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Reflecting the current trends, the utilization of frozen-thawed transfer cycles has been steadily increasing worldwide; outcome predictors of these cycles are therefore a major research goal. Our aim was to investigate whether the outcome of a fresh single blastocyst transfer (SBT) can serve as a prognostic factor for the subsequent vitrified–warmed SBT originating from the same cohort. A retrospective cohort study was performed at a single unit. Non-donor fresh cycles were analyzed as predictors of the following vitrified–warmed cycle. Only SBTs were included. Cycles designated to a freeze-all policy and cycles involving pre-implantation genetic analysis were excluded. A total of 1127 vitrified–warmed single blastocyst cycles were included. The indications for artificial reproductive technologies were comparable across the study groups. Vitrified–warmed cycles following a live birth outcome in the fresh cycle were more likely to result in a clinical pregnancy than those following a fresh cycle, which failed to reach a live birth. The same trend was observed for live birth rate following vitrified–warmed transfer in the fresh cycle. After correcting for possible confounders, age and embryo quality were significantly correlated with the chance for a live birth, but the previous fresh cycle did not affect the results. We therefore conclude that after adjustment for age, embryo quality and number of previous oocyte retrieval cycles, the fresh cycle outcome was not a significant influential factor for the following vitrified–warmed cycle. [ABSTRACT FROM AUTHOR]

Purpose: To assess the effects PCOS on live birth rates when transferring a single fresh ideal blastocyst. Methods: A retrospective cohort study performed at the university-affiliated reproductive center. Women with PCOS and a control group of normal ovulatory women who underwent their first fresh embryo transfer with single ideal grade blastocyst were included in the study. Demographic, stimulation information and pregnancy outcomes were collected and analysed. The primary outcome was live birth rates, and secondary outcomes included pregnancy and clinical pregnancy rates. Results: 71 Women with PCOS and 272 normal ovulatory controls underwent their first embryo transfer and met the inclusion and exclusion criteria. PCOS patient were younger (31.0 ± 3.7 vs. 33.1 ± 3.2, p = 0.0001), with higher AFC (40.0 ± 9.3 vs. 13.3 ± 4.6, p = 0.0001), required lower dose of gonadotropins to stimulate (1198 ± 786 vs. 1891 ± 1224, p = 0.0001), and had higher serum testosterone levels (2.3 ± 0.7 vs. 1.1 ± 0.3, p = 0.0001). No significant difference was found between the two groups regarding the number of previous pregnancies, the number of previous full-term pregnancies, the level of basal serum FSH, estradiol level at triggering and the BMI. When compared by Chi squared testing pregnancy rates, clinical pregnancy rates and live birth rates did not differ. However, when controlling (with multivariate stepwise logistic regression) for confounders, live birth rates were lower among the women with PCOS (p = 0.035, CI: 0.18−0.92). Conclusion: After controlling for confounders, when transferring a fresh single ideal blastocyst, live birth rates were lower among the women with PCOS than normal ovulatory controls. [ABSTRACT FROM AUTHOR]

Abstract Research question Does the addition of an aromatase inhibitor improve IVF outcomes in women with endometriomas when pretreating them with gonadotrophin-releasing hormone agonists? Design Retrospective two-centre cohort study involving 126 women aged 21–39 years who failed a previous IVF cycle and all subsequent embryo transfers and had sonographic evidence of endometriomas. Women were non-randomly assigned to either 3.75 mg intramuscular depo-leuprolide treatment alone or in combination with 5 mg of oral letrozole daily for 60 days prior to undergoing a fresh IVF cycle. Main outcome measures included clinical pregnancy rate and ongoing pregnancy rate after 24 weeks' gestation. Results Prior to treatment, antral follicle count (AFC), basal serum FSH and endometrioma diameter did not differ between groups. After treatment, AFC differed between letrozole and non-letrozole-treated groups (10.3 ± 2.0 versus 6.4 ± 2.5; P = 0.0001), as did mean endometrioma maximum diameter (1.8 ± 0.4 cm versus 3.2 ± 0.8 cm; P = 0.0001). At IVF, the gonadotrophin dose used was significantly lower in letrozole-treated subjects (2079 ± 1119 versus 3716 ± 1314; P = 0.0001), the number of mature oocytes collected was greater (9.1 ± 2.4 versus 4.0 ± 1.7; P = 0.0001), as were the number of two-pronuclear embryos and number of blastocysts. The clinical pregnancy rate was significantly higher in the letrozole-treated group (50% versus 22%, P = 0.003), as was the live birth rate (40% versus 17%, P = 0.008). Conclusions The combination of depo-leuprolide acetate monthly for 60 days combined with daily letrozole has better clinical outcomes at IVF in women with endometriomas than depo-leuprolide acetate treatment alone. [ABSTRACT FROM AUTHOR]

