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Technical requirements for conducting the suitability assessment of sperm and ova donors - Canada.ca
18 avr. 2025
legacy-hc-2025-04-21
ID 141634
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Technical requirements for conducting the suitability assessment of sperm and ova donors - Canada.ca
2 janv. 2026
hc-20260101
ID 428682
updated7 sections changed
7 sections modifiées0 ajoutées0 retirées+14 / -18 lignesVariation: 6%
--- +++ @@ -1,16 +1,16 @@ Technical requirements for conducting the suitability assessment of sperm and ova donors Download in PDF format-(512 KB, 15 pages)+(603 KB, 14 pages) Organization: Health Canada Published:-2024-05-08+2025-10-16 Cat.:-H164-279/2019E-PDF+H164-279/2025E-PDF ISBN:-978-0-660-31167-8+978-0-660-78599-8 Pub.:-190085+250200 On this page Purpose Abbreviations@@ -18,7 +18,7 @@ Donor suitability Transitional provisions Access the-archived version+archived versions of this page. Purpose The purpose of the Health Canada directive entitled@@ -50,8 +50,6 @@ Rhesus factor WNV West Nile virus-ZIKV-Zika virus Definitions Autosomal dominant@@ -104,11 +102,10 @@ person with infections of clinical significance person with any major systemic disorder, including systemic malignancies which might compromise the gamete person who has had a diagnosis or suspicion of WNV infection (based on symptoms and/or laboratory results or confirmed WNV viremia) in the preceding 120 days following diagnosis or onset of illness, whichever is later-sperm donor who within the past 3 months or ova donor who within the past 2 months: (i) has been diagnosed with ZIKV infection, (ii) has resided in, or travelled to, an area with ZIKV transmission or (iii) has had unprotected sex with a person who is known to have either of the risk factors listed in (i) or (ii) Subject to clause 2.1.2, in the case where the sperm donor is subject to the regular process requirements, indications of high risk for HIV, HBV, HCV or HTLV transmission, including: person who reports nonmedical intravenous, intramuscular or subcutaneous injection of drugs in the last 5 years person who has engaged in sex in exchange for money or drugs in the preceding 6 months-person who has had sex in the preceding 12 months with any person described in items (m1), (m2) or with a person known to have HIV, clinically active HBV or clinically active HCV+person who has had sex in the preceding 12 months with any person described in items (l1), (l2) or with a person known to have HIV, clinically active HBV or clinically active HCV person who has had anal sex with a new sexual partner in the preceding 3 months person who has had more than 1 sexual partner in the preceding 3 months and who has had anal sex with 1 of those partners during that time person who has been exposed, in the preceding 6 months, to known or suspected HIV-, HBV- and/or HCV-infected blood through percutaneous inoculation or through contact with an open wound, non-intact skin or mucous membrane@@ -120,7 +117,7 @@ in the case where the ova donor is subject to the regular process requirements and the donor is not required to be retested, indications of high risk for HIV, HBV, HCV or HTLV transmission, including: person who reports nonmedical intravenous, intramuscular or subcutaneous injection of drugs in the last 5 years person who has engaged in sex in exchange for money or drugs in the preceding 12 months-person who has had sex in the preceding 12 months with any person described in items (n1), (n2) or with a person known to have HIV, clinically active HBV or clinically active HCV+person who has had sex in the preceding 12 months with any person described in items (m1), (m2) or with a person known to have HIV, clinically active HBV or clinically active HCV person who has been exposed in the preceding 12 months Footnote *@@ -138,7 +135,7 @@ person who reports nonmedical intravenous, intramuscular or subcutaneous injection of drugs in the last 5 years person who in the preceding 4 months has taken any medications to prevent HIV infection, such as pre-exposure prophylaxis or post-exposure prophylaxis (sperm donor only) person who has engaged in sex in exchange for money or drugs in the preceding 12 months-person who has had sex in the preceding 12 months with any person described in items (o1), (o3) or with a person known to have HIV, clinically active HBV or clinically active HCV+person who has had sex in the preceding 12 months with any person described in items (n1), (n3) or with a person known to have HIV, clinically active HBV or clinically active HCV person who has had anal sex with a new sexual partner in the preceding 3 months (sperm donor only) person who has had multiple sexual partners in the preceding 3 months and who has had anal sex with 1 of those partners during that time (sperm donor only) person who has been exposed in the preceding 12 months@@ -157,7 +154,7 @@ 2.1.2 Alternative screening approach for imported donor sperm If the screening of a sperm donor is conducted outside of Canada, the structured questionnaire to assess the donor's risk of infectious disease transmission may include the persons described in the first criterion of section IV.E of the document entitled Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)-, published in 2007 by the United States Department of Health and Human Services, Food and Drug Administration, instead of the persons referred to in clauses 2.1.1(II)(m)(4) and (5), and in clauses 2.1.1(II)(o)(5) and (6)).+, published in 2007 by the United States Department of Health and Human Services, Food and Drug Administration, instead of the persons referred to in clauses 2.1.1(II)(l)(4) and (5), and in clauses 2.1.1(II)(n)(5) and (6)). 2.1.3 Genetic disease screening The genetic disease screening must be conducted using a structured questionnaire prepared by the medical director or a qualified professional designated by the medical director. The structured questionnaire to assess the risk of genetic disease transmission must include the following genetic disease screening criteria:@@ -233,7 +230,7 @@ 3.2.3 In the case of a repeat ova donor, testing for infectious disease agents set out in clause 2.3.3 (I) must be conducted in accordance with the donor testing requirements set out in clauses 2.3.1(I), (II), (IV) to (VI), at the time of each donation, using specimen collected within 30 days before obtaining ova or within 7 days of obtaining ova. 4. Donor exclusion A sperm or ova donor, except for a donor who is subject to the directed donation process requirements, who meets any of the following donor exclusion criteria must be determined unsuitable:-a sperm or ova donor who meets any of the infectious disease screening criteria set out in clause 2.1.1 (II) (a) to (n)+a sperm or ova donor who meets any of the infectious disease screening criteria set out in clause 2.1.1 (II) (a) to (m) a sperm or ova donor who is symptomatic or has previously been diagnosed with a serious autosomal dominant or X-linked genetic disease With the exception of Treponema pallidum@@ -253,15 +250,14 @@ A sperm donor that is screened in accordance with the criteria set out in clause 2.1 of the directive as it read on the day before 2024-05-08 may continue to meet those requirements for the purposes of donor screening under the current version of the directive. Footnotes Footnote *-The 12-month period specified in items (n4) and (n6) may be reduced to 6 months if NAT is used for the detection of HIV, HBV and HCV.+The 12-month period specified in items (m4) and (m6) may be reduced to 6 months if NAT is used for the detection of HIV, HBV and HCV. Return to footnote * referrer Footnote **-The 12-month period specified in items (o7) and (o9) may be reduced to 6 months if NAT is used for the detection of HIV, HBV and HCV.+The 12-month period specified in items (n7) and (n9) may be reduced to 6 months if NAT is used for the detection of HIV, HBV and HCV. Return to footnote ** referrer Page details-Date modified:-2024-11-05+2025-10-28