SASREG COVID-19 ART Guidelines Update | 24 April 2020

Apr 24, 2020

Introduction

We have been observing with great anticipation and concern on how the COVID-19 pandemic is unfolding. The South African’s infection rate has certainly demonstrated a unique character since the lockdown. Whilst the Ministerial Advisory Group is trying to predict what trajectory the graph is going to follow, we as fertility care providers are concerned about what health risks the pandemic pose to our patients but are equally concerned on the negative impact a prolonged lockdown might have on certain time-sensitive patients’ reproductive rights. We are following the guidance from other Societies which has been faced with similar challenges. There is however no blueprint and we need to continuously review our statement in order to balance our decision, whilst the pandemic unfolds. SASREG recognize that oncofertility cases need to be seen and treated during this pandemic. SASREG also acknowledges that the flattening of the infectious pandemic curve can also be prolonged and that some time-sensitive patients’ reproductive rights might be compromised. It is, therefore, the responsibility of the reproductive specialist to assess each case on its merits and to discuss the treatment options with the patient. Conventional fertility treatment in the good prognostic group of patients should be postponed.

SASREG has made three guidelines on COVID-19 and ART and they are published on the SASREG website. https://sasreg.co.za/guidelines/

  1. The first guideline was published on the 19th of March. This was a general guideline to do IVF in a safe way. https://sasreg.co.za/guidance-on-fertility-care-and-surgery-during-covid-19-19-march-2020/
  2. The second guideline was published on the 24th of March. This was the day after the President of South Africa declared a national lockdown. This guideline recommended a suspension of all non-urgent fertility services. https://sasreg.co.za/guidance-on-fertility-care-and-surgery-during-covid-19-240220/
  3. On the 10th of April, we published a legal opinion that defines infertility as an essential service and that legally urgent ART can be performed during the national lockdown if the clinical director finds it indicated. https://sasreg.co.za/guidance-on-fertility-care-during-covid-19-10-april-2020/

Based on this legal opinion SASREG feels that in certain circumstances fertility clinics could consider initiating fertility treatments. These categories could be considered as essential services:

  1. Patients of advanced age.
  2. Patients with a diminished ovarian reserve.
  3. Patients with poor prognosis for whom time is essential.
  4. Oncofertility patients.

All Fertility Units, freestanding or as part of a hospital needs to abide by regulations as stipulated by the Department of Health. Fertility Clinics, part of a hospital group needs to adhere to regulations stipulated by hospital management. Directors of fertility units have the obligation to secure a safe environment for patients and staff and to implement risk reduction strategies during this COVID-19 pandemic. This document is a guideline and can be revised in accordance with international standards and local developments. It is the responsibility of every clinic to decide if these recommendations are applicable to their specific situation. SASREG proposes the following strategies during the COVID-19 pandemic:

  1. Protective measures of staff and patients.
  2. Assisted Reproductive Techniques during COVID-19 pandemic
  3. Testing of suspected COVID-19 infection.
  4. Recommendations for ART unit cleaning for COVID-19.
  5. Psychological support during the COVID-19 pandemic.

1. Protective measures for staff and patients

Clinics should have a separate screening room for staff and patients prior to entering the clinic.

  • Use Informative posters throughout the clinic.
  • Compliance is easier if the guidelines are clear and simple.
  • Consider regular meetings with staff to address concerns.

1.1. Staff:

  1. Stagger shifts in order to maintain distance from one another.
  2. Create rotating teams were possible to limit exposure between staff members.
  3. At home before coming to work: self-screen: are you healthy?
  4. At work: Frequent hand washing. Sanitize hands when soap and water are not available.
  5. Cough etiquette.
  6. Mask etiquette (cloth or medical type according to local guidelines and availability).
  7. Maintain 1.5m distance in the staff dining area.
  8. Vaccination of health workers. The seasonal flu vaccine is regarded as mandatory by the DOH.
  9. Work in scrubs and change and shower once at home.
  10. Adequate planning of the clinic’s diary, to avoid crowding of patients in the waiting room.
  11. No paperwork should be done by the patients in the clinic. The patient should email the signed documents and referral letters where available together with a copy of ID or passport.

1.2. Patients:

“We are here to support you during your fertility care”

  1. Offer teleconsultation.
  2. Limit accompanying persons. Only patients to enter the clinic.
  3. Wearing a mask is compulsory.
  4. Screen for flu symptoms or recent exposure in a separate COVID-19 screening room prior to entering the clinic
  5. All patients should sanitize hands.
  6. Option to bring own gown.
  7. Maintain a safe distance (1.5m) in the waiting room.

