MicroSort® sperm sorting causes no increase in major malformation rate
Donald P. Marazzo A C D , David Karabinus A , Lawrence A. Johnson B and Joseph D. Schulman AA Genetics and IVF Institute, 3015 Williams Drive, Fairfax, VA 22031, USA.
B U.S. Department of Agriculture, 10300 Baltimore Ave, Bldg. 200, BARC-East Beltsville, MD 20705, USA.
C Institute for Healthy Reproductive Outcomes, 355 S Highland Avenue, Pittsburgh, PA 15206, USA.
D Corresponding author. Email: donm1027@gmail.com
Reproduction, Fertility and Development 28(10) 1580-1587 https://doi.org/10.1071/RD15011
Submitted: 9 January 2015 Accepted: 6 March 2015 Published: 22 April 2015
Journal Compilation © CSIRO Publishing 2016 Open Access CC BY-NC-ND
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.
Additional keywords: assisted reproductive technologies, birth defects, family balancing, genetic disease prevention, intracytoplasmic sperm injection, IVF, sexual selection, X-linked diseases.
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