In addition to the resources included on the ASRM COVID-19 Task Force Document #3, you may find it helpful to consult:  https://covid19.healthdata.org/united-states-of-america.  

Please also consult your local, municipal, and state ordinances which you must follow as you move ahead in your plans to resume fertility diagnostic testing and treatment. The situation is fluid, and local regulations need to be consulted frequently.

There is a possibility of a resurgence of COVID-19 as restrictions are loosened.

• Wear a face mask during entire stay in clinic
  
  
• Physical distance as much as possible when in the clinic
  
  
• Come in alone for all clinic visits. Videoconferencing using the patient’s phone can be done to engage the partner at discretion of physician and all other healthcare providers.
  
  
• Report any symptoms or COVID-19 exposure so that appropriate medical management can be undertaken.
  
  
• Make sure your temperature is checked before entering the clinic. All patients entering the clinic should have a temperature taken at entrance. Patients with temperature above 100.0 F should be treated as potentially COVID-19 positive.
  
  
• Monitor waiting areas to maintain appropriate physical distancing. Encourage your patients that if physical distancing can not persistently be achieved due to physical limitations of the space, encourage patients to notify your staff to look at alternative options.

See a sample communication template regarding such instruction and pre-screen questions that SART members can use prior to their visit to inform them of what to expect when they come in for a visit.

• If possible, operationally stagger clinic staff into two distinct teams to limit exposure.
  
  
• Implement sick leave policies for staff that are non-punitive, flexible, and consistent with public health guidance.
  
  
• Move desks or have employees work remotely to adhere to physical distancing standards. 
  
  
• Face masks should be worn by staff at all times while in the clinic.
  
  
• Consider requiring that staff change clothes upon arriving and when leaving work.
  
  
• Implement and educate staff regarding cleaning and disinfection (sanitization) protocols, consistent with CDC and OSHA guidance, with their work area. 
  
  
• Consider staggered scheduling and group scheduling to minimize the impact of COVID-19 exposure on your workforce.
  
  
• Impose appropriate limits on business travel.
  
  
• Request that staff be open and transparent about their personal travel plans.
  
  
• As part of routine practice, educate staff to regularly monitor themselves for fever and symptoms of COVID-19.
  
  
• Staff should stay home when they are ill.
  
  
• If a staff member develops a fever (T≥100.0^oF) or symptoms consistent with COVID-19 while at work, they should keep their face covering or facemask on, inform their supervisor, and promptly leave the workplace.
  
  
• All staff should be screened at the beginning of their shift for fever and other signs and symptoms consistent with COVID-19.
  • Fever is defined as either measured temperature >100 ^oF or subjective fever
    
    
• Document staff members’ temperature, and presence or absence of symptoms consistent with COVID-19 daily, in a written log.
  
  
• Develop a written policy and procedure for addressing employees who report COVID-19 symptoms, diagnosis, or potential exposure, with specifics for quarantining and testing of staff before returning to workplace. For examples, see https://www.cdc.gov/coronavirus/2019-ncov/hcp/return-to-work.html.

• Whatever a clinic elects to do, consider documenting your standard procedures in a policies and procedure document that is formally read and signed by all employees and kept in their staff human resources file.
  
  
• Any staff with symptoms should call their manager before coming into work so that alternative staffing can be arranged.
  
  
• Physical distancing between staff members should be maintained.
  
  
• After every encounter with patients, staff should perform hand washing for 20 seconds or use an alcohol-based hand sanitizer, which should be readily accessible at clearly marked areas around the clinic.
  
  
• Avoid touching face, eyes, mouth with unwashed hands.
  
  
• Do not share food or bottles.
  
  
• Follow PPE recommendation as outlined in Table in the ASRM task force recommendation update #3.
  
  
• All staff should wear face masks at all times, especially in natural gathering areas of the clinic, i.e. MA stations, breakroom, nursing administrative areas, laboratory administrative areas, etc., where physical distancing can be a challenge.
  
  
• As masks cannot be used during eating, if physical distancing cannot be accomplished when eating in the facility, staff should eat in appropriately spaced areas, e.g. cars, outside areas.
  
  
• Offer new and return patient consults performed by video (telehealth) or phone.
  
  
• Space in-person appointments to avoid crowding.
  
