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Research Question: What is the pregnancy and neonatal outcomes of an interpretable artificial intelligence (AI) model for embryo selection in a prospective clinical trial?, Design: This single-centre prospective cohort study was carried out from October 2021 to March 2022. A total of 330 eligible patients were assigned to their preferred groups, with 250 patients undergoing a fresh single-blastocyst transfer cycle after the exclusion criteria had been applied. For the AI-assisted group (AAG), embryologists selected the embryos for transfer based on the ranking recommendations provided by an interpretable AI system, while with the manual group, embryologists used the Gardner grading system to make their decisions., Results: The implantation rate was significantly higher in the AAG than the manual group (80.87% versus 68.15%, P = 0.022). No significant difference was found in terms of monozygotic twin rate, miscarriage rate, live birth rate and ectopic pregnancy rate between the groups. Furthermore, there was no significant difference in terms of neonatal outcomes, including gestational weeks, premature birth rate, birth height, birthweight, sex ratio at birth and newborn malformation rate. The consensus rate between the AI and retrospective analysis by the embryologists was significantly higher for good-quality embryos (i.e. grade 4BB or higher) versus poor-quality embryos (i.e. less than 4BB) (84.71% versus 25%, P < 0.001)., Conclusions: These prospective trial results suggest that the proposed AI system could effectively help embryologists to improve the implantation rate with single-blastocyst transfer compared with traditional manual evaluation methods., (Copyright © 2023 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Objective: Dose an elevated serum progesterone (P) level on the human chorionic gonadotropin (hCG) trigger day have a negative effect on clinical pregnancy outcomes for embryos transferred at different stages of development in long-acting gonadotropin-releasing hormone agonist (GnRHa) in vitro fertilization-embryo transfer (IVF-ET) cycles?, Study Design: This was a noninterventional, retrospective, observational, single-centre cohort study. A total of 1951 patients received long-acting GnRHa for pituitary downregulation in IVF-ET cycles at Nanjing Drum Tower Hospital from January 2018 to December 2020. The serum P levels on the day of hCG administration were measured, together with other cycle parameters, to explore the relationship between P levels and the clinical pregnancy rate (CPR) of different embryos transferred., Results: When the serum P level on the hCG day was higher than 1.5 ng/mL, the CPR did not decrease significantly. There was no correlation between the CPR of cleavage-stage embryo transfer and the serum P level on the hCG day. In addition, the interaction analysis suggested that the CPR of patients undergoing blastocyst transfer decreased as serum P levels on the hCG day increased. Progesterone levels on the day of hCG administration were closely related to the CPR of blastocyst transfer rather than cleavage-stage embryo transfer., Conclusion: An increased serum P level on the day of hCG administration did not affect the CPR of cleavage-stage embryo transfer, but it reduced the CPR of blastocyst transfer cycles., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: This study aimed to explore the relationship between serum oestrogen (E 2 ) levels before endometrial transformation and pregnancy outcomes of hormone replacement therapy-frozen embryo transfer (HRT-FET) cycles, which has been investigated for years without any consensus., Methods: A retrospective cohort study of 10,209 cycles HRT-FET cycles was conducted at the Reproductive Medicine Center of Nanjing Drum Tower Hospital from March 2017 to December 2020. A smooth fitting curve was constructed to identify the relationship between serum E 2 levels before endometrial transformation and the clinical pregnancy rate. Then, threshold and saturation effect analysis was employed to explore the cut-off value of serum E 2 levels. In addition, patients were divided into 2 groups based on their levels of serum E 2 measured before progesterone-induced endometrial transformation: Group 1, < 300 pg/mL (n = 6251) and Group 2, ≥ 300 pg/mL (n = 3958). The clinical pregnancy and miscarriage rates of all groups were compared. Further smooth fitting curve analysis was employed by different subgroups segmented according to different endometrial thicknesses., Results: When the serum E 2 level was greater than 300 pg/mL, the clinical pregnancy rate decreased significantly (62.9% vs. 59.8%, p < 0.01), but the miscarriage rates were similar (13.5% vs. 15.6%, p = 0.14). While serum E 2 level reached or exceeded 1400 pg/mL, there was no significant correlation between the clinical pregnancy rate and E 2 level. The clinical pregnancy rate reached its higher level at lower E 2 levels, regardless of the different endometrail thicknesses., Conclusions: Patients with a lower pretransformation serum E 2 level (less than 300 pg/mL) have a higher clinical pregnancy rate and there was no correlation between the clinical pregnancy rate and a higher serum E 2 level (greater than 1400 pg/mL) in HRT-FET cycles., (© 2022. The Author(s).)