Study Question: In IVF cycles in which the entire embryo cohort is slow growing, is it optimal to perform fresh transfer in Day 5 or to extend the culture and transfer in subsequent vitrified-warmed cycles?Summary Answer: The outcomes depend on the degree of embryo development on Day 5.What Is Known Already: Slow-growing blastocysts have lower implantation potential when transferred in fresh cycles. It has been suggested that embryo-endometrial asynchrony could explain this finding. However, studies that compared Days 5 and 6 embryos in frozen embryo transfer (FET) cycles showed contradictory results. There is still a lack of evidence regarding the best approach, performing fresh transfer or deferring transfer and continuing culture until fully developed blastocysts are achieved, when the entire cohort of embryos is slow growing.Study Design Size, Duration: This was a retrospective study that included 477 women aged <40 years who underwent fresh Day 5 single embryo transfer of slow-growing embryos and subsequent FET cycles of fully expanded blastocysts (FEB) originating from the same IVF cycle between 2012 and 2016.Participants/materials, Setting, Methods: The study included cycles in which the embryos either began blastulation by Day 5 of culture but did not reach the fully expanded stage (Gardner Stage III) or had delayed blastulation with only morula embryos present by Day 5 of culture. All of the subjects in the study underwent elective, single embryo transfer (slow or delayed blastocysts) on Day 5 and had at least one embryo that developed into a FEB on extended culture Day 6 that was suitable for vitrification. All subjects, regardless of the outcome of the fresh transfer, returned for at least one subsequent FET cycle of Day 6 embryos.Main Results and Role Of Chance: A total of 1070 embryo transfer cycles (fresh + FET) were included. Of them, 365 women had elective, fresh, single transfer of slow-growing blastocysts (Group I) and 112 had elective, fresh, single morula transfer (Group II). Groups I and II underwent a subsequent 457 and 136 FET cycles, respectively. The mean age of Group I was 33.8 ± 2.9 years, the proportion of Day 5 embryos that developed to FEB by Day 6 was 92%, and the number of blastocysts vitrified was 627 (average of 1.71 blastocysts per cycle). The outcomes of fresh and FET cycles were comparable regarding clinical pregnancy rate (CPR) (31.0 vs. 30.4%, P = 0.86) and live birth rate (LBR) (23.3 vs. 20.3%, P = 0.15). In Group II, the mean age was 35.8 ± 3.4 years and the proportion of morula embryos that developed to FEB by Day 6 was 72%. The number of blastocysts vitrified on Day 6 was 155 (1.38 per cycle). The transfer of fresh embryos in Group II resulted in significantly lower clinical pregnancy (5.3 vs. 30.1%, P < 0.001) and LBRs (1.8 vs. 20.5%, P < 0.001). The results did not change after controlling for possible confounding factors.Limitations and Reasons For Caution: The retrospective design of the study is a major limitation. Although we compared the outcomes of embryos that originated from the same cohort, the FET cycles could have been overrepresented by older patients and those with poorer prognoses. Furthermore, the study included only cycles in which there were blastocysts available for cryopreservation on Day 6; therefore, the results were not be applicable for those who had mandatory Day 5 transfer with no embryos available for vitrification.Wider Implications Of the Findings: Fresh transfer of embryos that begin blastulation on Day 5 results in similar outcomes to the transfer of FEB originating from the same cohort. However, in cases where only morula/compacting embryos are available by Day 5, extending culture until FEB are achieved and then performing subsequent FET will result in significantly higher LBRs.Study Funding/competing Interest(s): No external funding was used for this study. The authors have no conflicts of interest.Trial Registration Number: N/A. [ABSTRACT FROM AUTHOR]

