DNA Methylation, Reproductive Techniques, Assisted
Conditions
Brief summary
To determine whether using DNA methylome to select embryos can increase the live birth rate.
Detailed description
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.
Interventions
OTHERUsing DNA methylome 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
OTHERUsing morphologic score to select embryos
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.
Sponsors
RenJi Hospital
Reproductive & Genetic Hospital of CITIC-Xiangya
Nanjing Maternity and Child Health Care Hospital
ShangHai Ji Ai Genetics & IVF Institute
Suzhou Municipal Hospital
The First Hospital of Jilin University
Sir Run Run Shaw Hospital
The Affiliated Hospital Of Guizhou Medical University
The Second Hospital of Hebei Medical University
Third Affiliated Hospital of Zhengzhou University
Ruijin Hospital
International Peace Maternity and Child Health Hospital
Henan Provincial People's Hospital
The First Affiliated Hospital of Hainan Medical University
The First Affiliated Hospital of Anhui Medical University
Fujian Maternity and Child Health Hospital
General Hospital of Ningxia Medical University
The First Affiliated Hospital with Nanjing Medical University
900 Hospital of Joint Logistics Support Force of PLA
Guangzhou Womenand Children's Medical Center
Changhai Hospital
Shenzhen Maternity & Child Healthcare Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Liuzhou Hospital of Guangzhou Women and Children's Medical Center
Jining Medical University
Siriraj Hospital
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Women who plan to undergo IVF/ICSI/PGT-A treatment. 2. Women aged 20 years and older. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| live birth rate of initial embryo transfer | 22 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 36 months | Twenty days after conception, transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac. |
| Pregnancy loss rate | 36 months | Number of pregnancy losses / number of clinical pregnancies after transfer. |
| Multiple pregnancy rate | 36 months | Number of multiple pregnancy/number of clinical pregnancies after transfer. |
| Good Birth Outcome rate | 36 months | 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 |
| Birth weight | 36 months | Weight of newborns at delivery. |
| Maternal complications | 48 months | Number of pregnancies with complications / number of pregnancies. |
| Neonatal complications | 48 months | Number of live births with neonatal complications / number of live births. |
| Duration of pregnancy | 36 months | Duration of pregnancy is the period between conception and birth. |
Countries
China, Thailand
Contacts
Primary ContactYuan Gao, Professor
Outcome results
None listed