BackgroundFlow cytometric sorting can be used to separate sperm based on sex chromosome content. Differential fluorescence emitted by stained X- vs. 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. Herein we report the effectiveness of flow cytometric sorting of human sperm and its use in human ART procedures.MethodsThis 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. 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). 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. Sorted sperm were used for IUI (n = 4448) and IVF/ICSI (n = 2957). 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.ResultsSorted 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. Seventy-three percent of sorts were for girls. For babies born, 93.5% were females and 85.3% were males after sorting for X- and Y-bearing sperm, respectively. 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%.ConclusionsFlow cytometric sorting of human sperm shifted the X:Y sperm ratio. IUI, IVF/ICSI and FET outcomes were consistent with unimpaired sperm function. 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.Trial registrationNCT00865735 (ClinicalTrials.gov)
Abstract. The purpose of the present study was to evaluate the safety of MicroSort (MicroSort Division, GIVF, Fairfax, VA, USA) sperm sorting by monitoring major malformations in infants and fetuses conceived using sorted spermatozoa. Data were collected in a prospective protocol with monitoring that began from conception through birth until 1 year of life. Comprehensive ascertainment identified fetuses and stillbirths with malformations after 16 weeks gestation, pregnancies terminated for malformations and babies with major malformations. Outcomes in MicroSort pregnancies were compared with outcomes in published studies that used active and comprehensive ascertainment of malformations in the general population and in pregnancies established after assisted reproduction. Using comprehensive outcomes from all pregnancies, the rate of major malformations in MicroSort pregnancies conceived after IVF with or without intracytoplasmic sperm injection was 7.8%; this did not differ significantly from the rates reported in the three assisted reproductive technology control studies not associated with MicroSort (8.6%, 9.2% and 8.3%). Similarly, the rate of major malformations in MicroSort pregnancies initiated with intrauterine insemination was 6.0%, not significantly different from that reported in non-assisted reproductive technology pregnancies not associated with MicroSort (6.9%, 4.6% and 5.7%). Prospective record review of pregnancy outcomes and paediatric evaluation to 1 year indicate no association between MicroSort sperm sorting and major malformations.
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