RCT of niPGT for Aneuploidy and Morphology Compared With Morphology Alone in IVF

A Randomized Double Blind Controlled Trial of Non-invasive Preimplantation Genetic Testing for Aneuploidy and Morphology Compared With Morphology Alone in in Vitro Fertilisation

This study is to compare the efficacy in embryo selection based on morphology alone compared to morphology and non-invasive preimplantation genetic testing for aneuploidy (NIPGT-A) in infertile women undergoing in vitro fertilization (IVF). We supposed the embryo selection based on morphology and NIPGT-A results in a higher live birth rate and a lower miscarriage rate in IVF as compared with that based on morphology alone. Therefore we would like to conduct a double-blind randomized controlled trial. Infertile women undergoing IVF will be enrolled. The spent culture medium (SCM) of each blastocyst will be frozen individually. They will be randomized into two groups: (1) the intervention group based on morphology and NIPGT-A and (2) the control group based on morphology alone. In the control group, blastocysts with the best quality morphology will be replaced first. In the intervention group, blastocysts with the best morphology and euploid result of SCM will be replaced first.The primary outcome is a live birth per the first embryo transfer. We would like to compare live birth rates and miscarriage rates between the two groups.

Both morphology and NIPGT-A result will be used to prioritize the sequence of embryo transfer in the intervention group.

In the intervention group, comprehensive chromosome screening using NGS will be performed according to the recommendations of the company in all SCM samples. Sequence of replacement shall be altered by the NiPGT result after morpholgy.

Clinically recognized pregnancy loss before the 22 weeks of pregnancy and whose denominator is the clinical pregnancy.

Inclusion Criteria: Women aged less than 43 years at the time of ovarian stimulation At least two blastocysts suitable for freezing on day 5 or 6 after oocyte retrieval Exclusion Criteria: Less than two blastocysts suitable for freezing on day 5 or 6 after oocyte retrieval; Women undergoing PGT for monogenic diseases or structural rearrangement of chromosomes; Use of donor oocytes; Hydrosalpinx shown on pelvic scanning and not surgically treated

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