Local Ethics Committee Research Articles

Ethical Perspective on Planned Clinical Trials; Non-interventional Local Ethics Committee Observation

Ethical Perspective on Planned Clinical Trials; Non-interventional Local Ethics Committee Observation

Changes in blood biochemistry thrombosis parameters 24 hours after stent-assisted endovascular treatment of intracranial aneurysms.

This study aims to elucidate the early changes in blood biochemistry thrombosis parameters following stent-assisted endovascular treatment of intracranial aneurysms. Consecutive patients with unruptured aneurysms undergoing stent implantation during endovascular treatment were included in this prospective study with approval from the local ethics committee. Blood samples were collected immediately before and 24 h after the procedure for biochemical analysis, including basic thrombosis indicators, bleeding tests, and a complete blood count. The study included 80 patients (60 women, 20 men) with 134 aneurysms. A total of 135 stents (110 flow-diverting, 25 standard) were used. Additionally, intrasaccular coiling was utilized in 28 aneurysms among 27 patients. Following the procedure, there was a significant decrease in activated partial thromboplastin time, fibrinogen, hemoglobin, and platelet levels, and a significant increase in prothrombin time, D-dimer, von Willebrand factor (vWF) activity/antigen ratio, and leukocyte levels in all patients. Correlation analyses revealed significant positive associations between platelet and fibrinogen levels, and a negative association between D-dimer and fibrinogen levels in the coil (-) group. Additionally, there was a significant negative correlation between aneurysm volume and vWF activity/antigen ratio, and procedure duration and thrombocyte count, while a positive association was found between aneurysm number and leukocyte count in the coil (-) group. Analysis of blood chemistry alterations indicates that intravascular thrombosis occurs in the intracranial circulation following stent-assisted endovascular treatment of intracranial aneurysms. This thrombotic process is more pronounced in patients whose aneurysms were left open (i.e. flow-diverting stent alone).

Radiofrequency ablation via catheter and transpapillary access in patients with cholangiocarcinoma (ACTICCA-2 trial) – a multicenter, randomized, controlled, open-label investigator-initiated trial

BackgroundDespite the recent advances in cancer treatment, the therapeutic options for patients with biliary tract cancer are still very limited and the prognosis very poor. More than 50% of newly diagnosed patients with biliary tract cancer are not amenable to curative surgical treatment and thus treated with palliative systemic treatment. Malignant bile duct obstructions in patients with perihilar and/or ductal cholangiocarcinoma (CCA) represents one of the most important challenges in the management of these patients, owning to the risk represented by developing life-threatening cholangitis which, in turn, limits the use of systemic treatment. For this reason, endoscopic stenting and/or bile duct decompression is the mainstay of treatment of these patients. Data on efficacy and safety of adding radiofrequency ablation (RFA) to biliary stenting is not conclusive. The aim of this multicenter, randomized trial is to evaluate the effect of intraductal RFA prior to bile duct stenting in patients with unresectable perihilar or ductal CCA undergoing palliative systemic therapy.Methods/DesignACTICCA-2 is a multicenter, randomized, controlled, open-label, investigator-initiated trial. 120 patients with perihilar or ductal CCA with indication for biliary stenting and systemic therapy will be randomized 1:1 to receive either RFA plus bile duct stenting (interventional arm) or bile duct stenting alone (control arm). Patients will be stratified by trial site and tumor location (perihilar vs. ductal). Both arms receive palliative systemic treatment according to the local standard of care determined by a multidisciplinary tumorboard. The primary endpoint is time to first biliary event, which is determined by an increase of bilirubin to > 5 mg/dl and/or the occurrence of cholangitis leading to premature stent replacement and/or disruption of chemotherapy. Secondary endpoints include overall survival, safety according to NCI CTCAE v5, quality of life assessed by questionnaires (EORTC QLQ-C30 and QLQ-BIL21), clinical event rate at 6 months after RFA and total days of over-night stays in hospital. Follow-up for the primary endpoint will be 6 months, while survival assessment will be continued until end of study (maximum follow-up 30 month). All patients who are randomized and who underwent endoscopic stenting will be used for the primary endpoint analysis which will be conducted using a cause-specific Cox proportional hazards model with a frailty for trial site and fixed effects for the treatment group, tumor location, and stent material.DiscussionACTICCA-2 is a multicenter, randomized, controlled trial to assess efficacy and safety of adding biliary RFA to bile duct stenting in patients with CCA receiving palliative systemic treatment.Trial registrationThe study is registered with ClinicalTrials.gov (NCT06175845) and approved by the local ethics committee in Hamburg, Germany (2024-101232-BO-ff). This manuscript reflects protocol version 1 as of January 9th, 2024.Graphical

