Peri-operative SARS-CoV-2 infection increases postoperative mortality. The aim of this study was to determine the optimal duration of planned delay before surgery in patients who have had SARS-CoV-2 infection. This international, multicentre, prospective cohort study included patients undergoing elective or emergency surgery during October 2020. Surgical patients with pre-operative SARS-CoV-2 infection were compared with those without previous SARS-CoV-2 infection. The primary outcome measure was 30-day postoperative mortality. Logistic regression models were used to calculate adjusted 30-day mortality rates stratified by time from diagnosis of SARS-CoV-2 infection to surgery. Among 140,231 patients (116 countries), 3127 patients (2.2%) had a pre-operative SARS-CoV-2 diagnosis. Adjusted 30-day mortality in patients without SARS-CoV-2 infection was 1.5% (95%CI 1.4-1.5). In patients with a pre-operative SARS-CoV-2 diagnosis, mortality was increased in patients having surgery within 0-2 weeks, 3-4 weeks and 5-6 weeks of the diagnosis (odds ratio (95%CI) 4.1 (3.3-4.8), 3.9 (2.6-5.1) and 3.6 (2.0-5.2), respectively). Surgery performed ≥ 7 weeks after SARS-CoV-2 diagnosis was associated with a similar mortality risk to baseline (odds ratio (95%CI) 1.5 (0.9-2.1)). After a ≥ 7 week delay in undertaking surgery following SARS-CoV-2 infection, patients with ongoing symptoms had a higher mortality than patients whose symptoms had resolved or who had been asymptomatic (6.0% (95%CI 3.2-8.7) vs. 2.4% (95%CI 1.4-3.4) vs. 1.3% (95%CI 0.6-2.0), respectively). Where possible, surgery should be delayed for at least 7 weeks following SARS-CoV-2 infection. Patients with ongoing symptoms ≥ 7 weeks from diagnosis may benefit from further delay.
SARS-CoV-2 has been associated with an increased rate of venous thromboembolism in critically ill patients. Since surgical patients are already at higher risk of venous thromboembolism than general populations, this study aimed to determine if patients with peri-operative or prior SARS-CoV-2 were at further increased risk of venous thromboembolism. We conducted a planned sub-study and analysis from an international, multicentre, prospective cohort study of elective and emergency patients undergoing surgery during October 2020. Patients from all surgical specialties were included. The primary outcome measure was venous thromboembolism (pulmonary embolism or deep vein thrombosis) within 30 days of surgery. SARS-CoV-2 diagnosis was defined as peri-operative (7 days before to 30 days after surgery); recent (1-6 weeks before surgery); previous (≥7 weeks before surgery); or none. Information on prophylaxis regimens or pre-operative anti-coagulation for baseline comorbidities was not available. Postoperative venous thromboembolism rate was 0.5% (666/123,591) in patients without SARS-CoV-2; 2.2% (50/2317) in patients with peri-operative SARS-CoV-2; 1.6% (15/953) in patients with recent SARS-CoV-2; and 1.0% (11/1148) in patients with previous SARS-CoV-2. After adjustment for confounding factors, patients with peri-operative (adjusted odds ratio 1.5 (95%CI 1.1-2.0)) and recent SARS-CoV-2 (1.9 (95%CI 1.2-3.3)) remained at higher risk of venous thromboembolism, with a borderline finding in previous SARS-CoV-2 (1.7 (95%CI 0.9-3.0)). Overall, venous thromboembolism was independently associated with 30-day mortality ). In patients with SARS-CoV-2, mortality without venous thromboembolism was 7.4% (319/4342) and with venous thromboembolism was 40.8% (31/76). Patients undergoing surgery with peri-operative or recent SARS-CoV-2 appear to be at increased risk of postoperative venous thromboembolism compared with patients with no history of SARS-CoV-2 infection. Optimal venous thromboembolism prophylaxis and treatment are unknown in this cohort of patients, and these data should be interpreted accordingly.
