The effect of ICSI-related procedural timings and operators on the outcome

2020 ◽  
Vol 35 (1) ◽  
pp. 32-43 ◽  
Author(s):  
Roberta Maggiulli ◽  
Danilo Cimadomo ◽  
Gemma Fabozzi ◽  
Letizia Papini ◽  
Lisa Dovere ◽  
...  

Abstract STUDY QUESTION Do the ICSI-related procedural timings and operators affect the outcomes of an ART cycle? SUMMARY ANSWER The ICSI-related timings and operators do not associate with the mean blastulation rate per cohort of inseminated oocytes and the cumulative delivery rate per concluded cycle, except for a mild association between the times from induction of ovulation to oocyte denudation and the former outcome. WHAT IS KNOWN ALREADY In ART, specific timings, protocols and conditions must be complied with to preserve gamete developmental and reproductive competence during the required manipulations. ICSI represents a groundbreaking advancement that has been widely implemented. Nevertheless, the studies that examined the putative impact of ICSI-related procedural timings were mainly conducted in old-fashioned settings or in good prognosis patients. No report addressed issues like operators’ skills and experience and uncertainties exist dealing with the effect of cumulus cells in the pre-incubation period in vitro before ICSI. However, all this information is crucial to efficiently plan the daily routine of an IVF lab, fill the existing gaps of knowledge and define proper key performance indicators. STUDY DESIGN, SIZE, DURATION Observational study conducted at a private IVF clinic (January 2016 to January 2018). We included all consecutive ICSI procedures (n = 1084 infertile couples undergoing 1444 cycles with or without preimplantation genetic testing (PGT); mean ± SD maternal age: 38.1 ± 4.0 years) with fresh autologous oocytes (n = 7999 oocytes, 5.5 ± 3.2 per treatment) inseminated with fresh non-donor ejaculated sperm. All operators and critical procedural timings (induction of ovulation to oocyte denudation, denudation and ICSI) were automatically recorded through an electronic witnessing system. The primary outcome measure was the cumulative delivery rate among both non-PGT and PGT-concluded cycles (i.e. delivery achieved or no supernumerary cryopreserved blastocyst available). The secondary outcome measure was the mean blastulation rate per cohort of inseminated oocytes. All confounders were registered and included in generalized linear models and multivariate logistic regression analyses. PARTICIPANTS/MATERIALS, SETTING, METHODS Fourteen and 12 operators were involved in denudation and ICSI procedures, respectively. Denudation was performed after 4.1 ± 1.2 h (2–7) of pre-incubation in vitro after oocyte retrieval, and ICSI was started immediately after. Beyond procedural timings and operators, all the putative confounders (patients’ and cycles’ characteristics) on the primary and/or secondary outcomes were systematically registered and included in the statistical analyses. MAIN RESULTS AND THE ROLE OF CHANCE The mean time from induction of ovulation to oocyte denudation was 39.3 ± 1.3 h. The mean procedural timings for denudation and ICSI were 8.1 ± 3.8 and 12.6 ± 6.4 min; both these variables were significantly dependent on the number of inseminated oocytes and the operators’ skills and experience. The overall mean blastulation rate per cohort of inseminated oocytes was 34.0 ± 27.9%. This outcome was significantly associated with the time from induction of ovulation to oocyte denudation (mean blastulation rate stable in the time interval 38–42 h, but significantly higher for timings <38 h), maternal age (the mean blastulation rate drops especially beyond the age of 40 years) and categorized sperm concentration (highest mean blastulation rate for sperm concentrations ≥15 mil/ml and lowest for cryptozoospermic patients) through a generalized linear model that showed an adjusted r2 = 0.053 (P < 0.01). No association was found for denudation and ICSI timings and operators. Lastly, when adjusted for maternal age and number of inseminated oocytes, both ICSI-related procedural timings and operators did not associate with the cumulative delivery rate among both non-PGT- or PGT-concluded cycles. LIMITATIONS, REASONS FOR CAUTION This is a single private IVF center study. Its reproducibility should be assessed in different laboratory conditions, with different protocols and in the hands of different operators. Moreover, specific studies are warranted to address the beneficial/detrimental effect of the other putative confounders under investigation (e.g. kind of ovulation trigger, culture media, incubator, etc.). WIDER IMPLICATIONS OF THE FINDINGS Proactive communication between the embryologists and the clinicians might contribute to a reasoned and more efficient organization of the daily workload and increase the mean blastulation rate, especially when poor prognosis couples (advanced maternal age, reduced sperm count and/or ovarian reserve) are treated. STUDY FUNDING/COMPETING INTEREST(S) No funding. The authors declare no conflict of interest related to the present study.

