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      No Effect of Inactivated SARS-CoV-2 Vaccination on in vitro Fertilization Outcomes: A Propensity Score-Matched Study

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          Abstract

          Purpose

          To investigate the impact of inactivated SARS-CoV-2 vaccination on in vitro fertilization (IVF) outcomes.

          Patients and Methods

          This retrospective cohort study included 2185 patients undergoing fresh IVF cycles from June 1st to September 13th 2021 in a single university-affiliated hospital. Vaccine administration information was collected and ascertained via immunization records. Patients with two dosages of inactivated SARS-CoV-2 vaccines (Sinopharm or Sinovac) were categorized into the vaccinated group (n = 150), while those unvaccinated were classified as control (n = 2035). Propensity score matching was performed to balance the baseline characteristics (14 covariates) between the two groups at a ratio of 1:4. The main outcome measures were the number of oocytes retrieved, good-quality embryo rate and clinical pregnancy rate.

          Results

          There were 146 women in the vaccinated group and 584 in the control group after matching. The number of oocytes retrieved (9.9 ± 7.1 vs 9.9 ± 6.7; P = 0.893), good-quality embryo rate (33.5 ± 29.8% vs 29.9 ± 28.6%; P = 0.184) and clinical pregnancy rate (59.1% vs 63.6%; P = 0.507) were all similar between the two groups. In addition, no significant differences were observed regarding other cycle characteristics, laboratory parameters and pregnancy outcomes. The results were also comparable when vaccinated patients were subdivided into three categories based on the time interval from complete vaccination to cycle initiation: ≤1 month, >1–2 months, and >2 months.

          Conclusion

          Our study provided the first-time evidence that inactivated SARS-CoV-2 vaccination in females did not result in any measurable detrimental effects on IVF treatment. Owing to the present limitations, further prospective studies with larger cohort size and longer follow-up are warranted to validate our conclusion.

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          Most cited references36

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          An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies

          The propensity score is the probability of treatment assignment conditional on observed baseline characteristics. The propensity score allows one to design and analyze an observational (nonrandomized) study so that it mimics some of the particular characteristics of a randomized controlled trial. In particular, the propensity score is a balancing score: conditional on the propensity score, the distribution of observed baseline covariates will be similar between treated and untreated subjects. I describe 4 different propensity score methods: matching on the propensity score, stratification on the propensity score, inverse probability of treatment weighting using the propensity score, and covariate adjustment using the propensity score. I describe balance diagnostics for examining whether the propensity score model has been adequately specified. Furthermore, I discuss differences between regression-based methods and propensity score-based methods for the analysis of observational data. I describe different causal average treatment effects and their relationship with propensity score analyses.
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            Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19

            Background The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation. Methods In an international, randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned adult participants in a 1:1 ratio to receive a single dose of Ad26.COV2.S (5×10 10 viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe–critical coronavirus disease 2019 (Covid-19) with an onset at least 14 days and at least 28 days after administration among participants in the per-protocol population who had tested negative for SARS-CoV-2. Safety was also assessed. Results The per-protocol population included 19,630 SARS-CoV-2–negative participants who received Ad26.COV2.S and 19,691 who received placebo. Ad26.COV2.S protected against moderate to severe–critical Covid-19 with onset at least 14 days after administration (116 cases in the vaccine group vs. 348 in the placebo group; efficacy, 66.9%; adjusted 95% confidence interval [CI], 59.0 to 73.4) and at least 28 days after administration (66 vs. 193 cases; efficacy, 66.1%; adjusted 95% CI, 55.0 to 74.8). Vaccine efficacy was higher against severe–critical Covid-19 (76.7% [adjusted 95% CI, 54.6 to 89.1] for onset at ≥14 days and 85.4% [adjusted 95% CI, 54.2 to 96.9] for onset at ≥28 days). Despite 86 of 91 cases (94.5%) in South Africa with sequenced virus having the 20H/501Y.V2 variant, vaccine efficacy was 52.0% and 64.0% against moderate to severe–critical Covid-19 with onset at least 14 days and at least 28 days after administration, respectively, and efficacy against severe–critical Covid-19 was 73.1% and 81.7%, respectively. Reactogenicity was higher with Ad26.COV2.S than with placebo but was generally mild to moderate and transient. The incidence of serious adverse events was balanced between the two groups. Three deaths occurred in the vaccine group (none were Covid-19–related), and 16 in the placebo group (5 were Covid-19–related). Conclusions A single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe–critical disease, including hospitalization and death. Safety appeared to be similar to that in other phase 3 trials of Covid-19 vaccines. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722 .)
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              Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis

