Patient Population Research Articles

P-739 Hysteroscopic metroplasty and thin endometrium, some new indication? Results of a multicenter retrospective study

Abstract Study question Is there a place for hysteroscopic metroplasty in the management of thin endometrium? Summary answer Hysteroscopic metroplasty appears to significantly improve the chances of live birth in a population of infertile patients with thin endometrium. What is known already A thin endometrium is found in 1 to 12 % of the cases for patient treated in an infertility center. When a thin endometrium is repeatedly observed there is no specific protocol for resolving the situation. Numerous study have been carried out on this subject but here is insufficient evidence to recommend a specific treatment because the results are inconclusive, or not strong enough. Hysteroscopic-metroplasty is use by several teams to treat infertile women with T-Shaped uterus. We assumed that metroplasty could improve results in patients with a thin endometrium by stimulating endometrial recolonisation as observed in cases of synechia section. Study design, size, duration This is a multi-center retrospective observational study conducted between 1er January 2015 and 31 December 2021 at the Clinique Mutualiste de la Sagesse, Rennes, France and in the University Hospital of the Kremlin Bicêtre, APHP, France. T-Shaped uterus was diagnosed by an ultrasound expert, and a thin endometrium was defined as an endometrium less than 7mm thick after a minimum of 14 days of well-conducted stimulation. Participants/materials, setting, methods Exclusion criteria were age < 18 years, previous hysteroscopic metroplasty, past history of more than one synechia treatment. The primary outcome was first live birth after surgery. Secondary endpoints were pregnancy rate and spontaneous pregnancy rate, surgery complications, neonatal outcomes. This retrospective study used data collected prospectively. Main results and the role of chance Our objective was to evaluate hysteroscopic metroplasty in the management of infertile patients with T-shaped uterus type dysmorphia and / or a thin endometrium. The primary endpoint was the occurrence of a live birth rate post-surgery. One hundred and forty five infertile patients were included, including 126 nulliparous women (86.9%). The post-surgery live birth rate was 40.7% during the total post-operative follow-up, with similar result in case of thin endometrium or in case of T-Shaped uterus. In terms of pregnancy, we recorded 75 post-surgery pregnancies (51.7%), of which one third was obtain spontaneously. The duration of infertility suffered by patients before surgery ranged from 1 to 7 years and the average duration of conception after surgery was less than 1 year. We did not raise any major per or post operative complication for both mother and the future baby. Hysteroscopic metroplasty appears to significantly improve the chances of live birth in a population of infertile patients with at least one uterine pathology such as T-shaped uterus or thin endometrium Limitations, reasons for caution This is a retrospective study, with all the biases that this implies. More robust studies are therefore needed before the practice can be generalised. Furthermore these results were obtained in 2 expert centres. Although the technique is easily reproducible, caution must be exercised before generalising it. Wider implications of the findings This study is the first one to the best of our knowledge to provide an opportunity to consider this new treatment option for thin endometrium, what is still an under-recognised pathology. Our results can be used to justify the initiation of a randomised controlled trial. Trial registration number not applicable

Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide

Anecdotal experience raised the possibility that semaglutide, a glucagon-like peptide 1 receptor agonist (GLP-1 RA) with rapidly increasing use, is associated with nonarteritic anterior ischemic optic neuropathy (NAION). To investigate whether there is an association between semaglutide and risk of NAION. In a retrospective matched cohort study using data from a centralized data registry of patients evaluated by neuro-ophthalmologists at 1 academic institution from December 1, 2017, through November 30, 2023, a search for International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code H47.01 (ischemic optic neuropathy) and text search yielded 16 827 patients with no history of NAION. Propensity matching was used to assess whether prescribed semaglutide was associated with NAION in patients with type 2 diabetes (T2D) or overweight/obesity, in each case accounting for covarying factors (sex, age, systemic hypertension, T2D, obstructive sleep apnea, obesity, hyperlipidemia, and coronary artery disease) and contraindications for use of semaglutide. The cumulative incidence of NAION was determined with the Kaplan-Meier method and a Cox proportional hazards regression model adjusted for potential confounding comorbidities. Data were analyzed from December 1, 2017, through November 30, 2023. Prescriptions for semaglutide vs non-GLP-1 RA medications to manage either T2D or weight. Cumulative incidence and hazard ratio of NAION. Among 16 827 patients, 710 had T2D (194 prescribed semaglutide; 516 prescribed non-GLP-1 RA antidiabetic medications; median [IQR] age, 59 [49-68] years; 369 [52%] female) and 979 were overweight or obese (361 prescribed semaglutide; 618 prescribed non-GLP-1 RA weight-loss medications; median [IQR] age, 47 [32-59] years; 708 [72%] female). In the population with T2D, 17 NAION events occurred in patients prescribed semaglutide vs 6 in the non-GLP-1 RA antidiabetes cohort. The cumulative incidence of NAION for the semaglutide and non-GLP-1 RA cohorts over 36 months was 8.9% (95% CI, 4.5%-13.1%) and 1.8% (95% CI, 0%-3.5%), respectively. A Cox proportional hazards regression model showed higher risk of NAION for patients receiving semaglutide (hazard ratio [HR], 4.28; 95% CI, 1.62-11.29); P < .001). In the population of patients who were overweight or obese, 20 NAION events occurred in the prescribed semaglutide cohort vs 3 in the non-GLP-1 RA cohort. The cumulative incidence of NAION for the semaglutide vs non-GLP-1 RA cohorts over 36 months was 6.7% (95% CI, 3.6%-9.7%) and 0.8% (95% CI, 0%-1.8%), respectively. A Cox proportional hazards regression model showed a higher risk of NAION for patients prescribed semaglutide (HR, 7.64; 95% CI, 2.21-26.36; P < .001). This study's findings suggest an association between semaglutide and NAION. As this was an observational study, future study is required to assess causality.

PD-L1 and nectin-4 expression and genomic characterization of bladder cancer with divergent differentiation.

Bladder cancer with divergent differentiation (BCDD) comprises a heterogenous group of tumors with a poor prognosis, and differential expression of nectin-4 and programmed death ligand-1 (PD-L1) has been reported in BCDD. Importantly, nectin-4 expression in bladder cancer is associated with response to enfortumab vedotin, and PD-L1 expression is associated with responses to immune checkpoint inhibitors (ICIs). The authors conducted a retrospective review identifying 117 patients with advanced or metastatic BCDD who were treated at Winship Cancer Institute from 2011 to 2021. They performed immunohistochemistry staining for nectin-4 and PD-L1 expression by histologic subtype as well as genomic analysis of these patients, including RNA sequencing, whole-exome sequencing, and fusion detection analysis as well as a subgroup genomic analysis of patients with BCDD who received ICIs. The results indicated that nectin-4 expression was highest in the groups who had the squamous and plasmacytoid subtypes, whereas the group that had the sarcomatoid subtype (70.8%) had the highest proportion of PD-L1-positive patients. Genomic analysis yielded several key findings, including a 50% RB1 mutation rate in patients who had small cell BCDD, targetable PIK3CA mutations across multiple subtypes of BCDD, and significantly higher expression of TEC in responders to ICIs. In this study, the authors identified clinically relevant data on nectin-4 and PD-L1 expression in patients with rare bladder tumors. They also identified several novel findings in the genomic analysis that highlight the role of precision medicine in this population of patients. Larger, prospective studies are needed to validate these hypothesis-generating data.

