STUDY QUESTION Do inactivated coronavirus disease-2019 (COVID-19) vaccines affect IVF outcomes among the vaccine recipients? SUMMARY ANSWER The receipt of inactivated COVID-19 vaccines before ovarian stimulation has little effect on the outcomes of IVF, including ovarian stimulation outcomes, embryo development and pregnancy rates. WHAT IS KNOWN ALREADY Limited studies have reported that COVID-19 vaccines do not affect ovarian function, embryo development or pregnancy outcomes. STUDY DESIGN, SIZE, DURATION This was a retrospective cohort study performed at the Third Affiliated Hospital of Guangzhou Medical University on 240 women vaccinated with either CoronaVac or Sinopharm COVID-19 before ovarian stimulation in the exposed group and 1343 unvaccinated women before ovarian stimulation in the unexposed group. All participants received fresh embryo transfers between 1 March 2021 and 15 September 2021. The included women were followed up until 12 weeks of gestation. PARTICIPANTS/MATERIALS, SETTING, METHODS Vaccination information of all subjects was followed up by a nurse, and the IVF data were obtained from the IVF data system. The following aspects were compared between the vaccinated and the unvaccinated groups: parameters of ovarian stimulation, embryo development and pregnancy rates. Regression analyses were performed to control for confounders of embryo development and pregnancy rates. Propensity score matching (PSM) was performed to balance the baseline parameters of the two groups. The primary outcome was the ongoing pregnancy rate. MAIN RESULTS AND THE ROLE OF CHANCE Liner regression analysis revealed that the number of oocytes retrieved (regression coefficient (B) = −0.299, P = 0.264), embryos suitable for transfer (B = −0.203, P = 0.127) and blastocysts (B = −0.250, P = 0.105) were not associated with the status of vaccination before ovarian stimulation, after adjusting for the confounders. The ongoing pregnancy rate in the women of the vaccinated group was not significantly lower than that in the unvaccinated group (36.3% vs 40.7%, P = 0.199) (adjust odd ratio = 0.91, 95% CI = 0.68–1.22, P = 0.52). After PSM, the rates of ongoing pregnancy (36.0% vs 39.9%, P = 0.272), implantation (35.4% vs 38.3%, P = 0.325), biochemical pregnancy (47.3% vs 51.6%, P = 0.232), clinical pregnancy (44.4% vs 47.4%, P = 0.398) and early miscarriage (15.0% vs 12.1%, P = 0.399) were not significantly different between the vaccinated and the unvaccinated groups. LIMITATIONS, REASONS FOR CAUTION This is a retrospective study of women with infertility. The results from the present study warrant confirmation by prospective studies with a larger cohort. WIDER IMPLICATIONS OF THE FINDINGS This is the first study with a large sample size on the effect of inactivated COVID-19 vaccines on ongoing pregnancy rates of women undergoing IVF. The present results showed that vaccination has no detrimental effect on IVF outcomes. Therefore, women are recommended to receive COVID-19 vaccines before undergoing their IVF treatment. STUDY FUNDING/COMPETING INTEREST(S) This study was supported by the National Key Research and Development Program of China (No. 2018YFC1003803 to J.L.), the Guangzhou Science and Technology Plan Project (No. 202102010076 to H.L.) and the Medical Key Discipline of Guangzhou (2021-2023), as well as the Sino-German Center for Research Promotion Rapid Response Funding Call for Bilateral Collaborative Proposals between China and Germany in COVID-19 Related Research (No. C-0032 to Xingfei Pan). The authors declare no conflicts of interest. TRIAL REGISTRATION NUMBER N/A.

中文翻译：

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灭活的 COVID-19 疫苗接种不会影响女性的体外受精结果

研究问题 灭活的 2019 年冠状病毒病 (COVID-19) 疫苗会影响疫苗接种者的体外受精结果吗？总结答案 在卵巢刺激之前接种灭活 COVID-19 疫苗对 IVF 的结果几乎没有影响，包括卵巢刺激结果、胚胎发育和妊娠率。已知情况 有限的研究报告称，COVID-19 疫苗不会影响卵巢功能、胚胎发育或妊娠结局。研究设未曝光组。所有参与者在 2021 年 3 月 1 日至 2021 年 9 月 15 日期间接受了新鲜胚胎移植。对纳入的妇女进行了随访，直至妊娠 12 周。参与者/材料、设置、方法所有受试者的疫苗接种信息由一名护士跟踪，IVF数据来自IVF数据系统。比较了接种组和未接种组的以下几个方面：卵巢刺激参数、胚胎发育和妊娠率。进行回归分析以控制胚胎发育和妊娠率的混杂因素。进行倾向评分匹配（PSM）以平衡两组的基线参数。主要结果是持续妊娠率。主要结果和机会的作用 线性回归分析显示取回的卵母细胞数（回归系数 (B) = -0.299，P = 0.264）、适合移植的胚胎（B = -0.203，P = 0.127）和囊胚（B = -0.250，P = 0.105）在调整混杂因素后与卵巢刺激前的疫苗接种状态无关。接种组女性的持续妊娠率未显着低于未接种组（36.3% vs 40.7%，P = 0.199）（调整比值比 = 0.91，95% CI = 0.68-1.22，P = 0.52 ）。PSM后，持续妊娠率（36.0% vs 39.9%，P = 0.272）、着床率（35.4% vs 38.3%，P = 0.325）、生化妊娠率（47.3% vs 51.6%，P = 0.232）、临床妊娠率（ 44.4% 对 47.4%，P = 0.398）和早期流产（15.0% 对 12.1%，P = 0。399) 在接种组和未接种组之间没有显着差异。限制和谨慎的原因 这是一项对不孕症女性的回顾性研究。本研究的结果需要通过更大队列的前瞻性研究来证实。研究结果的更广泛意义 这是第一项关于灭活 COVID-19 疫苗对接受 IVF 的女性持续妊娠率影响的大样本研究。目前的结果表明，疫苗接种对体外受精结果没有不利影响。因此，建议女性在接受 IVF 治疗之前接种 COVID-19 疫苗。研究经费/竞争兴趣 本研究得到国家重点研发计划（No. 2018YFC1003803 to JL）、广州市科技计划项目（No. 202102010076 to HL）和广州市医学重点学科（2021-2023），以及中德研究促进中心快速响应基金征集中德COVID-19相关研究双边合作提案（C号） -0032 给潘兴飞）。作者宣称没有利益冲突。试用注册号 不适用。