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Although the classification and management of ovarian hyperstimulation syndrome (OHSS) are well described in the literature, little attention has been given to modalities that aim to prevent its occurrence. In this retrospective study, we sought to investigate whether a combination of modalities in addition to GnRH agonist triggering in GnRH antagonist cycles could result in better prevention of OHSS. The study included 170 hyperresponder patients who were stimulated with GnRH antagonist protocol and were triggered with GnRH agonist for final oocyte maturation. Freeze all embryos was performed in all patients. The intervention group included treatment with dopamine agonist and restarting the GnRH antagonist. Of the 170 patients included, 63 were included in the intervention group. Compared to no intervention, women in the intervention group were more likely to have: menses within 7 days of the oocyte retrieval, smaller ovarian diameter, the absence of free pelvic fluid, less hemoconcentration and higher serum sodium levels. It can be concluded that combining other modalities in addition to triggering with GnRH agonist in GnRH antagonist cycles, results in targeting several pathways that lead to OHSS and result in rapid resolution of signs of ovarian hyperstimulation. [ABSTRACT FROM AUTHOR]

Objective: In vitro maturation (IVM) of human oocytes can be an alternative treatment option to conventional in vitro fertilization. Women with polycystic ovary syndrome (PCOS) are considered the classical candidates for IVM because of the associated ovarian morphology and because IVM diminishes the risk of developing ovarian hyperstimulation syndrome. The objective of this study was to identify predictive factors for live birth in a cohort of women with PCOS who underwent IVM.Methods: This retrospective study included 159 patients with PCOS who had IVM cycles in which single or double embryo transfer was performed. The IVM protocol included three days of gonadotropin ovarian stimulation and hCG priming when the leading follicle size was 10-12 mm. Collected cumulus-oocyte complexes were cultured for 24 h for maturation. Intracytoplasmic sperm injection (ICSI) was used for fertilization. Embryo transfer was performed two days after fertilization. Demographic and clinical parameters were analyzed with logistic regression to identify predictors for live birth.Results: The women's mean age was 27.4 years, the mean number of retrieved oocytes was 14, and the live birth rate was 34.6%. The logistic regression revealed the following significant factors for live birth: infertility duration (OR 0.9; 95% CI, 0.82-0.98), number of collected oocytes (OR 1.56; 95% CI, 1.01-3.2), embryo cell number (OR 2.1; 95% CI, 1.4-3.5), and embryo grade (OR 1.84; 95% CI, 1.13-4.2).Conclusion: Infertility duration, oocyte number, embryo cell number, and embryo grade were the most significant predictors for live birth after IVM in PCOS patients. These prognostic factors can be used when planning treatment or counselling patients. [ABSTRACT FROM AUTHOR]

The use of GnRH agonist to trigger final oocyte maturation in GnRH-antagonistin vitrofertilization (IVF) cycles has been shown to significantly reduce or even eliminate the risk of ovarian hyperstimulation syndrome (OHSS) by inducing rapid luteolysis early in the luteal phase. The exact mechanism of this early luteolysis is still widely unknown. Since luteinizing hormone (LH) has a major role in corpus luteum support, we sought to explore the pattern of LH secretion early in the luteal phase. Ten high risk patients for developing OHSS and triggered with GnRH agonist were included. Frequent blood sampling (every 20 min for 6 h) to measure LH, estradiol and progesterone was done on the day of oocyte collection (n = 5, Group 1) and on the day of embryo transfer, 48 h after oocyte collection (n = 5, Group 2). We found that the mean LH concentration and its secretion rate decreased significantly in Group 2 compared to Group 1. Both groups had similar number of LH pulses characterized by very small amplitude. In Group 2, there was a steady significant decrease in estradiol and progesterone over time. The results of this study show that LH secretion deviates significantly from normal physiologic pattern, which can explain, at least in part, the post-GnRH-agonist trigger early luteolysis mechanism. [ABSTRACT FROM PUBLISHER]

