An interventional study of CNV in DNA Methylation, sponsored by Chen Zi-Jiang. Completed at 1 site in China. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-10-04.
Sponsored by Chen Zi-Jiang · Not applicable, Interventional, and Treatment
The purpose of this clinical trial is to determine the safety and effect of methylation level of DNA methylation in embryos on the outcome of assisted reproductive technology (ART) during blastocyst embryo screening. Subjects with blastocysts on day 5-7 of embryo culture will be biopsied. A Freeze-all strategy and a single frozen blastocyst transfer will be performed till all study-specific embryos have been transferred. Then whole genome bisulfate sequencing will be performed on all cells that obtained from biopsy.
The purpose of this clinical trial is to determine the safety and affect of DNA methylation level on ART. Subjects with blastocysts on day 5-7 of embryo culture will be biopsied. A Freeze-all strategy and a single frozen blastocyst transfer will be performed till all study-specific embryos have been transferred. Then whole genome bisulfate sequencing will be performed on all cells that obtained from biopsy. The investigators will perform whole genome DNA methylation sequence for two to seven blastocysts from one couple. The methylation level and genomic copy number variation will be analyzed by using the methylome data. Embryos with aneuploid chromosomes will be rejected for embryo transfer to uterus. The study will examine which kind of methylation level can produce the best clinical outcome for ART. Biopsied cells will perform with preimplnatation DNA methylation test (PIMT). DNA methylation level and chromosome copy number variation will be calculated by using whole genome DNA methylation sequencing data. As we do not kown which kind of methylation state can produce the best outcome in ART practice. This study will try to find a standard of selection embryos according to DNA methylation information. Under current stage, the selection of embryo is according to chromosome copy number. The embryo selection will not consider DNA methylation information for this study.
Chen Zi-Jiang is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will have blastocyst biopsy and whole genome DNA methylation sequencing done with 2 or 7 good-quality embryos on Day 5 to 7. Principle of freeze-all and single thawed blastocyst transfer will be applied. Only embryos with euploid chromosome will be transfered to the uterus. The outcome of all euploids transfers within 1 year will be followed up. During study, every subject will have at most one live birth.
Procedure: CNV
Embryo with euploid chromosome will transfer to uterus. The order of transfer is accroding to morphological grade.
The effect of DNA methylation level on live birth rate
The rate of live birth at different methylation level will be calculated. Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation, and cumulative live birth rate is calculated by dividing the number of women achieving live birth after transfers (up to 3 transfers of single blastocycst within 1 year).
Time frame: 22 months
The effect of DNA methylation level on pregnant rate, pregnant loss rate.
The rate of pregnant and pregnant loss at different methylation level will be calculated. Pregnancy loss refers to a complete spontaneous abortion or a nonviable pregnancy before 28 weeks of gestation.
Time frame: 22 months
Duration of pregnancy
The time from the first day of last menstrual period to the day of delivery.
Time frame: 22 months
Birth weight
Weight of newborns at delivery.
Time frame: 22 months
Cumulative incidence of maternal complications during whole
Number of pregnancies with complications / number of pregnancies over (up to) 3 transfers within 1 year;
Time frame: 22 months
Cumulative incidence of neonatal complications during whole
Number of live births with neonatal complications / number of live births over (up to)3 transfers within 1 year
Time frame: 22 months
Number of embryo transfers to achieve live birth
Number of embryo transfers the patients have gone through to achieve live birth.
Time frame: 22 months
Clinical pregnancy rate after the first transfer
Number of women with clinical pregnancies after the first transfer / number of women.
Time frame: 4 months
Pregnancy loss rate after the first transfer
Number of pregnancy losses / number of clinical pregnancies after the first transfer .
Time frame: 9 months
Live birth rate after the first transfer
Number of women with live births after the first transfer / number of women.
Time frame: 12 months
Plan to share: Undecided
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chen Zi-Jiang