Posted: 01 Dec 2020
Author: Kelli Peirce – Senior Embryologist and Acting Quality Manager
It’s because we know how fraught with danger it can be. We have had extensive training and worked in the field for more years than we care to admit. We have seen and heard the problems first hand and we know why the legislation and regulation exists. To imply that it is all about money is simply untrue.
These tests are carried out by registered, licensed pathology service providers and the results are interpreted by highly qualified clinicians. They are not only tested for blood borne diseases like hepatitis antibodies AND antigens (to reveal not only whether someone has an active infection but also whether they have been infected or immunised in the past) and HIV, but for sexually transmitted infections (STIs) like syphilis, gonorrhoea and chlamydia. They also have their blood group, hormone levels, full blood count and karyotype ascertained, which can flag any potential issues in regards to compatibility (Rhesus incompatibility during pregnancy can cause complications during pregnancy) and possible disease.
And this goes way beyond a basic karyotype, which is simply a picture of an individual’s chromosomes. In accordance with the latest Royal Australian and New Zealand College of Obstetrics and Gynaecology (RANZCOG) Guidelines, all women and couples planning pregnancy should be offered genetic carrier screening for genetic conditions, irrespective of the presence or absence of a family history of a genetic condition or the ethnicity of the individuals1. Screening should ideally be prior to a pregnancy, so reproductive options are available to the patient/s such as preimplantation genetic testing (PGT) or non-invasive prenatal testing (NIPT).
At Fertility North, donors AND recipients undergo comprehensive carrier screening, by way of a Beacon Screening Test. This simple blood test is used to identify carriers of >350 autosomal recessive mutations and (for female patients) >50 X-linked recessive mutations which cause serious childhood-onset disorders. Approximately 70% of Australian individuals are identified as carriers for one or more disorders using this investigation: in a recent study of over 30 000 people, 1 in 3.4 people were a carrier of at least one condition! 2 Most carriers do not have a family history of relatives affected by the disorder and are unaware that they are carriers. So for us, forewarned is forearmed.
Yes, we know the sperm motility, morphology and count for each semen sample, but Fertility North donors also have their sperm DNA integrity tested and sperm antibodies checked. These tests are used by our staff to determine not just the quantity of sperm present, but the quality as well and are not routinely available at your local pathology provider, nor in a kit bought from an online supplier. Each and every sample is thoroughly analysed by staff with years of professional training and experience, so we can be sure that it meets the required criteria for use. Private donors may have had one or two semen analysis, but it is unlikely that they can provide quality assurance results, completed in accordance with international standards (ISO 15189)3 and recommendations from the World Health Organisation4 for each and every sample they produce for an at-home treatment. But we can!
Semen samples from local donors utilised at Fertility North are collected under strict conditions, in purpose built rooms right next door to our laboratory. Our staff accompany the donor to the room, where they produce their sample in a clean, controlled and private environment and as soon as the sample has been produced, it is taken straight into the laboratory where it is processed following strict guidelines by qualified and experienced staff. Samples are electronically traced from receipt until final use, and labelled using three unique identifiers, to mitigate the risk of errors. Each sample stored undergoes a test thaw, where the survival of the sperm and its suitability for use is confirmed. Imported samples are processed in a similar fashion in a similarly accredited overseas Laboratory and Fertility North is the only West Australian clinic with approval to use these samples.
Despite claims to the contrary, this is done to maximise survival and minimise damage to the sperm, whilst at the same time offering the recipient the assurance of utilising a non-infectious sample that meets minimum quality requirements. And how do we know a sample is non-infectious? Well, following cryopreservation, a strict quarantine period of 6 months must be undertaken. At the conclusion of this quarantine period, the donor once again undergoes the comprehensive blood screening to ensure that they have not acquired or developed any communicable disease/s. How regularly are private donors being comprehensively screened?
It is locked within a secure storage vessel, behind two electronically locked doors, for which only specified staff have access, within a private hospital equipped with CCTV and 24 hour security. The storage vessel is connected to a continuous monitoring system, which feeds information back to a monitoring program every 15 minutes. If one sensor misses so much as one of its scheduled readings, our staff receive an alert and can log in electronically within minutes to determine the cause of the alert. Our back up power (hospital generator) has back up power (uninterrupted power supply batteries) and this system is checked daily and tested monthly. We have read the horror stories too, and do not ever want to see our own name up in lights for all the wrong reasons.
