Background/Objectives: The objective of this study was to evaluate, for the first time, the effectiveness and safety of 4% icodextrin solution by detecting the incidence of adhesion-related morbidities (adhesion-related hospital readmissions, including reoperations) when used as an adhesion prophylactic agent during laparoscopic gynecologic surgery. Methods: The study was a single-arm, two-center, retrospective study. The incidence of hospital readmissions that were directly or possibly related to adhesions following the use of 4% icodextrin in laparoscopic gynecologic surgery, 2 years from the date of index surgery, was assessed either via chart review alone or, when found necessary, in combination with patient-completed questionnaires. Patient safety was evaluated through reported adverse events. The relationship between clinical events and the use of 4% icodextrin was assessed by investigators based on patient-level data. Results: After 149 patients were screened, the study finally included 123 patients; 4 (3.3%; 95% CI: 0.89%, 8.12%) had at least one reoperation or readmission that was directly or possibly related to adhesion within 2 years of index surgery. In the supplemental analysis (67 patients using chart and questionnaire data), this incidence rate was 10.4% (95% CI: 4.30%, 20.35%). No adverse events related to the use of 4% icodextrin were reported. Conclusions: This is the first study ever evaluating hospital readmission/reoperation rates after application of a specific adhesion prophylactic agent. The results indicate that 4% icodextrin is safe and effective when used as an intraperitoneal instillate for reduction in adhesions in gynecological laparoscopic procedures. It has a lower readmission and reoperation rate compared to meta-analysis data in the international literature.
PurposeInfertility affects 1 in 6 couples, yet male fertility assessments often rely on semen analysis alone, which has limited predictive value for treatment success. This study evaluates an epigenetic tool for assessing sperm quality, aiming to provide a more comprehensive view of male fertility and improve personalized treatment strategies.MethodsDe-identified pregnancy outcomes from 537 couples treated at 10 US fertility clinics were analyzed. Partner ages, total motile sperm count, treatment type, and sperm epigenetic quality were considered to assess associations with fertility treatment outcomes.ResultsMen with abnormal sperm epigenetic profiles had significantly lower pregnancy success rates with intrauterine insemination (IUI) compared to those with normal profiles, despite similar sperm motility and concentration. In contrast, pregnancy rates did not differ between abnormal and normal profiles among couples undergoing in vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI), suggesting that ICSI may overcome sperm epigenetic quality issues.ConclusionThis real-world analysis was limited by the availability of detailed clinical and phenotypic data, which may introduce potential confounders. Nevertheless, the findings highlight the clinical value of epigenetic sperm assessment as part of male fertility evaluation and support its potential to guide more effective, personalized fertility treatment pathways.
Successful embryo implantation requires complex interactions between the embryo and the endometrium. Improvements in embryo testing have led to increased success rates for embryo transfer following in vitro fertilization, however, even with euploid embryos under ideal conditions, failure occurs in more than 30% of cases. Methods for diagnosing and improving endometrial function are currently lacking. Here we developed a functional test ("Simbryo FX") for the ability of the endometrium to support embryo implantation. We collected endometrial biopsy samples from over 100 patients, and used these to grow endometrial organoids. We interacted these organoids with blastoids, pluripotent stem cell based models of the human blastocyst, and measured the hCG produced by the blastoids as well as the degree to which the blastoids invaded the organoids. We found that both of these measures correlated with clinical outcomes, and that combining them allowed us to predict the likelihood of failure in the next embryo transfer with high specificity. Thus, interacting patient-derived endometrial organoids with blastoids represents a promising approach to evaluating endometrial function among patients preparing for embryo transfer. ### Competing Interest Statement ET, MK, GMG, SN, YK, and AW hold equity in Simbryo Technologies ET, SN, and YK are employees of Simbryo Technologies. Other authors declare no competing interests. ### Funding Statement This study was funded by a sponsored research agreement between Simbryo Technologies and Rice University. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: WCG IRB (wcgclinical.com) gave ethical approval for this work I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors
To develop and validate a predictive model for live birth (LB) outcomes in single euploid frozen embryo transfers (seFET) based on patient’s characteristics and embryo parameters. A retrospective cohort study was performed including 1979 seFET performed between March 2017 and December 2023. Prediction models were built using logistic regression (LR), random forest classifier (RFC), support vector machines (SVM), and a gradient booster (XGBoost). Considered variables associated with LB outcomes were blastocyst expansion, blastocyst inner cell mass (ICM) and TE quality, day (D) of TE biopsy (D5, D6, and D7), female age and body mass index (BMI), distance from the uterine fundus at embryo transfer, endometrial preparation as natural cycles (NC) or hormonal replacement therapy (HRT), and endometrial thickness. Model performance was evaluated using area under the precision-recall curve and calibration metrics. Variables that were negatively associated with LB rate were BMI (OR = 0.79 [0.64–0.96], P = 0.020 for overweight and OR = 0.76 [0.60–0.95], P = 0.015 for obese class I/II), ICM grade B (OR = 0.72 [0.57–0.90], P = 0.005) or C (OR = 0.21 [0.15–0.30], P < 0.001), TE grade C (OR = 0.32 [0.24–0.43], P < 0.001), and blastocyst biopsied on D6 (OR = 0.66 [0.55–0.80], P < 0.001 or D7 (OR = 0.19[0.09–0.37], P < 0.001). The LR model was the best in terms of overall classification performance (C-statistics: 0.626 ± 0.018 vs. 0.606 ± 0.018, 0.581 ± 0.018, 0.601 ± 0.017, LR vs. RFC, XGBoost, and SVM, respectively, P < 0.001). A prediction model of LB outcome was developed and is free to access: https://artfertilityclinics.shinyapps.io/ABLE/ . LR demonstrated a stable validation performance and superior LB prediction, aiding as a predictive tool for patient counselling and assessing success in seFET cycles.
