Cryopreservation services for Sperm, Embryos & Eggs for future transplant
PROTOCOL FOR THE TRANSFER AND STORAGE
OF DONATED CRYOPRESERVED EMBRYO(s)
DONATED CRYOPRESERVED EMBRYO(s) will not be released for implantation without the proper chain of custody.
SEBNJ is ready to undertake the transfer and storage of your DONATED CRYOPRESERVED EMBRYO(S) as per the protocol requirements set forth below:
It will be necessary for the Clients/Donors to contact the current facility that is storing your Embryo(s) prior to the transfer. You must allow sufficient time for both SEBNJ and your current facility to process all documents and schedule a smooth transfer.
SEBNJ must receive copies of a comprehensive physical by a licensed Medical Doctor for both the Oocyte Donor and Sperm Donor responsible for creating the donated Embryo(s).
Clients (Oocyte Donor and Sperm Donor) donating Embryo(s) must provide laboratory test results for "High Risk" infectious diseases as defined by the FDA and NYSDH. The laboratory testing must be performed by a CLIA licensed and FDA registered laboratory using FDA approved tests, prior to the transfer and acceptance for cryostorage of Embryo(s) at SEBNJ (see listing below):
The laboratory testing must have been completed not more than 30 days prior to the Embryo(s) creation. Alternatively, testing shall be performed to bring Clients/Donors to meet compliance requirements any time before the Embryo(s) are transferred to SEBNJ:
RPR (Syphilis Serology)
Hepatitis B Surface Antigen
Comprehensive Chemistry profile
(to incl. ALT) CMV, total
Hepatitis B Core Antibody
Hepatitis C Virus Antibody
Chlamydia and Gonorrhea, (DNA testing)
Cystic fibrosis screening
B- thalessimia screening
The Client/Donor of the Embryo(s) are required to complete and submit the following prior to transport and transfer (these forms are available at SEBNJ).
Request for Attestation for Origin of the Cryopreserved Human Embryo(s).
Request and Consent for Transfer and Waiver of Tissue Suitability.
The Oocyte Donor and the Sperm Donor must each complete an individual Informed consent, release and agreement for participation in the Embryo Donor program.
The Oocyte Donor and the Sperm Donor must each complete an individual Informed consent, release and agreement for laboratory and genetic testing for participation in the Embryo Donor program
It is the responsibility of the Clients/Donors to request the release to SEBNJ of the following documents from the current facility holding the Embryo(s) prior to the transport/transfer for the authorized release to SEBNJ:
A copy of the cryopreservation data such as (a) when the Embryo(s) were cryopreserved (b) the date of freezing (c) labeling information to ID the vial(s)/straw(s) and/or cane. In addition, the freezing and thawing protocol from the harvesting/freezing facility must be provided to SEBNJ prior to the transfer/transport of the Embryo(s).
A copy of a valid state license, if applicable, or a valid accreditation certificate and/or a valid certificate from a federal regulatory agency, for the harvesting/freezing facility. For Embryo(s) harvested and cryopreserved in New York State, a valid New York State Department of Health Tissue Bank License is necessary, unless a transfer order for Embryo(s) has been issued to SEBNJ by a Federal or State Health Department or agency or by a court order.
SEBNJ will not initiate or accept the transfer of any vial(s) and/or straw(s) containing the Embryo(s) without the receipt of all completed and signed documents and results for laboratory testing. Documents may be mailed, emailed or faxed prior to the transfer.