Benefits of a spine team for the surgical management of paediatric scoliosis

BackgroundFor many years, blood-saving techniques and the enhanced recovery after surgery approach have been used to optimise the quality of care and shorten hospital stays. The creation of dedicated spine teams combining surgeons and anaesthesiologists specialised in spine surgery has been proven beneficial in adults. The objective of this study was to determine whether involving a spine team in the management of paediatric patients with scoliosis treated by posterior spinal fusion was associated with shorter hospital stays. HypothesisThe hospital stay would be shorter in patients managed by a spine team. Materials and methodsThis single-centre, non-randomised, comparative study was initiated after approval by the local ethics committee. One group of patients was managed by a spine team composed of an anaesthesiologist and a surgeon with over 10 years of experience and the control group by an anaesthesiologist and a surgeon with less than 5 years of experience. The primary outcome was hospital stay length (median [interquartile range]). ResultsThe study included 157 paediatric patients who underwent spinal fusion in 2021 for adolescent idiopathic scoliosis (AIS, n = 106) or secondary scoliosis (n = 51). The spinal team was involved for 48 (45%) AIS procedures and 38 (74.5%) secondary-scoliosis procedures. Both operative time and anaesthesia time were significantly shorter in the spinal-team group, by 10% and 15% (p < 0.001 for both comparisons), respectively, for SIA and by 20% (p = 0.002) and 25% (p < 0.001), respectively, for secondary scoliosis. The spinal-team group had a shorter median hospital stay, the difference being significant for AIS (in days, 5 [4–7] versus 7.1 [5–10], p = 0.03) and nearly significant for secondary scoliosis (6.9 [5–10] versus 9 [6–23], p = 0.07). Fewer patients required blood transfusion in the spine-team group than in the control group (AIS: 0% versus 8.8%, p = 0.05; and secondary scoliosis, 28% versus 58%, p<0.01). ConclusionInvolvement of a spine team optimises the peri-operative management of patients with AIS, thus shortening the hospital stay. Further work is needed to assess the potential associations of spine team involvement with complication rates. Level of evidenceIII; non-randomised comparative study.

Деятельность локального этического комитета по повышению качества биомедицинских исследований молодых сотрудников университета

The article is devoted to the issues of clinical research: their ethical and legal regulation at the present time, the history of ethical expertise in the Russian Federation and at Kazan State Medical University. The role of ethical committees as a structure responsible for quality of scientific research and a guarantor of compliance with the principles of ethics, protection of the rights, safety and well-being of research participants is considered. The article presents the working experience of the local ethics committee of Kazan State Medical University on ethical examination of research projects with human participation and analysis of the most common mistakes in preparation of research documentation made by young scientists of clinical departments. The digital information showing typical errors and inaccuracies in the formation of a package of documents for ethical examination, based on the analysis of 284 initiative papers of PhD candidates from clinical departments: every fifth protocol required revision in accordance with the ethical and legal framework adopted in the Russian Federation, in 1.5% of cases the documentation was submitted for already conducted studies (i.e. ost factum), when no changes to its design are possible anymore. Typical mistakes were the following: inability to form research and control groups, calculate a representative number of participants, write an information sheet for a participant in a clinical trial and a sheet of informed consent, going beyond the specialty, desire to prescribe drugs beyond the scope of registered indications, etc. The ways of increasing both the awareness of young researchers and quality of ethical expertise by specialists of the ethics committee are proposed.

HIV-1 subtype-specific drug resistance on dolutegravir-based antiretroviral therapy: protocol for a multicentre study (DTG RESIST)

IntroductionHIV drug resistance poses a challenge to the United Nation’s goal of ending the HIV/AIDS epidemic. The integrase strand transfer inhibitor (InSTI) dolutegravir, which has a higher resistance barrier, was...

How do maternal socioeconomic and behavioral patterns affect oral health in early childhood?

A prospective longitudinal observational cohort study. The data analyzed were derived from a comprehensive observational study on BRISA prenatal cohort conducted in São Luís City, Brazil, between 2010 and 2013. A convenience sample included pregnant women recruited from both public and private prenatal health services in the city. To participate in the study, women needed to have undergone an obstetric ultrasound before the 20th week of pregnancy to estimate gestational age. Multiple pregnancies were excluded. Initially, the pregnant women were interviewed and assessed for oral health indicators between the 22nd and 25th weeks of pregnancy. A follow-up interview was conducted within 48 h after delivery. In the child's second year, the mothers were re-interviewed, and the children were examined for the second follow-up. The study received approval from the local ethics committee, and written informed consent was obtained from all participants. The research followed the STROBE guidelines for reporting observational studies. At baseline, a structured questionnaire was used to gather sociodemographic and lifestyle information like maternal age, family income, education level, occupation of the family head, pre-gestational BMI, alcohol and soft drink consumption, and smoking status during pregnancy. Dental examinations were conducted by 6 trained and calibrated dentists who assessed DMFT index and periodontal health indicators. In the second follow-up, children's oral health was evaluated using visible plaque index (VPI), gingival bleeding, and the modified dmft index. Children's weight and height were measured by a digital scale, and BMI z-scores were calculated based on WHO standards. Sugar-sweetened beverage intake was categorized by terciles based on the percentage of total daily energy from these beverages. Structural equation modeling (SEM) was used to analyze multiple pathways among a set of latent and observed variables. Three latent variables were proposed and measured: Socioeconomic Status and Periodontal Maternal Status in the mothers, and Chronic Oral Disease Burden (CODB) in the children. CODB was inferred from 3 observed indicators: VPI, gingival bleeding, and tooth decay. Total, direct, and indirect effects were calculated for variables from the gestational period and the child's second year of life. In total, 1141 mother-child dyads were included. Periodontal Maternal Status correlated with more decayed teeth in pregnant women (standardized coefficient (SC) = 0.089; p = 0.008). Addictive risk behaviors were highly correlated, with SCs of 0.679 (p < 0.001) for alcohol and smoking, and 0.262 (p < 0.001) for soft drink and alcohol consumption. Obesity (SC = 0.081; p = 0.048) and added sugar consumption (SC = 0.142; p = 0.040) were interconnected across generations from pregnant women to their offspring. Children's consumption of sugar was strongly associated with CODB (SC = 0.357; p = 0.005). Caries and periodontitis were correlated in pregnant women. Obesity and sugar consumption have intergenerational impacts. Early sugar intake relates to CODB in early childhood. Intergenerational behavioral risks affect oral health in the first 1000 days of life, influencing long-term health outcomes.