All donors (and recipients), under WA law, must undergo at least two sessions of Psychosocial counselling six months apart. These sessions must be conducted by an Australia and New Zealand Infertility Counsellors Association (ANZICA) accredited counsellor, a Psychologist who has undertaken training in the unique psychosocial factors that donors (and recipients) must consider. What are the donor’s motivators for donating? Are they aware of their legal rights and responsibilities? How to tell future partner/s about being a donor? Implications for the donor’s own children? How to react when donor offspring seek contact with their donor parent? Donating sperm might seem a straightforward enough transaction, but there are a myriad of issues that require due consideration.
In Western Australia, donors can donate to no more than five families. Worldwide. Such family limits were recommended by donor conceived children and put in really simple terms, they exist to avoid the risk of inadvertent inbreeding or incest as a result of too many siblings. ‘Consanguinity’ refers to a partnership or marriage between two individuals from the same family. It is widely accepted that consanguine relationships can increase the risks of serious genetic disease in any resultant children. Given the significant stigma that attaches to consanguinity, the inadvertent formation of such a relationship could also lead to serious legal, social and personal consequences for a couple and their children5. But, the family limit is also important because the number of families a donor creates will have a direct and lasting impact on the life of a donor-conceived child (as well as many other people’s), and those impacts may not be all ‘rainbows and lollipops’. How would an individual feel to discover he or she has 47 half siblings distributed among 30 families located across the globe, unable to trace them, not knowing if their next encounter could be with a brother or a sister?
By utilising a licensed practitioner for donor insemination, patients have access to accurate and reliable cycle tracking. Not by using an app or body temperature, which do also have their place, but by regular blood testing and ultrasounds carried out by accredited facilities and qualified staff. A specialist clinic can determine with pinpoint accuracy when ovulation and insemination should occur and can deposit the washed sample with a known number of quality sperm higher up into the female reproductive tract in a clean and clinical setting, to optimise your chance of success, and thus minimise the number of months you actually need to try.
We have to do this as frequently as quarterly to both state and national regulatory bodies. If we fail to meet standards, we have to explain why and we are ethically obligated to put measures in place to improve on any shortcomings. We are legally required to disclose adverse events and non-conformances as well.
Fertility clinics are not all shareholder-owned and profit-driven organisations! They are owned and staffed by individuals with scruples, who put their reputation on the line. Clinics are obligated to adhere to regulations, and failure to do so can result in not just the closure of an entire clinic, but complete humiliation as well.
In Western Australia, clinics must conform with state legislation: the Human Reproductive Technology Act of WA (1991)6, the Directions under the HRT Act (2004)7 and the Surrogacy Act (2008)8. Then there are the national regulations and legislation we must abide by too: the National Health and Medical Research Council (NHMRC) Ethical guidelines on the use of assisted reproductive technology in clinical practice and research (2017)9, the Reproductive Technology Accreditation Committee (RTAC) Code of Practice (2017)10 and the Family Law Act (1975)11. All aspects of a fertility clinic’s practice are independently audited at least once a year. Clinics literally have nothing to hide and no incentive to do so either.
A private donor might claim to have 100% success rate, but how credible can such claims be? As the recipient of privately donated material, what rights and responsibilities do you have? What rights and responsibilities does the donor have? Little is known of the horror stories behind private and online sperm donation (which are likely to impact the donors just as much as the recipients), because they are not regulated and the practice requires no license, there is no independent body holding them to account. By choosing to use a private donor, you are relying on the honestly and integrity of internet strangers who may well be telling you what you want to hear. This impacts on the safety, health and wellbeing, both physical and emotional, of yourself and your donor child, not just now, but twenty, thirty and forty years from now and beyond.
No system is fool proof, and with enough determination and / or desperation, individuals will always find a way to cheat the system. However, donor treatment through an accredited clinic is really the only safe, trustworthy, accountable and proven pathway to your own family. We’re with you every step of the way.