Objective: To investigate the reproductive outcomes after the use of GnRH agonist (GnRHa) compared with hCG for the induction of final oocyte maturation in GnRH antagonist cycles performed in hyper-responder women aged 35-40 years.Design: Retrospective study.Setting: Academic fertility center.Patient(s): Two hundred seventy-two hyper-responder women aged 35-40 years who underwent controlled ovarian stimulation under GnRH antagonist suppression were included. Final oocyte maturation was performed with GnRHa (n = 168) or hCG (n = 104). Embryos were cryopreserved at the blastocyst stage and transferred in subsequent warming cycles (n = 542). Subjects were included in the analysis until live birth was achieved, after which they were excluded from further analysis.Intervention(s): None.Main Outcome Measure(s): Cumulative live birth rate.Result(s): Subjects in the GnRHa group achieved a higher number of oocytes (22 vs. 21) and a higher number of mature oocytes (16 vs. 14). The number of cryopreserved blastocysts (median of five blastocysts in both groups) was similar. Women in the hCG group needed a lower number of warming cycles to achieve live birth (1.32 vs. 2.12), had higher embryo implantation rates (48% vs. 39%), and the proportion of embryos transferred until live birth was lower (33% vs. 57%). The cumulative live birth rate was similar between the groups (48.15% vs. 48%).Conclusion(s): Although the cumulative live birth rate is similar, a single dose of GnRHa possibly results in suboptimal oocyte and embryo competence, as manifested by decreased embryo implantation rates and increased time needed to achieve live birth. [ABSTRACT FROM AUTHOR]

Objective: To compare the influence of dual suppression with the use of GnRH agonist plus aromatase inhibitor compared with suppression with the use of GnRH agonist alone or no suppression at all in patients with idiopathic recurrent implantation failure (RIF).Design: Retrospective cohort study.Setting: University-affiliated reproductive center.Patient(s): A total of 523 infertile women who failed two blastocyst transfers underwent a third frozen blastocyst transfer. Women with known endometriosis were excluded.Intervention(s): A total of 204 subjects were not pretreated, 143 received 2 months of GnRH agonist (3.75 mg intramuscular leuprolide acetate monthly) only, and 176 received GnRH agonist and aromatase inhibitor (5 mg oral letrozole daily for 60 days). Demographic and stimulation information was collected and cycle outcomes reported.Main Outcome Measure(s): Clinical pregnancy rates.Result(s): Age, antral follicle count, basal FSH levels, duration of infertility, previous pregnancies, and full-term deliveries were similar (P>.05). Clinical pregnancy rates were higher among women who received GnRH agonist plus letrozole compared with women who received GnRH agonist only or women without pretreatment (63%, 42%, and 40%, respectively; P<.0001). Live birth rates were higher among women who received GnRH agonist plus letrozole compared with the other groups (56%, 36%, and 34%; P<.0001). No differences in pregnancy outcomes were noted between patients who did not receive pretreatment and those in the GnRH agonist only group.Conclusion(s): In patients with RIF, treatment with a GnRH agonist plus letrozole may improve live birth rates in subsequent cycles. We hypothesize that this improvement is due to alterations in the endometrium receptivity or treatment of undiagnosed endometriosis. [ABSTRACT FROM AUTHOR]

Do uterine size parameters measured by baseline transvaginal ultrasound predict live birth after single embryo transfer (SET) of a high-quality blastocyst? Retrospective cohort study including women undergoing their first SET between August 2010 and March 2014 at a large university hospital reproductive centre. The effects of baseline uterine dimensions on live birth rate (LBR) were analysed while controlling for confounding effects. A total of 437 nulliparous and 70 parous women were included. The nulliparous group had lower body mass index (BMI) (24.4 ± 5.1 versus 25.9 ± 4.5 kg/m2; P = 0.015) and a higher number of fibroids (0.4 ± 1.0 versus 0.2 ± 0.5; P = 0.005) than the parous group. While controlling for confounding effects, none of the uterine parameters appeared to be a significant predictor of LBR among nulliparous and parous women (P > 0.05 in all cases). A subsequent analysis of endometrial length was done, whereby the endometrial lengths were divided into quartiles (20.0–32.2 mm; 32.3–36.5 mm; 36.6–40.0 mm; 40.1–54.0 mm). After controlling for confounders, the shortest quartile in the nulliparous group had a significantly lower LBR (P = 0.02) than the other groups. Receiver operating characteristic curves suggested that endometrial cavity length and cervical length did not aid clinically. Uterine parameters do not have a clinically useful impact on LBR after SET of a blastocyst in infertile women. The use of baseline endometrial length to predict live birth is no better than chance, while cervical length only predicts failure to live birth. [ABSTRACT FROM AUTHOR]