The role of ecology in the region of residence of patients with epidermolysis bullosa and during the experiment.

A person is constantly under the influence of the environment, which determines the state of his health. Animal testing is used to determine the danger of certain chemical agents of inanimate nature. To extrapolate the experimental result to a person, the body of patients with a dystrophic form of epidermolysis bullosa (DVBE), which has a low threshold of resistance to aggressive stimuli, is preferred. Goal - to study the effect of anthropogenic physico-chemical factors on the skin of white mice, as well as environmental ecology on the population of patients with a dystrophic form of congenital epidermolysis bullosa. Materials and methods. Five groups of white mice were exposed to plant protection products. The chronic experiment lasted 6 months, and the daily dose of the chemical compound was 1/50 of LD50. The influence of ecology on 35 patients with DBE was also studied. Results. In the experiment, it was found that the seed with agrochemicals causes skin eczema, periorbital dermatitis, finger mutation and contracture, claw deformity and chronic itching in white mice. We have established the possibility and criteria for extrapolating the results of the experiment to patients suffering from DVBE. Such criteria include itching of the skin, mutation and pseudosyndactyly of the fingers, deformation of the nails The impact on the body of patients with DVBE toxic agents was carried out by the living environment. As a result of observation of these patients, we found that in order to achieve the positive effect of complex therapy, in addition to highly qualified medical care, they need an environmentally safe living environment. They need to organize trips and accommodation in conditions that do not pose an environmental hazard to humans, which will help reduce the severity of the disease and improve their quality of life. Conclusions. The ecology of the living environment determines the effectiveness of therapy in patients with VBI, as well as the timing of manifestation and the severity of the course of the disease. A prosperous ecology contributes to the epithelization of ulcerative elements and the disappearance of itching.

P-437 Are serum progesterone levels predictive for reproductive outcomes in artificial cycles if individualized luteal phase support is only administered when progesterone is below 5 ng/ml?

Abstract Study question Do serum progesterone levels predict reproductive outcomes in artificial cycles when individualized luteal phase support is administered only if progesterone falls below 5 ng/ml? Summary answer The low 5 ng/ml progesterone threshold appears to be sufficient for the patient not to require additional progesterone injections when progesterone is above 5 ng/ml. What is known already Serum progesterone (P4) level is negatively associated with ongoing pregnancy rate (OPR) and miscarriage rate in artificially prepared frozen embryo transfer (FET) cycles using standard micronized vaginal progesterone (MVP) for luteal phase support. Individualized luteal support is considered a successful rescue strategy in cycles with low serum progesterone levels eliminating the effect of P4 levels on outcome. Cut-off levels for this rescue strategy range from 8.8 to 10 ng/ml. Study design, size, duration A retrospective single-centre cohort study including a total of 1,016 vitrified-warmed single blastocyst transfers performed at a tertiary fertility centre between October 2021 and December 2022. Blastocysts of ≥ 3CC Gardner score were eligible for vitrification on day 5 or day 6 (Vit-kit or Vit-kit NX, FuijiFilm). Embryos were warmed and subsequently transferred on the same day which was day 5 in the cycle, regardless if the embryo was vitrified on day 5 or day 6. Participants/materials, setting, methods We included 595 patients undergoing an artificially prepared embryo transfer (ET) cycle using MVP 800mg BID for luteal phase support. Serum P4 levels were determined on the day of ET with the initiation of additional injections of subcutaneous P4 from the day after ET in patients with P4 &amp;lt; 5ng/ml. Primary endpoint was OPR. Multivariable logistic regression was performed to correct for confounders. Generalized estimating equations (GEE) models were fitted for primary and secondary outcomes. Main results and the role of chance OPR was comparable for the 3 groups: 9/40 (22.5%) for patients with P4 &amp;lt;5ng/ml, 64/275 (23.3%) for patients with P4 5-10 ng/ml and 181/701 (25.8%) for patients with P4 &amp;gt;10ng/ml (p = 0.377). No significant association between P4 category and likelihood for OPR was found after adjusting for confounders. Early clinical miscarriage rate was significantly different between the 3 groups: 5/40 (12.5%) in patients with P4 &amp;lt;5ng/ml, 26/275 (9.5%) with P4 5-10ng/ml and 37/701 (5.3%) with P4 &amp;gt;10ng/ml (P = 0.005). Limitations, reasons for caution Higher clinical miscarriage rate in cycles with a P4 level under 10 ng/ml questions the efficacy of rescue progesterone in cycles with a low P4. The patient population also exists of a subgroup of PGT-a tested cycles which was not included as a potential confounder in this analysis. Wider implications of the findings The 5 ng/ml P4 threshold appears to be sufficient for the patient not to require additional P4 injections when P4 is above 5 ng/ml. Consequently, a significantly lower proportion of cycles would need to be supplemented with rescue progesterone; 3.8% versus 31.3% for the 10 ng/mL cut off. Trial registration number ONZ-2023-0223

Locoregional Therapy for Early and Locally Advanced Breast Cancer

Objective: The objective of this article is to conduct a comprehensive review of recent advances in locoregional therapies for early and locally advanced breast cancer, emphasizing the integration of these approaches into comprehensive treatment plans. Initially, this study explores contemporary findings related to surgical techniques, radiation therapy, and the integration of systemic treatments, such as targeted therapies and chemotherapy, as part of a cohesive treatment strategy. Theoretical Framework: Breast cancer remains a significant public health issue, with locoregional therapy playing a critical role in the management of early and locally advanced stages of the disease. The evolution of treatment strategies reflects a deepening understanding of the disease's biological behavior and the necessity for tailored therapeutic approaches. Method: A systematic review was conducted using major scientific databases to collect relevant articles on recent advances in locoregional therapy for breast cancer, from surgical innovations to advanced radiation techniques. Specific keywords were used to identify studies that address new findings and interdisciplinary approaches, facilitating the synthesis of effective strategies and the identification of gaps in current research. Results and Discussion: Recent research has improved surgical precision and radiation delivery techniques, reducing side effects and enhancing treatment efficacy. Innovations in intraoperative radiation and the growing use of neoadjuvant therapies offer promising results, optimizing tumor control and preserving patient quality of life. However, challenges remain in achieving consistent results across different patient populations, underscoring the need for personalized treatment plans tailored to individual patient characteristics and tumor biology.