2016 ◽  
Vol 44 (7) ◽  
Author(s):  
Edwin Eseoghene Omih ◽  
Stephen Lindow

AbstractAim:Pregnancy in women of advancing maternal age is linked to incrementally worsening perinatal outcome. The aim of this study is to assess the impact of maternal age on delivery outcome in women that spontaneously labour at term.Methods:This was a retrospective study of women that spontaneously labour at term. Women with singletons in spontaneous onset labour beyond 37 weeks of gestation were divided into five maternal age groups: <19 years, 20–24 years, 25–29 years, 30–34 years and >35 years by their age at delivery. The main outcome variables are augmentation of labour, caesarean section, assisted vaginal delivery, and perineal trauma, while admission of the newborn into the neonatal unit within 24 h following delivery was the secondary outcome measure.Results:A total of 30,022 met the inclusion criteria with primiparae and multiparae accounting for 46 and 54%, respectively. Increasing age in primiparae was associated with; augmentation of labour OR 2.05 (95% CI 1.73–2.43), second degree perineal tear 1.35 (1.12–1.61), assisted vaginal delivery 1.92 (1.53–2.41) and caesarean section 4.23 (3.19–5.12). While that for multiparae; augmentation of labour OR 1.93 (1.05–3.52), perineal trauma 2.50 (1.85–3.34), assisted vaginal delivery 4.95 (91.82–13.35) and caesarean section 1.64 (1.13–2.38). The secondary outcome measure did not reach statistical significance.Conclusion:Increasing maternal age is an independent risk factor for operative delivery, and perineal trauma. However, maternal age has no significant effect on admission of infants into the NICU during the first 24 h following delivery.


2019 ◽  
Vol 9 (8) ◽  
pp. 802-806 ◽  
Author(s):  
Arvind G. Kulkarni ◽  
Sandeep Tapashetti ◽  
Viraj S. Tambwekar

Study Design: Technical note. Objectives: Coccygectomy for chronic coccydynia has a high rate of successful clinical outcome. However, the procedure is associated with increased incidence of wound dehiscence and surgical site infection. The main objective was to evaluate the clinical outcomes of coccygectomy using the Z plasty technique of wound closure. Methods: Patients with chronic coccydynia refractory to conservative treatment underwent coccygectomy followed by Z plasty technique of wound closure between January 2013 and February 2018. Primary outcome measure was evaluation of the wound healing in the postoperative period and at follow-up; secondary outcome measure included visual analogue scale (VAS) score for coccygeal pain. Results: Ten patients (male:female 6:4) fulfilled the inclusion criteria. The mean age of patients was 40.78 years (range 19-55 years). The mean follow-up was 1.75 years (range 6 months to 5 years). All wounds healed well with no incidence of wound dehiscence or surgical site infections. The mean VAS improved from 7.33 ± 0.5 to 2.11 ± 1.2 ( P < .05). Nine patients reported excellent outcomes and 1 patient reported poor outcome with regards to relief from coccydynia. Conclusion: Z plasty technique of wound closure is recommended as procedure of choice to avoid wound healing problems and surgical site infections associated with coccygectomy. Coccygectomy remains a successful treatment modality for chronic coccydynia.


2018 ◽  
Vol 103 (10) ◽  
pp. 1395-1400 ◽  
Author(s):  
Rashmi G Mathew ◽  
Sahar Parvizi ◽  
Ian E Murdoch

AimsTo compare success proportions at 5 years in three surgical groups: group 1, trabeculectomy alone; group 2, trabeculectomy followed by cataract surgery within 2 years; and group 3, trabeculectomy performed on a pseudophakic eye.MethodsA retrospective cohort study. 194 eyes of 194 patients were identified with at least 5 years’ follow-up post trabeculectomy (N=85, 60 and 49 in groups 1, 2 and 3, respectively).Main outcome measures1. Primary outcome measure: intraocular pressure (IOP) at 5 years post-trabeculectomy surgery, 2.Secondary outcome measure: change in visual acuity at 5 years.ResultsAt 5 years, the mean IOP (SD) was 12.9 (3.5), 12.5 (4.8) and 12.7 (4.8) mm Hg in groups 1, 2 and 3, respectively. Overall success was almost identical, 58%, 57% and 59% in groups 1, 2 and 3, respectively. There was no significant difference between the groups in terms of percentage IOP reduction, number of medications, proportion restarting medication and reoperation rates at 5 years. Logistic regression for an outcome of failure showed men to be at increased risk of failure OR 1.97 (95% CI 1.10 to 3.52, p=0.02). Nearly 80% of patients retained or improved their vision following their initial trabeculectomy.ConclusionsThe sequence in which surgery is carried out does not appear to affect trabeculectomy function at 5 years, success being similar to trabeculectomy alone. In our study, men may be at increased risk of failure.