Assessing Blood Donors&amp;apos; Knowledge, Attitudes, and Practices Regarding Blood Donation - A Cross-Sectional Study

&amp;lt;i&amp;gt;Introduction: &amp;lt;/i&amp;gt;Blood donation is vital for saving lives in critical medical conditions, making it a global concern. Ensuring a stable blood supply is essential for emergency treatments, surgeries, and chronic disease therapies. Blood donors, including influential figures like imams, play a critical role in promoting and normalizing blood donation within communities. &amp;lt;i&amp;gt;Aim of the study: &amp;lt;/i&amp;gt;The aim of this study was to assess the knowledge, attitude and practices of blood donors toward blood donation. &amp;lt;i&amp;gt;Methods: &amp;lt;/i&amp;gt;This cross-sectional study at Imam Training Academy of the Islamic Foundation, Bangladesh, included 200 Imams aged 18 above. Conducted from February 2023 to January 2024, data on knowledge, attitudes, and practices were collected through face-to-face interviews using a semi-structured questionnaire. Statistical analysis was performed with SPSS Version 26, considering a P-value of &amp;lt;0.05 as significant. Ethical clearance was obtained from the local ethical committee. &amp;lt;i&amp;gt;Result: &amp;lt;/i&amp;gt;The study findings indicate that the majority (61.5%) of participants were aged between 20-29 years, with 19.5% aged 30-39 years. Awareness about blood donation was moderate, with 45% aware of their blood group and Rh factor. Most participants (83.5%) understood that receiving infected blood can transmit diseases, and 65% correctly identified the interval for safe blood donation. Knowledge of local blood transfusion centers beyond BSMMU was low at 36%. Attitudes toward blood donation were overwhelmingly positive, with high agreement that donation saves lives (96.5%) and is a moral activity (97.5%). The preference for voluntary non-remunerated donation was unanimous (98%). However, only 35% of respondents had donated blood at least once, with 33.5% donating voluntarily. &amp;lt;i&amp;gt;Conclusion:&amp;lt;/i&amp;gt; The study found that blood donors had good knowledge and a positive attitude toward blood donation. However, most individuals were not donating blood regularly as volunteers.

Reproducibility study of intravoxel incoherent motion and apparent diffusion coefficient parameters in normal pancreas.

The consistency of pancreatic apparent diffusion coefficient (ADC) values and intravoxel incoherent motion (IVIM) parameter values across different magnetic resonance imaging (MRI) devices significantly impacts the patient's diagnosis and treatment. To explore consistency in image quality, ADC values, and IVIM parameter values among different MRI devices in pancreatic examinations. This retrospective study was approved by the local ethics committee, and informed consent was obtained from all participants. In total, 22 healthy volunteers (10 males and 12 females) aged 24-61 years (mean, 28.9 ± 2.3 years) underwent pancreatic diffusion-weighted imaging using 3.0T MRI equipment from three vendors. Two independent observers subjectively scored image quality and measured the pancreas's overall ADC values and signal-to-noise ratios (SNRs). Subsequently, regions of interest (ROIs) were delineated for the IVIM parameters (true diffusion coefficient, pseudo-diffusion coefficient, and perfusion fraction) using post-processing software. These ROIs were on the head, body, and tail of the pancrease. The subjective image ratings were assessed using the kappa consistency test. Intraclass correlation coefficients (ICCs) and mixed linear models were used to evaluate each device's quantitative parameter values. Finally, a pairwise analysis of IVIM parameter values across each device was performed using Bland-Altman plots. The Kappa value for the subjective ratings of the different observers was 0.776 (P < 0.05). The ICC values for inter-observer and intra-observer agreements for the quantitative parameters were 0.803 [95% confidence interval (CI): 0.684-0.880] and 0.883 (95%CI: 0.760-0.945), respectively (P < 0.05). The ICCs for the SNR between different devices was comparable (P > 0.05), and the ICCs for the ADC values from different devices were 0.870, 0.707, and 0.808, respectively (P < 0.05). Notably, only a few statistically significant inter-device agreements were observed for different IVIM parameters, and among those, the ICC values were generally low. The mixed linear model results indicated differences (P < 0.05) in the f-value for the pancreas head, D-value for the pancreas body, and D-value for the pancreas tail obtained using different MRI machines. The Bland-Altman plots showed significant variability at some data points. ADC values are consistent among different devices, but the IVIM parameters' repeatability is moderate. Therefore, the variability in the IVIM parameter values may be associated with using different MRI machines. Thus, caution should be exercised when using IVIM parameter values to assess the pancreas.

Study protocol of the HessenKohorte2042: a prospective, longitudinal cohort study characterising quality of life in people with Parkinson’s disease and their caregivers using a bio-psycho-social approach

IntroductionQuality of life (QoL) is of paramount importance as an outcome to monitor and guide therapies for people with Parkinson’s disease (PwPD). In particular, due to the heterogeneous symptoms that...

