**5. Sperm donation**

#### **5.1 Applications for sperm donation**

In cases of severe male infertility, single or lesbian women, the use of donor sperm is the only approach to address fertility issues (Botchan et al., 2001; Golombok, 2005). Advances in

term storage of semen samples (Clarke, 1999). Newer types of high efficiency LN2 vapour freezers and others that have a LN2 "jacket"' provide working environments of below -

Amongst the many government or professional organizations that require periodic inspection of frozen samples, the standards put forward by Health Canada are the strictest (Health Canada, 2000). Rigorous standards of operation are essential for sperm banks. Sperm banks must have specific requirements for screening, processing and quarantine of samples. Licensing is required in some countries and sperm banks are inspected in accordance with existing standards or regulations. While auditing is absolutely necessary, it might pose the risk of exposure of frozen specimens to room temperature while such inventory is performed. Straws thaw more rapidly than vials and can warm up to -80°C within 8 to 15 seconds at room temperature, dramatically increasing the possibility of damaging samples during inventory or verification of samples' identity (Tyler et al., 1996). Clear labelling systems to easily identify and link samples to a specific donor or patient must be in place to enable sample location and for performing inventory. The samples should remain in LN2 during the duration of inventory performance and the audit must be

Several facility and equipment-related quality control and risks factors must be considered for cryopreservation and storage of semen. Physical security of bank facilities and proper identification of sample location within freezers is crucial. Equipment must be appropriate and functional, with defined periodic service and maintenance schedules. Staff must be supplied with all necessary personal protective equipment. Adequate supplies of LN2 gas must be guaranteed and spare LN2 prefilled tank must be available in case of emergency. All staff involved in handling LN2 must be properly trained by a certified organization. Standard operating procedures must be developed to clearly describe each step of the process of sample collection, processing, banking and handling. Annual reviews of both proper documentation and LN2 training must be performed. Temperature of freezers chambers and LN2 levels in tanks must be monitored on a continuous basis and all data logged in secure databases. Alarm systems and appropriate call procedures must be in place to attend to any emergencies. 24 hour monitoring and response is absolutely essential to safely maintain the integrity of the clinical samples in storage. Storage rooms must be monitored continuously for O2 levels and staff activity in enclosed spaces must be monitored to avoid hypoxic injury. Backup power generation must be available in the event of a power failure. Each sample designated for storage has to be properly verified, assessed, processed, labelled, frozen and stored. Double-checking the identity of samples at each step is highly recommended. Some banks choose to divide samples from individual patients or couples and store them in different tanks or locations to minimize the risk of total loss of

In cases of severe male infertility, single or lesbian women, the use of donor sperm is the only approach to address fertility issues (Botchan et al., 2001; Golombok, 2005). Advances in

160°C and are more suitable for sperm banks.

**4.4 Quality control and quality assurance** 

performed by qualified and skilled staff.

their biologic material (WHO, 2010).

**5.1 Applications for sperm donation** 

**5. Sperm donation** 

sperm cryopreservation have created opportunities for many families to achieve pregnancies through therapeutic donor insemination or IVF with donor sperm. Pregnancy rates are estimated to be around 10-12% per unstimulated cycle and can be achieved when at least 5 × 106 progressively motile spermatozoa inseminated into the lower cervical canal on 2–3 occasions during the ovulatory phase of menstrual cycle (Scott et al., 1990). At present, some 30,000 births per year worldwide are attributable to frozen donor sperm inseminations (Mortimer, 2004). While this seems like a large number, it may fall in the future, as the recruitment of sperm donors is increasingly difficult due to complicated and strict regulatory procedures, as well as lack of interest from potential donors.

The screening process for donor sperm is quite rigorous and includes obtaining a complete medical and sexual history, physical examination, psychological assessment and laboratory work-up on blood, urine and semen specimens to screen for pathogens including Hepatitis B, C, Human Immunodeficiency Virus (HIV 1&2), Human T-cell Lymphotrophic Virus (HTLV 1&2), Treponema pallidum (Syphilis), Cytomegalovirus, Chlamydia trachomatis and Neisseria gonorrhoea. Sperm banks perform genetic screening for heritable diseases based on the ethnic background of sperm donors (eg. Cystic Fibrosis for Caucasians). Donors must be retested after the required quarantine interval, and specimens may be released only if the results of repeat testing are negative. Specimens can only be used after they have been quarantined for a minimum of 180 days to avoid the risk of HIV transmission. Donor eligibility restrictions apply to employees of sperm banks, poor donors' health or quality of the semen and in some countries by sexual orientation of the donor, as gay or bisexual men are considered at higher risk for HIV and prohibited from being sperm donors in some countries (including Canada and USA). Many countries have age restrictions for sperm donation. The minimum age is usually 18 and the maximum 40 years of age (Health Canada 2000, American Society for Reproductive Medicine (ASRM), 2004)