O-193 Age-related normograms of AMH in women with polycystic ovary syndrome using three different assays

Abstract Study question To develop an age-specific percentile distribution of anti-Müllerian hormone (AMH) in patients with polycystic ovary syndrome (PCOS) measured by three different assays. Summary answer Our age-related normograms may help to interpret AMH levels in PCOS patients and facilitate the use of AMH as a diagnostic tool across age ranges. What is known already In the last years, AMH assessment has gained widespread use in the clinical settings of several conditions. However, several challenges still exist to adopt the AMH as a marker of polycystic ovary morphology (PCOM), as included in the recently updated international guideline. Although different evaluations of age- and assay-specific reference ranges have been published in the last years, these studies have mainly been conducted in normo-ovulatory or infertile women and little is known about the higher range of AMH levels, especially in women with PCOS. Study design, size, duration Retrospective single-center cross-sectional study, including 2,725 women with PCOS who consulted the Reproductive Endocrinology and Infertility Clinic of the Erasmus University Medical Center, Rotterdam, The Netherlands. Participants/materials, setting, methods A total of 2,725 women aged 20 to 40 years with PCOS were included. PCOS was diagnosed according to the Rotterdam Criteria. Serum AMH levels were measured using the following AMH assays: (1) Gen II AMH ELISA, 2) picoAMH assay, and 3) Elecsys AMH plus assay. Age-specific centile curves were constructed using the LMS method. The correlations between AMH with clinical, endocrine, and ultrasound features were also evaluated. Main results and the role of chance To our knowledge, this is the first study with real-world data reporting AMH age-specific percentile nomograms in a large population of PCOS women using three different assays. The 5th, 10th, 25th, 50th, 75th, 90th, and 95th percentiles were calculated according to a population/based approach per age (years) for the Gen II, the picoAMH, and the Elecsys assays. We also considered the age-percentile values of AMH in PCOS patients for the Gen II, the picoAMH and the Elecsys assays according to the cut-offs previously proposed in literature for each specific assay. Interestingly, in our population, a high percentage of women with polycystic ovarian morphology (PCOM) showed AMH levels lower than the cut-offs proposed. Serum AMH levels were significantly higher in patients with phenotype A compared to all other phenotypes for all three assays. For all three assays, we found a statistically significant positive correlation between AMH levels and LH, LH/FSH ratio, testosterone, androstenedione, FAI, mean follicular number, and mean ovarian volume. In contrast, AMH levels were negatively correlated with BMI in all groups. Limitations, reasons for caution This is a retrospective cross-sectional study. Longitudinal studies with a large cohort of women that could be followed for many years are needed to validate our nomogram. Wider implications of the findings AMH threshold levels can be influenced by several variables, making it difficult to identify a general cut-off to diagnose PCOM. Further research should overcome the concept of a single cut-off value. The results of the present study may help clinicians interpret AMH levels in PCOS patients across age ranges. Trial registration number In this retrospective cross-sectional study, 2,725 women who consulted the Reproductive Endocrinology and Infertility Clinic of the Erasmus University Medical Center, Rotterdam, The Netherlands, were included. The Medical Ethical Review Board of the Erasmus University Medical Center Rotterdam approved retrospective studies within this patient population, which includes women with ovulatory dysfunction (MEC-2020-0534).

P-227 Blastocyst rate prediction by artificial intelligence: evaluation of static oocyte images in patients and donors

Abstract Study question Can a deep learning tool accurately predict blastocyst development from single static oocyte images across diverse patient populations? Summary answer The automatic oocyte score was directly correlated with the blastocyst formation rate in conventional treatments using patient oocytes and in the egg donation program. What is known already The implementation of artificial intelligence (AI)-based algorithms has revolutionized gamete and embryo evaluation in assisted reproduction, providing a standardized basis for clinical decisions. Despite these advances, the implementation of AI algorithms in oocyte evaluation has faced unique challenges. This study explores the predictive ability of an AI algorithm on the actual blastocyst arrival rate from static oocyte images, focusing on finding differences or similarities in these predictions between patients and donors. Study design, size, duration This retrospective cohort study analyzed 1092 static images of oocytes before ICSI. The sample included 791 donor and 301 patient oocyte images. A deep learning algorithm was employed to assess oocyte scores, categorizing them into quartiles. The study explored the correlation between oocyte scores and the actual rate of blastocyst arrival for all oocytes. The rates were also compared between patients and donors, assessing an effective cut-off point to improve the accuracy of the predictions. Participants/materials, setting, methods The oocyte images analyzed were captured with cameras connected to microinjection microscopes immediately before the ICSI procedure. Oocyte images and oocyte age were used as input data for the blind analysis performed by the deep learning-based algorithm. The algorithm predicted blastocyst arrival probability for each oocyte, and these predictions were compared with actual outcomes. This evaluation assessed the algorithm’s performance across patient and donor populations, providing valuable insights into its predictive accuracy for blastocyst arrival. Main results and the role of chance Significant differences in blastocyst formation rates were observed between quartiles of scores assigned by the artificial intelligence (AI) algorithm. Oocytes classified in Quartile 1 showed a significantly lower blastocyst arrival rate (54.63±49.99, n = 216) compared to Quartiles 3 (71.88±45.06, n = 224) and 4 (66.82±47.19, n = 220)*. In general, each increased unit in the algorithm was significantly associated with an increased probability of blastocyst formation (OR = 1.10 [95% CI: 1.02-1.16])*. The algorithm successfully predicted the blastocyst arrival rate, with an area under the curve (AUC) of 0.60 (95% CI: 0.56-0.65). When assessing differences between patients and donors, both groups exhibited similar rates in the first quartile (59.68% and 52.60%, respectively) and the three last quartiles combined (67.55% and 66.02%, respectively). However, an effective cutoff point was identified at 2.8 (between first and second quartile), where both populations experienced a notable increase in blastocyst formation rates. (*p&amp;lt;.05) Limitations, reasons for caution This project is limited by its retrospective, single-center nature and small sample size. Consequently, it would be advisable to conduct a large-scale multicenter study to confirm the conclusions of this study. Wider implications of the findings This study highlights the efficiency of the artificial intelligence algorithm in predicting blastocyst arrival from oocyte images. Establishing a cutoff point in oocyte scoring could enhance the management of the egg donation program and provide individualized guidance to patients based on the quality of their gametes. Trial registration number not applicable

Surgical Technique For Chronic Symptomatic Peroneal Sheath Pain in Young Patients

To present the clinical and radiographic data, emphasize our surgical technique and how it was used, and the outcome measures in a case series of patients with chronic symptomatic peroneal sheath pain. A retrospective chart and radiograph review was conducted involving 36 adolescent patients (ages 8 to 20 y) treated surgically for chronic symptomatic peroneal sheath pain from 2010 to 2020. Findings that include chief complaint, magnetic resonance imaging findings, and surgical measures were documented. The patients’ postoperative and clinic visit notes were analyzed and outcome scores (FAOS Foot &amp; Ankle Survey, AOFAS Ankle-Hindfoot Scale, and Kaikkonen Functional Scale) were calculated to determine the long-term results of the procedure. In our case series of 36 patients undergoing surgical treatment for chronic symptomatic peroneal sheath pain the procedures performed were as follows: 35 peroneal sheath repairs (97.22%), 34 ankle arthroscopies (94.44%), 27 resections of anomalous peroneus brevis muscle belly (75.00%), 2 resections of accessory peroneus quartus muscle (5.56%), 7 partial synovectomies (19.44%), 29 debridements (80.56%), and 6 Brostrom repairs (16.67%). magnetic resonance imaging findings showed 50% of our patient population had low-lying peroneus brevis muscles, and on examination during surgery, 61.11% of peroneus brevis muscles extended past the fibular tip. The average time in the cast post-operatively was 4.33 weeks. The average time from surgery to return to activity was 9.03 weeks. Twenty-two of the 36 patients (61.11%) were athletes and 100% were able to return to their sport. Outcome scores were retrospectively determined to be 99.27 for the FAOS Foot and Ankle Survey, 98.72 for the AOFAS Ankle-Hindfoot Scale, and 99.31 for the Kaikkonen Functional Scale. Complications were minimal and included 1 postoperative infection, 3 cast impingements, and 2 reported instances of post-operative pain. In our retrospective case series of 36 patients, the outcomes of surgical intervention for peroneal tendon pathology unresponsive to nonsurgical management in pediatric patients were evaluated. Our surgical method utilizes debridement, synovectomy, excision of low lying peroneus brevis muscle belly, excision of peroneus quartus if present, repair of split-tears of the tendons, and repair of the peroneal tendon sheath using “pants over vest” sutures to tighten the sheath. Our chart review shows all 36 patients were satisfied with the outcome, demonstrated improvement in relevant patient-reported outcome measures, and would elect to undergo the procedure again. Therefore, the novel surgical techniques outlined in this study appear to be viable options to treat chronic symptomatic peroneal tendon sheath pain resistant to conservative methods. Level of Evidence: Retrospective Case Series, Level IV.