Deregulation of MicroRNA-146a and 155 expression levels might underlie complicated pregnancy in Toxoplasma Gondii seronegative women

BackgroundTo evaluate the ability of the estimated plasma expression levels of genes of microRNA (MiR-) 146a and 155 to differentiate between samples of pregnant women suspected to be infected by T. gondii. 50 newly pregnant women who had at least one of the criteria of high risk for toxoplasma infection and 50 newly primigravida women free of these criteria gave blood samples for qualitative determination of serum toxoplasma antibodies and estimation of plasma expression levels of MiR-146a and 155 using the qRT-PCR. During the pregnancy course, the incidence of pregnancy complications was recorded.ResultsTwenty-six women were IgM−/IgG−, 17 women were IgM+/IgG− and 7 women were IgM+/IgG+. Thirty-two women had pregnancy complications with significantly lower incidence in IgM−/IgG− women. Plasma expression levels of MiR-146a and 155 were significantly higher in total patients compared to control levels and were significantly higher in samples of IgM+/IgG+ patients than in other samples. Statistical analyses defined a high plasma level of MiR-155 as the highly significant predictor for oncoming pregnancy complications and high levels of both microRNAs as predictors for the presence of toxoplasmosis despite seronegativity. Kaplan-Meier regression analysis defined increasing cumulative risk of having toxoplasmosis despite seronegativity with plasma levels of MiR-146a and MiR-155 of 1.2 and 3, respectively.ConclusionThe incidence of pregnancy complications is high, irrespective of the seronegativity of women at high risk of toxoplasmosis. Estimated plasma levels of MiR-155 might identify women liable to develop complications and differentiate seronegative women vulnerable to having T. gondii infection.Trial registrationThe study protocol was approved preliminarily by the Local Ethical Committee at Benha Faculty of Medicine. Before enrollment, the study protocol was discussed in detail with the study participants, and those accepted to participate in the study signed written fully informed consents. The final approval of the study protocol was obtained after the end of case collection and registered by RC: 5-11-2022.

The role of the hospital pharmacist to guarantee access and continuity of care for the management of epilepsy

In this article the pivotal role of hospital pharmacists in the multidisciplinary management of epilepsy is discussed. Hospital pharmacists are members of national and local ethics committees, oversee clinical trials, and ensure adherence to regulations for patient access to novel therapeutic treatments. They actively contribute to regulatory processes and the definition of prescribing centers. In the post-launch phase, hospital pharmacists are a key member in the multidisciplinary team, they are involved in decisions relating to the local introduction of drugs, in the management of the drug within the hospital structure and with the direct distribution, and to ensure proper and timely treatment. The pharmacovigilance network, including hospital and community pharmacists, monitors and prevents adverse effects related to epilepsy medications and enhances a collaborative approach with specialists to promote prescription appropriateness, targeting therapy for better patient outcomes. Finally, the potential benefits of deprescribing are briefly discussed, underscoring the importance of a multidisciplinary approach involving doctors and clinical pharmacists to gather comprehensive data and enhance patient care in epilepsy management.

Prevalence of fetal anomalies, stillbirth, neonatal morbidity, or mortality in pregnancies complicated by placenta accreta spectrum disorders.

Placenta accreta spectrum disorders (PAS) lead to major complications in pregnancy. While the maternal morbidity associated with PAS is well known, there is less information regarding neonatal morbidity in this setting. The aim of this study is to describe the neonatal outcomes (fetal malformations, neonatal morbidity, twin births, stillbirth, and neonatal death), using an international multicenter database of PAS cases. This was a prospective, multicenter cohort study based on prospectively collected cases, using the international multicenter database of the International Society for PAS, carried out between January 2020 and June 2022 by 23 centers with experience in PAS care. All PAS cases were included, regardless of whether singleton or multiple pregnancies and were managed in each center according to their own protocols. Data were collected via chart review. Local Ethical Committee approval and Data Use Agreements were obtained according to local policies. There were 315 pregnancies eligible for inclusion, with 12 twin pregnancies, comprising 329 fetuses/newborns; 2 cases were excluded due to inconsistency of data regarding fetal abnormalities. For the calculation of neonatal morbidity and mortality, all elective pregnancy terminations were excluded, hence 311 pregnancies with 323 newborns were analyzed. In our cohort, 3 neonates (0.93%) were stillborn; of the 320 newborns delivered, there were 10 cases (3.13%) of neonatal death. The prevalence of major congenital malformations was 4.64% (15/323 newborns), most commonly, cardiovascular, central nervous system, and gastrointestinal tract malformations. The overall prevalence of major neonatal morbidity in pregnancies complicated by PAS was 47/311 (15.1%). There were no stillbirths, neonatal deaths, or fetal malformations in reported twin gestations. Although some outcomes may be too rare to detect within our cohort and data should be interpreted with caution, our observational data supports reassuring neonatal outcomes for women with PAS.