Background: Previous studies suggested higher serum progesterone (P) levels were strongly associated with a lower clinical pregnancy rate (CPR) for in vitro fertilization-embryo transfer (IVF-ET). However, the effect of increased serum P levels on the day of human chorionic gonadotropin (hCG) administration on clinical outcomes in short-acting gonadotropin-releasing hormone agonist (GnRHa) downregulated IVF-ET cycles remains unclear.Methods: We conducted a retrospective cohort study from January 2017 to December 2021, which included a total of 1664 patients receiving their first short-acting GnRHa IVF-ET cycles at our reproductive medicine centre of Nanjing Drum Tower Hospital. The smooth curve fitting and interaction analysis were employed to analyse the association between the CPR and the serum P levels with different embryo types (cleavage-stage embryo or blastocyst). In addition, total cycles were grouped according to different P levels on the trigger day of hCG administration for further analysis.Results: The CPR of patients with increased serum P level (higher than 1.5 ng/mL) on the hCG day did not decrease. A smoothing curve fitting showed that the CPR did not change obviously with the increase in serum P levels. Subgroup analysis of different types of embryos transferred showed that no correlation was observed between the CPR and serum P levels on the day of hCG administration in cleavage-stage embryo transfer cycles. However, the CPR of patients receiving blastocyst transfer showed a downward trend with the increase in serum P levels. At the same time, an interaction analysis also confirmed that the CPR of blastocyst transfer was more likely to be affected by elevated serum P levels on the hCG day.Conclusion: In the luteal phase short-acting GnRHa downregulated IVF-ET cycles, the elevated serum P levels on the hCG day did not affect the CPR of cleavage-stage embryo transfer but reduced the CPR of blastocyst transfer. [ABSTRACT FROM AUTHOR]

Background: Infertility is one of the most important and underappreciated reproductive health problems in developing countries. Currently, in vitro fertilization and embryo transfer is the most effective treatment strategy for infertility. In a frozen-thawed cycle, single-blastocyst transfer can not only ensure relatively higher pregnancy and live birth rates but also effectively reduce the risk of maternal and neonatal complications. In frozen-thawed cycles, progesterone is initiated to promote the final phase of endometrial preparation prior to embryo transfer. However, the optimal duration of exposure to progesterone has remained inconclusive. Therefore, we designed a randomized controlled trial (RCT) to compare the effects of different prolonged progesterone transformation times (P+6 and P+7) on the pregnancy outcomes of D6 single blastocyst transfer in a frozen-thawed cycle. Methods: This is a single-center, prospective, randomized controlled clinical trial involving 900 patients with single blastocyst transfer in the frozen-thawed cycle, aged from 20 to 38 years, with less than three transfers, and with HRT-cycle single D6 blastocyst transfer in the current cycle. Participants will be randomly assigned (1:1) into two parallel groups: the transfer of day 6 blastocysts on the 7th day of progesterone supplementation and the transfer of day 6 blastocysts on the 6th day of progesterone supplementation. The primary outcome measure is the clinical pregnancy rate. Secondary outcome measures include the miscarriage rate and live birth rate. Discussion: This is the first randomized controlled trial to compare the transfer of day 6 blastocysts on the 6th and 7th day of progesterone supplementation. The results of this study will provide evidence for whether to prolong the duration of exposure to progesterone prior to embryo transfer. Trial registration: ClinicalTrials.gov, ID: NCT04938011. Registered on 19 June 2021. [ABSTRACT FROM AUTHOR]

Objective: To minimize twin birth rate by establishing an elective single cleavage embryo transfer strategy based on a twin live birth prediction model from fresh double cleavage embryos transfer (cleavage DET) patients.Methods: A total of 2478 patients underwent fresh cleavage DET in Nanjing Tower Hospital were enrolled to establish the twin live birth prediction model by logistic regression analysis and the cutoff value was calculated by ROC curve. Another 300 fresh cleavage DET patients and 550 cleavage single-embryo transfer (SET) patients were selected to testify the sensitivity, specificity and usefulness of this model.Results: The twin live birth probability (TLBP) = eX/(eX + 1), e is a natural logarithm, X = -1.763 - (0.319 × female age) + (0.329 × endometrial thickness) + (0.282 × the number of transferred top embryos) - (0.314 × previous transfer times), and the cutoff value of TLBP was 24.2%. The sensitivity of this model for predicting twin live birth was 75.6%, while the specificity was 52.5% in the external validation of 300 DET patients. Furthermore, the validation of 550 SET patients showed that the live birth rate of TLBP value positive patients was significantly higher than that in negative patients (54.3% vs. 35.5%, p < .001). When adopted an elective single cleavage embryo transfer strategy, the patients with a positive TLBP value choose SET, while still undergo DET who with a negative TLBP value, the live birth rate would maintain as 56.7%; however, the twin birth rate would significantly decline to 7.4%.Conclusion: Female age, endometrial thickness, the number of transferred top embryos and previous embryo transfer times were critical variables for the twin live birth prediction model. An elective single cleavage embryo transfer strategy according to this model can maintain the relatively high live birth rate, meanwhile get the acceptable low twin birth rate. [ABSTRACT FROM AUTHOR]

