Overview of the Study

Discuss about the Implantation Potential & Clinical Impact.

A research study was organized on the reproductive epidemiology in the journal article “Neonatal health including congenital malformation risk of 1072 children born after vitrified embryo transfer” by the authors F. Belva, M. Bonduelle, M. Roelants, G. Verheyen, and L. Van Landuyt. This research study was submitted on February 16, 2016. This study was commissioned for advance study of artificial methods of human reproduction. These methods are differ than the natural methods and human interference was performed in the process of human reproduction. This research study mainly focus on the vitrified embryo transfer and the congenital malformation risks of born children by using this method. This study focuses on the research question, “Does vitrification of Day 3 and Day 5 embryos diversely affect the birth outcomes of singletons and twins in comparison with peers born after fresh embryo transfer?” The main purpose of the study is to compare the malformation risk in the children born after vitrified embryo transfer and the children born naturally. Comparably high rates have been reported after vitrification in comparison with slow freezing methods (Abdelhafez et al., 2010). For this research study, observations are collected from the Centre for Reproductive Medicine of the university hospital UZ Brussels. Data for this research study was collected for the variables such as birth weight, gestational age, prematurity rate, perinatal death, and major/minor total malformation rate. This clinical research study provides the evidence that the transfer of vitrified day 3 and day 5 embryos does not adversely affect the neonatal health of the offspring in comparison with transfer of fresh embryos. For this research study, researchers reports the favourable outcomes for singletons born after transfer of vitrified day 3 and day 5 embryos in terms of different variables such as birth weight, gestational age rate, comparable congenital malformation rate, etc.

Different analysis methods were used for this epidemic study. Systematic study was organized for finding the results for this study. For this study, all study set up and follow up program is already described in the previous publication by Bonduelle et al., 2002. This research study consist of 1072 children and data for these children was collected for the variables such as birth weight, gestational age, prematurity rate, perinatal death, and major/minor total malformation rate. Observations were taken at different time period such as on the time of baby born, day 3, day 5, etc. This study was organized during the year 2008 and 2013 at the Centre for Reproductive Medicine of the university hospital UZ Brussels. Data is collected for large sample and this will results in getting unbiased observations. If the personnel appointed for data collection is not well educated or skilled, then observations will not be measured accurately and this will results in biased outputs for the study. Also, data is collected between the three to four years. This period for study is comparatively high and even though researchers keeps the proper follow up for the process of data collection at every stage of the research study. This study consists of 11 stillborns and 1061 live born babies. In the 1061 live born babies, 827 were singletons and 234 twins. After the three months of baby births, children were allocated in the two study groups randomly. These two study groups were assessed clinically with special attention regarding the congenital malformations. Single blinding and double blinding techniques in the clinical study were used for getting unbiased results for this study (Hansen, 2009). Paediatricians were blinded to the type of embryo transfer. Methodology for this analysis is arranged in a systematic way. Two study groups were prepared for this genre analysis and regarding the fresh cycles, analysis of data is restricted to patients who had at least one supernumerary embryo for vitrification. This analysis includes the steps such as ovarian stimulation and IVF-ICSI, evaluation of embryos and selection criteria for transfer and vitrification, follow-up of pregnancy, Preparation of the frozen embryo transfer cycle, outcome measures, and statistical analysis. Paediatricians were blinded to the type of embryo transfer. Cobo et al., (2012) explained the process of blinding in clinical trials. The technique of blinding is used properly for this clinical trial. Data is collected at each stage of the research. Data for twins is corrected by using technique of correlation. For this purpose, researchers use the correlation between the observations by using the generalized linear mixed effects model which included random effect for each pair of observations. The associations between the different types of treatment and study variables were measured by using logistic regression. Power calculations for the outcome measure congenital malformations were carried out for this analysis. The maternal ages in the analysis was shown in the form of confidence intervals such as mean plus minus margin of error. The P-values for the claims are given in the brackets after the statement. Dhont (1997) explains the role of data analysis in clinical research study and case control study.

Methodology Used for the Study

After the collection of data, different statistical tools and techniques were used for the analysis of collected data for the variables birth weight, gestational age, prematurity rate, perinatal death, and major/minor total malformation rate. A descriptive statistics were used for getting primary idea about the variables. Statistical data analysis for this clinical research study includes multiple linear regression model, logistic regression model, adjusted for treatment variables and maternal characteristics. By using the linear regression model and logistic regression model, researchers predict the malformation risk of children born after vitrified embryo transfer (Belva et al., 2008). Also, some statistical techniques such as confidence intervals, sample proportions, statistical hypothesis tests, etc. were used for the analysis of collected data. Descriptive statistics were used for all parameters included in this clinical research study for the determination of the different characteristics of the sample. The Chi square test was used for checking the independence between the two categorical variables. A Student’s t-tests were used for checking the significant differences between the population means for the continuous variables. Also, this study includes the Pearson correlation coefficients for checking the amount of relationship between the two variables. The SPSS software is used for the data analysis purpose.

From the given results in the article, it was observed that data was analysed in a well manner by using proper statistical tools and techniques. Results were accurately summarised in a tabular forms.

For this clinical research study, researchers were tried to keep high quality for this research study. A well study design was used for the comparison of different variables in the both study groups. Actual data was collected from the university hospital. Data is collected for 1072 children and therefore results will be more reliable as researchers used adequate sample size for this study. Also, there are systematic comparisons were performed by using different statistical techniques. A proper statistical tools and methods were used for the prediction of congenital malformation risk. A well set up was organized for this research study. This research study includes so many steps and data is collected at every step in a systematic way.