P-105 Gender affirming hormone therapy affects the spermatogonial cell compartment in transwomen

Abstract Study question What are the specific changes under gender affirming hormone therapy (GAHT) in the spermatogonial cell compartment in testicular tissues of transwomen? Summary answer GAHT has a negative effect on the most undifferentiated PIWIL4+ spermatogonia potentially leading to reduced chances for fertility preservation in transwomen. What is known already Transwomen take GAHT to achieve transition between the gender assigned at birth and their gender identity. GAHT leads to a reduction of the most advanced germ cells and a reduction of MAGEA4 positive spermatogonia (pan spermatogonial marker). Single-cell RNA sequencing studies identified spermatogonial subpopulations based on the expression of the marker genes PIWIL4, FGFR3, NANOS3, GFRA1, KIT, UTF1. PIWIL4+ cells are considered the origin of germ cell differentiation (state 0). State 1 and 2 spermatogonia are characterized by expression of GFRA1 and KIT, respectively. Study design, size, duration On the day of gender affirming surgery (GAS) testicular tissues and blood samples were collected of 25 age matched trans women (mean 28.1 yr), who underwent comparable GAHT regimens (10 or 12.5 mg cyproterone acetate and estrogens) between 2013 and 2018. 8 adult cis men (mean 34.5 yr) with complete spermatogenesis served as controls. Age, start and type of GAHT were assessed using a questionnaire. This study was approved by the local ethics committee. Participants/materials, setting, methods We performed immunohistochemical stainings to evaluate the expression of spermatogonial markers (MAGEA4, UTF1, PIWIL4, FGFR3, NANOS3, GFRA1) in Bouin’s-fixed testicular tissue sections. For each marker the number of positive cells per round tubular cross-section was determined in 25 round tubules. The spermatogonial proliferation rate was evaluated using immunofluorescence co-stainings for GFRA1/MIKI67/MAGEA4 and KIT/MKI67/MAGEA4. We scored 400 MAGEA4+ cells per individual and determined the proportion of GFRA1+/KIT+. MKI67+ cells among the GFRA1+/KIT+ were evaluated. Main results and the role of chance The number of MAGEA4+ spermatogonia and the proportion of PIWIL4+ spermatogonia within the MAGEA4+ spermatogonia were reduced in transwomen compared to controls (p &amp;lt; 0.001). In contrast, the relative proportion of UTF1+, FGFR3+ and NANOS3+ spermatogonia was comparable. The number of spermatogonia per tubule correlated negatively with the age at start of GAHT (p &amp;lt; 0.01) and the age on the day of GAS (p &amp;lt; 0.001). The treatment duration correlated negatively with the proportion of PIWIL4+ (p &amp;lt; 0.01) and NANOS3+ spermatogonia (p &amp;lt; 0.05). The immunofluorescence stainings in transwomen revealed a similar ratio of proliferating KI67+ spermatogonia, both within the GFRA1+ and KIT+ cells, compared to controls. These results show the negative effects of the GAHT itself on the population of spermatogonia as well as the individual susceptibility depending on age-related factors. These results have the potential to better define the chances for fertility preservation under GAHT. Limitations, reasons for caution Transwomen are a very heterogeneous patient group varying in age, different GAHT, different treatment durations, intake of co-medications and possible pre-existing medical conditions. Hence, testicular size and histological appearance of transwomen’s testes are heterogeneous. Wider implications of the findings Transwomen, who wish to have own biological children, have to be counseled with regard to fertility preservation, best before initiation of GAHT, in order to avoid adverse effects on spermatogonia. Individual counselling has to take place with regard to fertility preservation. Trial registration number 2012-555-f-S

P-347 In search of the most efficient device to freeze low numbers of spermatozoa: a comparative evaluation of various vitrification device

