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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Enrollment
517
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.
Department of Obstetrics and Gynaecology
Hong Kong, Hong Kong, China
Live birth
Birth beyond 22 weeks of gestation per the first FET
Time frame: Number of live births beyond 22 weeks of gestation
Cumulative live birth rate
Number of pregnancies leading to live birth within 6 months of randomization
Time frame: Number of pregnancies leading to live birth within 6 months of randomization
Time to pregnancy
between time of IVF and pregnancy
Time frame: 1 year
Positive urine pregnancy test
Urine pregnancy test positive
Time frame: Positive urine pregnancy test 14 days after embryo transfer
Clinical pregnancy
Presence of intrauterine gestational sac on scanning at gestational week 6
Time frame: 6 weeks
Ongoing pregnancy
Presence of a fetal pole with pulsation at 8-10 weeks of gestation
Time frame: 10 weeks
Miscarriage defined
Clinically recognized pregnancy loss before the 22 weeks of pregnancy and whose denominator is the clinical pregnancy.
Time frame: Pregnancy loss up to 22 weeks
Multiple pregnancy
presence of more than one intrauterine sac at 6 weeks of gestation
Time frame: more than one intrauterine sac at 6 weeks
Ectopic pregnancy
Pregnancy not in the uterus
Time frame: 12 weeks
Birth weight
Pregnancy outcome
Time frame: 1 year
Apgar score
Pregnancy outcome
Time frame: 1 year
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