Does the addition of a gonadotrophin-releasing hormone (GnRH) antagonist to cabergoline treatment during the luteal phase in fresh IVF cycles triggered with a GnRH agonist, and planned for freeze-all, reduce the rate of mild and moderate ovarian hyperstimulation syndrome (OHSS)? Retrospective cohort study of 480 IVF patients at risk for OHSS with GnRH agonist trigger from 2011 to 2018, stratified into three groups based on treatment received: GnRH agonist trigger alone (Group 1, n = 208), GnRH agonist trigger + cabergoline (Group 2, n = 167) or GnRH agonist trigger + cabergoline + GnRH antagonist (Group 3, n = 105). Data on patient demographics, incidence, severity and symptomatology of OHSS and laboratory findings were collected. Group 1 had more free peritoneal fluid than Group 2 (28% versus 19%, P = 0.04) or Group 3 (28% versus 5%, P = 0.001). Group 1 reported abdominal discomfort and bloating more than Group 2 (33% versus 21%, P = 0.01) or Group 3 (33% versus 18%, P = 0.006). Group 1 had more electrolyte abnormalities than Group 2, who had more than Group 3. No patients developed severe OHSS. Mild and moderate OHSS rate was higher in Group 1 (38%) than Group 2 (29%, P = 0.048) or Group 3 (18%, P = 0.006) and in Group 2 than Group 3 (P = 0.046). Addition of cabergoline to GnRH agonist triggering in high-risk OHSS patients, and subsequent addition of GnRH antagonist for 5 days in the luteal phase, sequentially reduces the risk of mild and moderate OHSS and improves patient comfort compared with GnRH agonist trigger alone. [ABSTRACT FROM AUTHOR]

Objectives: The limited data regarding obstetrical outcomes in multiple pregnancies following both fresh embryo transfer and frozen-thawed embryo transfer (FET), along with the association between multiple pregnancies and increased pregnancy complications compared to singleton pregnancies, highlight the need for research on this topic. Therefore, this study aimed to compare obstetrical and neonatal outcomes of twin pregnancies after fresh embryo transfer versus FET., Design: This was a retrospective single-center study., Participants: There were in vitro fertilization (IVF) dichorionic twin pregnancies ≥23 weeks of gestation during 2010-2022., Setting: This retrospective study was based on data recorded at Galilee Medical Center, a tertiary-care university-affiliated hospital, Israel., Methods: We conducted a comparative analysis of obstetrical and neonatal outcomes between IVF dichorionic twin pregnancies after fresh embryo transfer and those after FET. This analysis included variables such as gestational age at delivery, birthweight, preterm birth rates, low birthweight rates, neonatal intensive care unit admissions, and complications related to prematurity., Results: The study included 389 IVF twin pregnancies: 253 after fresh embryo transfer and 136 after FET. Following fresh embryo transfer compared to FET, the mean gestational age at delivery was earlier (34 + 6 vs. 35 + 5 weeks, p = 0.001) and the rate of preterm birth (&lt;37 weeks) was higher (70.4% vs. 53.7%, p = 0.001). This difference in gestational age at delivery remained significant after adjustment for maternal age, parity, and BMI (OR = 2.11, 95% CI: 2.11-3.27, p = 0.001). Similarly, the difference in preterm birth rates remained significant after adjustment of the same variables (p = 0.001). For the fresh embryo transfer compared to the FET group, the mean birthweight was lower (2,179.72 vs. 2,353.35 g, p = 0.003); and low birthweight and very low birthweight rates were higher (71.2% vs. 56.3%, p &lt; 0.001 and 13.5% vs. 6.7%, p = 0.004, respectively). For the fresh embryo transfer compared to the FET group, the proportions were higher of neonates admitted to the neonatal intensive care unit (23.3% vs. 16.0%, p = 0.019), of neonates with respiratory distress syndrome (10.5% vs. 5.9%, p = 0.045) and those needing phototherapy (23.3% vs. 16.0%, p = 0.019)., Limitations: Limitations of the study include its retrospective nature. Furthermore, we were unable to adjust for some confounders, such as the number of eggs retrieved, the number of embryos transferred, and methods for ovarian stimulation or preparation of the endometrium for embryo transfer., Conclusions: Obstetrical and neonatal outcomes of twin pregnancies were worse after fresh embryo transfer than after FET. The findings support favorable fetal outcomes after FET and support the current trend of shifting from fresh embryo transfer to FET. Prospective studies are needed to support our results., (© 2024 The Author(s). Published by S. Karger AG, Basel.)

