ABSTRACT
Background COVID-19 continues to cause significant illness and mortality worldwide. Solid Organ Transplant Recipients (SOTR) have a higher rate of COVID-19 infection and worse outcomes than those who are immunocompetent. Dexamethasone, tocilizumab, and baricitinib have improved inpatient outcomes. Sotrovimab, remdesivir, and nirmatrelvir/ritonavir have recently been approved for used in high risk, minimally symptomatic outpatients. Previous experience has shown that use of monoclonal antibodies and oral antiviral agents have reduced morbidity and mortality of COVID-19 in SOTR. Purpose To assess the experiences and outcomes of COVID-19 and access to directed therapy in SOTR in British Columbia (BC). Method Data was compiled from patient disclosure to liver transplant clinicians on COVID-19 infection and gathered from patient charts in the SOTR Clinic at Vancouver General Hospital. Inclusion criteria were patients followed at the clinic with a positive COVID-19 test or clinical confirmation of COVID-19 syndrome. This is a retrospective, quality assurance study and did not require ethics review. Result(s) 158 SOTR reported COVID-19 infections between March 2020 and September 2022. 3 patients died within 30 days of COVID-19 infection, 2 (1.26%) of which the cause of death was directly due to COVID-19, and the other who had cholangitis with severe sepsis and multi-organ system failure. 24 patients required admission to hospital, 7 requiring critical care support. 41 patients did not receive any therapy for COVID-19: there was none available at that time (n=26), it was contraindicated due to a drug interaction (n=2) or medical condition (n=1), was refused (n=1), or the infection was reported too late to qualify (n=10). 83% (92/112) of outpatients received available anti-viral treatment: sotrovimab (n=27), remdesivir (n=63), or nirmatrelvir/ritonavir (n=2). In inpatients (n=24), 13 received corticosteroids, 6 dual treated with tocilizumab (n=4) or baracitinib (n=2). 4 inpatients received remdesivir. Three patients were treated in hospital after initiating outpatient therapy, one with progression of COVID-19 illness despite starting remdesivir. Two patients had adverse effects of medications provided: one was prescribed nirmatrelvir/ritonavir by a physician outside of the transplant program, which caused tacrolimus toxicity (serum concentration of 69.4 ng/mL) with nausea, vomiting, and diarrhea. Another patient had an episode of hypotension after receiving sotrovimab and sustained an acute kidney injury (AKI). Both patients fully recovered. There were no deaths on antiviral therapy. Of 145 patients who had laboratory investigations done within 30 days of COVID-19 infection, 16 had a transient rise in liver enzymes, 14 had an AKI and 11required an adjustment in their tacrolimus dose. Conclusion(s) Involving the liver transplant team early in the course of COVID-19 illness allows patients to safely access COVID-19 directed therapy to avoid progression of illness, and medication interactions or toxicity. Please acknowledge all funding agencies by checking the applicable boxes below None Disclosure of Interest None Declared
ABSTRACT
Objective: This study aimed at evaluating whether subcutaneous and pre-peritoneal abdominal fat as well as follicular fluid leptin (FFL) predict intracytoplasmic sperm injection (ICSI) outcomes in women without polycystic ovary syndrome (PCOS). Design: Prospective cohort study (NCT03778684) in an University-affiliated Assisted Conception Center. University IRB approved the study. Materials and Methods: Infertile non-PCOS women indicated for ICSI were considered for enrollment after consent. Included women were grouped based on their waist circumference (WC) into women with central obesity (WC ≥ 80 cm;COB group) and without (WC< 80 cm;Non-COB group). At baseline evaluation, women underwent assessment of obesity using different measures and assessment of homeostasis-model for insulin resistance (HOMA-IR). Obesity measures included body mass index (BMI), visceral adiposity index (VAI), and the novel body fat index (BFI). BFI was calculated by multiplying pre-peritoneal and subcutaneous fat (in mm) and divided by height (in cm). FFL was measured from pooled follicular fluid of ≥ 17 mm follicles, containing cumulus oocyte complex. Our primary endpoint was ongoing pregnancy rate (OPR). Comparisons between groups were evaluated utilizing the independent t, Wilcoxon rank sum, and chi-square tests as appropriate. Logistic regression model, receiver operating characteristic (ROC) curve and correlation coefficient (r) were also utilized. We planned a sample size of 168 women. Recruitment was