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FAQs Related to COVID-19

Presented by ASRM and SART
 
This communication from SART and ASRM is a frequently asked questions (FAQ) on the ASRM COVID-19 Taskforce Recommendations for current and future patients who need fertility medical treatments.

Q: What do we know about the COVID-19 Vaccine and Pregnancy?

A: We understand it can be confusing when respected physicians or their organizations come to different conclusions. However, the virus and what we know about treatments and vaccines are all rapidly changing. As we learn more about COVID-19 care and management, recommendations will evolve. In reality, currently, there is little data on which to evaluate the impact of the vaccine or the disease on pregnant individuals. Also, given the challenges of enrolling pregnant individuals in clinical trials, it is unlikely we will have full data for many years. Meanwhile, patients must make decisions about their health now. Our conclusion is that the vaccines are safe for pregnant individuals or those contemplating pregnancy. However, it is important that each patient discuss vaccination with their physician and decide what the best course of action is for them and their family.

Please review the ASRM COVID-19 Task Force Update 11 and Update 12 for information on which the Task Force bases its recommendations.

What we know:

  • While the majority of those infected will survive, the overall death rate from COVID-19 remains over 1%. It is increasingly recognized that some people suffer from long term consequences after COVID-19 infection. These lingering symptoms can include muscle weakness, sleep difficulties, anxiety, depression, hair loss, anosmia, joint pain, palpitations and decreased pulmonary function. In a recent study, 76% of patients hospitalized with COVID-19 reported at least one lingering symptom six months after infection, and this proportion was higher in women. Given the continued morbidity and mortality of COVID-19, prevention remains a top priority.

  • Widespread vaccination is critical to slowing the spread of SARS-CoV-2 virus, reducing COVID-19, and bringing an end to the pandemic.

  • Currently available mRNA-based COVID-19 vaccines from Pfizer-BioNTech and Moderna have documented safety and efficacy in large randomized clinical trials, preventing up to 95% of severe disease.

  • The known and potential benefits of these vaccines outweigh the known and potential harms of COVID-19 infection.

  • Available data indicate that COVID-19 vaccines do not cause infertility in women or men.

  • In the randomized blinded Pfizer-BioNTech trial, a similar number of women conceived after receiving the vaccine as those who received the placebo.

  • mRNA vaccines are taken up rapidly by muscle cells at the injection site and the mRNA is degraded in the cell once the protein is made so it does not cross the placenta.

  • COVID-19 vaccination is recommended for women who are contemplating pregnancy or who are pregnant in order to minimize risks to themselves and their pregnancy.

  • The Task Force does not recommend withholding the vaccine from patients who are planning to conceive, who are currently pregnant, or who are lactating. These recommendations are in line with those of the Advisory Committee for Immunization Practices (ACIP) of the U.S. Centers for Disease Prevention and Control (CDC), the American College of Obstetricians and Gynecologists (ACOG), and the Society for Maternal-Fetal Medicine (SMFM).

  • Patients undergoing fertility treatment and pregnant patients should be encouraged to receive vaccination based on eligibility criteria. Since the vaccine is not a live virus, there is no reason to delay pregnancy attempts because of vaccination administration or to defer treatment until the second dose has been administered.

  • A shared decision-making model between patients and providers should be used when considering vaccination and should take into consideration the ethical principles of autonomy, beneficence, and non-maleficence. Consideration of local COVID-19 transmission and risk of acquisition, personal risk of contracting COVID-19, risks of COVID-19 to the patient and potential risks to a fetus, efficacy of the vaccine and known side effects, and the lack of data about the vaccine during pregnancy should all be taken into consideration as patients make decisions regarding vaccination. Some individuals may elect to defer conception attempts until both doses of vaccine have been administered.

  • Recent studies have suggested that pregnancy is a risk factor for severe COVID-19 disease. Furthermore, many women who are pregnant or contemplating pregnancy have additional risk factors such as obesity, hypertension or diabetes which may further increase the chance of severe disease from COVID-19 infection. These considerations should be included in decisions regarding vaccination.