Abstract Study question Can different vitrification devices be used for cryopreservation of few spermatozoa for patients with varying sperm concentrations and which device is the most efficient? Summary answer The study demonstrates the efficacy of Cryotop, CBS, and Vitrifit devices in cryopreservation of low numbers of spermatozoa, with Cryotop Open showing superior performance. What is known already Sperm cryopreservation is crucial for managing male-factor infertility, yet conventional methods, reporting significant reduction in motility with only 30 to 40% viability post-thawing, fall short of optimal cryopreservation of small numbers of spermatozoa. Currently, ongoing efforts to enhance cryopreservation techniques seek to minimize cryodamage and optimize outcomes, particularly for spermatozoa from patients with conditions like oligozoospermia, cryptozoospermia, or azoospermia, where each spermatozoa is of substantial importance. Several devices have shown promising results regarding cryopreservation of small numbers of spermatozoa. However, to date, no comparison has been performed between multiple embryo-vitrification devices in terms of recovery and viability post thawing. Study design, size, duration Between January 2023 and May 2023, this study included 50 fresh ejaculated routine samples: 25 with spermatozoa concentrations &amp;gt;1 million/ml and 25 samples with concentrations &amp;lt;1 million/ml. For each sample, 10 motile spermatozoa were loaded on four different embryo-vitrification devices performed in triplicate: Cryotop Open (Kitazato), Cryotop Closed (Kitazato), CBS (Cryo BioSystem) and Vitrifit (Cooper Surgical). Recovery, motility, immotile vitality rates, user-friendliness as well as the duration of the freezing/thawing procedures were examined. Participants/materials, setting, methods Ten spermatozoa, selected in Hepes-HSA, were loaded into a 2 µl mixture of SpermFreeze and HEPES-HSA. Held 3 cm above LN2 for 2 minutes, straws were plunged into LN2. Thawing involved immersing straws in 2 µl Hepes-HSA under oil. Hypo-Osmotic-Swelling test was used for the vitality assessment of the immotile spermatozoa. Thawing protocols showed minor variations based on the carrier type. The study was approved by the local Ethics Committee. Main results and the role of chance This study conducted a detailed analysis of four vitrification devices for cryopreservation of low spermatozoa numbers. For concentrations &amp;gt;1 million/ml, Vitrifit, Cryotop Open, Cryotop Closed, and CBS displayed comparable recovery rates (mean % ± SD) (85±0.09, 89±0.06, 84±0.10, 86±0.07); motility rates (76±0.12, 79±0.08, 78±0.13, 80±0.08); immotile vitality rates (16±0.08, 13±0.07, 13±0.09, 12±0.07). In this group, Vitrifit and Cryotop Open exhibited similar freezing and recovery times (4’10’’/7’42’’ and 4’11’’/7’40’’ respectively). Cryotop Closed and CBS had slightly longer freezing times (4’33’’ and 5’31’’ respectively), with Cryotop Closed showing the fastest recovery (7’11’’). Similarly, for sperm concentrations &amp;lt;1 million/ml, devices demonstrated similar recovery (87±0.09, 91±0.06, 88±0.07, 83±0.12), motility (55±0.10, 61±0.09, 56±0.07, 50±0.09), and immotile vitality (26±0.07, 26±0.06, 27±0.07, 27±0.06). For concentrations &amp;lt;1 million/ml, all devices showed similar freezing and recovery times. Statistical analyses, including ANOVA and Levene’s test, revealed no significant inter-device differences, substantiated by minimal Cohen’s d effect sizes. Regarding the practical aspect, due to the ergonomic design and plastic composition that allows better microscopic visibility, Cryotop (both closed and open) demonstrated superior handling performance to CBS. Considering both statistical validation and manipulation, Cryotop Open distinguishes itself as the most efficient and user-friendly device for cryopreservation of low spermatozoa numbers. Limitations, reasons for caution The study’s main limitation is the limited sample size. Further research with larger cohorts and exploration of fertilization potential is necessary to validate these findings. Additionally, our study did not explore potential variations in cryopreservation outcomes related to additional sperm sample characteristics, which could impact the results. Wider implications of the findings Successful cryopreservation of low sperm numbers provides hope for cryptozoospermia and (non-)obstructive azoospermia patients. It allows the use of their own sperm, potentially avoiding donation. With superior frozen sperm survival, recovery rates, and a shorter search time, this method enhances fertility preservation accessibility, guiding patients in future IVF treatments effectively. Trial registration number EC-2022-272

P-402 Comparison of uterine contractions in artificial hormone treatment versus aromatase inhibitor stimulated frozen embryo transfer cycles

Abstract Study question does uterine contractions differ between aromatase inhibitor stimulated (AIS) or artificial hormone treatment (AHT) Frozen Embryo transfer (FET) cycles Summary answer uterine contraction activity did not show any difference between artificial hormone treatment and aromatase inhibitor stimulated FET cycles What is known already FET cycles are prepared by different protocols. aromatase inhibitor stimulated (AIS) or artificial hormone treatment (AHT) protocols are two common protocols among others. These protocols have different cycle dynamics and might differ in pregnancy rates and different effects on perinatal outcomes. Although embryo related factors are most important for implantation endometrial receptivity and therefore uterine contractions might have a role in implantation. English literature provides scarce data on uterine contractions and pregnancy outcomes. Presence of prominent contractions were related to poor pregnancy outcomes in some studies whereas other few studies failed to show any effect in this sense Study design, size, duration this study is an observational cohort study of successive frozen embryo transfer (FET) cycles of eligible patients between 1st of july 2023 to 31th of October 2023 in a tertiary university hospital in vitro fertilization clinic with ultrasonographic video recordings at transfer day. During study period of four months, 147 out of 265 consecutive FET cycles were included in this study and study is approved by local ethical committee of the affiliated university (KA23/388). Participants/materials, setting, methods Total study group was composed of 99 artificial hormone treatment cycles and 48 aromatase inhibitor stimulated FET cycles after exclusion of patients with uterine congenital malformations, uterine fibroids,adenomyosis patients and patient with previous uterine surgery. Implantation rates, pregnancy rates and clinical pregnancy rates were recorded. Transvaginal ultrasonographic sagittal uterine video image recordings were obtained at transfer day one hour before embryo transfer. Recordings were reviewed by two researchers and uterine contractions were documented by agreement. Main results and the role of chance This is the first study comparing different FET cycles and uterine contraction activities. Patient characteristics were similar between two groups. Artificial hormone treatment and aromatase inhibitor stimulated cycle groups showed similar endometrial thicknesses (11.47±1.92 and 11.24±1.02, respectively p = 0.42) and top quality embryo transfer rates (22.6 % and 26.8% p = 0.82). Although AIH group showed a statistically insignificant advantage, clinical and ongoing pregnancy rates were similar between protocols (supplementary data). Uterine peristaltic activity was not statistically different between aromataze inhibitor stimulated and artificial hormone treatment FET cycle (1.54±1.75 versus 1.63±2.15 p = 0.81 recpectively). Furthermore uterine persistalsizm were similar in pregnant and non-pregnant patients /1.52±2.07 vs 1.72±1.93 p = 0.57). However as far as Aromatase inhibitor stimulated FET cycles were considered; pregnant patients had less uterine peristaltic activity when compared ton non-pregnant patient (45.7% and 15.4%, respectively p = 0.054 ) although this difference was at the border of statistical significance. Limitations, reasons for caution This is an observational study of relatively short duration with limited number of patients. Our study in AIS cycles have a tendency to fewer contractions in cycles ended up in pregnancy. Larger series of FET cycles might prove differences in uterine contraction frequencies and pregnancy outcomes in AIS FET cycles. Wider implications of the findings Our study supported new information on uterine contractility in different FET cycles protocols. Further large scale studies might provide new insights to uterine factor and its role in implantation as far as uterine contraactions are concerned. Trial registration number (KA23/388) local ethic committee approval

