An interventional study of Using DNA methylome to select embryos and Using morphologic score to select embryos in Reproductive Techniques, Assisted and DNA Methylation, sponsored by Shandong University. Recruiting at 28 sites in 2 countries. Open to female participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by Shandong University · Not applicable, Interventional, and Treatment
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.
Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
b) Women who obtain 2 or more good-quality blastocysts that defined as morphological score of inner cell mass B or A, trophectoderm C or better, and grade 4 or better on Day 5 of embryo culture.
Exclusion Criteria:
4.2 Exclusion Criteria
Couples in the PIMS group will have up to 6 blastocysts screened with PIMS and a single euploid embryo with the optimal state of whole-genome DNA methylation and the highest morphologic score will be selected for the initial transfer. The optimal state of whole-genome DNA methylation includes methylation level closest to the optimal level (0.26 according to our preliminary results) and proper methylation state for some specific regions.
Other: Using DNA methylome to select embryos
For women between 20 and 37 years of age,couples in the conventional-IVF group will have a single best blastocyst by morphologic criteria selected for the initial transfer.For women over 37 years old, couples in the PGT-A group will have up to 6 blastocysts tested with PGT-A and a single euploid embryo with the highest morphologic score will be selected for the initial transfer.
Other: Using morphologic score to select embryos
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.
Time frame: 48 months
Neonatal complications
Number of live births with neonatal complications / number of live births.
Time frame: 48 months
Plan to share: No
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