  • Because COVID-19 mRNA vaccines are not composed of live virus, they are not thought to cause an increased risk of infertility, first or second trimester loss, stillbirth, or congenital anomalies. It should be noted that pregnant and lactating women were excluded from the initial phase III trials of these two vaccines, so specific safety data in these populations are not yet available and further studies are planned. However, the mechanism of action of mRNA vaccines and existing safety data provide reassurance regarding the safety of COVID-19 mRNA vaccines during pregnancy. The FDA EUA letter permits the vaccination of pregnant and breastfeeding individuals with a requirement that the company engage in post-authorization observational studies in pregnancy.

  • While COVID-19 vaccination can cause fever in some patients (up to 16% of those vaccinated and mostly after the second dose), this risk should not be a concern when deciding whether to vaccinate a pregnant individual or a patient desiring pregnancy. While fever in pregnancy (particularly the 1st trimester) has been associated with an increased risk of neural tube defects, a recent study demonstrated the association no longer remained significant if the patient is taking >400 mcg of folic acid daily. Another large Danish cohort study did not demonstrate any increased risk of congenital anomalies of those who reported fever in the first trimester. Additionally, the most common symptom of COVID-19 infection itself is fever (83-99% of affected patients). Patients who experience fever following vaccination should take an antipyretic medication, like acetaminophen. 
If you would like to read the full documents with references to research studies, reports, and papers, please view them here:

Q: Should I get the COVID19 vaccine?

A: While the COVID vaccine is new and there is a lot we do not know about it, the risks of developing severe illness from COVID are higher for pregnant woman.  In severe cases, pregnant women with COVID are more likely to need ICU care and/or a ventilator than women with COVID who are not pregnant.  The COVID-19 vaccine is made without live virus.  In previous vaccines that used a similar design (i.e., those that also did not contain live virus), getting vaccinated was not associated with developing severe illness in either the pregnant mother or her unborn baby.   Both the American College of Obstetrics and Gynecology (ACOG) and Society for Maternal and Fetal Medicine (SMFM) have released statements supporting use of the COVID-19 vaccine in pregnant and breastfeeding women (see links below), and although we do not know all the risks associated with taking the vaccine, when considering whether to take any medication prior to or during pregnancy, we always must consider the benefits relative to the theoretical or known risks. In this case, given how dangerous COVID can be during pregnancy, and the lack of evidence of harm to pregnant women associated with receiving the vaccine, we recommend that eligible women get the vaccine.

Q: Can I get COVID from the vaccine?

A: No, it is impossible to get COVID from the vaccine. The vaccine does not contain live SARS COV2 virus. It is an mRNA vaccine. Please reference the CDC website for more information: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html.

There are several different types of vaccines in development. All of them teach our immune systems how to recognize and fight the virus that causes COVID-19. Sometimes this process can cause symptoms, such as fever. These symptoms are normal and are a sign that the body is building protection against the virus that causes COVID-19.

It typically takes a few weeks for the body to build immunity (protection against the virus that causes COVID-19) after vaccination. That means it is possible a person could be infected with the virus that causes COVID-19 just before or just after vaccination and still get sick. This is because the vaccine has not had enough time to provide protection.

Q: Will the vaccine affect my existing medical conditions?

A: No, the vaccine will not impact your current medical conditions. In fact, if you have underlying medical conditions, you may be at higher risk of having severe complications from COVID-19. As a result, getting the vaccine which, after both doses offer approximately 95% protection from COVID 19, will lower your overall risk of illness.

Q: I am nervous about the vaccine side effects.

A: Side effects are more common after the 2nd dose than the 1st. The most common side effect after the 1st dose is arm soreness. Additional side effects include tiredness, headache, muscle pain, chills, joint pain, and fever. These typically last about 24 hours and can be improved with Tylenol or Advil.

Q: Can I still transmit the virus to other people even when I am vaccinated and protected?

A: In theory, yes. Scientists are still unsure whether vaccination is protective against asymptomatic viral shedding. Preliminary data is promising in that vaccinated individuals may be less likely to be asymptomatic carriers than non-vaccinated individuals. However, it is still recommended that those who receive the vaccine continue to practice social distancing, masking, hand washing, etc.

Q: How safe is the COVID-19 vaccine? Should I get it if I am trying to conceive?

A: Because COVID-19 mRNA vaccines are not composed of live virus, they are not thought to cause an increased risk of infertility, first or second trimester loss, stillbirth, or congenital anomalies. It should be noted that pregnant and breastfeeding women were excluded from the initial phase III trials of these two vaccines, so specific safety data in these populations are not yet available and further studies are planned.

Because of this lack of data, we understand there are some organizations have chosen to recommend not to get vaccinated when trying to get pregnant and currently pregnant, we believe the risk-benefit ratio favors vaccination given the severity of COVID19 and its ability to be transmitted easily.

Q: There is a lot of misinformation on vaccines. Where can I find the truth?

A: Talk to your doctor or fertility specialist.  Misinformation is common during any public health measure rollout.

There are other more reliable sources of information found with these organizations: 

Q: Should I take steps to avoid pregnancy during the COVID-19 pandemic?

A: No.  We do not recommend avoiding pregnancy during this pandemic.  At the same time, we are also not suggesting that a pandemic pregnancy is risk-free.  The risk of acquiring the coronavirus in the first trimester is not known and will not be known for some time. We do know that severe illness can lead to pregnancy complications. If you are already pregnant, it is important to take all precautions possible to reduce your risk of exposure to the coronavirus by following CDC current recommendations, such as handwashing with soap, not touching your face, and practicing social (physical) distancing, whether you receive the vaccine or not.

Q: Will postponing my care affect my ability to have a child?

A: It is extremely difficult to consider postponing your treatment. Most people have gone through tremendous loss and grief by the time they get to the place where they are doing an IVF cycle.  In addition, navigating the cost and insurance coverage aspects is daunting.  Now that you are at this point in your family building, you are dealt a huge unknown with the COVID-19 pandemic, and how you should proceed, or start, this medical treatment. It should be some helpful to hear that there is no evidence that delaying treatment until vaccinated will affect your ability to have a child, even if you have concerns about advanced age and / or diminished ovarian reserve (low egg supply). 

A recent 2020 paper in the peer reviewed article in Human Reproduction concluded, “A delay in IVF treatment up to 180 days does not affect the live birth rate for women with diminished ovarian reserve when compared to women who initiate IVF treatment within 90 days of presentation” to the clinic.

Q: I hear that elective medical procedures in my geographic area are supposed to stop; are IVF and other fertility treatments considered "elective"?

A: No one providing your care believes that any fertility treatment is elective. Infertility is a disease, and treatment of infertility is medically necessary. There is a distinction between a treatment that cannot be postponed even for a few days (such as surgery for a ruptured appendix), and treatment that is time sensitive and extremely important (such as IVF) but not a medical emergency. Unfortunately, there is not a universal definition, and we have seen many misleading terms used, even by state public health agencies.

We know that other important non-emergency treatments also are being postponed during this pandemic. Fertility treatment is not being singled out. Orthopedic surgery, eye surgery, kidney stone procedures, dental procedures, and many other treatments also are being postponed due to the COVID-19 pandemic.

Q: Can my clinic prevent me from getting infected by screening patients and staff?

A: ASRM/SART has developed guidelines to minimize risk of viral transmission while pursuing fertility care.  The most recent guidance can be found here and is updated periodically.  

As anyone who has been through fertility treatment or has prepared to begin fertility treatment knows, multiple clinic visits and procedures are required. Unfortunately, even if a clinic screens patients and staff to lower the risk of COVID-19 exposure in the fertility clinic, there is no way to guarantee prevention of exposure. COVID-19 is spreading rapidly throughout the United States. People who have the COVID-19 are contagious days before they develop any symptoms. The virus can be in the air that they breathe out and the air you breathe in.  This risk is reduced by wearing masks and by increasing physical distance between people. 

However, these precautions are not foolproof and do not guarantee your safety.  We wish we could screen in a way that could eliminate risk, but we honestly cannot.

Q: Is there a risk that my cycle could be cancelled if I proceed with treatment now?