O-319 A randomised trial of time-lapse imaging of embryos in in-vitro-fertilisation treatment

Abstract Study question Do time-lapse imaging (TLI) systems used in IVF/ICSI treatment improve live birth either due to undisturbed culture conditions or improved embryo selection or both? Summary answer In women undergoing IVF/ICSI treatment the use of TLI systems does not significantly increase the odds of live birth compared to standard care without TLI. What is known already TLI systems used in IVF treatment have the potential to improve fertility outcomes either due to undisturbed culture conditions or improved embryo selection or both. However, there remains uncertainty about its benefits. Existing reviews and primary studies predominantly report no differences between the use of TLI and conventional methods. However none of the previous trials were adequaltely powered to detect meaningful differences in live birth and the quality of most trials was deemed to be low to very low. Study design, size, duration TILT (Time-lapse Imaging Trial) is a multi-centre, three-arm, parallel-group, double-blind, randomised controlled trial. Participants were randomly assigned in a 1:1:1 ratio to the TLI system for both undisturbed culture and embryo selection (TLI arm), TLI system for undisturbed culture conditions alone (undisturbed culture arm), and standard care without TLI (control arm). From June 2018 to September 2022, we randomised 1575 participants based on a pre-specified sample size to detect an 8.75% difference in live births. Participants/materials, setting, methods We randomised 1575 couples undergoing IVF/ICSI with broad inclusion criteria across seven IVF centres. The primary outcome was live birth. Secondary outcomes included clinical pregnancy, pregnancy loss, and multiple pregnancy. Primary analysis was performed based on the intention-to-treat principle for all participants with primary outcome data available and the effect estimate reported as an adjusted odds ratio (aOR). Pre-specified sensitivity analyses and subgroup analyses for age and method of embryo transfer were performed. Main results and the role of chance We recruited 2191 and randomised 1575 participants. Live birth data were available for 1558/1575 (98.92%) participants. The livebirth rates were 33.7% (175/520) in the TLI arm, 36.6% (189/516) in the undisturbed culture arm and 33.0% (172/522) in the control arm. The aOR was 1.04 (97.5% confidence interval (CI) 0.73 to 1.47) for TLI arm vs control and 1.20 (97.5% CI 0.85 to 1.70) for undisturbed culture vs control. The clinical pregnancy rates were 42.2% (219/519) in the TLI arm, 43.4% (225/518) in the undisturbed culture arm, and 40.9% (212/519) in the control arm. There were no significant differences for TLI vs control arm (aOR 1.06, 95% CI 0.82-1.38) and undisturbed culture vs control arm (aOR 1.11, 95% CI 0.86-1.46). The rates of pregnancy loss between clinical pregnancy and 24 weeks’ gestation were not statistically different when TLI (8.7%, 45/515) and undisturbed culture arms (6.4%, 33/513) were compared with control arm (8.1%, 42/517) with aOR 1.09 (95% CI 0.66-1.77) and 0.76 (95% CI 0.45-1.29) respectively. None of the other secondary outcomes demonstrated significant differences between the arms The findings were similar irrespective of the woman’s age and use of fresh or frozen embryo replacement, and for all sensitivity analyses, for primary and secondary outcomes. Limitations, reasons for caution Although the trial recruitment was delayed by the SARS-CoV-2 pandemic, this did not impact the results as patient populations, clinical care pathways and time-lapse technology remained similar. The remit of this trial did not allow assessment of the influence of TLI systems on embryology laboratory workflow or perform a health-economic analysis. Wider implications of the findings Our trial provides high-quality definitive evidence of no benefit of the use of TLI systems for embryo incubation and selection to improve success rates in women having IVF and ICSI treatment. Trial registration number ISRCTN17792989

P-745 effectiveness and safety of consecutive single embryo transfer compared to double embryo transfer: results from UK HFEA registry

Abstract Study question How does two-consecutive single embryo transfer (2xSET) affect reproductive outcomes of in-vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) compared to double embryo transfer (DET)? Summary answer 2xSET may provide greater or comparable live birth rates with lower multiple birth, preterm birth, and pregnancy loss or neonatal death rates compared to DET. What is known already Elective single embryo transfer (SET) in IVF/ICSI is widely encouraged over DET to minimise the risk of multiple birth and associated morbidities. Despite this, UK multiple birth rates following IVF remain higher than spontaneous conception, with 5% of IVF pregnancies resulting in multiple birth compared to 0.4%-1.2% multiple gestation rates following spontaneous conception. Owing to advancements in cryopreservation techniques, live birth and ongoing pregnancy rates are now comparable between fresh and frozen embryo transfer. Consequently, 2xSET has been suggested as an alternate technique to achieve comparable live birth rates with fewer multiple gestation pregnancies compared to DET. Study design, size, duration This retrospective cohort study was conducted using Human Fertilisation and Embryology Authority (HFEA) register data, which encompasses national data from all IVF clinics in the UK. Within this analysis, all women who underwent their first oocyte collection and IVF or ICSI treatment cycle with subsequent SET, DET or 2xSET between 2010 and 2019 using either blastocyst or cleavage stage embryos were included (N = 125,149). Participants/materials, setting, methods This national retrospective cohort study utilised UK HFEA register data from 2010-2019, including all women who underwent their first oocyte collection and subsequent embryo transfer (N = 125,149). The rate of live birth, multiple birth, preterm birth, and pregnancy loss or neonatal death was compared between SET, DET, and 2xSET IVF/ICSI pregnancies using either blastocyst or cleavage stage embryos, and was stratified by maternal age. Data analysis was conducted in RStudio v4.2, alpha equals 0.05. Main results and the role of chance 2xSET pregnancies following blastocyst-stage transfer achieved a greater live birth occurrence rate of 0.47 (0.13) (median (interquartile range)) than SET, 0.41 (0.13), and DET, 0.38 (0.13) (P &amp;lt; 0.05). When using SET as a reference standard, 2xSET achieved a lower multiple birth rate, odds ratio (OR) of 6.87 (95%CI 6.14-7.68), than DET, OR 28.20 (95%CI 25.20-31.57), and lower preterm birth rate; OR 1.11 (95%CI 1.06-1.15) in 2xSET, and OR 2.80 (95%CI 2.67-2.94) in DET. Pregnancy loss or neonatal death rate was also lower in 2xSET, OR 1.14 (95%CI 1.08-1.21), compared to DET, OR 2.11 (95%CI 1.98-2.24). Conversely, in cleavage-stage embryo transfer pregnancies, no significant difference in live birth occurrence rate was observed, achieving rates of 0.27 (0.21) for SET, 0.26 (0.13) for DET, and 0.29 (0.18) for 2xSET. 2xSET was less likely to result in multiple birth than DET, OR 0.14 (95%CI 0.11-0.19). Moreover, when using SET as a reference standard, 2xSET was less likely to result in preterm birth than DET, OR 1.02 (95%CI 0.87-1.23) and 2.48 (95%CI 2.17-2.82) respectively, as well as pregnancy loss or neonatal death, OR 1.07 (95%CI 0.85-1.35) and 2.03 (95%CI 1.70-2.42) respectively. Limitations, reasons for caution Certain confounders are not recorded within HFEA registry data, including patient body mass index (BMI), evaluation of embryo quality, and endometrial thickness at embryo transfer. Consequently, while our analysis identifies broad trends in embryo transfer success and morbidity, results may differ within certain patient populations. Wider implications of the findings 2xSET may provide greater or comparable live birth rates with lower multiple birth and morbidity than DET. Promotion of 2xSET where appropriate for maternal age and embryo quality should be implemented to enhance reproductive outcomes and reduce the risk of morbidity in IVF/ICSI pregnancies. Trial registration number Not Applicable

