Heusler Adi Anis, Weintraub Amir, Stein Diana, Melamed-Yekel Yael, Kalfon Sarit, Pasternak Yael, Kulak David
The Adelson School of Medicine, Ariel University, Ariel, Israel.
IVF Unit, Department of OBGYN, Laniado Hospital, Netanya, Israel.
Hum Vaccin Immunother. 2025 Dec;21(1):2541495. doi: 10.1080/21645515.2025.2541495. Epub 2025 Aug 3.
In December 2020, the FDA granted emergency use approval for 2 separate mRNA vaccines to combat the COVID-19 pandemic. While many questions as to the long-term safety of the vaccine were raised, this was particularly acute for those patients trying to conceive and among those utilizing assisted reproductive technologies. The study aimed to assess the effect of recent mRNA SARS-CoV-2 vaccination on IVF cycle outcomes. A retrospective case-control study, including all IVF patients under the age of 40 years in a hospital-based practice from January 1 to May 31, 2021. The study group included patients who received two doses of the Pfizer/BioNTech vaccine BNT162b2 SARS-COV-2 vaccine between 7 days to 6 months prior to starting IVF. The control group included unvaccinated patients from the same time period in the same year and in 3 previous years. IVF cycle results were compared between the groups. Three hundred and eighty-five women met the inclusion criteria; 349 in the control group and 36 in the vaccinated group. Demographic and clinical characteristics were comparable between the groups. The pregnancy rate was 33.3% ( = 12) in the vaccinated group vs 31.8% ( = 111) in the control group ( > .1). There were no statistically significant differences between the control and vaccine groups. with a small non-significant trend to higher pregnancy rates in vaccinated patients: pregnancy rate OR for vaccination group was 1.17 (95% CI 0.56-2.44). We observed no influence of mRNA SARS-CoV-2 vaccine on patients' IVF cycle outcomes; vaccination did not change pregnancy rates.
2020年12月，美国食品药品监督管理局（FDA）批准了两种不同的信使核糖核酸（mRNA）疫苗用于抗击新冠疫情。尽管人们对该疫苗的长期安全性提出了诸多疑问，但对于那些试图怀孕的患者以及使用辅助生殖技术的人群来说，这一问题尤为突出。本研究旨在评估近期接种mRNA新冠疫苗对体外受精（IVF）周期结局的影响。这是一项回顾性病例对照研究，纳入了2021年1月1日至5月31日在一家医院接受治疗的所有40岁以下的IVF患者。研究组包括在开始IVF前7天至6个月内接种了两剂辉瑞/ BioNTech疫苗BNT162b2新冠疫苗的患者。对照组包括同年及此前三年同一时期未接种疫苗的患者。比较了两组的IVF周期结果。385名女性符合纳入标准；对照组349名，接种疫苗组36名。两组的人口统计学和临床特征具有可比性。接种疫苗组的妊娠率为33.3%（n = 12），对照组为31.8%（n = 111）（P>0.1）。对照组和疫苗组之间无统计学显著差异。接种疫苗的患者妊娠率有升高的小趋势但无统计学意义：接种疫苗组的妊娠率比值比为1.17（95%可信区间0.56 - 2.44）。我们观察到mRNA新冠疫苗对患者的IVF周期结局没有影响；接种疫苗并未改变妊娠率。
