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Comparison of two protocols of blastocyst biopsy submitted to preimplantation genetic testing for aneuploidies: a randomized controlled trial.

PURPOSE: To compare the effectiveness of two protocols of blastocyst biopsy submitted to preimplantation genetic testing for aneuploidies (PGT-A).

METHODS: This is a randomized controlled trial of a cohort of 221 patients undergoing PGT-A. 106 female patients aged ≤ 40 years with no less than 8 mature oocytes retrieved and ≥ 3 good-quality embryos on day 3 were randomly assigned to the day-3 hatching-based TE biopsy. The remaining 115 females aged ≤ 40 years with ≥ 8 MII oocytes obtained and no less than 3 high-quality embryos on day 3 were assigned to the TE biopsy without hatching group (also called the new biopsy group). The primary outcome was measured by a live birth after the first embryo transfer.

RESULTS: The live birth rate did not differ significantly between the two groups (50.00% vs. 59.26%, P > 0.05, OR 1.46; 95% CI 0.78-2.70). There was no significant between-group difference in the rates of implantation, clinical pregnancy, and miscarriage. However, the frozen blastocyst rate was significantly lower in the day-3 hatching-based TE biopsy compared with the new biopsy group (47.54% vs. 53.96%, P < 0.05, OR 1.29; 95% CI 1.08-1.56).

CONCLUSIONS: Our study provides strong evidence that the new blastocyst biopsy method exhibits advantages over day-3 hatching-based TE biopsy method. Using this method, we were able to obtain more blastocysts to perform trophectoderm biopsy in patients subjected to PGT-A.

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