              Abstract Objective To determine the clinical manifestations, risk factors, and maternal and perinatal outcomes in pregnant and recently pregnant women with suspected or confirmed coronavirus disease 2019 (covid-19). Design Living systematic review and meta-analysis. Data sources Medline, Embase, Cochrane database, WHO COVID-19 database, China National Knowledge Infrastructure (CNKI), and Wanfang databases from 1 December 2019 to 26 June 2020, along with preprint servers, social media, and reference lists. Study selection Cohort studies reporting the rates, clinical manifestations (symptoms, laboratory and radiological findings), risk factors, and maternal and perinatal outcomes in pregnant and recently pregnant women with suspected or confirmed covid-19. Data extraction At least two researchers independently extracted the data and assessed study quality. Random effects meta-analysis was performed, with estimates pooled as odds ratios and proportions with 95% confidence intervals. All analyses will be updated regularly. Results 77 studies were included. Overall, 10% (95% confidence interval 7% to14%; 28 studies, 11 432 women) of pregnant and recently pregnant women attending or admitted to hospital for any reason were diagnosed as having suspected or confirmed covid-19. The most common clinical manifestations of covid-19 in pregnancy were fever (40%) and cough (39%). Compared with non-pregnant women of reproductive age, pregnant and recently pregnant women with covid-19 were less likely to report symptoms of fever (odds ratio 0.43, 95% confidence interval 0.22 to 0.85; I2=74%; 5 studies; 80 521 women) and myalgia (0.48, 0.45 to 0.51; I2=0%; 3 studies; 80 409 women) and were more likely to need admission to an intensive care unit (1.62, 1.33 to 1.96; I2=0%) and invasive ventilation (1.88, 1.36 to 2.60; I2=0%; 4 studies, 91 606 women). 73 pregnant women (0.1%, 26 studies, 11 580 women) with confirmed covid-19 died from any cause. Increased maternal age (1.78, 1.25 to 2.55; I2=9%; 4 studies; 1058 women), high body mass index (2.38, 1.67 to 3.39; I2=0%; 3 studies; 877 women), chronic hypertension (2.0, 1.14 to 3.48; I2=0%; 2 studies; 858 women), and pre-existing diabetes (2.51, 1.31 to 4.80; I2=12%; 2 studies; 858 women) were associated with severe covid-19 in pregnancy. Pre-existing maternal comorbidity was a risk factor for admission to an intensive care unit (4.21, 1.06 to 16.72; I2=0%; 2 studies; 320 women) and invasive ventilation (4.48, 1.40 to 14.37; I2=0%; 2 studies; 313 women). Spontaneous preterm birth rate was 6% (95% confidence interval 3% to 9%; I2=55%; 10 studies; 870 women) in women with covid-19. The odds of any preterm birth (3.01, 95% confidence interval 1.16 to 7.85; I2=1%; 2 studies; 339 women) was high in pregnant women with covid-19 compared with those without the disease. A quarter of all neonates born to mothers with covid-19 were admitted to the neonatal unit (25%) and were at increased risk of admission (odds ratio 3.13, 95% confidence interval 2.05 to 4.78, I2=not estimable; 1 study, 1121 neonates) than those born to mothers without covid-19. Conclusion Pregnant and recently pregnant women are less likely to manifest covid-19 related symptoms of fever and myalgia than non-pregnant women of reproductive age and are potentially more likely to need intensive care treatment for covid-19. Pre-existing comorbidities, high maternal age, and high body mass index seem to be risk factors for severe covid-19. Preterm birth rates are high in pregnant women with covid-19 than in pregnant women without the disease. Systematic review registration PROSPERO CRD42020178076. Readers’ note This article is a living systematic review that will be updated to reflect emerging evidence. Updates may occur for up to two years from the date of original publication.
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                Author and article information

                Journal
                J Inflamm Res
                J Inflamm Res
                jir
                Journal of Inflammation Research
                Dove
                1178-7031
                09 February 2022
                2022
                : 15
                : 839-849
                Affiliations
                [1 ]Center for Reproductive Medicine, Jiangxi Maternal and Child Health Hospital , Nanchang, People’s Republic of China
                [2 ]Department of Assisted Reproduction, Shanghai Ninth People’s Hospital , Shanghai, People’s Republic of China
                [3 ]Department of Laboratory Medicine, Huanan Hospital of Shenzhen University , Shenzhen, People’s Republic of China
                [4 ]Department of Gynecology, Jiangxi Maternal and Child Health Hospital , Nanchang, People’s Republic of China
                [5 ]Department of Otorhinolaryngology, The First Affiliated Hospital of Nanchang University , Nanchang, People’s Republic of China
                [6 ]Center for Reproductive Medicine, Shangrao Maternal and Child Health Hospital , Shangrao, People’s Republic of China
                Author notes
                Correspondence: Lifeng Tian; Qiongfang Wu, Center for Reproductive Medicine, Jiangxi Maternal and Child Health Hospital , Nanchang, People’s Republic of China, Email 64554076@qq.com; wuqfivf@126.com
                [*]

                These authors contributed equally to this work

                Article
                347729
                10.2147/JIR.S347729
                8843422
                35177919
                3b12406e-7215-431a-aee6-87cbe483eeaf
                © 2022 Huang et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 04 November 2021
                : 15 January 2022
                Page count
                Figures: 2, Tables: 11, References: 40, Pages: 11
                Funding
                Funded by: the National Natural Science Foundation of China;
                Funded by: the Key Research and Development Program of Jiangxi Province;
                This study was funded by the National Natural Science Foundation of China (81960288) and the Key Research and Development Program of Jiangxi Province (20203BBGL73159).
                Categories
                Original Research

                Immunology
                covid-19,sars-cov-2,vaccination,in vitro fertilization
                Immunology
                covid-19, sars-cov-2, vaccination, in vitro fertilization

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