STUDY QUESTION Does oral antioxidant pretreatment for the male partner improve clinical pregnancy rate in couples undergoing ART for male factor subfertility? SUMMARY ANSWER There was no significant difference in clinical pregnancy rate following oral antioxidant pretreatment for male partner in couples undergoing ART for male factor subfertility compared to no pretreatment. WHAT IS KNOWN ALREADY Damage to sperm mediated by reactive oxygen species (ROS) contributes significantly to male factor infertility. The ROS-related injury reduces fertilization potential and adversely affects the sperm DNA integrity. Antioxidants act as free radical scavengers to protect spermatozoa against ROS induced damage. During ART, use of sperms which have been exposed to ROS-mediated damage may affect the treatment outcome. Pretreatment with antioxidants may reduce the ROS-mediated sperm DNA damage. Currently, antioxidants are commonly prescribed to men who require ART for male factor subfertility but there is ambiguity regarding their role. STUDY DESIGN, SIZE, DURATION This was an open label, randomized controlled trial conducted at a tertiary level infertility clinic between February 2013 and October 2019. The trial included 200 subfertile couples who were undergoing ART treatment for male factor subfertility. PARTICIPANTS/MATERIALS, SETTING, METHODS Couples were randomized into treatment arm (n = 100) and control arm (n = 100). In the treatment arm, the male partner received oral antioxidants (Vitamin C, Vitamin E and Zinc) for 3 months just prior to the ART cycle. In the control arm, no antioxidant was given to the male partner. The primary outcome was clinical pregnancy rate, while live birth rate (LBR), miscarriage rate and changes in semen parameters were the secondary outcomes. MAIN RESULTS AND THE ROLE OF CHANCE Out of 200 women randomized, 135 underwent embryo transfer as per protocol. Following intention to treat analysis, no significant difference was noted in clinical pregnancy (36/100, 36% vs 26/100, 26%; odds ratio (OR) 1.60, 95% CI 0.87 to 2.93) and LBR (25/100, 25% vs 22/100, 22%; OR 1.18, 95% CI 0.61 to 2.27) between antioxidant and no pretreatment arms. The clinical pregnancy rate per embryo transfer was significantly higher following antioxidant pretreatment (35/64, 54.7% vs 26/71, 36.6%; OR 2.09, 95% CI 1.05 to 4.16) compared to no pretreatment. There was no significant difference in LBR per embryo transfer (25/64, 39.1%, vs 22/71, 31.0%; OR 1.43, 95% CI 0.70 to 2.91) after antioxidant pretreatment versus no pretreatment. The semen parameters of sperm concentration (median, interquartile range, IQR) (18.2, 8.6 to 37.5 vs 20.5, 8.0 to 52.5, million/ml; P = 0.97), motility (median, IQR) (34, 20 to 45 vs 31, 18 to 45%; P = 0.38) and morphology (mean ± SD) (2....
STUDY QUESTION What is the knowledge, anxiety levels and attitudes of infertile couples towards coronavirus disease 2019 (COVID-19) and its impact on undergoing self-funded treatment cycles? SUMMARY ANSWER In spite of a high level of awareness about COVID-19, anxiety levels were low and many participants wanted to continue fertility treatment during the pandemic. WHAT IS KNOWN ALREADY The COVID-19 pandemic has strained the already overburdened public health infrastructure in many of the resource-limited settings across the world. After an initial decision to suspend fertility treatments, regulatory authorities advocated phased resumptions of treatment. Owing to limited healthcare resources and the detrimental impact of COVID-19 on the economy and job losses, fertility services have been disproportionately affected. It is important to understand the perceptions of infertile couples, who are the key stakeholders in shared decision-making, especially for self-funded treatments, on the continuation of fertility treatment during the current COVID-19 pandemic. STUDY DESIGN, SIZE, DURATION This was a questionnaire-based cross-sectional study conducted among 502 participants (251 infertile couples) at a tertiary level infertility clinic between May 2020 and November 2020. The study recruitment period (6 months) coincided with the increase and peak of COVID-19 infection in India. The study included infertile couples who had attended the clinic either for assessment or fertility treatment. PARTICIPANTS/MATERIALS, SETTING, METHODS An interviewer administered the questionnaire survey, which was conducted in two stages for each participant. In the first stage, knowledge about COVID-19 and anxiety levels caused by the ongoing pandemic were assessed using a validated Generalized Anxiety Disorder-7 (GAD-7) tool. Following this, all the participants were provided with a COVID-19 information pamphlet. Subsequently, in the second stage, participants were administered another questionnaire to assess their attitudes towards fertility treatment and pregnancy during the COVID-19 pandemic. MAIN RESULTS AND THE ROLE OF CHANCE The results showed that the knowledge levels and awareness about COVID-19 was high among infertile couples attending the infertility clinic. The majority of the participants were aware of the mode of spread (87.6–93.4% correct answers to different questions), common symptoms (64.1–96.2%) and the importance of preventative measures (95.6–97.4%). Most of the participants (474/502; 94.4%) did not show anxiety when being assessed using GAD-7. A vast majority (96.5–99.2%) of the participants were in agreement with the need for following preventative measures for reducing the spread of COVID-19. About one-third of the participants wanted to delay the fertility treatment until the pandemic is over (166/502; 33.1%). Approximately 42.2% (212/502) of the participants did not feel the need to suspend fertility treatment during the pandemic. Further analysis revealed that participants’ education levels significantly influenced the desire to continue fertility treatment: participants with lower levels of education (below graduate) were less likely to continue fertility treatment (adjusted odds ratio 0.34, 95% CI, 0.12–0.98). LIMITATIONS, REASONS FOR CAUTION Questionnaire-based responses could have limited the ability of the interviewer to capture the entire range of thoughts and views of the participants on the COVID pandemic and their fertility treatments. Furthermore, a language barrier was encountered for some couples for which assistance from a translator was sought. WIDER IMPLICATIONS OF THE FINDINGS Given the impact of infertility and the associated stigma, public health policy makers, regulatory authorities and fertility societies should consider a way to sustain the treatment options and develop appropriate guidelines to continue treatment, particularly when much of the world is experiencing the second and third waves of the COVID pandemic. STUDY FUNDING/COMPETING INTEREST(S) This study has not received any specific grant from funding agencies in the public, commercial or not-for-profit sectors. M.S.K. is an associate editor with Human Reproduction Open. The other authors have no competing interests to declare. TRIAL REGISTRATION NUMBER N/A.
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