Objective: To evaluate the endometrial histopathological profile of patients undergoing curettage and the association of the histopathological profile with the pregnancy outcome during the subsequent in-vitro fertilization (IVF) cycle., Methods: In this retrospective cohort study, a total of 248 women with at least one failed attempt of IVF and who underwent curettage and a subsequent IVF were included. Demographic data, endometrial histopathological records, stimulation information, and pregnancy outcomes were collected and analyzed., Results: The histopathological analysis of endometrial tissues showed that 130 women (52.4%) had endometrial pathologies. Of these women, 103 (41.5%) had endometrial polyps, 22 (8.9%) had chronic endometritis, and five (2.0%) had both polyps and endometritis. No statistical difference was observed between the normal histopathology group and the abnormal histopathology group in the outcome of the subsequent IVF cycle. Subgroup analyses were performed to further characterize and compare women with normal histopathology and women with endometrial polyps (polyp subgroup) or chronic endometritis (endometritis subgroup). No statistical differences were found among the three groups in the rates of pregnancy (44.1% vs. 49.5% vs. 45.5%, P=0.72), biochemical pregnancy loss (13.5% vs. 15.7% vs. 20.0%, P=0.86), clinical pregnancy loss (25.0% vs. 31.4% vs. 30.0%, P=0.77), and live birth (27.1% vs. 26.2% vs. 22.7%, P=0.91) during the subsequent IVF cycle., Conclusion: Women with previously failed IVF and abnormal endometrial histopathology treated with curettage had the same outcome in the subsequent IVF cycle as women with normal endometrial histopathology.

Objective: To determine whether 2 months of pretreatment with 5 mg of letrozole daily plus leuprolide acetate at 3.75 mg monthly in women with laparoscopically confirmed American Society of Reproductive Medicine stage I-II endometriosis improves in vitro fertilization (IVF) outcomes., Design: Prospective cohort study., Setting: University-affiliated tertiary hospital., Patient(s): Women with laparoscopically confirmed endometriosis treated in the period from 2012 to 2016., Intervention(s): None., Main Outcome Measure(s): Primary outcomes: clinical pregnancy and live-birth rate; secondary outcomes: stimulation parameters and pregnancy., Result(s): A total of 68 patients were included in the final analysis. Thirty-six women received a gonadotropin-releasing hormone (GnRH) agonist and an aromatase inhibitor (AI), and 32 women received a GnRH agonist alone. The women did not differ in mean age, antral follicle count, basal serum level of follicle-stimulating hormone, or previous pregnancies. The stimulation parameters were similar between both groups: gonadotropin dose, number of collected oocytes, number of blastocysts. All women underwent a single blastocyst transfer. The grade of embryos transferred did not differ. Clinical pregnancy (24 [66.7%] vs. 13 [40.6%]) and live-birth (22 [61.1%] vs 10 [31.3%]) rates improved with aromatase inhibitor added to the GnRH agonist treatment versus a GnRH agonist alone., Conclusion(s): In this study, we present the first comparison in the medical literature comparing IVF outcomes in women with minimal and mild endometriosis pretreated with a GnRH agonist with or without an AI. This prospective cohort study suggests that combining these two treatment modalities which work at different sites may improve pregnancy outcomes with IVF treatment., (Copyright © 2020 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Introduction: Endometrial cancer is the most common gynecologic malignancy. Most women present with abnormal vaginal bleeding. Cervical stenosis can prevent early uterine bleeding leading to delayed diagnosis of the disease., Case Presentation: A 67 years old Caucasian woman presented with three days history of right flank pain and difficulty in urination. Her medical history included cervical cautery due to ectropion 15 years previously. In physical exam a huge cystic mass that proved to be a large hematocervix was bulging in the vagina. Computed tomography of the abdomen revealed a distended cervix adjacent to distended urinary bladder secondary to endometrial cancer., Conclusion: To our knowledge this is the first case report describing acute urinary retention secondary to hematocervix. Cervical stenosis is common in elderly postmenopausal women and can prevent early manifestation of endometrial pathology and can be associated with local complications.