To determine whether using DNA methylome to select embryos can increase the live birth rate.
The rationale for the study is to establish the risk/benefit ratio of PIMS in women with in vitro fertilization (IVF) treatment, as DNA methylome is a potential biomarker in blastocyst selection in assited reproductive technology (ART). DNA methylation plays an important role during embryogenesis, global abnormal methylome reprogramming often occurs in human embryos, and DNA methylome pattern is associated with live birth rate. However, there is still no technology using DNA methylome as an indicator in preimplantation embryo screening. Recent paper reported that using Pre-implantation Methylome Screening (PIMS) can select embryos with better methylation state and euploid chromosomes. The efficiency of PIMS needs further validation through randomized clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,146
DNA methylation level Embryo with methylation level closest to the optimal level (from one couple patients) is the one for embryonic transfer to uterus
blastocyst will transferred according to morphologic score or blastocysts will be biopsied on trophectoderm, sequenced with next-generation sequencing (NGS). Euploidy will transferred one by one according to morphologic score.
live birth rate of initial embryo transfer
Live birth rate is defined as delivery of any viable infant at 28 weeks or more of gestation, after initial embryo transfer in women using the embryos selected through PIMS or PGT-A or morphological criteria alone.
Time frame: 22 months
Good Birth Outcome rate
Defined as a live birth of an infant born at ≥ 37 weeks, with a birth weigh between 2500 and 4000g and without a major congenital anomaly
Time frame: 36 months
Clinical pregnancy rate
Twenty days after conception, transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac.
Time frame: 36 months
Pregnancy loss rate
Number of pregnancy losses / number of clinical pregnancies after transfer.
Time frame: 36 months
Multiple pregnancy rate
Number of multiple pregnancy/number of clinical pregnancies after transfer.
Time frame: 36 months
Duration of pregnancy
Duration of pregnancy is the period between conception and birth.
Time frame: 36 months
Birth weight
Weight of newborns at delivery.
Time frame: 36 months
Maternal complications
Number of pregnancies with complications / number of pregnancies.
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Shandong University
Jinan, Shandong, China
RECRUITINGCenter for Reproductive Medicine, Center for Prenatal Diagnosis First Hospital, Jilin University
Changchun, China
RECRUITINGClinical Research Center for Reproduction and Genetics in Hunan Province, Reproductive and Genetic Hospital of CITIC-XIANGYA
Changsha, China
RECRUITING900 th Hospital of Joint Logistics Support Force
Fuzhou, China
RECRUITINGFujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University
Fuzhou, China
RECRUITINGGuangzhou Womenand Children's Medical Center
Guanzhou, China
RECRUITINGThe Sixth Affiliated Hospital of Sun Yat-sen University
Guanzhou, China
NOT_YET_RECRUITINGCenter for Reproductive Medicine, The Affiliated Hospital of Guizhou Medical University
Guiyang, China
RECRUITINGThe first affiliated hospital of Hainan Medical University
Haikou, China
RECRUITINGAssisted Reproduction Unit, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
RECRUITING...and 18 more locations
Time frame: 48 months
Neonatal complications
Number of live births with neonatal complications / number of live births.
Time frame: 48 months