1082 Maximising Surgical Outcomes in Midline Incisional Hernia Repairs: Are We Employing Every Possible Optimisation?

Abstract Introduction Large midline Incisional hernia repair can involve complex surgery which poses many challenges, with a high recurrence and complication rate. The recently published European Hernia Society Guidelines has identified several risk factors contributing to the increased complications after surgical repair. We aim to assess the effect of these modifiable risk factors for adverse outcomes within our patient population. Method All adult patients who underwent a repair of midline incisional hernias larger than 3cm in a DGH hospital between July 2021 and July 2022 were included. Data on patient demographics, modifiable risks factors and complications were collected. Analysis was performed using Microsoft Excel. Results 26 patients (age: 64 [33-84] years; M:F, 9:17) underwent a midline incisional hernia repair were included. The average hernia size was 8cm. The average body mass index (BMI) was 33.1, seven were smokers and three had diabetes mellitus. Of the three patients who developed a recurrence, average BMI was 36 and two were smokers. None of the patients were counselled for weight loss or smoking cessation. Conclusions In our cross-sectional study, patients with a large hernia, high BMI, diabetes, a smoking history are associated with adverse outcomes. We aim to highlight and raise the awareness to surgeons who perform these repairs to counsel their patients on their modifiable risk factors and its associated risk of hernia recurrence. Preoperative optimisation improves surgical outcome and subsequently reduces healthcare costs.

P-054 Paternal age and cryopreservation impact sperm chromatin status as indicated by changes in protamine and histone levels

Abstract Study question Do paternal age and cryopreservation alter sperm chromatin status in normospermic men? Summary answer Paternal age and cryopreservation appear to impact sperm chromatin condensation by altering protamine and histone DNA levels. What is known already Semen parameters do not accurately reflect male fertility and thus are not adequate to assess the impact of patient profile and semen manipulation/conservation on sperm functional quality. DNA protamination leads to sperm chromatin condensation, which is associated with sperm maturity but also appears to function as a defence mechanism against oxidative attack. In the face of contrasting/insufficient previous data, the impact of advanced paternal age (APA) and cryopreservation on sperm chromatin condensation and histone/protamine balance remains unclear. Study design, size, duration Twenty-two normospermic men, 11 of which with advanced paternal age (APA; ≥42) and 11 pre-APA (≤35), provided semen samples by masturbation (1-5 days abstinence). Fresh and cryopreserved/thawed samples from all patients were assessed for chromatin histone staining, while samples from a subgroup of 10 patients (5 pre-APA and 5 APA) were assessed for protamine presence. The effects of age and cryopreservation on the percentage of stained cells were assessed with the Fisher’s exact test. Participants/materials, setting, methods Semen samples were provided by male partners of couples treated at our fertility centre. Sample aliquots were cryopreserved and analyzed after thawing (CryoSperm &amp; Sperm Preparation Medium, Origio). Histone presence was assessed through aniline blue staining and protamine presence was indirectly assessed through staining with the protamine competitor Chromomycin A3 (CMA3); stained cells were visualized by bright field and fluorescence microscopy, respectively. Two hundred sperm cells were evaluated in each sample by the same embryologist. Main results and the role of chance Mean paternal age was 31.5±3.9 and 44.4±2.1 years for pre-APA and APA patient-groups, respectively. Major parameters observed in fresh semen samples were: 2.3±0.7 vs. 3.6±1.6mL (volume); 39±28 vs. 38±12 x10ˆ6/mL (concentration); 7±12 vs. 6±5% (rapid progressive motility); 41±12 vs. 38±13% (slow progressive motility); 12±5 vs. 11±4% (non-progressive motility); 40±17 vs. 45±16% (immotile) and 5±1 vs. 6±2% (normal morphology), for pre-APA and APA, respectively. The percentage of aniline blue (histone marker) positive cells was less than half in fresh samples from APA as compared to pre-APA patients (10.2% and 23.4%, respectively, p &amp;lt; 0.0001). Consistently, the percentage of CMA3 (protamine absence marker) positive cells was less than half in APA as compared to pre-APA patients (6.4% and 16.4%, respectively, p &amp;lt; 0.0001). In both age groups, the percentages of aniline blue and CMA3 positive cells were higher in cryopreserved/thawed samples as compared to their fresh counterparts (aniline blue positive: 35.2% vs. 23.4% and 22.0% vs. 10.2%; CMA3 positive: 27.2% vs. 16.4% and 18.8% vs. 6.4%, in cryopreserved vs. fresh in pre-APA and APA, respectively, p &amp;lt; 0.0001). Limitations, reasons for caution Our study is limited by the potential interference of confounding factors not equally distributed in age groups. The conclusions from this study must be confirmed in other patient populations with different race/genetics and habits. Wider implications of the findings Our findings suggest that APA increases, while cryopreservation decreases, sperm chromatin condensation, as indicated by changes in DNA histone and protamine abundance. Our study thus sheds light on the impact of paternal age and cryopreservation on sperm quality, providing new valuable parameters for reproductive medicine practice and research. Trial registration number na

O-155 Limited utility of mosaicism reporting in PGT-A: independent confirmation from a European multisite, double-blinded analysis including 4293 embryo transfers following the first US experience

