tanks are available that will keep the specimens frozen for 14 days for an additional charge. Contact Client Services for details.
f. If a specimen’s TMC tests below our quality standard prior to any additional processing, the physician/clinic must report specific specimen data and submit a complaint within 30 business days of thawing. Notification is to be made by calling 1-800-338-8407 to file a complaint over the phone with our Client Services department and receive the necessary Specimen Complaint Form or by downloading the Specimen Complaint Form directly from our website at: Medical Professionals.
g. Shipping costs cannot be refunded unless specimens arrive thawed.
h. If pregnancy or fertilization is achieved, the client is not eligible for any refund or credit, regardless of the total motile count (TMC) of the specimen prior to or after any processing.
i. The Cryobank’s liability for any deficiency in specimen quality will be limited to supplying a replacement specimen or full or partial refund for the cost of the specimen only, excluding shipping fees, at the Cryobank’s discretion. The Cryobank will in no event be liable for any consequential or incidental damages, including but not limited to any additional or associated expenses incurred by the patient during infertility treatment.
j. This specimen quality standard is void if ownership of specimens is transferred to a different owner prior to use.