No abstract

No abstract

primary objective was met, with a cumulative spontaneous abortion rate of 7.4% with upper bound of the 95% confidence interval (CI; 4.4%, 11.5%) below the predefined threshold of 15.0% set based upon the observed 10.0% rate (CI 7.6%, 12.8%) in the pivotal trial (Stadtmauer 2013). Clinical pregnancy rates were 43.2% at 10 weeks post OR.CONCLUSIONS: This trial established a safety bridge between PVR produced via enhanced manufacturing processes and the legacy PVR based upon a rate of spontaneous abortion comparable to that observed in the pivotal phase 3 trial. Weekly administration of the PVR was well-tolerated with good pregnancy outcomes associated with its use in conjunction with HP-hMG stimulation. Based upon demonstrated safety and efficacy coupled with more convenient dosing than existing therapeutics, PVR offers an important option for luteal phase supplementation.

stage and the TE cells herniated from the artificial opening biopsied. Protocol 2: the embryos are cultured to the blastocyst stage, zona-drilling and TE biopsy are performed sequentially; ¼ of the ZP is removed after the biopsy. A total of 835 frozen embryo transfer (FET) cycles (October 2015-September 2016) utilizing protocol 1 were compared with 835 FET cycles (October 2016-September 2017) utilizing protocol 2. Patients of the two groups were matched 1:1 for female age (+/-1 year), number of embryo transferred and use of gestational carrier and/or egg donor. Survival rate after thawing (SR), clinical pregnancy rate (CPR), implantation rate (IR) and abortion rate (AR) were evaluated. Fisher's exact test was used for statistical analysis.RESULTS: The results are reported in table 1 CONCLUSIONS: SR after thawing, PR and IR were all significantly improved after switching from a TE biopsy protocol that involved a prior zona breaching at day 3 to a protocol where zona breaching and TE biopsy are sequentially performed and ¼ of the ZP is removed. Manipulating the zona in day 3 could cause stress to the embryo in terms of ZP thinning, blastocyst expansion and overall TE cell count. With the second protocol, the embryo does not undergo artificial hatching and since the blastocyst collapses away from the ZP after biopsy, ¼ of the zona can be safely removed reducing the possibilities of embryo trapping. Even though the two groups were well matched, the study was limited due to being retrospective. More data contribution from other laboratories is needed to standardize the technique. References:Capalbo A, Romanelli V, Cimadomo D, et al. Implementing PGD/PGD-A in IVF clinics: considerations for the best laboratory approach and menagement.

No abstract