Abstract Study question Are results showing limited clinical utility of mosaicism reporting in PGT from a blinded mosaic embryo transfer American study, confirmed in a European setting? Summary answer Even between different patient populations and clinical settings, putative mosaicism reporting has limited clinical utility for embryo selection when co-evaluated with other clinical/embryological factors. What is known already Intermediate chromosomal copy number (ICN) results in NGS-based PGT-A are commonly interpreted as embryo mosaicism. A recent prospective, non-selection study in America showed that reporting mosaicism would not significantly improve embryo selection. At odds with this, results suggesting that embryo selection based on putative mosaicism can improve clinical outcomes continue to be reported, possibly reflecting limitations in accurate mosaicism identification or retrospective analysis biases. This study replicates the design of previously reported American study, using the same PGT-A assay, examining the predictive value of whole-chromosome ICN (wICN) and segmental ICN (sICN) following concurrent copy-number and genotyping-PGT in a European setting. Study design, size, duration A multisite double-blinded study involving 14 European IVF clinics was conducted from April 2022 to July 2023, including 3365 patients and 4293 single embryo transfers. Embryos, reported as negative for uniform aneuploidies, including those with wICN or sICN, were chosen for transfer based solely on standard developmental and morphological evaluation. Primary outcome measure was live birth rate defined as any pregnancy reaching the 24th week of gestation (LBR). Participants/materials, setting, methods Trophectoderm biopsies were analysed using a validated targeted-NGS assay with approximately 5000 loci across the genome, providing both quantitative and genotyping information to support aneuploidy classification. Putative mosaicism was inferred from ICN deviations from the expected two copies for autosomes and partly supported by corresponding SNP B-allele frequency patterns. Related clinical and embryological variables were analysed in a multivariate analysis and a Random Forrest regression used to model the clinical utility of putative mosaicism. Main results and the role of chance Of the embryos transferred, 6.8% (293/4293) were wICN only; 6.2% (269/4293) were sICN only and 0.5% (23/4293) were a combination of wICN and sICN. The detected ICN ranged from 23%-84% with no overrepresentation of any individual chromosomes. The LBR of embryos in the control group (without ICN), sICN and wICN were 46.8% (1736/3708; 95%CI:45.2-48.4%), 36.4% (98/269; 95%CI:30.9-42.3%) and 39.2% (115/293; 95%CI:33.8-44.9%) respectively. The miscarriage rate for control, sICN and wICN were 12.9% (257/1993; 95%CI:11.5-14-4%), 19.7% (24/122; 95%CI:13.6-27-6%) and 16.7% (23/138; 95%CI:11.4-23.8%), respectively. Logistic regression (P = 0.05) showed that the presence of sICN (OR: 0.7; 95%CI: 0.54-0.9) and wICN (OR: 0.62; 95%CI: 0.36-1.07) were modestly but significantly associated with LBR along with other embryological and clinical factors including embryo morphology (OR: 0.89; 95%CI: 0.84-0.96), day of biopsy (OR: 0.65;95%CI: 0.56-0.75), previous ET failures (OR: 0.79; 95%CI: 0.71-0.88) that were more strongly associated. No significant effect was observed of any specific intermediate CN cut-off on the association with LBR. Random Forrest regression, considering all correlating variables, showed a LBR prediction (AUC) equal to 0.578 without putative mosaicism and AUC of 0.583 with putative mosaicism included, a negligible increase considering the low incidence of mosaicism in our clinical setting along with its modest predictive value. Limitations, reasons for caution Follow-up prenatal and post-natal data at this time was not available, hence conclusions about these outcomes wasn’t possible. Despite the overall large sample size, the analysis of specific effects at different ICN values lacked sufficient power. Furthermore, this study’s data is platform-specific and cannot be translated to other PGT-A assays. Wider implications of the findings Although putative mosaicism was associated with modestly impaired pregnancy rate, two independent studies now confirm that reporting mosaicism has limited impact when prospectively selecting embryos for transfer based on standard embryological parameters. Considering the established downsides, including potential embryo disposal, the practice of mosaicism reporting in PGT is questionable. Trial registration number Not applicable

P-198 Time to maximum blastocyst expansion (tmBE) may represent a novel metric for assessing embryo competence

Abstract Study question Can the time to achieve maximum blastocyst expansion (tmBE) and the frequency of spontaneous collapses serve as useful indicators of embryo competence? Summary answer Compared to the frequency of spontaneous collapses, tmBE was a better indicator of embryo competence, potentially serving as a valuable metric for embryo selection. What is known already Identifying the most viable blastocyst for transfer is essential for success in assisted reproduction. In scenarios with good prognosis, such as oocyte donation, blastocyst selection may require a more nuanced approach, given the high number of available good quality embryos. Exploring indicators of embryo competence beyond traditional morphology-based criteria may be beneficial, however an in-depth understanding is still lacking. Blastocyst expansion and contraction dynamics have been suggested to play a role in developmental and chromosomal fitness. However, their predictive value has not been investigated across a wide range of patient populations. Study design, size, duration This is a single-center retrospective study of 287 blastocysts transferred in autologous (n = 88) and heterologous (n = 199) cycles, performed between September 2019 and September 2022. Only fresh single embryo transfers were considered. We compared blastocysts across two groups: advanced maternal age (AMA) patients (&amp;gt;35 years old, n = 88) and oocyte donors (&amp;lt;35 years old, n = 199). We evaluated well-established indicators of embryo quality, as well as novel metrics, including tmBE and the frequency of spontaneous collapses. Participants/materials, setting, methods Conventional indicators of embryo quality included blastocyst grade and morphokinetic timings (tPNf, t2, t3, t4, t5, t8, tSB and tB). tMBE was defined as the maximum time (hpi) required for the blastocyst to reach its largest diameter, extending beyond tB. Blastocyst contractions were measured as a decrease and subsequent recovery of the blastocoel area over time. ImageJ was employed for size measurements. p&amp;lt;0.05 was considered statistically significant after Two-tailed Student’s t-test or Chi-square test. Main results and the role of chance We observed a significant difference in live birth rates between oocyte donors and AMA patients (40% vs 18%, p=0.0004). Nevertheless, there were no differences across blastocyst expansion scores between oocyte donors and AMA patients (5= 58% vs 65%; 4= 38% vs 30% and 3= 4% vs 5%, p &amp;gt; 0.05), nor in their morphology score (Excellent= 57% vs 61%; Good= 24% vs 18%; Average= 15% vs 16% and Poor= 4% vs 5%). In terms of morphokinetics, when comparing oocyte donor and AMA embryos, the only significant difference was observed at tPNF (22.0±2.4 vs 22.6±2.3; p= 0.04). No differences were found at t2, t3, t4, t5, t8, tSB and tB. Additionally, the frequency of spontaneous collapses showed no significant differences between the oocyte donor and AMA group (1.4±1.2 vs 1.5±1.0, p=0.66). However, blastocysts from oocyte donors reached tmBE significantly faster than AMA embryos (115.0±4.8 vs 117.2±3.4; p = 0.0003). When these variables were further correlated to clinical outcomes, the frequency of spontaneous collapses did not appear to influence live birth in either group. Notably, however, tmBE was significantly shorter for embryos resulting in a live birth, across both the oocyte donor (113.5 vs 115.4, p = 0.04) and AMA group (115.6 vs 117.6, p = 0.04). Limitations, reasons for caution This is a single center retrospective study with a relatively small sample size, especially in the AMA group. Caution should be made when generalizing results to other patient populations, as confounding were not taken into consideration. No data on the chromosomal status of embryos was available. Wider implications of the findings Our results suggest that tMBE may serve as a reliable indicator of embryo potential, allowing a more nuanced embryo selection, particularly in cases with a high number of good quality embryos. This study opens avenues for further research into novel metrics for assessing embryo competence Trial registration number not applicable