  
• Tests and diagnostic procedures should be consolidated to avoid multiple patient visits to the clinic, assuming wait times between tests/procedures can be minimized.
  
  
• Allow only the patient in the clinic (i.e. no partner or “support person”). If needed, emotional support by partner via cell phone can be suggested during the visit.
  
  
• Ensure patients wear face coverings/masks for all their in-person appointments.
  
  
• All persons entering the clinic must complete and pass a standardized screening (see question 2 for specifics).
  
  
• Monitor reception areas/waiting rooms for physical distancing, utilizing alternate spaces when needed. When possible, use of waiting rooms should be avoided altogether.
  
  
• Whenever possible, encourage staff to work remotely from home.
  
  
• Perform regular and frequent disinfection (sanitization) of the clinical facility and equipment throughout the day, such as computer workstations, desk surfaces and doorknobs, preferably in a prescribed fashion that is standardized throughout the clinic spaces.
  
  
• Provide patients with COVID-19 information/counseling and consider asking them to sign a consent. Consider also documenting counseling of patient in the medical record before any treatment begins, in addition to, or instead of, utilizing a consent form (see question 5 below for specifics).
  
  
• Formally ask pre-screen questions regarding symptoms and COVID-19 exposure 1-2 days prior to scheduled visit or when the patient books their appointment. (See Appendix A) At the same time, reassure all patients that their safety is your primary concern and that the above safety measures are being done.

This decision is ultimately up to you regarding whether or not to ask patients to sign a formal consent form. Regardless of whether you use a consent form, it is critical that patients be informed about the potential risks involved in proceeding with fertility testing and treatment during the COVID-19 pandemic and this counseling be recorded in the medical record. A consent form or standardized template that is shared with the patient can provide a systematic approach to ensure that all patients are provided with key information to allow them to make an informed decision about proceeding or not with fertility testing and treatment.

Elements to discuss with patient:

• Unknown impact of pregnancy on susceptibility to or severity of COVID-19, and unknown impact of COVID-19 on pregnancy including maternal and fetal risks.  Some warnings should be given related to general risk of febrile illness and experience with other viral infections.
• Limited access to or unknowns regarding COVID-19 testing.
  
  
• Potential for treatment cancellation due to exposure, infection, unavailability of PPE/supplies, or changes in regulations.  Statement of treatment cancellation should include the practice’s policy and procedures concerning the financial consequences of cancellation.
  
  
• If any, please advise financial policies which limit monetary risk to patients if their treatment is cancelled due to a reported symptom or exposure.
  
  
• Risk of exposure at clinic during treatment.
  
  
• Option to postpone treatment.
  
  
• Opportunity to have questions answered.

See the SART COVID-19 Toolkit for examples of medical record template, patient handout and consent forms. These should be individualized for your practice.  Please use as you wish when developing material for your clinic with your clinic branding and letterhead. 

Please note such examples do not constitute legal advice or create an attorney-client relationship.  SART members should use these documents in consultation with legal counsel in conjunction with local laws and regulations.  Please revise as needed as they apply to your practice patterns.   The example documents are tools for a practice to formally counsel your patients before undergoing ART treatment, but do not release the practice from potential liability from any complications that can occur when treating patients with ART in the COVID-19 pandemic.

• No reliable testing is available currently to predict disease because of the high false negative rate. As a result, all patients should be treated as if they are coronavirus positive.
  
  
• Follow your local institution’s recommendation if testing is available.
  
  
• For those in independent surgical sites that are not affiliated with large institutions:
  • All staff who will be in the operating room should be fitted for N95 masks. Clinics should document such fitting in the staff-member’s file.
  • All patients coming to the operating room should be screened 1-2 days prior to surgery via phone/portal message with standard questions (see appendix A for specific questions that can be asked of patients).
    
    
• Currently, no studies exist that assess the risk of different airway techniques and anesthetic choices. Laryngeal mask airway (LMA) and intubation are at greater risk of generating aerosols and PPE for aerosol-generating procedures should be worn by all staff, i.e. N95 masks.
  
  
• For oocyte retrievals, D&Cs, paracenteses, and certain urology procedures, the use of local anesthesia, oxygen mask, and IV meds (e.g. propofol, midazolam and fentanyl), are encouraged.
  
  
• If the risk of intubation or aerosolization is low, generally a non-N95 PPE can be used.
  
