The mean post-sort purity was 87.9% for Xsort ® and 73.4% for Ysort ® (Table 1). A total of 5871 sorts were performed 74.9% were Xsort ® and 25.1% were Ysort ®. Through December 2006, 3952 couples had enrolled as participants in the MicroSort ® clinical trial, 8.2% were for genetic disease avoidance and 91.8% were for family balancing. Family balancing is defined as a desire for a child whose gender is the least frequent among all the living children of the family. Couples with infertility undergoing IVF for other indications that qualified and desired participation were also included. In this Institutional Review Board- and FDA-approved clinical trial, participants were primarily fertile, married couples who met inclusion criteria and who sought reduced genetic disease risk or balanced sex distribution among their children. MICROSORT XSORT TRIALIn this paper the updated results of the ongoing MicroSort ® clinical trial are reported. Early results from the clinical trial reported the first human pregnancies and babies resulting from the use of flow cytometrically sorted human sperm for IUI, IVF, or ICSI. MicroSort ® sperm have been successfully used to achieve pregnancies after intrauterine insemination (IUI), in vitro fertilization (IVF), and intracytoplasmic sperm injection (ICSI). The United States Food and Drug Administration (FDA) approved an Investigational Device Exemption in 2000 for GIVF to conduct a clinical trial of safety and efficacy of the MicroSort ® Sperm Separation Technology.įresh- and frozen-thawed human sperm have been sorted to yield populations enriched in X-bearing (Xsort ®) or Y-bearing (YSort ®) sperm. The clinical study was expanded in 1995 to offer family balancing to couples. Institutional Review Board approval was received in 1993 to initiate clinical studies for application of flow cytometric sperm sorting to couples at risk for having children with sex-linked disease. MICROSORT XSORT LICENSEThe Genetics & IVF Institute (GIVF) was granted an exclusive license by the United States Department of Agriculture to the patented flow cytometric sperm separation technology for development and use in humans in 1992. Y-chromosome bearing sperm allows the identification and subsequent recovery of highly enriched populations of X- or Y-bearing sperm. Utilizing the 2.8% difference in DNA content between X- and Y-bearing human sperm, , the detection of differential fluorescence emitted by stained X-chromosome bearing sperm vs. Sorting human sperm by flow cytometry is a pre-conception method of sex selection that can be employed to reduce sex-linked disease risk or to balance the sex distribution of children in a family (family balancing). Fertilization, cleavage, spontaneous abortion, and pregnancy rates as well as incidence of major congenital malformations were comparable to those in literature reports utilizing unsorted sperm. FISH results confirmed MicroSort ® enrichment of X- and Y-bearing sperm populations that closely corresponded with the sex of the resultant child. Postnatal follow-up showed a 2.6% major congenital malformation rate, with no recurrent pattern or clustering of malformations. For babies born, XSort ® resulted in 92.0% females and YSort ® yielded 81.5% males. A total of 1125 clinical pregnancies yielded 943 babies born and 167 ongoing pregnancies. Post-sort purity averaged 87.9% (XSort ®) and 73.4% (YSort ®). The pregnancy rates for IUI, IVF/ICSI, and FET were 15.6, 32.0, and 33.3%, respectively, while miscarriage rates were 15.7, 14.3, and 33.3%, respectively. IVF/ICSI fertilization rate was 70.7% and 93.8% of 2PN embryos cleaved. Of 5871 total sorts, 74.9% were XSort ® and 25.1% were YSort ®. Between June 1994 and January 2007, patients underwent 3629 IUI cycles, 1642 IVF/ICSI cycles with fresh embryo transfer (ET) and 99 frozen embryo transfer (FET) cycles after MicroSort ®. Birth and pediatric records were evaluated for incidence of congenital malformations. Fluorescence in situ hybridization (FISH) analysis determined the post-sort enrichment (purity) for X- and Y-bearing sperm. Sperm were stained with Hoechst 33342, sorted by flow cytometry, then used or cryopreserved for subsequent use. Clinical trial participants were married couples seeking reduced X-linked genetic disorder risk or family balancing. This report provides a summary of MicroSort ® efficacy in separation of X- from Y-chromosome bearing human sperm (XSort ® and YSort ®, respectively), clinical outcomes, and the sex of the resultant babies when sorted sperm were used for intrauterine insemination (IUI), in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI).
0 Comments
Leave a Reply. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |