Ep 85: In Vitro Fertilization and Pregnancy Outcomes After COVID-19 Vaccination with Dr. Devora Aharon
Fertility Forward Episode 85:
The COVID-19 pandemic has not made things any easier for pregnant women, or those who are planning to conceive. Pregnant women are at higher risk for severe infection from COVID-19 as well as an increased likelihood of ICU admission, deaths, preterm labor, stillbirth, and other complications. While the development of COVID-19 vaccines has posed its own questions, due to its novelty, a new study offers robust reassurance that vaccines are not only safe for pregnant women and their fetuses, they are also a beneficial protective measure. Today on the show we speak with Dr. Devora Aharon about her most recently authored manuscript Early Vitro Fertilization, and Pregnancy Outcomes After COVID-19 Vaccination, and its findings. Tuning in you’ll hear Dr. Devora describe which vaccines were included in the study and why, how the data was collected, and why their findings are so robust and trustworthy. To learn more about the details of the study and why pregnant women can feel safe getting vaccinated, make sure you tune in today!
Rena: Hi everyone. We are Rena and Dara and welcome to Fertility Forward. We are part of the wellness team at RMA of New York, a fertility clinic affiliated with Mount Sinai Hospital in New York City. Our Fertility Forward podcast brings together advice from medical professionals, mental health specialists, wellness experts, and patients, because knowledge is power and you are your own best advocate.
Dara: Dr. Devora Aharon is currently completing her final year of fellowship in reproductive endocrinology and infertility at the Icahn School of Medicine at Mount Sinai and Reproductive Medicine Associates of New York. Dr. Aharon is passionate about clinical research and has authored numerous scientific abstracts and peer reviewed manuscripts and we have her on today because most recently she first-authored a manuscript called "In vitro fertilization and early pregnancy outcomes after COVID-19 vaccination". And this was published in the Green Journal. This is one of the largest studies to date demonstrating that the COVID-19 vaccine does not affect reproductive potential. Thank you so much for being here. And I know our listeners are gonna be really excited to hear all about this really monumental research. So thanks for coming on.
Dr. Aharon: Thank you. Thank you so much for having me here today. Really excited to be here and share what we found.
Rena: Yeah, we're, we're super excited and I mean, this study is huge. It's really, you know, I think what people have kind of been waiting for in terms of feeling some security.
Dr. Aharon: Yeah. I think that this study provides a lot of reassuring data that, you know, tells us that the COVID vaccine really doesn't seem to have any impact on fertility or early pregnancy outcomes in women who are undergoing fertility treatment.
Rena: Amazing. Yeah. So, I mean, tell us, tell us from the beginning, how, you know, you started the study, what went into it, the data we'd love to hear everything.
Dr. Aharon: Sure. So one of the reasons that we wanted to do the study was cause as you know, there's been concerns out there in the media that the COVID vaccine could potentially have an impact on fertility or early pregnancy, and there really was very little data that existed, you know, clinical data looking for pregnancy outcomes, fertility outcomes. As time has gone on since the vaccine came out, we've been gathering more information on pregnant vaccinated women and have seen no negative impact. But we wanted to really look at the earlier stages of fertility and pregnancy. So we looked at two types of patients. One group was undergoing ovarian stimulation so IVF with medication that stimulate the ovaries. And in that group of patients, the outcomes that we looked at were eggs retrieved, mature eggs. So looking at kinda the egg quality, the fertilization rate, how the embryos were growing out to the blastocyst stage and the euploidy rate, so the rate of embryos that were chromosomally normal. So really looking at multiple markers of egg and embryo quality. And then in the second group of patients, we looked at patients who were undergoing an embryo transfer of an embryo that had been created and tested in a prior cycle and was a normal embryo and was frozen and then thawed in this cycle and transferred into the uterus to create a pregnancy. And we looked at early pregnancy outcomes. We looked at the pregnancy rate, the clinical pregnancy rate, which is the ability to see the pregnancy on the ultrasound and we looked at biochemical pregnancy loss and clinical pregnancy loss. So early stages of miscarriage. In the IVF stimulation group we had over 200 vaccinated patients and in the embryo transfer group, we also had about 200 vaccinated patients and then between seven and nine patients in each group and the controls. So good numbers of patients and essentially what we found that there were no differences in any of the many outcomes that we looked at between patients who were vaccinated and unvaccinated. So, you know, again, saw no changes in eggquality, embryo quality, the ability for an embryo to implant, or the miscarriage rates in women who were vaccinated compared to unvaccinated. So this indicates to us that the vaccine had no impact on these outcomes or changed these outcomes in women who were undergoing IVF treatment.
Dara: So Dr. Aharon, that's my question to you is what, was there a specific type of vaccine that you were looking at? Did you include all of them or just some of them, and also what were the, the dates that you did this research? I think this is a great thing for our, our listeners to, to learn.
Dr. Aharon: Yeah, that's a great question. So we looked only at mRNA vaccines, the Pfizer and Moderna vaccines. We did that because these are the vaccines where the, it's, you know, relatively newer technology, there's been more concern surrounding these vaccines specifically and we wanted to be able to really hone in on the technology. We looked at Pfizer and Moderna, and we looked at the patients overall who got either vaccine, but we also did subanalysis looking at the Pfizer group individually and the Moderna group individually and comparing them to one another. And we saw no differences in, in any outcomes when we did those subanalysis as well. So there doesn't to be different kinda impact depending on which mRNA vaccine someone received. The study was done between, so it was everyone who cycled between February 2021 and September 2021. The reason that we chose those dates was because we started right after the first patients we had were fully vaccinated. So everyone in the study who was in the vaccinated group was at least two weeks from their second vaccine dose when they started the medications for their cycle. So we only looked at patients who were fully vaccinated. And our first patients who cycled who were fully vaccinated started in February 2021. And we stopped in September 2021, because at that point, we felt that we were able to collect enough data to give strong conclusions about whether the vaccine can have any impact. And the control group came from the same exact time period. So all of the unvaccinated patients underwent cycles during the same time period where the protocols were the same, they had the same kind of exposures out in the community, same kind of exposures to natural COVID infections. So we wanted the groups to be as comparable as possible in terms of other baseline characteristics.
Rena: What about, did the study look at people that were partially vaccinated or got vaccinated during a cycle?
Dr. Aharon: We didn't. We chose to only include patients who were fully vaccinated so 14 days or more from their second dose and this is because we really wanted to be able to assess the impact of being fully vaccinated with a fully mounted immune response to the vaccine and see if that had any effect on outcomes. You know, we didn't wanna kinda muddle things with people who might have only had a partial response.
Dara: My assumption also I was gonna say is in terms of the booster, I believe the boosters probably only started around September so that was something that was not studied in this particular paper.
Dr. Aharon: Correct. Yeah. We didn't include the booster in this particular paper just because it's more recent. We do plan to update our data and do another analysis that includes the booster shot to be able to put that data out there as well. The booster is the same vaccine so we have no reason to suspect that there would be any difference in outcomes, but we do want to, you know, look at the actual data and, and publish that as well once we have enough cycles to do so.
Rena: And what about beyond people that were cycling. Did it look at all on birth outcomes or, you know, impact on babies?
Dr. Aharon: Yeah. So that's another thing that we really want to look at that just because it's so new, we don't have full data on that yet, but we are collecting that data. And once we have a good amount of cycles to include and you know, a good number of patients, we do want to publish that data as well, looking at live birth and neonatal outcomes, comparing vaccinated versus unvaccinated patients.
Dara: So it sounds like that this is a continuation of research. So although you have this data from February 2021, September 2021, you will continue and hopefully publish further data along the, the line.
Dr. Aharon: Definitely, definitely. There are multiple further directions that we want to take this and, you know, I, I think there are still obviously going to be concerns out there about long term effects and it’s something that we will continue to be looking at and updating and hopefully putting out more and more reassuring data once we have that information.
Rena: And what about, you know, at this point, I think luckily, you know, the majority of people are vaccinated and boosted, but you know, certainly there are still people who are scared or, you know, waiting on research. So what about people who maybe they're still in the first trimester and they're thinking about holding off, is there any data to suggest that you should wait until you're in the second trimester to get vaccinated or boosted?
Dr. Aharon: So all of the data that we have looking at vaccination during pregnancy, whether it was first, second, third trimester before pregnancy, which is, you know, the study that we did, all the studies have found no harmful impact of vaccination on any outcomes. And so there is no evidence to suggest that it's safer to do it at one point versus another point. There's no reason to wait to get vaccinated. The recommendation is to get vaccinated as soon as it's available to you and there's no potential harm or danger that we are aware of from getting it in the first trimester. So I would advise anyone who's pregnant to get the vaccine in order to protect themselves and their fetus during pregnancy. We do know, we do have good data that the vaccine is effective in pregnant women. It lowers the risk of severe infection from COVID. We do know that pregnant women are at higher a risk for severe infection from COVID. They're at higher risk for ICU admission, death, preterm labor, still birth, lots of, you know, various complications the vaccine is protective. So again, there's no reason to wait. The only thing to look out for would be that fever early in pregnancy is not ideal. So if one were to have a fever as a side effect from the vaccine, just to take Tylenol to bring down that fever, you know, so just to have that in mind, but not a reason to delay vaccination
Dara: Along those lines of, of getting vaccinated, that it's OK to get vaccinated during the first and second trimester of a pregnancy - what about during treatments? Actual treatments? Is there any contraindication?
Dr. Aharon: So same kinda thing, no contraindication. You know, again, our study looked at patients who were vaccinated before, but based on the mechanism of the vaccine and based on what we found we have no reason to believe that getting a vaccine during your cycle would harmful impact your treatment cycle. And so you can get it at any point. There's no reason to wait. The only thing to keep in mind is the side effects from the vaccine. So if you were to get a fever, you know, we wouldn't know if it's from COVID infection or just a side effect from the vaccine, and so that could impact your ability to come into the office. And so, we are typically advising patients not to get the vaccine 2 days before or after a treatment procedure or their first appointment because it could interfere with your ability to come into the office beforehand. And if the vaccine is given after the procedure, you know, if you are not feeling well, we won't know if a complication from the procedure or a side effect from the vaccine. And again, this is not because of concern for harm from the vaccine itself, just the side effects and you know, timing so that's really the only consideration to keep in mind.
Rena: So, okay. You know, I kinda know our patient population and people are hearing this, this all sounds amazing. Great. But you know, look, going through fertility treatments where being pregnant is such a time, you know, that's delicate, fraught with anxiety, especially if someone's been trying for a long time. So how can someone know that they can really trust the study?
Dr. Aharon: So this study was peer reviewed, which means that multiple sort of experts in the field have reviewed the paper and made sure that the methodology was sound and that the results were sound. The statistics that were used were valid and that the conclusions are valid based on the results that we found. And so that gives a sense of reliability to the study that, you know, we can trust the findings and the way that the study was done. And it was published in a one of the top Obstetrics and Gynecology Journals so this is, you know, shows that the findings are something that we can trust.
Rena: And so that's the gold standard, you know, peer reviewed, top journal. It sort of went through a series of checks and balances?
Dr. Aharon: Yeah, exactly.
Rena: So what about any sort of next steps for research? What do you think is coming up on the pipeline? You know, after this?
Dr. Aharon: I think continuing to get more and more data, bigger numbers, long term studies. The more information that we have the better and the more numbers that we have, the more and more confident we can be in the results that we're finding, which is that vaccination is safe.
Dara: Yeah, definitely.
Rena: I mean, this is so important. I think I'm so happy we can get this message out that you did this. You know, as you know, COVID obviously is, is ever changed, but you know, I think vaccinations, you know, have been and will continue to be such a hot topic, both with pregnancy and, you know, our population of people trying to conceive. And so I think this is gonna be so reassuring to people to hear that you've done this study, you've found this data and hopefully this will help people, you know, rest assured and feel safe about, you know, getting backs and boosted.
Dara: I'm excited to see where the research goes from from here. I mean, we've already, six months since September, I'm sure there's a lot more interesting data and beyond. And in terms of finding this journal, is it to find this actual publication - is it free? Can you go online? What's the best way to access this research paper?
Dr. Aharon: The article is available online at the journal’s website.
Dara: And for free?
Dr. Aharon: Yeah, I believe so
Dara: Amazing. I think that's great.
Rena: Sorry. Before we wrap, I was just thinking though about my patients - what about breastfeeding? Is there any correlation, you know, should you wait vaxed, boosted while your breastfeeding? Did you look at that at all?
Dr. Aharon: We didn't look at that in our study, but there is evidence that antibodies from the vaccine do transmit to the fetus or to the baby through breast milk. And so being vaccinated while breastfeeding definitely has potential benefits to the baby and no harmful impact that we have seen in any studies.
Rena: So it is safe though, to get vaccinated or boosted while you are breastfeeding, you don't have to have done it before?
Dr. Aharon: Correct. It is safe. And it can protect the mother and the baby.
Dara: That's reassuring.
Dr. Aharon: Yeah. I think a good, a good way to kinda think about things for, for patients and for people who are, you know, sort of thinking about vaccination is that when the vaccine first came out, pregnant women were excluded from initial vaccine trials and so we didn't have data on vaccination and pregnancy. And so there was this risk-benefit calculation where we knew that the vaccine was likely to be beneficial and protected against COVID. The risks were mostly theoretical. There weren't any known risks, but we also didn't have data to relate, you know, know that for sure. But at that point the risk to, I'm sorry, the benefits seem to outweigh the risk. Over time, we have more and more data coming out, showing very clearly the benefit of COVID vaccination for pregnant women and women who are trying to conceive and really not finding any risk for fertility or pregnancy. And so it's more and more clear that the benefit of vaccination is huge and the risk is small to, you know, nonexistent based on the data that we have.
Dara: That's great to hear, and that really hopefully will help. You know, there's definitely a lot of stress going on in this day and age and then on top of that, in terms of fertility and pregnancy, and I think this, this study can hopefully provide some reassurance to this population group.
Rena: Well, thank you so much for coming on and sharing this. And then of course the, all of the work you put into this to get the data out there. You know, I'm so happy we can share this with people. I think, again, this is gonna help people feel a lot more reassured, hopefully alleviate some anxiety about, you know, it's a really stressful topic.
Dr. Aharon: Yeah. Thank you so much again for having me. And I'm happy to be able to share our findings.
Dara: We are so grateful for what you do and what you've done and what's to come. And on that gratitude note, we like to end our podcast with our daily gratitude, what you're grateful for at this very moment. So Dr. Aharon, what are you grateful for today?
Dr. Aharon: I am grateful for, that’s a good question.
Rena: We're watching her look out the window…
Dr. Aharon: I'm grateful for the ability to have been able to look at this data and find the findings that we did to be able to provide reassurance to people and to provide information and confidence to people that vaccination is safe.
Rena: Love that. Dara, what about you?
Dara: I'm grateful for, a little different, but my, my community, especially you Rena. We had dinner last night and caught up, which has been a while. And just for my friendships and my peers and my family. My community. Rena?
Rena: I am grateful for recalibration and the ability to have the awareness to know when I need to, to dial it back, recenter, come back to who I am, what's important. And you know, like Dara said, we had dinner last night, it was the first time I had seen her not on zoom in so long and just friendship and people who, you know, receive you when you're open and honest and people who can receive when you reach out and ask for help. So grateful for that.
Dara: So much love all around. Thanks again, Dr. Aharon. Looking forward to getting an update, hopefully down the road with the next study. To be continued.
Rena: Yes to be continued.
Dr. Aharon: Thank you so much.
Dara: Thank you so much for listening today and always remember: practice gratitude, give a little love to someone else and yourself, and remember you are not alone. Find us on Instagram @fertility_forward and if you're looking for more, visit us at www.rmany.com and tune in next week for more Fertility Forward.