  
• If intubation is required intraoperatively, all staff need to put on N95 masks, gown, double gloves, and eye protection, and the operating room door to remain closed for at least 20 min. after extubation to allow for room air to be fully exchanged.
  
  
• Patients undergoing surgery with planned anesthesia should wear a mask at check-in and during their entire time on-site, other than when in the operating or recovery rooms.

If you are associated with a larger institution such as a hospital, comply with your hospital’s policy when classifying patients as urgent, non-urgent, or elective.

If a SART member clinic is affiliated with a free-standing surgery center, comply with local municipal and/or state ordinances.  Ectopic pregnancies and surgical management of miscarriages are considered urgent and can be done under the appropriate operating room circumstances (see question #6 above).  Prior to surgical intervention, medical therapy, such as methotrexate for ectopic pregnancies and misoprostol for miscarriages, must be considered, perhaps at a lower threshold than previously.

Before reopening, it is imperative that safety measures be in place to protect patients and staff.  Many clinics will not be able to accommodate the same patient volumes they once did before the COVID-19 crisis, while maintaining appropriate screening and social distancing.  Therefore, prioritization of patient treatments may be necessary.

Prior to treatment, a formal patient acknowledgement in the medical record and/or patient consent is recommended (see Appendix B) regarding data on coronavirus and pregnancy is limited (see question 5 above). Patient prioritization can be based on:

• Patient age, known AMH levels in the past 6-12 months, and AFC. As an example of possible criteria:  age >38 years, AMH <1 pg/mL, and/or antral follicle count <10
• Fertility preservation for medical reasons, i.e. cancer
• Diminished ovarian reserve.
• Advanced maternal age.
• Severe endometriosis.
• Donor oocyte recipients where frozen eggs were used and thawed during treatment
• Frozen oocytes thawed for embryo creation cycles combined with PGT
• Mental health issues such as severe anxiety/depression, where delay in treatment will can exacerbate the condition, in consultation with their mental health provider
• Insurance coverage is time limited.
• Solely needing a frozen embryo transfer (FET), as monitoring visits are limited.

• Use stimulation and monitoring protocols which minimize the required blood samples and ultrasounds.
• The risk of OHSS should be minimized more than usual, potentially with the use of an agonist trigger if possible.
  
  
• The dose of gonadotropins should be lower.
  
  
• Consider utilizing fixed antagonist start day on all ART cycles, i.e. day 7 of stimulation, rather than follicle size criteria to reduce an ultrasound needing to be done.

• Patient who choose to delay due to anxiety surrounding the COVID-19 pandemic itself.
  
  
• To avoid potential SARS-CoV-2-related complications during pregnancy, if preconceptionally healthy.
  
  
• Patients who have preconception medical conditions which raise their risk of complications from the ART treatment itself or from COVID-19, including but not limited to severe asthma, poorly controlled diabetes, chronic lung disease, severe heart disease, severe obesity, hypertension, chronic liver or kidney disease.
  
  
• To mitigate the unknown risk of vertical transmission in SARS-CoV-2 positive patients.
  
  
• To support the necessary reallocation of healthcare resources in their local communities.
  
  
• If similar treatment can be performed at a later time without detriment to patient prognosis.
  
  
• Patients at high risk of OHSS.
  
  
• Patients who are undergoing treatment with oocyte donation (fresh and frozen cycles), unless recipient is near the ceiling of the clinic’s age criteria. A SART member clinic could consider extending clinic-specific age criteria by a year for donor oocyte recipient.

Yes, diagnostic testing and bloodwork can be done if appropriate mitigation strategies, for example as described in the ASRM task force recommendation, update #3. 

Diagnostic testing including ultrasounds, hysterosalpingograms, saline infusion sonograms, office hysteroscopies, semen analyses, and blood samplings can be offered.

Each SART member clinic must continually evaluate their operational ability to comply with above advice as resuming care continues and local stay at home ordinances are lifted.

Ideally, testing for the SARS-CoV-2 virus should be performed on a widespread basis to track disease and reduce the spread by quarantine strategies. ASRM continues to support testing when available prior to surgical procedures including oocyte retrievals (see The Society for Reproductive Surgeons (SRS) Recommendations Regarding Reproductive Surgery during  the Covid-19 Pandemic. Update #1 published May 4, 2020  and the ASRM Taskforce update #5 on the resumption of reproductive surgery published June, 8, 2020).

