Department of Reproductive Medicine, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Shanghai Key Laboratory for Assisted Reproduction and Reproductive Genetics, Shanghai, China.
Hum Reprod. 2024 Jun 3;39(6):1239-1246. doi: 10.1093/humrep/deae068.
Does severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during the frozen-thawed embryo transfer (FET) cycle affect embryo implantation and pregnancy rates?
There is no evidence that SARS-CoV-2 infection of women during the FET cycle negatively affects embryo implantation and pregnancy rates.
Coronavirus disease 2019 (COVID-19), as a multi-systemic disease, poses a threat to reproductive health. However, the effects of SARS-CoV-2 infection on embryo implantation and pregnancy following fertility treatments, particularly FET, remain largely unknown.
STUDY DESIGN, SIZE, DURATION: This retrospective cohort study, included women who underwent FET cycles between 1 November 2022 and 31 December 2022 at an academic fertility centre.
PARTICIPANTS/MATERIALS, SETTING, METHODS: Women who tested positive for SARS-CoV-2 during their FET cycles were included in the COVID-19 group, while those who tested negative during the same study period were included in the non-COVID-19 group. The primary outcome was ongoing pregnancy rate. Secondary outcomes included rates of implantation, biochemical pregnancy, clinical pregnancy, early pregnancy loss, and ongoing pregnancy. Multivariate logistic regression models were applied to adjust for potential confounders including age, body mass index, gravidity, vaccination status, and endometrial preparation regimen. Subgroup analyses were conducted by time of infection with respect to transfer (prior to transfer, 1-7 days after transfer, or 8-14 days after transfer) and by level of fever (no fever, fever <39°C, or fever ≥39°C).
A total of 243 and 305 women were included in the COVID-19 and non-COVID-19 group, respectively. The rates of biochemical pregnancy (58.8% vs 62.0%, P = 0.46), clinical pregnancy (53.1% vs 54.4%, P = 0.76), implantation (46.4% vs 46.2%, P = 0.95), early pregnancy loss (24.5% vs 26.5%, P = 0.68), and ongoing pregnancy (44.4% vs 45.6%, P = 0.79) were all comparable between groups with or without infection. Results of logistic regression models, both before and after adjustment, revealed no associations between SARS-CoV-2 infection and rates of biochemical pregnancy, clinical pregnancy, early pregnancy loss, or ongoing pregnancy. Moreover, neither the time of infection with respect to transfer (prior to transfer, 1-7 days after transfer, or 8-14 days after transfer) nor the level of fever (no fever, fever <39°C, or fever ≥39°C) was found to be related to pregnancy rates.
LIMITATIONS, REASONS FOR CAUTION: The retrospective nature of the study is subject to possible selection bias. Additionally, although the sample size was relatively large for the COVID-19 group, the sample sizes for certain subgroups were relatively small and lacked adequate power, so these results should be interpreted with caution.
The study findings suggest that SARS-CoV-2 infection during the FET cycle in females does not affect embryo implantation and pregnancy rates including biochemical pregnancy, clinical pregnancy, early pregnancy loss, and ongoing pregnancy, indicating that cycle cancellation due to SARS-CoV-2 infection may not be necessary. Further studies are warranted to verify these findings.
STUDY FUNDING/COMPETING INTEREST(S): This study was supported by the National Key Research and Development Program of China (2023YFC2705500, 2019YFA0802604), National Natural Science Foundation of China (82130046, 82101747), Shanghai leading talent program, Innovative research team of high-level local universities in Shanghai (SHSMU-ZLCX20210201, SHSMU-ZLCX20210200, SSMU-ZLCX20180401), Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital Clinical Research Innovation Cultivation Fund Program (RJPY-DZX-003), Science and Technology Commission of Shanghai Municipality (23Y11901400), Shanghai Sailing Program (21YF1425000), Shanghai's Top Priority Research Center Construction Project (2023ZZ02002), Three-Year Action Plan for Strengthening the Construction of the Public Health System in Shanghai (GWVI-11.1-36), and Shanghai Municipal Education Commission-Gaofeng Clinical Medicine Grant Support (20161413). The authors have no conflicts of interest to declare.