2021 ◽  
Vol 3 ◽  
Author(s):  
Moa Jederström ◽  
Sara Agnafors ◽  
Christina Ekegren ◽  
Kristina Fagher ◽  
Håkan Gauffin ◽  
...  

Introduction: Although figure skating attracts several hundred thousand participants worldwide, there is little knowledge about physical health and sports injuries among young skaters. The present study aimed to describe the health status of a geographically defined Swedish population of licensed competitive figure skaters and to examine injury determinants.Methods: All licensed competitive skaters in the southeastern region of Sweden were in April 2019 invited to participate in a cross-sectional study using an online questionnaire. Multiple binary logistic regression was used for the examination of injury determinants. The primary outcome measure was the 1-year prevalence of a severe sports injury episode (time loss &gt;21 days). The secondary outcome measure was the point prevalence of an ongoing injury. The determinants analyzed were age, skating level, relative energy deficiency indicators, and training habits.Results: In total, 142 (36%) skaters participated, 137 (96%) girls [mean (SD) age: 12.9 (SD 3.0) years]. Participating boys (n = 5) were excluded from further analysis. The 1-year prevalence of a severe sports injury episode was 31%. The most common injury locations for these injuries were the knee (25%), ankle (20%), and hip/groin (15%). In the multiple model, having sustained a severe injury episode was associated with older age (OR 1.2, 95% CI 1.1–1.4; p = 0.002) and an increased number of skipped meals per week (OR 1.1, 95% CI 1.0–1.3; p = 0.014). The point prevalence of an ongoing injury episode was 19%. The most common locations were the knee (24%), ankle (24%), and foot (24%). Having an ongoing injury episode was associated with older age (OR 1.4, 95% CI 1.2–1.7; p &lt; 0.001) and an increased number of skipped meals per week (OR 1.1, 95% CI 1.0–1.3; p = 0.049).Conclusion: One-third of young female Swedish competitive figure skaters had sustained a severe injury episode during the past year, and a fifth reported an ongoing episode. Older age and an increased number of skipped meals per week were associated with a sports injury episode. Long-term monotonous physical loads with increasing intensity and insufficient energy intake appear to predispose for injury in young female figure skaters. Further examination of injury determinants among competitive figure skaters is highly warranted.


1995 ◽  
Vol 1 (2) ◽  
pp. 118-135 ◽  
Author(s):  
LD Jacobs ◽  
DL Cookfair ◽  
RA Rudick ◽  
RM Herndon ◽  
J R Richert ◽  
...  

The design and conduct of a randomized, double-blinded, placebo-controlled, multicenter, phase III study of recombinant interferon beta-1a (IFN-β-1a) as treatment for exacerbating-remitting MS are described, as are baseline characteristics of the study population. The purpose of the study was to determine if 6.0 × 106 IU (30 μg) of IFN-β-1a, administered by weekly intramuscular (i.m.) injections, was effective in delaying the onset of sustained disability. The primary outcome measure was time to onset of treatment failure, defined as a worsening on the Kurtzke Expanded Disability Status Scale (EDSS) of greater than or equal to 1.0 point compared with baseline, persisting for at least 6 months. An intent-to-treat design was used. The primary outcome measure was analyzed using the Mantel-Cox log-rank statistic and Kaplan-Meier survival curves. Secondary outcomes included quantitative measures of upper and lower extremity function, neuropsychological test performance, functional and quality of life assessments and several measures derived from annual brain MRI studies. Entry criteria included prestudy exacerbation rates of at least 0.67 per year and EDSS scores of 1.0–3.5. A total of 301 MS patients were randomly assigned to receive weekly i.m. injections of IFN-β-1a or placebo. The average age of the study population at entry was 37 years; 92% were Caucasian and 73% were women. The mean prestudy disease duration was 6.5 years, mean prestudy exacerbation rate was 1.2 per year and the mean EDSS score was 2.3. The randomization yielded well-balanced treatment arms. Various aspects of the study are discussed, including: (1) the decision to focus study design on sustained disability; (2) the rationale for the treatment regimen; (3) measures taken to assure the reliability of the primary outcome measure; and (4) a description of the secondary outcome measures.