Risk of Atrial Fibrillation Induced by Ivabradine in Correlation with Left Atrial Size

Abstract Background Ivabradine (Procoralan, Servier) is a heart rate lowering drug which acts by specifically inhibiting the pacemaker If current, which causes spontaneous depolarization in the sino-atrial node that regulates the heart rate. Objective To correlate Left atrial size with development of AF in patients treated with ivabradine over a 12 week period. Patients and Methods Our study was conducted upon 180 patients referred to Ain Shams University Hospital and Misr University for Science and Technology hospital, from September 2020 to February 2021 to undergo treatment for HF or IHD with the appropriate medications with AF being the primary outcome of interest and how it correlates with Ivabradine therapy. Results Our results showed that there was no statistically significant difference between the two groups regarding the incidence of AF (p = 0.587). Likewise, there was no statistically significant difference between the two groups regarding duration till AF at 1st month, 2nd month and 3rd month (p &amp;gt; 0.05). This could be explained by the lower number of patients included in the study as compared to other similar studies. When the entire patient population who developed AF was pooled regardless of their Ivabradine use, there was a statistically significant increase in AF incidence with larger left atrial volume indices. Conclusion In the present study, Ivabradine treatment was not associated with a higher incidence of AF in patients with heart failure and/or ischemic heart disease. Also, there was no significant difference in the duration until AF occurrence when it was evaluated at the end of the 1st, 2nd, and 3rd months. Higher LAVI was associated with a higher incidence of AF in the total studied patient population regardless of Ivabradine use.

P-798 A feasible clinical model to generate genotyped oocytes for infertile women

Abstract Study question Is it possible to generate genotyped oocytes by utilizing accessible somatic cells in a somatic cell nuclear transfer model? Summary answer Genotyped oocytes generated through haploidization of endometrial somatic cells exhibited reliably completed embryo development and yielded healthy offspring. What is known already The generation of genotyped oocytes through neogametogensis or somatic cell nuclear transfer (SCNT) would be the ultimate solution to treat female infertility due to primary ovarian insufficiency or agonadism. Among the various approaches, somatic cell haploidization appears more feasible (Lee, et al 2022). Unfortunately, this approach has only been successful in a murine model using cumulus cells. However, this donor cell type is not ideal when translated into clinical setting, due to the absence of cumulus cells in patients who are void of oocytes, which arguably is the patient population that would potentially benefit the most from this technique. Study design, size, duration In a mouse SCNT model, endometrial stromal cells (EMSCs) were injected into enucleated oocytes. Cumulus cells (CCs) were used as another source of nuclear donor. Intact MII oocytes were used as control. Post-SCNT oocytes and controls were inseminated by spermatozoa from B6-EGFP mice to monitor paternal genome presence through embryo development and offspring. Embryos were cultured in a time-lapse microscope. To prove gamete competence, blastocysts were transferred into pseudo-pregnant recipients and offspring health was assessed. Participants/materials, setting, methods Endometrial stromal cells were cultured for 4 days and exposed to aphidicolin overnight to synchronize at G1 phase of cell cycle. Cumulus cells were collected after denudation. Oocytes from B6D2F1 mice were enucleated under polarized light microscope. SCNT was performed with CCs or EMSCs by lipofectamine-mediate fusion. Oocytes were inseminated with spermatozoa from GFP-positive transgenic mice. Embryos morphokinesis were assessed by a time-lapse system. Blastocysts were transferred into 2.5-dpc surrogate CD1 mice. Main results and the role of chance Control oocytes(n = 75) fertilized at 93.3%(70/75) and progressed to 2-cell stage at 93.3%(70/75), 8-cell at 93.3%(70/75) and blastocyst at 89.3%(67/75). The control embryos started syngamy at 14.4±1h, reaching the 4-cell stage at 37.3±3h and blastulation at 80.6±8h. A total of 484 oocytes were enucleated, 470(97.1%) survived and underwent SCNT using CCs(n = 85) or EMSCs(n = 385). Fusion rate was 95.5% for CC with a haploidization rate of 70.9%(56/79) that led to a fertilization rate of 64.3%(36/56). The CC cohort developed to 2-cell, 8-cell, and morula at 47.4%, 35.4%, and 22.8%, with a delay in development at syngamy at 19.0±8h(P&amp;lt;0.0001). In the EMSC cohort, fusion rate was 96.0%(361/376). Haploidization rate was 65.4%(236/361), comparable to the CC cohort(P = 0.35). Fertilization was lower in the EMSC cohort at 47.0%(P&amp;lt;0.01) compared to the CC cohort. Subsequently, EMSC cohort yielded similar cleavage rates to 2-cell stage at 30.7%, 8-cell stage at 29.4%, and morula stage at 28.5%. The blastocyst rate was higher in the EMSC cohort at 28.0%(P&amp;lt;0.05). The EMSC cohort yielded similar developmental timing comparing to controls from pronuclear appearance to 4-cell cleavage but a delay manifested afterward at 37.3±3h(P&amp;lt;0.0001). In the EMSC cohort, 42 blastocysts were transferred, yielding 3 healthy pups(2 male,1 female). Limitations, reasons for caution While we generated consistent haploidization and satisfactory fertilization, full pre-implantation development remained low. Even more limited was the live birth rate, which probably related to subtle factors such as an imprinting issue due to insufficient reprogramming of the somatic cell donor. Wider implications of the findings The SCNT model described to generate genotyped oocytes, although still with limited efficiency, represents a feasible reproductive option for women with agonadism and compromised ovarian reserve. This model is still a better approach to complete neogametogenesis. Trial registration number not applicable

