Sperm Donor Requirements Canada
The donor`s sperm and eggs must be quarantined until certain conditions are met, including until the donor has been deemed appropriate as part of due process. In addition, donor sperm and eggs must be quarantined in the event of an error, accident or side effect. The evaluation of sperm motility is essential to determine its quality. Sperm motility should be assessed as soon as possible after sample liquefaction to limit the harmful effects of dehydration, pH or temperature changes on motilityFoot 7. In cases where sperm motility is low (less than 40%), an assessment of sperm vitality may be considered. Sperm vitality is estimated by assessing the membrane integrity of cells to distinguish immobile live sperm from dead sperm. 60 1. An establishment and a health professional who have reasonable grounds to believe that an error or accident at another establishment has occurred during the processing, distribution or importation of that semen or ova must take this into account immediately. In addition, the Medical Director should consider giving donors at risk of transmission of severe autosomal dominant diseases and dominant X-linked diseases with different manifestations and degrees of severity (such as neurofibromatosis type 1, deletion syndrome 22q11.2, fragile X syndrome and polycystic kidney disease), because donors may not know they are affected. 46 An establishment shall establish and maintain a system for tracing sperm and ova. A top-down approach was used to estimate the number of potential altruistic sperm donors in Canada. Each step of the model reflects an element that would impact donor care.
The factors included were: population, donor behaviour, medical fitness and health policy criteria. Age and sex criteria were applied to the population to identify all possible donors in Canada, while behavioural factors, medical abilities and health policy criteria were used to “filter” the pool of potential donors to estimate the potential altruistic supply of donor sperm. If screening for the donor`s genetic disease indicates a risk of serious transmission of genetic diseases, Health Canada recommends that appropriate follow-up testing be conducted to rule out a risk of disease transmission. The medical director may also consider recommending follow-up testing for serious genetic diseases that prevail in the donor`s ethnicity. It is important to note that the safety rules do not apply to sperm and eggs from a spouse, life partner or sexual partner of the recipient. The need for re-validation should be assessed when changes are made to a validated process. Depending on the type and extent of the changes, revalidation may be required. For example, changes that could affect initial validation, process characteristics and/or human health and safety or sperm and ova safety must be revalidated. The terms “genetic disease screening” and “genetic disease testing” have often been used interchangeably in the literature.
However, the safety rules have been developed with a clear distinction between these two terms. Donor genetic testing is the systematic application of the examination or collection of information about a donor`s family medical and genetic history in order to identify and assess the risk of transmission of a particular genetic disease to a person born from his or her donation. This includes screening a donor for clinical evidence of a genetic disease or determining the donor`s potential carrier status through their family genetic history. Genetic testing, on the other hand, involves performing a test to analyze the donor`s DNA, RNA, chromosomes, proteins or metabolites to detect the presence of mutations or chromosomal changes in the donor that could indicate the risk of transmission of genetic diseases. Like many parents of a child born from anonymous sperm donation, Nancy Bowe joined the Donor Sibling Registry to connect with some of her daughter`s half-siblings. That was about ten years ago. She knew there would be many – her Hamilton fertility clinic said her donor had been popular – but when she looked at the photos of the families listed there, she realized she knew one of them. It turned out that his ex-wife`s ex had chosen the same donor. Health Canada may suspend part of a registration to address certain issues or elements of a registration without affecting any recorded activity. This could include a partial suspension to remove from registration an entity carrying out activities on behalf of the principal entity (e.B. removal from a test facility where there are reasonable grounds to believe that the semen or oocytes have been or may be affected). This could also include the elimination of activities related to one of the sperm or eggs, but the other elements of the registration would still be valid (for example.B problems with sperm processing but not eggs were detected).
As part of the directed donation process, directed sperm donors do not need to be retested for infectious agents (i.e. at least 180 days after donation) and the use of fresh sperm is allowed. However, revised donor selection criteria have been included to account for some of the risks that may be associated with the use of fresh sperm. For example, referred donors are screened for the use of antiretroviral drugs to prevent HIV infection (including pre-exposure (PrEP) or post-exposure (PEP) prophylactic drugs in the past 4 months. In the rare cases where a person gets an HIV infection despite PrEP or PEP, these drugs can delay the detection of HIV infection. An establishment must have procedures in place to ensure that the integrity of the sperm or ova obtained is preserved. This procedure shall be specified in the standard operating procedures of the establishment and may include the following documented evidence: 90 1. This Section applies to semen obtained before the date of entry into force of this Regulation and which, despite the requirements of Sections 22 to 40, may be distributed, imported and used only if, with the exception of Treponema pallidum and CMV, a donor of semen or ova: which has tested positive for any of the infectious agents listed in section 2.3.3 (I).
Donations received between test intervals during which chlamydia trachomatis and Neisseria gonorrhoeae infection cannot be excluded will be rejected. Affected sperm or oocytes that are being examined by mistake or accident should remain in quarantine until the results of the examination determine that the safety of the sperm or ova has not been compromised. As part of the process control program, a change control system must be established and maintained to identify, document, review, approve and control all processes. Any changes to processes, supplies, equipment and facilities that may affect human health and safety or the safety of sperm and ova must be properly documented, validated, carefully evaluated, approved and managed. .