DONATED CRYOPRESERVED OOCYTES 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 OOCYTES as per the protocol requirements set forth below:
- It will be necessary for the Client/Donor to contact the current facility that is storing your Oocytes 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.
- A copy of a comprehensive physical by a licensed Medical Doctor for the individual female donating their Oocytes. Clients donating Oocytes 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 oocytes at SEBNJ (see listing below):
The laboratory testing must have been completed not more than 30 days prior to the Oocytes retrieval. Alternatively, testing shall be performed to bring Client/Donor to meet compliance requirements any time before the Oocyte(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 Oocytes 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 Oocyte(s).
- Request and Consent for Transfer and Waiver of Tissue Suitability.
- Informed consent, release and agreement for participation in Oocyte(s) Donor program
- Informed consent, release and agreement for laboratory and genetic testing for Oocyte Donor program
- It is the responsibility of the Client/Donor to request the release to SEBNJ of the following documents from the current facility holding the Oocyte(s) prior to the transport/transfer for the authorized release to SEBNJ:
- A copy of the cryopreservation data such as (1) when the Oocyte(s)were cryopreserved (2) the date of freezing (3) 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 Oocyte(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 Oocytes 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 Oocyte(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) 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.