Reproductive medicine and biology · 2026
A Prospective Study on Clinical Utility of Preimplantation Genetic Testing for Aneuploidy and Structural Rearrangement Under Advanced Medical Care B in Japan.
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Takiuchi Tsuyoshi, Saji Fumie, Handa Mika, Wakui Nao, Nakano Tatsuya, Kobayashi Ryota, Nagatakidani Yoshie, Miyake Tatsuya, Iwasa Takeshi, Kuwahara Akira, Irahara Minoru, Nakaoka Yoshiharu, Fukuda Aisaku, Morimoto Yoshiharu, Yamada Tomomi, Kodama Michiko, Kimura Tadashi
Аннотация
PURPOSE: To evaluate the clinical utility of preimplantation genetic testing for aneuploidy and structural rearrangements (PGT-A/SR) under Advanced Medical Care B in Japan.
METHODS: This prospective, single-arm, multicenter benchmarking study included couples with recurrent implantation failure, recurrent pregnancy loss, or structural chromosomal rearrangements who underwent PGT-A/SR and first transfer of a category A/B embryo. The primary endpoint was ongoing pregnancy rate per transfer (oPR) at 12-13 weeks; clinical pregnancy rate (cPR) was prespecified as supportive because the registry benchmark used cPR. Outcomes were compared with age-adjusted national registry thresholds using a one-sample proportion test with a normal approximation.
RESULTS: Of 375 couples, 344 underwent PGT-A/SR and 218 reached first transfer. oPR was 48.6% versus 42.4% (p = 0.064) and did not reach statistical significance; cPR was 57.8% versus 42.4% (p < 0.001). Miscarriage rate was 15.9% versus 23.4% (p = 0.045). In women aged 35-39 and 40-42 years, oPR and cPR exceeded age-adjusted thresholds, whereas no benefit was demonstrated in women aged < 35 years.
CONCLUSIONS: On a per-transfer basis, PGT-A/SR was associated with higher cPR and lower miscarriage rate, particularly in women aged ≥ 35 years. Interpretation is limited by the single-arm design and the mismatch between the study endpoint and the registry comparator.
TRIAL REGISTRATION: This study was registered in the Japan Registry of Clinical Trials (jRCT) (jRCT1052220197).
METHODS: This prospective, single-arm, multicenter benchmarking study included couples with recurrent implantation failure, recurrent pregnancy loss, or structural chromosomal rearrangements who underwent PGT-A/SR and first transfer of a category A/B embryo. The primary endpoint was ongoing pregnancy rate per transfer (oPR) at 12-13 weeks; clinical pregnancy rate (cPR) was prespecified as supportive because the registry benchmark used cPR. Outcomes were compared with age-adjusted national registry thresholds using a one-sample proportion test with a normal approximation.
RESULTS: Of 375 couples, 344 underwent PGT-A/SR and 218 reached first transfer. oPR was 48.6% versus 42.4% (p = 0.064) and did not reach statistical significance; cPR was 57.8% versus 42.4% (p < 0.001). Miscarriage rate was 15.9% versus 23.4% (p = 0.045). In women aged 35-39 and 40-42 years, oPR and cPR exceeded age-adjusted thresholds, whereas no benefit was demonstrated in women aged < 35 years.
CONCLUSIONS: On a per-transfer basis, PGT-A/SR was associated with higher cPR and lower miscarriage rate, particularly in women aged ≥ 35 years. Interpretation is limited by the single-arm design and the mismatch between the study endpoint and the registry comparator.
TRIAL REGISTRATION: This study was registered in the Japan Registry of Clinical Trials (jRCT) (jRCT1052220197).