Data is collected for large sample and this will results in getting unbiased observations. If the personnel appointed for data collection is not well educated or skilled, then observations will not be measured accurately and this will results in biased outputs for the study. Also, data is collected between the three to four years. This duration is so long and the process of data collection will not be consistent due to changes in persons appointed for data collection purpose. Although researchers try to avoid any chance causes in the study, there are some limitations for this study. The main limitation for this clinical research study is the rather small twin group. So, it is important to interpret the results cautiously for twin group. Due to these reasons, the quality of the research study will be decrease. Most of the results were stated in interval form for avoiding errors in the exact parameter values. It was observed that the p-values for the claims for this research study are mentioned every time. Also, related table numbers were indicated in the report so that one may be seen it in the appendix. Some statistical techniques such as confidence intervals, sample proportions, statistical hypothesis tests, etc. were used for the analysis of collected data. Descriptive statistics were used for all parameters included in this clinical research study for the determination of the different characteristics of the sample. The Chi square test was used for checking the independence between the two categorical variables. A Student’s t-tests were used for checking the significant differences between the population means for the continuous variables. All limitations, advantages and disadvantages of this research were explained by the researchers. All report writing formalities and academic requirements were completed in the given paper.

Data Analysis Techniques Used for the Study

This clinical study is outlined with proper research design and statistical results were shown properly. All statistical measurements are stated in a systematic way. Results for this research study were stated properly in context of study variables. Significance levels were mentioned for all statistical tests used for this clinical study. For most of the statistically tests, 5% level of significance was used for drawing the conclusions. So, results will be significant at 5% level for this research study. All confidence intervals used the 95% confidence level. All test statistic values such as t-value, Chi square, F, etc. were clearly mentioned in this research study. Also, degrees of freedom and associated P-values were given for each test conducted for this research study. Tables with parameters, comparisons, different values are provided in the appendix. Researchers also mentioned the limitations of this study. Researchers tries to overcome these limitations by making some corrections for the collected data.

Researchers work very hard to perform this clinical study. The results for this study are based on the large sample size. So, results would be clinically significant and these results will be helpful for future investigation in this research area. All results of this experiment or research study were analysed by using several statistical tests and techniques. Statistical techniques such as hypothesis testing, multiple regression, logistic regression, t tests, Chi square tests, ANOVA tests were used for the analysis of collected data. Also, required corrections were made in the analysis for getting more reliable and unbiased results. For different results of this research study, confidence intervals were mentioned or given for more reliability. This study is clinically significant for the future work on this topic and one can use this material for reference purpose. Researchers for this study also explain the limitations, advantages and disadvantages for this research study. Although there are some limitations for this research study, results are significant and conclusions drawn for this study are important for further work in this area.

From the above analysis of research articles, the learning outcomes from this research article are summarised as below:

1. Use of Proper research design: Researchers were used the proper research design for arranging this clinical study. Researchers divided all subjects under study in the two study groups and observations were collected for these two groups simultaneously for the comparison purpose. Blinding methods were used for effectiveness of the research design.

1. A well set up for long duration study: For this research study, observations collected during the three to four years and therefore researchers maintained data in a systematic way for further analysis.

1. Proper assumptions made for research study: Before the start of this clinical research study, researchers made some assumptions for this research study and then they conduct this research study.

1. Methods of data collection: For collection of data, researchers use proper methods and data is collected from the university hospital centre. Data is collected systematically for the different variables under study. Data is measured by using proper scales of measurements.

1. Use of different statistical tools and techniques for data analysis: Statistical data analysis for this clinical research study includes multiple linear regression model, logistic regression model, adjusted for treatment variables and maternal characteristics. Also, some statistical techniques such as confidence intervals, sample proportions, statistical hypothesis tests, etc. were used for the analysis of collected data. The Chi square test was used for checking the independence between the two categorical variables. A Student’s t-tests were used for checking the significant differences between the population means for the continuous variables.

1. Making proper inferences: Researchers used the 5% significance levels for this clinical study and concludes the results. For different comparisons between two study groups, researchers provide test values and other necessary values.

1. Proper outline of the results: Researchers used proper outline for explaining their results for the clinical study. All required terms were defined in the research study. Also, limitations of this research study were explained by researchers for avoiding further complex situations.

For the given research study, researchers work hard for drawing the conclusions. This study was performed during more than three years and continuous follow up of the different study points were necessary. A proper method of data collection, data analysis was used for this research study. Researchers use the proper statistical tests for checking different claims regarding the variables involved in this research study. Researchers also explain the scope and limitations of this research study.

References

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Bonduelle M, Liebaers I, Deketelaere V, Derde MP, Camus M, Devroey P, Van Steirteghem A. Neonatal data on a cohort of 2889 infants born after ICSI (1991–1999) and of 2995 infants born after IVF (1983–1999). Hum Reprod 2002;17:671–694.

Cobo A, de los Santos MJ, Castello D, Gamiz P, Campos P, Remohi J. Outcomes of vitrified early cleavage-stage and blastocyst-stage embryos in a cryopreservation program: evaluation of 3150 warming cycles. Fertil Steril 2012;98:1138–1146.

Dhont M, De Neubourg F, Van der Elst J, De Sutter P. Perinatal outcome of pregnancies after assisted reproduction: a case-control study. J Assist Reprod Genet 1997;14:575–580.

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