A: States and local governments have different local requirements. A clinic that begins a treatment cycle could be forced to cancel it by their city or state regulations. Furthermore, health care workers who are exposed to the coronavirus may not be able to come to work that could affect your care. It is possible that even if you begin to invest time and money into fertility treatment now, it could be cancelled due to governmental restrictions or lack of available staff.

Q: Are my frozen embryos, eggs, or sperm safe?

A: Yes.  While we are still learning about the virus and where it resides or if it is present or active in reproductive tissues/cells, there is no evidence of cross contamination of COVID-19 between samples in storage in the IVF Lab. 

Q: I’m pregnant. Is there a risk that a COVID-19 infection will affect my pregnancy outcome?

A: Based on currently available information, pregnant women who become infected with COVID-19 do not appear to be at increased risk of miscarriage or other complications of pregnancy. However, pregnant women are known to be at greater risk of severe complications from other respiratory viral infections such as influenza and SARS. For that reason, pregnant women are considered an at-risk population for COVID-19.

Notably, in many reports cesarean delivery has been used for women who presented in labor and delivery. Though evidence is limited, there are anecdotal cases where pregnant women infected with COVID-19 have encountered an exacerbation of breathing difficulties after delivery.

A recent report from the CDC suggests that pregnant women with COVID-19 appeared to be at increased risk of mechanical ventilation and admission to the intensive care unit (ICU) compared to nonpregnant women, though the total number of women with severe complications overall is low.  Pregnant women were not found to be at increased risk of death associated with COVID-19 compared with non-pregnant women.

Q: What is the risk that a COVID-19 infection will affect my unborn child?

A: Infection with COVID-19 can be particularly concerning for those who are pregnant, as they may be at higher risk for severe complications. Although the effects of COVID-19 infection during pregnancy have not yet been fully defined, including effects of infection in the first trimester of pregnancy, infection may precipitate premature labor and/or delivery.  However, full term newborns delivered from mothers with active COVID-19 infections have done well.

Q: This year has been very difficult to handle and I’m having a hard time. What resources are available to me?

A: We know that the infertility treatment is often stressful. The upheaval in many life domains created by the COVID-19 pandemic adds to that strain., There are several strategies you can use to cope.  First, remember that your fertility nurse is likely experienced in providing emotional support for patients coping with infertility and pregnancy loss.  Start by sharing what you are feeling with her/him.  Your nurse also can connect you with your clinic’s specialized fertility counselor.  This counselor can consult with you on how to manage the stress and emotions surrounding this extremely difficult set of circumstances. You also locate a fertility counselor through the Mental Health Professional Group of ASRM.  Click here for a directory of mental health providers.  Most of these fertility counselors offer telehealth services that may be covered by your insurance carrier.  Here are some additional ideas for coping:

  • Get accurate and current information to reduce anxiety. Utilize reliable sources such as the CDC, WHO and ASRM.

  • Limit your use of social media and other sources of news. Set a certain time of day for gathering news. Choose a time when you are not likely to be triggered. Stop using tech devices an hour or more before bedtime…turn them off.

  • Utilize relaxation or mindfulness apps to reduce anxiety and tension and improve sleep.  Focus on the present moment. Some examples are Ferticalm (for women), FertiStrong (for men), Buddhify, Headspace, MindshiftCBT, and Personal Zen.

  • Engage in pleasurable activities and hobbies.  What do you do for fun?  Taking even ½ hour per day to focus on things other than the pandemic and your fertility journey will help.

  • Pay attention to the messages you give yourself. Positive self-talk can be powerful. Saying things like “This isn’t the situation I expected but it doesn’t mean it won’t work out eventually” can be helpful.

  • Stay in touch with others in your support network, either socially distanced or virtually.  Staying connected with others reduces the sense of isolation.  If you are experiencing Zoom fatigue, consider connecting on the weekend or after you have given yourself a break.

  • Join RESOLVE: The National Infertility Association (www.resolve.org).  RESOLVE has an online support community, local support groups (now meeting virtually), webinars and other content to help you connect, get support, and stay informed.

 

ReproductiveFacts.org
is a patient education website of ASRM.
 

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