temporarily suspended due to COVID-19 pandemic. Recruitment will continue, once IVF procedures are resumed based on our governmental policy Results: Of 340 women screened, 72 eligible women were included in this preliminary analysis;40 in COB group and 32 in Non-COB group. Both groups were comparable in age, AMH, duration of infertility, IVF indication, HOMA-IR, cycle characteristics and FFL concentrations. Women in COB group were more likely to have higher BMI (mean±SD;30.5±3.9vs25.3±2.8 p < 0.005), BFI (median(IQR),1.8(1.8) vs0.73(0.2), p<0.005), and VAI ( median(IQR),1.9 (1.06) vs 1.2 (0.65), p<0.001). Both groups showed comparable maturation index (73.8%vs77.9%), fertilization rate (71.2%vs72.1%), and OPR (37.5% vs 43.8%). In the correlation analysis, central obesity was more likely to be due to subcutaneous (r=0.8, p<0.001) rather than preperitoneal fat (r=0.4, p<0.001). None of the obesity measures were correlated with either FFL or OPR. No significant correlation was found between FFL levels and number of oocytes retrieved, maturation and fertilization indices, or rate of good-quality embryos. In ROC analysis, comparable trend was observed among BMI, BFI, VAI, and FFL for predictability of ongoing pregnancy (AUC: 0.48, 0.53, 0.50, and 0.48, respectively). None of these variables was predictor for OPR in the multivariable logistic regression. The only predictors were peak estradiol (OR:1.2,CI:1.1-1.3, p< 0.05) and number of mature retrieved oocytes (OR:0.08,CI:0.67-0.92,p<0.004). Conclusions: Based on this analysis, we could not find evidence that FFL and abdominal fat thickness affect ICSI outcomes. References: Body fat index: A novel alternative to body mass index for prediction of gestational diabetes and hypertensive disorders in pregnancy. European Journal of Obstetrics & Gynecology and Reproductive Biology, 228, 243-248.
ABSTRACT
Objective: Human chorionic gonadotropin (hCG) is produced by the syncytiotrophoblast and plays a key role in implantation. However, quality evidence on intrauterine administration of hCG prior to embryo transfer (ET) is lacking. Our study aimed at evaluating whether intrauterine administration of hCG before ET improves in vitro fertilization (IVF) outcomes. Design: A double-blinded randomized controlled trial (RCT) (NCT03238807) in an University-affiliated IVF center in Assiut, Egypt. The study protocol was approved by the University’s Institutional Review Board (IRB) (approval number: 17200094). Materials and Methods: We included infertile women scheduled for intra-cytoplasmic sperm injection (ICSI). After informed consent, women were randomized using a simple computer-generated random allocation in a 1:1 ratio to receive either 500 IU hCG intrauterine (hCG group), or culture media intrauterine (control group) prior to ET. Women in the hCG group received 500 IU of hCG in 0.1 mL of tissue culture media via intrauterine injection 4 minutes before ET, while women in the control group received 0.1 mL of tissue culture media. In both groups, an intra-uterine insemination (IUI) catheter was used for intrauterine administration. The patients and the clinician who conducted the procedure were blinded to the allocated intervention. Our primary outcome was live birth, while ongoing pregnancy and clinical pregnancy were secondary outcomes. According to the intention-to-treat principle, analyses of outcomes were done and were represented as risk ratios (RRs) with 95% confidence intervals (CIs). We needed a sample size of 204 to show an increase of live birth from 28% to 48% at 80% power with an alpha error of 0.05. Accounting for 8% of drop-outs, we planned to recruit 220 participants. Due to the COVID-19 pandemic, all IVF procedures have been suspended in our center since March 2020. As a consequence, recruitment was halted on 27 February 2020 at 181 participants. At the time of abstract submission, data on ongoing pregnancy are available. At the congress, we will be able to present data on live birth. Results: From July 2018 to February 2020, 181 women were randomized into the hCG group (n=90) and the control group (n=91). Baseline and cycle characteristics were comparable between the two groups. In the control group, one woman was lost to follow-up after confirmation of clinical pregnancy. Ongoing pregnancy was 23% (21/90) in the hCG group versus 19% (17/90) in the control group (RR 1.24, 95% CI 0.70 – 2.19), while clinical pregnancy was 34% (31/90) in the hCG group versus 26% (24/91) in the control group (RR 1.31, 95% CI 0.84 – 2.04). Conclusions: From the available data in this RCT, we did not find evidence that intrauterine hCG administration before ET improves ongoing pregnancy rates.