Journal
BMJ OPEN
Volume 12, Issue 7, Pages -Publisher
BMJ PUBLISHING GROUP
DOI: 10.1136/bmjopen-2021-057254
Keywords
antenatal; embryology; prenatal diagnosis
Categories
Funding
- National Key Research and Development Program of China [2018YFC1003100]
- National Science Foundation of China [82071721]
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This study aims to evaluate the non-invasive genetic testing method for embryonic aneuploidy and determine its clinical effectiveness in evaluating embryos.
Introduction Morphological evaluation is used to select embryos for in vitro fertilisation. However, it does not fully reflect the implantation potential. Preimplantation genetic testing for aneuploidies (PGT-A) can detect embryonic aneuploidy, but biopsy procedure is invasive. Currently, a non-invasive PGT (ni-PGT) approach using spent medium is being evaluated. However, the clinical benefit of ni-PGT has not been clearly demonstrated. A multicentre randomised trial is needed to verify whether ni-PGT can be an new effective tool for evaluating embryos. Methods and analysis Overall, 1148 couples aged 35 similar to 42 (women) receiving in vitro fertilization-intracytoplasmic sperm injection are planned to be enrolled. Couples will be digitally randomised to (1) ni-PGT and (2) conventional morphology groups at a 1:1 treatment ratio. The primary outcome will be the ongoing pregnancy rate related to the first transfer cycle within 6 months after oocyte retrieval. Ethics and dissemination The study protocol is approved by the Ethics Committee of Peking University Third Hospital and the participating hospitals. The results will be disseminated through international conferences and scientific journals.
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