Frailty in Hemodialysis Patient

Abstract Background Frailty has been defined as a state of increased vulnerability to stressors as a consequence of degeneration in multiple systems. There remain two schools of thought with regard to frailty: one which sees frailty as a physical phenotype characterized by sarcopenia and another that views frailty as an accumulation of deficits across a variety of domains. Aim of the Work The aim of this study was to assess the prevalence of frailty among dialysis population. Patients and Methods This cross section study carried out in Hemodialysis Unit of the Nasr City Health Insurance Hospital between October 2020 and July 2021. The total number of the study was 325 hemodialysis patients, 25 were excluded from the study, thus the enrolled final number became 300 hemodialysis patients on maintenance hemodialysis therapy for at least 6 months. Results The mean age of the patients was 45.57±11.79 years (range 25-65 years) 50% of them were under 45 years of age. 258 (86%) of patients were males and 42 (14%) females, with male to female ratio about 6.14:1. 37 patients (12.3%) has positive HCV, while the results also show that none of the HBV and HIV of the study group. 10 patients (3.3%) of vulnerable, 89 (29.7%) patients at mild frailty, table also clarified that, 126 (42.0%) patients at moderat4e frailty, furthermore, 75 (25%) patients at severe frailty in Edmonton frail scale. There was significant positive association between frailty and age with p-value &amp;lt;0.001. Males more affected by frailty than females. Conclusion The differences in the frailty prevalence among CKD patients could be caused by the different definitions of frailty that each study adopted. It is important to prevent early-onset disability in end-stage renal disease, which may be accelerated by frailty in this patient population, which includes individuals who already carry a high risk of morbidity and mortality. We adopted the Edmonton Frail Scale (EFS) based on self-report, it is very simple to administer and can be carried out by hemodialysis nursing staff after minimal training, without the need for specialist medical staff, in less than 15 min. Its association with poor short-term outcome highlights its utility in detecting frail patients, but because it is a multi-domain test, it also gives health professionals information about which areas of frailty are affected. This would allow specialists to administer specific, more complex scales to detect deficits in independence for basic and instrumental activities of daily life, cognition, emotional status, and social support. Our findings allow us to recommend the inclusion of the frailty comprehensive assessment of patients starting the dialysis program to timely identification of frailty syndrome.

The effect of Empagliflozin on echocardiographic parameters in diabetic patients after acute myocardial infarction: A systematic review and meta-analysis with trial sequential analysis.

Patients with diabetes mellitus (DM) are at higher risk of cardiovascular events, particularly acute myocardial infarction (MI). Sodium-glucose cotransporter 2 inhibitors (SGLT2i) can improve cardiac outcomes among heart failure individuals, however, the effects on acute myocardial infarction remain unclear. This meta-analysis investigates the impact of empagliflozin in diabetic patients following acute myocardial infarction. We comprehensively searched PubMed, Scopus, Cochrane, and Web of Science through August 10th, 2023. We included studies comparing empagliflozin versus placebo in diabetes patients with acute myocardial infarction. We used Revman to report the data as mean difference (MD) and 95% confidence interval (CI), and our effect size with a random effects model. Additionally, we performed Trial Sequential Analysis (TSA) to test the robustness of the results. The study protocol was published on PROSPERO with ID: CRD42023447733. Five studies with a total of 751 patients were included in our analysis. Empagliflozin was effective to improve LVEF% (MD: 1.80, 95% CI [0.50, 3.10], p = 0.007), left ventricular end-diastolic volume (LVEDV) (MD: -9.93, 95% CI [-16.07, -3.80], p = 0.002), and left ventricular end-systolic volume (LVESV) (MD: -7.91, 95% CI [-11.93, -3.88], p = 0.0001). However, there was no difference between empagliflozin and placebo groups in terms of NT-pro BNP (MD: - 136.59, 95% CI [-293.43, 20.25], p = 0.09), and HbA1c (MD: -0.72, 95% CI [-1.73, 0.29], p = 0.16). Additionally, empagliflozin did not prevent hospitalization due to heart failure (RR: 0.59, 95% CI [0.16, 2.24], p = 0.44, I-squared = 0%), and mortality (RR: 1.34, 95% CI [0.15,11.90], p = 0.79, I-squared = 25%). Empagliflozin initiation in diabetic patients following acute MI may improve echocardiographic parameters. However, empagliflozin might not be effective in heart failure prevention and optimal glycemic control in this patient population. Further large-scale trials are warranted to ascertain our findings.

P-214 Direct unequal cleavage-1 (DUC1) in IVF/ICSI cycles: relationship with patient characteristics and insemination method

Abstract Study question Does the incidence of DUC1 in IVF/ICSI cycles vary with the maternal profile and insemination method? Summary answer The incidence of DUC1 cycles is higher in patients with a more favourable prognosis. DUC1 embryos are more frequent in ICSI than in IVF cycles. What is known already The emergence of Time-Lapse Microscopy (TLM) has enabled a dynamic and thorough evaluation of in vitro embryo development, unveiling the occurrence of morphological phenomena unobserved with static observation, such as direct unequal cleavage (DUC), which is associated with a drastically reduced competence to implant. The incidence of DUC-1 (DUC immediately after syngamy) has been reported to vary from 8.3% to 26%, but the reasons underlying its occurrence and variability are unknown. There is evidence that the maternal profile and insemination method can impact embryo developmental competence, but whether they impact the incidence of DUC is also unknown. Study design, size, duration The study includes 2920 first IVF/ICSI cycles (2018 to 2022) providing 12492 embryos. Cycles presenting male infertility were excluded from the analysis. The percentages of DUC1 embryos in relation to total embryos and of cycles providing at least one DUC1 embryo in relation to total cycles were compared between AMA (advanced maternal age; ≥35) and pre-AMA (&amp;lt;35) cycles. Patient/cycle characteristics were compared between cycles with and without DUC1 occurrence in AMA and pre-AMA cycles, separately. Participants/materials, setting, methods Ovarian stimulation was induced with rFSH or with a combination of FSH and LH using classic antagonist or short agonist protocols. Oocytes were inseminated with either IVF or ICSI standard methodology. Embryo culture was performed in an integrated embryo culture Time-lapse System (EmbryoScope; Vitrolife). Differences between percentages were assessed by the Fisher’s exact test, while differences between continuous variables were assessed with the Wilcoxon sum rank test. Main results and the role of chance The percentage of DUC1 embryos in relation to total embryos did not vary between pre-AMA (5.4%) and AMA (5.2%; p &amp;gt; 0.05) cycles. Alternatively, the incidence of cycles providing at least one DUC1 embryo was higher in pre-AMA (21.7%) as compared with AMA patients (16.0%; p &amp;lt; 0.0001). In both pre-AMA and AMA cycles, DUC1 occurrence was associated with higher oocyte yield (13.5±7.7 vs. 10.6±6.7 and 11.0±6.3 vs. 7.5±5.5, respectively; p &amp;lt; 0.0001), higher AMH serum levels (4.4±4.7 vs. 3.4±3.2 and 3.0±3.6 vs. 2.1±2.1ng/mL, respectively; p &amp;lt; 0.004) and lower basal FSH serum levels (7.0±2.1 vs. 7.6±2.9 and 7.8±3.3 vs. 8.5±3.4mU/mL, respectively; p &amp;lt; 0.0001). Overall, the percentage of DUC1 embryos was higher in ICSI (5.6%) as compared to IVF (4.4%, p &amp;lt; 0.01) cycles. However, when the data was stratified by maternal age, DUC1 incidence was significantly higher in ICSI vs. IVF in AMA (5.6 vs 4.0%; p = 0.002) but not in pre-AMA (5.7 vs 5.0%; p = 0.19). All 21 DUC1 embryos transferred during the study failed to implant. Limitations, reasons for caution Our study is limited by its retrospective nature. The present conclusions must be confirmed in other patient populations with different race/genetics and habits. Wider implications of the findings The occurrence of cycles providing DUC1 embryos is paradoxically associated with a more favourable patient prognosis, and the percentage of DUC1 embryos is higher in ICSI as compared to IVF cycles in AMA patients. Our findings represent new valuable clues for the clarification of DUC1 underlying causes. Trial registration number NA