1.3. If an employee develops flu-like symptoms during the workday:

  1. Sent home immediately.
  2. Surfaces in the workplace should be cleaned immediately and disinfected.
  3. Compile a list of people who had close contact with the employee including 24 hours prior. Close contact is defined as greater than 15 minutes of face-to-face contact.
  4. Anyone with close contact with the employee should be considered exposed until the final diagnosis. NICD guidelines should be followed.

 2. Assisted Reproductive Techniques during COVID-19 Pandemic

  1. ART treatment to be initiated for time-sensitive patients as defined by SASREG.
  2. Patients wanting to start treatment should be asymptomatic and should have had no contact with someone diagnosed with COVID-19.
  3. The use of telehealth (telephone consultation, Skype etc.) is recommended for treatment cycle planning and patient counselling.
  4. The number of treatment cycle monitoring visits should be reduced where possible. Blood tests to be done only if absolutely essential during the treatment cycle to minimize visits to laboratories.
  5. Patients to come alone for treatment cycle monitoring visits.
  6. All standard precautions and preventative measures as stated by the National Department of Health should be strictly adhered to during all patient visits to the clinic.
  7. OHSS to be avoided. The use of the antagonist protocol for IVF treatment, with the use of the GnRH agonist to trigger for the maturation of the oocytes, is recommended in patients at risk of developing OHSS.
  8. Elective egg freezing or embryo freezing for later embryo transfer is strongly recommended.
  9. Screening of patients to be done prior to admission to theatre for egg retrieval, according to case definitions published and adapted by the NICD.
  10. Patients who are currently on a treatment cycle and then develop symptoms or come into contact with someone with COVID-19 should not come to the clinic. They must inform the clinic immediately via telephone or email. The local authority dealing with COVID-19 should be informed.
  11. Patients to avoid all non-essential travel during the treatment cycle.

3. Recommendations on COVID-19 testing of staff and patients

No facility can be regarded as COVID-19 free due to the limitations of testing. All measures in keeping with international and local guidelines will be taken to protect patients and staff.

  1. Testing of suspected COVID-19 infection should be done according to NICD Guidelines. (V9. 31 March 2020).
  2. Universal testing of all staff or patients are currently not supported by evidence but could be justified in a high prevalence area or where there is an outbreak. Clinics can consider testing all patients for SARS-Cov-2 at the start of IVF stimulation.
  3. The National Pathology Group does not currently recommend the use of rapid point-of-care serology tests for the diagnosis of COVID-19, nor does it consider these tests to be appropriate.
  4. SASREG recognises that the guidelines on COVID-19 testing can be reviewed and that routine testing of staff and patients could become mandatory.

4. Recommendations for ART unit cleaning for COVID-19

4.1. General notes

  1. Due to the novelty of the SARS-CoV-2, routes of infection of embryos and within IVF culture systems are not yet clear.
  2. Stringent infectious control policy should be implemented, with SOP’s updated to include:
    • meticulous cleaning at increased frequencies of all working and touched areas and equipment,
    • strict procedures while handling of infectious samples and
    • obliged use of PPE.
  3. In the case of staff rotations, the entire ART unit should be cleaned between changes of teams.
  4. Disinfectants must be examined to ensure to be an effective viricide that specifically includes enveloped viruses. Instructions of use to provide the necessary viricidal effect must be followed strictly.

4.2. Clinic and other areas that patients have access to 

  1. The male patients should be encouraged to produce semen samples at home, and their partner can bring the sample to the laboratory within an hour.
  2. Commercial viricidal disinfectants may be used to clean communal areas and non-lab items, but the build-up of any residue should be avoided by wiping with tap water afterwards.
  3. After consultation with a patient, door handles and chairs that patients occupied should be wiped with disinfectant. The floors and surfaces (including chairs and table-tops) of the clinic and other communal areas should be thoroughly cleaned at the beginning or end of each day.

4.3. Laboratory

Movement between sections (people, deliveries, samples)

  1. Movement between the laboratory and clinic staff should be reduced to a minimum. Telephonic communication between clinical and laboratory staff or patients are encouraged.
  2. Since the SARS-CoV-2 virus is transmitted in droplets that adhere to surfaces, the external surfaces of any item entering the laboratory should be considered potentially contaminated.
  3. Deliveries to the laboratory should be removed from outer packaging, and sealed products wiped with ART safe disinfectant, before entry into the IVF laboratory.

