This provides a preconception reproductive option for parents wishing to reduce sex-linked and sex-limited disease risk for their future children or to balance the sex ratio among their children. Human sperm sorted by flow cytometry can increase the likelihood that a child so conceived will be of a particular sex. Results provide evidence supporting the effectiveness of flow cytometric sorting of human sperm for use as a preconception method of influencing a baby’s sex. IUI, IVF/ICSI and FET outcomes were consistent with unimpaired sperm function. Conclusionsįlow cytometric sorting of human sperm shifted the X:Y sperm ratio. IUI, IVF/ICSI, and FET clinical pregnancy rates were 14.7%, 30.8%, and 32.1%, respectively clinical miscarriage rates were 15.5%, 10.2%, and 12.7%. For babies born, 93.5% were females and 85.3% were males after sorting for X- and Y-bearing sperm, respectively. Seventy-three percent of sorts were for girls. Sorted specimens averaged 87.7 ± 5.0% X-bearing sperm after sorting for X and 74.3 ± 7.0% Y-bearing sperm after sorting for Y. Measures of effectiveness were the percentage of X- and Y-bearing sperm in sorted samples, determined by fluorescence in situ hybridization, sex of babies born, IVF/ICSI fertilization- and cleavage rates, and IUI, IVF/ICSI, FET pregnancy rates and miscarriage rates. Sorted sperm were used for IUI (n = 4448) and IVF/ICSI (n = 2957). Fresh or frozen-thawed semen was processed and recovered sperm were stained with Hoechst 33342 and sorted by flow cytometry (n = 7718) to increase the percentage of X-bearing sperm (n = 5635) or Y-bearing sperm (n = 2083) in the sorted specimen. After meeting inclusion criteria, married couples (n = 4993) enrolled to reduce the likelihood of sex-linked or sex-limited disease in future children (n = 383) or to balance the sex ratio of their children (n = 4610). This prospective, observational cohort study of the series of subjects treated with flow cytometrically sorted human sperm was conducted at investigational sites at two private reproductive centers. Herein we report the effectiveness of flow cytometric sorting of human sperm and its use in human ART procedures. Y-chromosome-bearing sperm enables sorting and collection of samples enriched in either X- or Y-bearing sperm for use to influence the likelihood that the offspring will be a particular sex. Differential fluorescence emitted by stained X- vs. 235Ĭhapter 1: Introduction to Statistics Section 1-2 1.Flow cytometric sorting can be used to separate sperm based on sex chromosome content. Statistical significance is indicated when methods of statistics are used to reach a conclusion that some treatment or finding is effective, but common sense might suggest that the treatment or finding does not make enough of a difference to justify its use or to be practical. Yes, it is possible for a study to have statistical significance but not a practical significance. If the source of the data can benefit from the results of the study, it is possible that an element of bias is introduced so that the results are favorable to the source.Ī voluntary response sample is a sample in which the subjects themselves decide whether to be included in the study. A voluntary response sample is generally not suitable for a statistical study because the sample may have a bias resulting from participation by those with a special interest in the topic being studied.Įven if we conduct a study and find that there is a correlation, or association, between two variables, we cannot conclude that one of the variables is the cause of the other. There does appear to be a potential to create a bias. There does not appear to be a potential to create a bias. There does appear a potential to create a bias. The sample is a voluntary response sample and is therefore flawed.ġ0. The sample is a voluntary response sample and is therefore flawed. Because there is a 30% chance of getting such results with a diet that has no effect, it does not appear to have statistical significance, but the average loss of 45 pounds does appear to have practical significance. Because there is only a 1% chance of getting the results by chance, the method appears to have a statistical significance. The result of 540 boys in 1000 births is above the approximately 50% rate expected by chance, but it does not appear to be high enough to have practical significance.
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