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严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-2）在冻融胚胎移植（FET）周期中感染是否会影响胚胎着床和妊娠率？
目前尚无证据表明女性在 FET 周期中感染 SARS-CoV-2 会降低胚胎着床和妊娠率。
作为一种多系统疾病的 2019 年冠状病毒病（COVID-19）对生殖健康构成威胁。然而，SARS-CoV-2 感染对生育治疗（特别是 FET）后胚胎着床和妊娠的影响在很大程度上仍不清楚。
研究设计、规模、持续时间：这是一项回顾性队列研究，纳入了 2022 年 11 月 1 日至 12 月 31 日期间在一家学术生育中心接受 FET 周期的女性。
参与者/材料、地点、方法：在 FET 周期中检测到 SARS-CoV-2 阳性的女性被纳入 COVID-19 组，而在同一研究期间检测到 SARS-CoV-2 阴性的女性被纳入非 COVID-19 组。主要结局是持续妊娠率。次要结局包括着床率、生化妊娠率、临床妊娠率、早期妊娠丢失率和持续妊娠率。应用多变量逻辑回归模型调整了潜在混杂因素，包括年龄、体重指数、孕次、疫苗接种状态和子宫内膜准备方案。通过感染与移植的时间（移植前、移植后 1-7 天或移植后 8-14 天）和发热程度（无发热、发热<39°C 或发热≥39°C）进行亚组分析。
COVID-19 组和非 COVID-19 组分别纳入 243 名和 305 名女性。生化妊娠率（58.8% vs 62.0%，P=0.46）、临床妊娠率（53.1% vs 54.4%，P=0.76）、着床率（46.4% vs 46.2%，P=0.95）、早期妊娠丢失率（24.5% vs 26.5%，P=0.68）和持续妊娠率（44.4% vs 45.6%，P=0.79）在感染组和未感染组之间均无差异。逻辑回归模型的结果（调整前和调整后）均显示，SARS-CoV-2 感染与生化妊娠率、临床妊娠率、早期妊娠丢失率或持续妊娠率之间无关联。此外，感染与移植的时间（移植前、移植后 1-7 天或移植后 8-14 天）或发热程度（无发热、发热<39°C 或发热≥39°C）均与妊娠率无关。
局限性、谨慎的原因：研究的回顾性性质使其容易受到选择偏倚的影响。此外，尽管 COVID-19 组的样本量对于该研究来说相对较大，但某些亚组的样本量相对较小，且缺乏足够的效力，因此这些结果应谨慎解释。
研究结果表明，女性在 FET 周期中感染 SARS-CoV-2 不会影响胚胎着床和妊娠率，包括生化妊娠率、临床妊娠率、早期妊娠丢失率和持续妊娠率，这表明由于 SARS-CoV-2 感染而取消周期可能没有必要。需要进一步的研究来验证这些发现。
研究资金/利益冲突：本研究得到了国家重点研发计划（2023YFC2705500、2019YFA0802604）、国家自然科学基金（82130046、82101747）、上海市领军人才计划、上海市高水平地方高校创新团队计划（SHSMU-ZLCX20210201、SHSMU-ZLCX20210200、SSMU-ZLCX20180401）、上海交通大学医学院附属仁济医院临床研究创新培育基金项目（RJPY-DZX-003）、上海市科学技术委员会（23Y11901400）、上海扬帆计划（21YF1425000）、上海市公共卫生三年行动计划（Shanghai's Three-Year Action Plan for Strengthening the Construction of the Public Health System in Shanghai）（GWVI-11.1-36）和上海市教委高峰高原学科建设计划（20161413）的支持。作者没有利益冲突声明。
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