Problem: Intrauterine administration of autologous peripheral blood mononuclear cells (PBMCs) or human chorionic gonadotropin (hCG) has been proposed to facilitate embryo implantation, while its effect on clinical outcome of women with previous implantation failure (RIF) in frozen/thawed embryo transfer (FET) cycles is still unclear. Method of study: A total 523 patients having not experienced successful clinical pregnancy were enrolled in our study, including 207 repeat implantation failure (RIF) patients, and 316 patients with previous implantation failures but failed to meet the diagnostic criteria for RIF (non‐RIF). Autologous PBMCs were cultured with hCG for 4 h in the hCG‐activated PBMC‐treated group (n = 73 in RIF patients, n = 112 in non‐RIF patients), and then intrauterine administered 2 days before FET. In the hCG‐treated group (n = 67 in RIF patients, n = 100 in non‐RIF patients), recombinant hCG was administered 2 days before FET. The control group (n = 67 in RIF patients, n = 104 in non‐RIF patients) underwent FET without intrauterine administration. Results: In RIF patients, the clinical pregnancy rate of the above three groups are 56.16%, 53.73%, and 43.28%, respectively (p =.276). The implantation rate and live birth rate showed no significant differences (p >.05). For non‐RIF patients, higher clinical pregnancy rate was also seen in PBMC intrauterine group (57.15%) and hCG intrauterine group (58.00%) than controls (50.96%) but without statistical significance. There were no significant differences of implantation rate and live birth rate (p >.05). Conclusion: Intrauterine administration of hCG‐activated PBMC and hCG did not improve clinical outcomes for both RIF and non‐RIF patients before FET embryo transfer. [ABSTRACT FROM AUTHOR]

Background: Gestational trophoblastic disease (GTD) usually affects young women of childbearing age. After treatment for GTD, 86% of women wish to achieve pregnancy. On account of the impacts of GTD and treatments as well as patient anxiety, large numbers of couples turn to assisted reproductive technology (ART), especially in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI). But few studies have investigated whether a history of GTD affects the outcomes of IVF/ICSI in secondary infertile patients and how it occurs. We investigate whether a history of GTD affects the IVF/ICSI outcomes and the live birth rates in women with secondary infertility. Methods: This retrospective cohort study enrolled 176 women with secondary infertility who underwent IVF/ICSI treatment at the reproductive medical center of Nanjing Drum Tower Hospital from January 1, 2016, to December 31, 2020. Participants were divided into the GTD group (44 women with GTD history) and control group (132 women without GTD history matched from 8318 secondary infertile women). The control group and the study group were matched at a ratio of 3:1 according to patient age, infertility duration, number of cycles and body mass index (BMI). We assessed retrieved oocytes and high-grade embryos, biochemical pregnancy, miscarriage, ectopic pregnancy, gestational age at delivery, delivery mode and live birth rates. Result(s): We found a significantly reduced live-birth rate (34.1% vs 66.7%) associated with IVF/ICSI cycles in patients with a GTD history compared to those without a GTD history. The biochemical pregnancy and miscarriage rates of the GTD group were slightly higher than those of the control group. In addition, there was a difference in gestational age at delivery between the GTD and control groups (p < 0.001) but no differences in the mode of delivery (p = 0.267). Furthermore, the number of abandoned embryos in the GTD group was greater than that in the control group (p = 0.018), and the number of good-quality embryos was less than that in the control group (p = 0.019). The endometrial thickness was thinner (p < 0.001) in the GTD group. Immunohistochemistry (IHC) showed abnormal endometrial receptivity in the GTD group. Conclusion(s): The GTD history of patients undergoing IVF/ICSI cycles had an impact on the live-birth rate and gestational age at delivery, which might result from the thinner endometrium and abnormal endometrial receptivity before embryo transfer. [ABSTRACT FROM AUTHOR]

Can a non-invasive embryo transfer strategy provide a reference for embryo selection to be established? Chromosome sequencing of 345 paired blastocyst culture medium and whole blastocyst samples was carried out and a non-invasive embryo grading system was developed based on the random forest machine learning algorithm to predict blastocyst ploidy. The system was validated in 266 patients, and a blinded prospective observational study was conducted to investigate clinical outcomes between machine learning-guided and traditional non-invasive preimplantation genetic testing for aneuploidy (niPGT-A) analyses. Embryos were graded as A, B or C according to their euploidy probability levels predicted by non-invasive chromosomal screening (NICS). Higher live birth rate was observed in A- versus C-grade embryos (50.4% versus 27.1%, P = 0.006) and B- versus C-grade embryos (45.3% versus 27.1%, P = 0.022) and lower miscarriage rate in A- versus C-grade embryos (15.9% versus 33.3%, P = 0.026) and B- versus C-grade embryos (14.3% versus 33.3%, P = 0.021). The embryo utilization rate was significantly higher through the machine learning strategy than the conventional dichotomic judgment of euploidy or aneuploidy in the niPGT-A analysis (78.8% versus 57.9%, P < 0.001). Better outcomes were observed in A- and B-grade embryos versus C-grade embryos and higher embryo utilization rates through the machine learning strategy compared with traditional niPGT-A analysis. A machine learning guided embryo grading system can be used to optimize embryo selection and avoid wastage of potential embryos. [ABSTRACT FROM AUTHOR]