Objective
This agreement provides a description of how a human sperm survival assay requested by CUSTOMER will be performed at FertiPro NV.
Responsibilities
- It is the responsibility of FertiPro NV to assure that a human sperm survival assay requested by CUSTOMER is performed according to this Standard Operating Procedure (SOP) and according to FertiPro’s internal work procedures and instructions.
- It is the responsibility of CUSTOMER, with each request, to complete the Sample Submission Form in Annex of this SOP with all necessary information and requirements in order for FertiPro NV to perform a human sperm survival assay that meet CUSTOMER’s needs. Further, CUSTOMER is responsible to ship an adequate volume of the required test sample(s) under adequate conditions to FertiPro NV and to keep FeriPro N.V. updated on these shipments (e.g. tracking number).
Test requests
A human sperm survival assay is requested by CUSTOMER via email (test@fertipro.com) by providing the completed Sample Submission Form in Annex of this SOP.
If upon receipt of the samples by FertiPro NV there would be any unclarity (i.e. on the identification of the test samples, on the test procedure to follow, …) or deviation from a specified condition, CUSTOMER will be contacted to provide more information before a human sperm survival assay is started by FertiPro NV.
Test procedure
During a human sperm survival assay, the motility of human sperm (i.e. 100% x (A+B+C)/(A+B+C+D) (motility category system according to the World Health Organisation)) is determined after exposure to a test item (ratio 1:1) for a CUSTOMER-defined period of time and compared to sperm exposed to a control medium for the same period of time. A human sperm survival assay is always performed on fresh sperm (no frozen-thawed sperm is used).
Test criteria
Following criteria apply for valid human sperm survival assays performed by FertiPro NV:
- Following 1 hour or 4 hours exposure of sperm to the positive control, the % recovery of motile sperm cells must be respectively ≥ 80% when compared to analysis after 10 minutes exposure.
- Following 24 hours exposure of sperm to the positive control, the % recovery of motile sperm cells must be respectively ≥ 75% when compared to analysis after 10 minutes exposure.
Reporting results
Human sperm survival assay results are documented on a HSSA-Certificate of Analysis (HSSA-COA) according to FertiPro’s internal procedures and instructions. Compiled HSSA-COAs are provided to CUSTOMER as PDF by email.
Failure and retests
FertiPro NV will notify CUSTOMER via mail or telephone in case of failure of a performed human sperm survival assay. Confirmation will be asked to CUSTOMER to schedule a re-test. Retesting will be performed on an unopened back-up sample. If no back-up sample is available, CUSTOMER will be asked to provide an additional test sample.
Administrative notes
- All records related to a human sperm survival assay are retained by FertiPro NV for a period of 10 years.
- Invoices will be mailed to CUSTOMER upon completion of the requested human sperm survival assay(s).
- After testing, test samples will be discarded at FertiPro NV, unless it is otherwise stated by CUSTOMER.
- FertiPro NV guarantees impartiality in all human sperm survival assays performed.
- FertiPro NV guarantees confidentiality in all information obtained during human sperm survival assays performed on CUSTOMER’s test product(s). No information will be placed in the public domain, unless this would be required by law (in which case CUSTOMER would be notified, as permitted by law).
Internal references
| FP09 I53 | Instruction: Performing a human sperm survival assay. |