O-186 A novel micro-insemination method, assisted sperm fusion insemination, increases the embryo utilization rate compared to conventional intracytoplasmic sperm injection

Abstract Study question Does a novel micro-insemination method, assisted sperm fusion insemination (ASFI), improve fertilization and embryonic development compared to conventional intracytoplasmic sperm injection (C-ICSI)? Summary answer ASFI showed comparable fertilization and blastocyst formation rates to C-ICSI, while achieving significantly higher embryo utilization rates. Furthermore, there were no degenerated oocytes after ASFI. What is known already We have reported that ASFI yielded fertilization and blastocyst rates similar to those obtained with rescue ICSI performed at 6 hours after in vitro fertilization (IVF). In ASFI, fertilization is achieved by pressing a zona pellucida (ZP)-bound sperm onto the oocyte membrane without breaking the oocyte membrane. However, there was a risk of artificial polyspermy because the sperm were pressed against the unfertilized oocytes after IVF. Moreover, it is uncertain whether fertilization occurred with sperm that penetrated into the oocyte via IVF or that were pressed against the oocyte membrane. Clarifying this requires performing ASFI of the oocyte without IVF. Study design, size, duration We prospectively evaluated the effectiveness of ASFI in a sibling oocyte study including 14 subjects from which at least two metaphase II (MII) oocytes and one immature or degenerated oocyte were retrieved. Between December 2022 and October 2023, 119 MII oocytes were obtained in 22 oocyte retrieval cycles and used in the study. Sibling MII oocytes were randomly assigned to a C-ICSI or ASFI group. The present study was approved by the local ethics committee. Participants/materials, setting, methods In the ASFI group, 10,000 motile sperm were incubated with at least one immature or degenerated oocyte for 3 hours in 100 μL of medium per patient. After incubation, the motile sperm bound to the ZP were aspirated directly using an injection pipette. The heads of these ZP-bound sperm were pressed onto the membrane of MII oocytes for 10 seconds using the injection pipette. C-ICSI was conducted using the conventional method. Main results and the role of chance The mean and standard deviation of age of the women and number of MII oocytes per cycle were 39.9 ± 2.2 years and 5.5 ± 1.8, respectively. All sperm collected from the ZP adhered to the MII oocyte membrane after ASFI. Furthermore, time-lapse imaging revealed that all sperm adhering to the MII oocyte membrane were subsequently incorporated into the oocyte. Comparison of the ASFI and C-ICSI groups did not reveal any significant differences in 2 pronuclear embryo rate (ASFI group: 85.4% vs. C-ICSI group: 71.8%), degeneration rate (0% vs. 5.6%), good-quality embryo rate at day 3 (63.4% vs. 52.9%), blastocyst formation rate (67.6% vs. 51.9%), or good-quality blastocyst (Grade 3BB and above by the Gardner criteria) formation rate (29.4% vs. 15.4%). On the contrary, the embryo utilization rate (defined as the total number of embryos transferred and cryopreserved divided by the number of MII oocytes) was significantly higher in the ASFI group compared to the C-ICSI group (47.9% vs. 25.4%, P &amp;lt; 0.05). Limitations, reasons for caution This study was limited by using the ZP for sperm selection. To expand its applicability, a method to identify sperm capable of fusing with an oocyte without using the ZP must be established. Additionally, since our sample size was small, larger studies are required to confirm our findings. Wider implications of the findings ASFI is expected to enhance the survival rate of oocytes and to increase the number of embryos available for implantation, not only compared to rescue ICSI but also C-ICSI. ASFI could aid in understanding fertilization mechanisms by enabling direct observation of oocyte-sperm fusion during the process. Trial registration number UMIN000050184

Outcome of Neonatal Registry Through Electronic Medical Registry at Neonatal Intensive Care Units, Children's Hospital of Ain Shams University

Abstract Background The neonatal mortality rate is 19 deaths per 1000 live births worldwide. Studies have shown that neonatal registry network systems can provide the necessary data for establishing evidence- based strategies to decrease the complications in high-risk neonates and consequently reduce neonatal mortality rate. Aim of the Work To determine the frequency and distribution of neonatal critical illnesses in Neonatal Intensive Care Unit (NICU) of Ain Shams University. Patients and Methods This descriptive study was conducted in NICU, Children's Hospital, Ain Shams University. The data collected from initiated neonatal registry through electronic medical record to reach sample size number (381) patients. The current study was conducted after approval by the Department of Pediatrics, and the local Ethics and Research Committee, Faculty of Medicine, Ain Shams University. Results The mean ± (SD) age at admission was 5.52 ± 6.9 days, gestational age was 36.19 ± 2.47 weeks, more than half of our patients were males (55.6%) and females represented in (44.4%). Two- thirds (64.2%) of our participants were full term, and preterm were only (35.7%). The main etiology of NICU admission was respiratory disease (35.7%), followed by neonatal sepsis (25.2%), neonatal jaundice (21%), congenital anomalies (12.3%), CNS diseases (6.8%), inborn errors of metabolism (1%) and mortality rate was 10.5%. Four cases had inborn errors of metabolism in the form of: Maple syrup urine disease (one case), organic academia (one cases) and 2 cases referred to genetic clinic for further assessment. Congenital heart diseases in our study was reported in (7.9%) of neonates. The main etiology among them was reported in following order: PDA / pulmonary hypertension (26.7%), VSD (13.3%), Fallot tetralogy (10%), transposition of great arteries (10%), supraventricular tachycardia (6.7%) then many etiologies represented in 3.3% as Ebstein anomaly, right single ventricle, heart block, pulmonary artery stenosis, arrhythmia, tricuspid atresia and left hypoplastic heart disease. Conclusion This study showed the ability of the electronic medical record to store large amounts of data which creates a potential for information overload in the intensive care (ICU) setting. This will stimulate and facilitate research on neonatal critical illness and its management, mortality and morbidity outcomes of neonates admitted to NICUs in Children's Hospital, Ain Shams University, Egypt.

