Abstract

1. To establish whether the SDD assay predicts failed pregnancies for egg donor patients. 2. To identify other semen or sperm parameters during In-Vitro Fertilization (IVF) which positively correlate with SDD values. Sperm DNA function plays an important role in establishing ongoing pregnancies. The SDD assay provides insight into sperm function during fertilization compared to semen analysis parameters. The SDD assay measures the rate of sperm decondensation in a controlled in-vitro environment of Xenopus laevis frog egg extract. This critical step of fertilization is time-dependent. It is theorized that untimely sperm decondensation effects normal gene activation sequences during fertilization. Breakdowns in gene activation may produce normal phenotypic embryos that are incapable of going to full-term delivery. This study aims to utilize the sperm SDD assay to predict outcomes of IVF procedures using donor eggs. Six couples underwent an IVF cycle using donor eggs with ICSI. No couple had the same anonymous egg donor. On the morning of egg retrieval the male partner collected a semen sample by masturbation. A portion of the semen was prepared for overnight shipment to Repromedix, Inc; the remainder was used for the ICSI procedure. The data collected included; age of donor, age of recipient, age of male partner, Kruger strict morphology on neat semen, Kruger strict morphology on post-density gradient (DG) sperm, sperm deformity index (SDI) on neat semen, SDI on post-DG sperm, SDD, round cells (identified), fertilization rate, density, motility, total motile sperm post-DG, number of embryos at 6-cell or greater on day 3, number of embryos transferred (ET) on day 3, cleavage rate and ongoing pregnancy rate on fresh and frozen embryos (FE). Of the six couples tested thus far, 3 have established an ongoing pregnancy (one of the 3 couples failed on fresh ET but has an ongoing pregnancy following subsequent FET). All 3 ongoing pregnancies had normal SDD values. Two subjects had normal SDD values with negative pregnancy outcomes. Interestingly, subject 4 had the only abnormal SDD value thus far and the recipient had a miscarriage late in the first trimester of pregnancy. This couple also failed a subsequent FET. Other parameters which seem to indicate fecundity potential were number of 6-cell embryos or greater on day 3, fertilization rate, Kruger strict morphology and the SDI (See table).Tabled 1 The SDD assay may diagnose unexplained failed pregnancies in Men with normal semen parameters. Results show thus far that normal semen parameters alone are not reliable criteria for predicting the establishment of a full-term pregnancy. However, our data shows that Kruger strict morphology and the SDI may provide valuable information into failed pregnancies following IVF when their SDD values are in normal range. The SDD assay may be a useful tool in predicting negative pregnancies or miscarriages following IVF.

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