2021 ◽  
pp. 175045892110640
Author(s):  
Benjamin Thomas Vincent Gowers ◽  
Michael Sean Greenhalgh ◽  
Kathryn Dyson ◽  
Karthikeyan P Iyengar ◽  
Vijay K Jain ◽  
...  

Background: Hip fractures are common presentations to orthopaedic departments, and their surgical management often results in blood transfusions. Compared with general anaesthesia, regional anaesthesia reduces the need for transfusions and mortality in the wider surgical population. Aims: In hip fracture patients, our primary outcome measure was to examine any relationship between anaesthetic modality and transfusion rates. The secondary outcome measure was to assess the relationship between anaesthetic modality and one-year mortality. Methods: A retrospective cohort study of 280 patients was carried out in 2017 and 2018. Data were collected from patient records, local transfusion laboratory and the national hip fracture database. Results: A total of 59.6% had regional and 40.4% general anaesthesia. Regional anaesthesia patients were younger with fewer comorbidities (p < .05). About 19.8% regional and 34.5% general anaesthesia patients received transfusions (odds ratio (OR) = 0.47, p < .05); 13.6% were taking anticoagulants and were less likely to receive a regional anaesthetic (31.6% versus 64%, OR = 0.26, p < .05). One-year mortality was 27% for regional and 37% for general anaesthetic patients (OR = 0.64, p = .09). Conclusion: Regional anaesthesia halved the risk of blood transfusion. Anticoagulated patients were 74% less likely to receive regional anaesthetics, but had no additional transfusion risk. With optimisation, a larger proportion of patients could have regional anaesthesia.


2019 ◽  
Vol 6 (1) ◽  
pp. e000426
Author(s):  
Robert Slade ◽  
Raza Alikhan ◽  
Matt P Wise ◽  
Lam Germain ◽  
Simon Stanworth ◽  
...  

BackgroundPredicting patient outcomes following critical illness is challenging. Recent evidence has suggested that patients with blood group AB are more likely to survive following major cardiac surgery, and this is associated with a reduced number of blood transfusions. However, there are no current data to indicate whether a patient’s blood group affects general intensive care outcomes.ObjectiveThe objective of this study was to determine if ABO blood group affects survival in intensive care. The primary outcome measure was 90-day mortality with a secondary outcome measure of the percentage of patients receiving a blood transfusion.DesignRetrospective analysis of electronically collected intensive care data, blood group and transfusion data.SettingGeneral intensive care unit (ICU) of a major tertiary hospital with both medical and surgical patients.PatientsAll patients admitted to ICU between 2006 and 2016 who had blood group data available.InterventionNone.Measurements and main results7340 patients were included in the study, blood group AB accounted for 3% (221), A 41% (3008), B 10.6% (775) and O 45.4% (3336). These values are similar to UK averages. Baseline characteristics between the groups were similar. Blood group AB had the greatest survival benefit (blood group AB 90-day survival estimate 76.75, 95% CI 72.89 to 80.61 with the overall estimate 72.07, 95% CI 71.31 to 72.82) (log-rank χ2 16.128, p=0.001). Transfusion requirements were similar in all groups with no significant difference between the percentages of patients transfused (AB 23.1%, A 21.5%, B 18.7%, O 19.9%, Pearson χ2 5.060 p=0.167).ConclusionAlthough this is primarily a hypothesis generating study, intensive care patients with blood group AB appeared to have a higher 90-day survival compared with other blood groups. There was no correlation between blood group and percentage of patients receiving transfusion.


2019 ◽  
Vol 28 (7) ◽  
pp. 446-452
Author(s):  
Nicole E. Spruijt ◽  
Maarten M. Hoogbergen ◽  
Servaas J.E. Buijs ◽  
Marcel J.W. Grosveld ◽  
Jaap Buth

Objective: Wound risk-stratified analyses are clinically relevant as they can assist in identifying hard-to-heal wounds. The aim of the study is to develop risk categories for wound healing based on a limited number of reliably recordable clinical data. Method: This retrospective study used observational data. The primary outcome measure was wound healing at the end of treatment and the secondary outcome measure was the time to wound healing. A stratification model using regression analyses was developed to assign the patients to risk categories for wound healing and the time-to-heal. Results: The study cohort comprised of 540 patients. The most common wound diagnoses were diabetic ulcers, wounds in irradiated areas and wound dehiscence after surgery. Average wound duration before starting treatment at the wound centre was 11.7 months. Healing was achieved in 382 (71%) wounds, after an average treatment time of 4.4 months. A total of four risk categories for wound healing were developed by combining wound diagnosis (favourable versus unfavourable) and duration (<3 months versus >3 months). These risk categories demonstrated healing percentages ranging from 69–97% (p=0.0004) and mean time-to-healing varying from 2.7–5.9 months (p=0.01). Conclusion: Using two clinical wound variables, diagnosis and duration, stratification categories were identified with significant associations with wound healing outcomes. Longer wound duration and unfavourable diagnoses, when combined into unfavourable risk categories, were associated with a lower percentage of wound healing and a longer treatment time until healing.


2020 ◽  
pp. 175319342097946
Author(s):  
Preetham Kodumuri ◽  
Andrew McDonough ◽  
Victoria Lyle ◽  
Zaf Naqui ◽  
Lindsay Muir

We reviewed the outcomes of our dedicated clinic for suspected scaphoid fractures. The primary outcome measure was to test the reliability of accurately diagnosing an occult scaphoid fracture with a combination of anatomical snuff box, scaphoid tubercle, longitudinal compression tenderness, ulnar deviation and the pinch test. Cost savings of the new patient pathway was our secondary outcome measure. Between December 2016 and March 2020, 922 patients were recruited at a mean of 12 days post-injury. Sixty-five per cent ( n = 602) with a low clinical suspicion were discharged and 35% ( n = 320) with a high clinical suspicion had same day MRI scan. Fifty-eight scaphoid fractures were diagnosed and treated with no nonunions reported. Anatomical snuff box tenderness was the most sensitive test (90%). A combination of five tests better excluded an occult fracture (80% accuracy). The dedicated scaphoid clinic pathway resulted in 350 fewer follow-up visits and an overall saving of £59,666. Level of evidence: III


2020 ◽  
Vol 123 (12) ◽  
pp. 1434-1440 ◽  
Author(s):  
M. Leeman ◽  
R. P. M. Gadiot ◽  
J. M. A. Wijnand ◽  
E. Birnie ◽  
J. A. Apers ◽  
...  

AbstractLaparoscopic Roux-en-Y gastric bypass (RYGB) is considered the ‘gold standard’ for surgical treatment of morbid obesity. It is hypothesised that reducing the length of the common limb positively affects the magnitude and preservation of weight loss but may also impose a risk of malnutrition. The aim of this study was to compare patients’ nutrient and vitamin deficiencies in standard RYGB with a very long Roux limb RYGB (VLRL-RYGB). This study was part of the multicentre randomised controlled trial (Dutch Common Channel Trial), including 444 patients undergoing an RYGB or a VLRL-RYGB. Laboratory results, use of multivitamin supplements and reoperations were collected at baseline and 1 year postoperative. Primary outcome measure was nutrient deficiency after 1 year postoperative. Secondary outcome measure was the reoperation rate due to malabsorption. In total, 227 patients underwent RYGB and 196 patients underwent VLRL-RYGB. Most common deficiencies at 1 year postoperative were ferritin (17·2–18·2 %), Fe (23·4–35·6 %), K (7·4–15·2 %), vitamin B12 (9·0–9·9 %) and vitamin D (22·7–34·5 %). Patients undergoing VLRL-RYGB had slightly but significantly lower levels of Ca, Fe and vitamin D compared with those undergoing RYGB at 1 year postoperative, but significantly higher levels of folic acid and Na. Reoperation rates due to malabsorption were not significantly different between RYGB (2/227, 0·9 %) and VLRL-RYGB (7/196, 3·6 %) (P = 0·088). We concluded that patients undergoing VLRL-RYGB had significantly lower levels of Ca, Fe and vitamin D compared with those undergoing RYGB at 1 year postoperative, but higher levels of folic acid and Na. Reoperation rates did not differ. Close monitoring on nutrient deficiencies should be performed in patients undergoing VLRL-RYGB.


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