However, six months into the pandemic in the U.S., the lack of widely available testing persists.  Several issues have hampered our ability to broadly test the reproductive care population, including:

• Slow turnaround of test results.
• Lack of testing availability.
• Inconsistent accuracy of testing, i.e. variable false negative rates along the timeline from asymptomatic carrier state to manifest disease.

Most infected individuals no longer shed live virus that can be cultured after 10 days from the onset of illness or, if not symptomatic, from the date of their first positive test, although very severely ill or severely immunocompromised patients may shed replication competent virus in respiratory tract samples for up to 20 days. However, a surprising number of individuals demonstrate detectable RNA in upper respiratory specimens after recovery, some for up to 12 weeks. If viral testing is performed and noted to be persistently positive more than 10 days from symptom onset or first positive result, the findings most likely reflect the presence of viral RNA, but not infectious risk.

Consequently, recommendations regarding pre-op, pre-ART, or intracycle cycle testing using PCR vary across institutions and often are controversial. Some institutions require pre-operative testing, while other institutions and free-standing fertility centers may not have readily available PCR testing.

If a clinic or institution has access to such testing and the patient is positive for coronavirus, the ART cycle should be cancelled regardless of the absence of symptoms due to the known asymptomatic window of COVID-19.

When accurate and timely testing for the presence of the SARS-CoV-2 virus remains unavailable, the following clinical practice alternatives may be considered:

• Universal patient screening using questionnaire for symptoms and temperature assessment.
• Cancellation of the procedure or appropriate use of PPE in an operating room equipped to minimize transmission of disease via aerosolized droplets when patients present with fever or with COVID-19 symptoms. If planned, embryo transfers should be delayed until patients are symptom free for at least 10 days.
• Use of appropriate PPE by all medical personnel caring for all patients undergoing surgical procedures (see Table in question below: Risk assessment and mitigation for reproductive care procedures and activities).

The ASRM Taskf Force suggests following the table below: 

The following can be templated in your medical records for every patient you provide fertility treatment:

I discussed the guidance and recommendations for trying to conceive, fertility treatments, and risks with coronavirus (COVID-19) in pregnancy. New data are continuing to emerge and the guidance and recommendations are expected to change over time. Current considerations include the following:

According to the most recent information from the Centers for Disease Control and Prevention (CDC), pregnant women seem to be at higher risk of severe illness due to COVID-19 including intensive care unit (ICU) admission (1.5% vs 0.9%), and receipt of mechanical ventilation (0.5% vs 0.3%), compared with nonpregnant women. Importantly, pregnant women do not appear to be at increased risk of death compared to nonpregnant women in the same age group (currently calculated at 0.2%).

There are unknown impacts of COVID-19 on pregnancy including maternal and fetal risks. In the first trimester, febrile illness from any cause may be associated with increased risk of miscarriage. Later in pregnancy there may be adverse obstetrical outcomes associated with COVID-19, specifically increased risk of preterm delivery and complications of prematurity.

Pregnant women and their families should take measures to ensure their health and prevent spread of infection. Every effort will be made to reduce risk of exposure during evaluation and treatment at SRM; however, some residual risk may still be present. There is the potential for treatment cancellation due to exposure, infection, availability of PPE, or changes in regulations, and there would be associated financial consequences of cancellation. There also may be limitations of COVID-19 testing.

The patient has the option to postpone evaluation and treatment. The patient is aware of the increased risks and the limited data regarding COVID-19 and wishes to proceed with treatment when feasible. All questions answered.

“This document was developed by members of the SART executive council (SEC) of the American Society for Reproductive Medicine as an educational resource and service to its members and other practicing clinicians. While this document reflects the views of members of the SEC, it is not intended to be the only approved standard of practice or to dictate an exclusive course of treatment.   Physicians and other health care providers should always use their best judgment in determining a course of action and be guided by the needs of the individual patient, available resources, and institutional or clinical practice limitations. This document was reviewed and approved by SART leadership, the presidential chain and members of the SEC.

Review Process, Financial Relationships/Disclosures, Update Policy and the Role of Participants:
Address the review process, financial relationships/disclosures, update policy (if any) and the role/participation of particular committee members and experts, separate from the disclaimer.