Cleaning

  1. Washable cloth masks may be used outside of the laboratory and during routine work, while surgical masks and safety glasses are recommended when processing bodily fluids.
  2. Cleaning of laboratory areas, ART items and equipment should be performed with ART safe disinfectants.
  3. Hands (with or without gloves) should regularly be washed or doused with ART safe disinfectant. Clean gloves should be donned between cases and samples.
  4. Door handles and pens used in the lab should regularly be wiped with disinfectant (frequency dependent on lab activities and at the discretion of laboratory managers).
  5. Ensure at least five complete air changes between procedures (twenty minutes) in procedure rooms where patients are present (oocyte screening and embryo transfer), in order to remove possible airborne droplets containing viral elements.

Handling semen

  1. Semen sample cups:
    1. may be wiped with ART safe disinfectant upon receipt and before being placed in a warming oven,
    2. should only be opened within a Class II Biosafety Cabinet (BSC), to avoid any aerosol escaping the sample cup into the laboratory,
    3. can be handled while wearing two pairs of gloves over each other, to facilitate removal of a contaminated pair, if needed, without compromising staff safety.
  2. Due to aerosol formation during centrifugation, semen processing tubes should only be opened inside the BSC and the use of closed centrifuge buckets is advised.
  3. Upon the final step of semen processing, care must be taken not to contaminate the outside of the sperm container. In addition, this container can be securely capped and wiped with ART safe disinfectant before taken into the embryology section of the IVF laboratory.

Handling oocytes & embryos

  1. Aseptic techniques must be adhered to when handling aspiration tubes and equipment.  If preferred, only the embryologist could handle the aspiration tubes. Alternatively, a theatre staff nurse, observing sterile techniques, can assist with the aspiration tubes.
  2. Once inside the laboratory, the screening of oocytes can commence as per the usual protocol, within a BSC, or IVF workstation while appropriate PPE is worn. Oocytes should be rinsed thoroughly before transfer to culture droplets to ensure any possible trace of blood (possibly containing SARS-CoV-2) is removed.
  3. Standard laboratory protocols for insemination of oocytes and culturing of embryos can continue, however, it is at every ART Unit’s own discretion to employ more stringent embryo protection protocols, such as semen decontamination, ICSI etc. Repetitive rinsing of oocytes and embryos in wash droplets are advised.
  4. To avoid cross-contamination between cryopreserved samples (either gametes or embryos), or contamination during thawing, closed cryopreservation carriers and/or dedicated liquid nitrogen dewars are recommended.

5. Psychological support during the COVID-19 pandemic

  1. Creating video clips a few times a week of 59 seconds with information, direction, encouragement to provide support- on all social media platforms. Get House of Fertility, IFAASA, Empty Wombs and all alliances to promote- not clinic specific but SASREG driven.
  2. Weekly Webinars via Zoom with various topics for patients to access for support and debriefing.
  3. Online stress management course due to COVID-19 which is a ten-session stress management program available on an application.
  4. Provide frequent debriefing to staff.
  5. Consider continuing with egg donor assessments virtually, so psychological assessments are done.
  6. Surrogacies with existing applications can be considered as an essential service as their applications are running out of time. Encourage patients to apply for an extension through an advocate.
  7. Each clinic to have a psychologist available for support via online media.

This document was made by the SASREG board and the SIG Embryology Committee. 

The following people have contributed to the SASREG guidelines on COVID-19 and ART:

Dr Jack Biko, Prof Igno Siebert, Dr Nomathamsanqa Matebese, Dr Sagie Naidu, Dr Victor Hulme, Dr Gerhard Hanekom, Dr Yusuf Dasoo, Dr Abri De Bruin, Dr Chris Venter, Dr Paul le Roux, Mrs Gloria Raidani, Mr Gerhard Boshoff, Prof Carin Huyser, Mrs Lydia-Els Smit, Mr Neville Moodley, Dr Marie-Lena Windt de Beer, Dr Zozo Nene, Mrs Mandy Rodrigues, Prof Silke Dyer and Dr Sulaiman Heylen.