Evaluation of Serum Procalcitonin as a Diagnostic and Prognostic Biomarker for Sepsis in Major Burn Patients: A Prospective Study

Abstract Background Sepsis in burns worsens the patient’s prognosis and increases the risk of organ failure and death. Multiple organ dysfunction syndrome (MODS), which is a direct response to sepsis is the main reason for death in burn patients. Identifying early sepsis is very important, given that every 6 h delay in the diagnosis of sepsis reduces survival by 10%. Complexity in diagnosing sepsis in the burn is due to the systemic response to the burn itself clinically simulating sepsis. Aim of the Work The aim of this study is: To investigate the diagnostic validity of PCT in burn sepsis as an early diagnostic tool and to identify its prognostic value in major burn patients with sepsis. Patients and Methods The study was a prospective study carried out in the Burn Intensive Care Unit (ICU) of Ain Shams University Hospitals on 30 patients that were admitted from October 2021 to April 2022 with major burn (more than 20% of TBSA) were included and the Local Ethics Committee approved the study, and informed consent was obtained from all participants or their guardians. Results It had been revealed that the first 3 samples have no significant increase in PCT levels in relation to sepsis. However, the following 2 samples which had been withdrawn on day 5 show a significant increase in PCT levels, and these on day 7 on admission are highly significant with a median (IQR) range of 9 ng/dl and median (IQR) range of 13.2 ng/dl respectively. Moreover, it had been noted that the PCT level on admission was significant for the prognosis of death with a median (IQR) range of 1.65 ng/dl while in survivor patients the median was 0.45 ng/dl. Conclusion Our study demonstrated that PCT level in major burn patients is a promising diagnostic biomarker in detecting sepsis that could facilitate ideal management and initiate proper antimicrobial therapy and good prognostic value as an early predictor of mortality.

Impact of Exercise-Based Cardiac Rehabilitation on Metabolic Syndrome in Post-Acute Coronary Syndrome Patients

Abstract Background Metabolic syndrome (MetS) is characterized by a cluster of cardiovascular risk factors including hypertension (HTN), impaired fasting blood sugar (FBS), increased central obesity (WC) and dyslipidemia; hypertriglyceridemia (TG) and low high-density lipoprotein- cholesterol (HDL-C). The MetS adversely affects cardiovascular outcomes, individuals with at least 4 out of 5 features of MetS have a 3.7-fold increased risk of coronary artery diseases at a 5-year follow-up. Objective to determine the effectiveness of exercise based-cardiac rehabilitation (CR) program on MetS in post-Acute Coronary Syndrome (ACS) patients versus guideline directed medical therapy over a 12 weeks period. Patients and Methods The study included 62 patients who suffered from ACS with evidence of MetS. All patients were recruited from Ain Shams University Hospitals (ASUHs) from July 2021 to December 2021 and were assessed at baseline and after 12 weeks of follow up for MetS parameters. After approval by the local ethics committee all patients were provided voluntary informed consent. The study subjects were classified into two groups: Group A (case group): included 32 patients who completed at least 80% of 12 weeks of CR program in ASUHs. Group B (control group): included 30 patients who did not attend the CR program and completed 12 weeks of guideline directed medical therapy alone. Results The results revealed that -when compared group A at baseline and after 12 weeks of CR-program there was a significant reduction in WC, FBS and TG levels, while there was a significant rise in HDL-C level. However, there was no statistically significant difference found regarding BP in this group. Regarding group B there was no statistically significant difference between the baseline MetS parameters and at follow up after 12 weeks of guideline directed medical therapy alone. Conclusion The present study revealed that there was a statistically significant improvement regarding WC, FBS, TG and HDL after completion of 12 weeks of the CR Program, while there was no statistically significant difference found regarding BP in the study group. In the control group there was no statistically significant difference found at baseline and follow up after 12 weeks of guideline directed medical care alone. Thus, the exercise-based CR program is superior than the regular medical care alone in improving the WC, FBS, TG and HDL. Key words: Metabolic Syndrome, Cardiac Rehabilitation, Exercise Training, ACS. Abbreviations and Acronyms. Acronyms: ACS: Acute Coronary Syndrome ASUHs: Ain Shams University Hospitals BP: Blood Pressure CR: Cardiac Rehabilitation FBS: Fasting Blood Sugar HDL-C: High Density Lipoprotein-Cholesterol HTN: Hypertension MetS: Metabolic Syndrome TG: Triglyceridemia WC: Central Obesity