Department of Obstetrics and Gynecology, Center for Reproductive Medicine, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Key Laboratory for Reproductive Medicine of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Hum Reprod. 2022 Nov 24;37(12):2942-2951. doi: 10.1093/humrep/deac220.
Does inoculation with inactivated vaccines against coronavirus disease 2019 (Covid-19) before frozen-thawed embryo transfer (FET) affect live birth and neonatal outcomes?
Inactivated Covid-19 vaccines did not undermine live birth and neonatal outcomes of women planning for FET.
Accumulating reports are now available indicating the safe use of mRNA vaccines against Covid-19 in pregnant and lactating women, and a few reports indicate that they are not associated with adverse effects on ovarian stimulation or early pregnancy outcomes following IVF. Evidence about the safety of inactivated Covid-19 vaccines is very limited.
STUDY DESIGN, SIZE, DURATION: This is a retrospective cohort analysis from Reproductive Medical Center of a tertiary teaching hospital. Clinical records and vaccination record of 2574 couples with embryos transferred between 1 March 2021 and 30 September 2021 were screened for eligibility of this study.
PARTICIPANTS/MATERIALS, SETTING, METHODS: Clinical and vaccination data of infertile couples planning for FET were screened for eligibility of the study. The reproductive and neonatal outcomes of FET women inoculated with inactivated Covid-19 vaccines or not were compared. The primary outcomes were live birth rate per embryo transfer cycle and newborns' birth height and weight. Secondary outcomes included rates of ongoing pregnancy, clinical pregnancy, biochemical pregnancy and spontaneous miscarriage. Multivariate logistical regression and propensity score matching (PSM) analyses were performed to minimize the influence of confounding factors. Subgroup analyses, including single dose versus double dose of the vaccines and the time intervals between the first vaccination and embryo transfer, were also performed.
Vaccinated women have comparable live birth rates (43.6% versus 45.0% before PSM, P = 0.590; and 42.9% versus 43.9% after PSM, P = 0.688), ongoing pregnancy rates (48.2% versus 48.1% before PSM, P = 0.980; and 52.2% versus 52.7% after PSM, P = 0.875) and clinical pregnancy rate (55.0% versus 54.8% before PSM, P = 0.928; and 54.7% versus 54.2% after PSM, P = 0.868) when compared with unvaccinated counterparts. The newborns' birth length (50.0 ± 1.6 versus 49.0 ± 2.9 cm before PSM, P = 0.116; and 49.9 ± 1.7 versus 49.3 ± 2.6 cm after PSM, P = 0.141) and birth weight (3111.2 ± 349.9 versus 3030.3 ± 588.5 g before PSM, P = 0.544; and 3053.8 ± 372.5 versus 3039.2 ± 496.8 g after PSM, P = 0.347) were all similar between the two groups. Neither single dose nor double dose of vaccines, as well as different intervals between vaccination and embryo transfer showed any significant impacts on reproductive and neonatal outcomes.
LIMITATIONS, REASONS FOR CAUTION: The main findings might be limited by retrospective design. Besides, inoculations of triple dose of Covid-19 vaccines were not available by the time of data collection, thus the results cannot reflect the safe use of triple dose of inactivated Covid-19 vaccines. Finally, history of Covid-19 infection was based on patients' self-report rather than objective laboratory tests.
Eligible individuals of inactivated vaccines against Covid-19 should not postpone vaccination plan because of their embryo transfer schedule, or vice versa.
STUDY FUNDING/COMPETING INTEREST(S): This study was supported by the Medical Key Discipline of Guangzhou (2021-2023). All authors had nothing to disclose.
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在冷冻胚胎移植（FET）前接种新冠灭活疫苗是否会影响活产率和新生儿结局？
新冠灭活疫苗不会降低计划进行 FET 的女性的活产率和新生儿结局。
现在有越来越多的报告表明，在孕妇和哺乳期妇女中使用 mRNA 疫苗接种新冠病毒是安全的，少数报告表明它们与体外受精（IVF）后的卵巢刺激或早期妊娠结局不良无关。关于新冠灭活疫苗安全性的证据非常有限。
研究设计、规模、持续时间：这是一家三级教学医院生殖医学中心的回顾性队列分析。筛选了 2021 年 3 月 1 日至 2021 年 9 月 30 日期间进行胚胎移植的 2574 对夫妇的临床记录和疫苗接种记录，以确定本研究的入选标准。
参与者/材料、设置、方法：筛选了计划进行 FET 的不孕夫妇的临床和疫苗接种数据，以确定本研究的入选标准。比较了接种和未接种新冠灭活疫苗的 FET 女性的活产率和新生儿出生时的身高和体重。次要结局包括持续妊娠率、临床妊娠率、生化妊娠率和自然流产率。采用多变量逻辑回归和倾向评分匹配（PSM）分析来最小化混杂因素的影响。还进行了亚组分析，包括疫苗接种一剂或两剂以及疫苗接种和胚胎移植之间的时间间隔。
接种疫苗的女性的活产率（未进行 PSM 前为 43.6%，45.0%；进行 PSM 后为 42.9%，43.9%）、持续妊娠率（未进行 PSM 前为 48.2%，48.1%；进行 PSM 后为 52.2%，52.7%）和临床妊娠率（未进行 PSM 前为 55.0%，54.8%；进行 PSM 后为 54.7%，54.2%）与未接种疫苗的对照组相当。与对照组相比，新生儿的出生长度（未进行 PSM 前为 50.0±1.6cm，49.0±2.9cm；进行 PSM 后为 49.9±1.7cm，49.3±2.6cm）和出生体重（未进行 PSM 前为 3111.2±349.9g，3030.3±588.5g；进行 PSM 后为 3053.8±372.5g，3039.2±496.8g）也相似。疫苗接种一剂或两剂，以及疫苗接种和胚胎移植之间的时间间隔均未对生殖和新生儿结局产生显著影响。
局限性、谨慎的原因：主要发现可能受到回顾性设计的限制。此外，在数据收集时，还无法接种三剂新冠病毒疫苗，因此结果不能反映三剂新冠病毒灭活疫苗的安全使用情况。最后，新冠病毒感染史是基于患者的自我报告，而不是客观的实验室检测。
符合条件的新冠灭活疫苗接种者不应因胚胎移植计划而推迟疫苗接种计划，反之亦然。
研究资金/利益冲突：本研究得到广州医学重点学科（2021-2023）的支持。所有作者均无利益冲突。
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