References

  1. Adams JG, Walls RM. Supporting the Health Care Workforce During the COVID-19 Global Epidemic. JAMA. Published online March 12, 2020. doi:10.1001/jama.2020.3972.
  2. American college of Surgeons: COVID – 19: Guidance for Triage of Non-Emergent surgical Procedures, Online March 17, 2020. https://www.facs.org/covid-19/clinical-guidance/triage.
  3. ASRM: Patient Management and Clinical Recommendations During the Coronavirus (COVID-19) Pandemic – As of March 17, 2020. https://www.asrm.org/globalassets/asrm/asrm-content/news-and-publications/covid-19/covidtaskforce.pdf.
  4. Baukloh V. (2017). Chapter 26: Hygienic Standards in the IVF Laboratory. In: Rizk, B. & Montag, M. (Eds.). (2017) Standard Operational Procedures in Reproductive Medicine: Laboratory and Clinical Practice. CRC Press. p 64-6.
  5. Cascella M, Rajnik M, Cuomo A, et al. Features, Evaluation and Treatment Coronavirus (COVID-19) [Updated 2020 Mar 20]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK554776 (Accessed: 16 April 2020)
  6. Centers for Disease control: Coronavirus Disease Guidelines 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html.
  7. Chen H, Guo J, Wang C, Luo F, Yu X, Zhang W, et al. Clinical characteristics and 
intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020;395(10226):809-15.
  8. Elder K, Van Den Bergh M & Woodward, B. (2015). Troubleshooting and Problem-Solving in the IVF Laboratory. Cambridge University Press.
  9. ESHRE: Coronavirus Covid-19: ESHRE statement on pregnancy and conception, 02 
Arpil 2020. https://www.eshre.eu/Press-Room/ESHRE-News#COVID19_April2.
  10. Esteves SC, Varghese AC & Worrilow KC (Eds). (2017). Clean Room Technology in ART Clinics: A Practical Guide. CRC Press.
  11. Favre G, Pomar L, Qi X, Nielsen-Saines K, Musso D, Baud D. Guidelines for pregnant women with suspected SARS-CoV-2 infection. Lancet Infect Dis. 2020.
  12. He F, Deng Y & Li W. (2020). Coronavirus disease 2019: What we know? Journal of Medical Virology. 2020: 1-7. DOI: 10.1002/jmv.25766.
  13. HFEA Coronavirus (COVID-19) guidance – current status as of 18 March 2020. https://www.hfea.gov.uk/about-us/news-and-press-releases/2020-news-and-press-releases/hfea-coronavirus-covid-19-guidance/.
  14. Liu D, Li L, Wu X, Zheng D, Wang J, Yang L, Zheng C. Pregnancy and Perinatal Outcomes of Women With Coronavirus Disease (COVID-19) Pneumonia: A Preliminary Analysis. AJR American journal of roentgenology 2020: 1-6. https://www.ajronline.org/doi/10.2214/AJR.20.23072.
  15. Liu Y, Chen H, Tang K, et al., Clinical manifestations and outcome of SARS-CoV-2 infection during pregnancy. J Infect, 2020. https://doi.org/10.1016/j.jinf.2020.02.028
  16. Royal College of Obstetricians and Gynaecologists. Coronavirus (COVID-19) Infection in 
Pregnancy: Information for healthcare professionals. 2020 18 March. https://www.rcog.org.uk/en/guidelines-research-services/coronavirus-covid-19-pregnancy-and-womens-health/.
  17. Tesarik J. (2020). After corona: there is life after the pandemic. Reproductive BioMedicine Online, In press. DOI: 10.1016/j.rbmo.2020.04.002.
  18. The Fertility Society of Australia: Statement of the Covid-19 FSA Response Committee (19 March 2020). https://www.fertilitysociety.com.au/home/fsa-statement-covid-19/.
  19. Wang X, Zhou Z, Zhang J, et al. A case of 2019 Novel Coronavirus in a pregnant woman with preterm delivery. Clinical Infectious Diseases 2020; org/10.1093/cid/ciaa200.
  20. World Health Organization. Coronavirus disease 2019 (COVID-19) Situation Report – 58. 2020 18 March. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200318-sitrep-58-covid-19.pdf?sfvrsn=20876712_2.
  21. Zeng L, Xia S, Yuan W, et al., Neonatal Early-Onset Infection With SARS-CoV-2 in 33 Neonates Born to Mothers With COVID-19 in Wuhan, China. JAMA Pediatr, 2020.

Supplementary reading

  1. Gvakharia M, Berger DS, Chang TA, Holmes L, et al. (2020). IVF Laboratory management during COVID-19 pandemic: Checklists from the College of Reproductive Biology. https://www.aab.org/images/CRB/2020/PAMF%20and%20COLLEGE%20OF%20REPRODUCTIVE%20BIOLOGY%20REPORT%20on%20COVID19%20%20%20procedures%20FINAL%20%2020200403%20copyright4.pdf.
  2. Huyser, C., & Richter, K. (2018). Sperm viral decontamination: a juncture between prevention and risk minimization in the ART laboratory. Global Reproductive Health, 3(4), e22.