CITIC Xiangya Assisted Reproduction Data Repository: a Real Medical Environment Based Research Database
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Assisted Reproductive Technology
- Sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Enrollment
- 119590
- Primary Endpoint
- Cleavage rate
- Last Updated
- 3 years ago
Overview
Brief Summary
Human Assisted Reproductive Technology (ART) has become a very effective and nearly irreplaceable clinical treatment for infertility, helping millions of women achieve fertility. However, ART may still have potential health risks to mothers and offspring. To better research and monitor the efficacy and safety of ART, the investigators established CXARDR based on the real medical data in Reproductive and Genetic Hospital of CITIC-Xiangya, which is the world's largest ART single treatment center. CXARDR covers the ART full-cycle treatment records since the hospital perfected its electronic medical record system in 2016, as well as biological samples from the CITIC-Xiangya Genetic Resource Bank. From the preoperative investigation of ART to the 1-year follow-up of ART offspring, CXARDR provides the details of the whole process of treatment and the follow-up outcomes of ART patients, making up for the gap in the data of reproductive and obstetric institutions. The huge biological samples with clinical information also provide more possibilities for in-depth basic researches in the field of reproduction and genetics.
During the past five years (January 2016 to November 2020), the CXARDR has accumulated data concerning more than 223,000 ART treatment cycles from 120,000 infertile couples. The CXARDR also links more than 180,000 blood samples, 65,000 follicular fluid samples, 80,000 semen samples, and 31,000 granulosa cell samples from 75,000 couples. The data volume is substantial with over 800 variables being documented, and most variables are designed as structured fields. The whole process of data access, data extraction, data processing and data analysis was conducted through a dedicated server inside the CITIC-Xiangya Data Center. All investigators cannot access sensitive information, are required to sign data confidentiality agreement, and need to be approved by the CITIC-Xiangya Ethics Committee.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All infertile couples undergoing ART treatment in our hospital (CITIC-Xiangya) were enrolled.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Cleavage rate
Time Frame: Up to 3 days after insemination
The proportion of zygotes that cleave to become embryos on Day 2 (44 ± 1 h post-insemination) .
Clinical pregnancy
Time Frame: Up to 30 days after transplantation
A pregnancy diagnosed by ultrasonographic examination of at least one fetus with a discernible heartbeat.
Gestational age at birth
Time Frame: Up to 42 weeks after transplantation
The age of a fetus is calculated by the best obstetric estimate determined by assessments which may include early ultrasound.
Height of offspring 1 year old
Time Frame: Up to 1 year after delivery
Self-measurement
Miscarriage
Time Frame: Up to 42 weeks after transplantation
The spontaneous loss of an intrauterine pregnancy.
Birthweight
Time Frame: Up to 42 weeks after transplantation
Birth weight should be collected within 24 hours of birth and assessed using a calibrated electronic scale with ten-gram resolution.
Weight of offspring 1 year old
Time Frame: Up to 1 year after delivery
Self-measurement
Implantation rate
Time Frame: Up to 30 days after transplantation
The number of gestational sacs divided by the total number of embryos transferred, irrespective of whether a pregnancy was established.
Live birth
Time Frame: Up to 42 weeks after transplantation
The complete expulsion or extraction from a woman of a product of fertilization, after 20 completed weeks of gestational age.
Secondary Outcomes
- 1PN rate(Up to 2 days after insemination)
- Proportion of good blastocysts(Up to 7 days after insemination)
- Gestational diabetes(Up to 30 weeks after transplantation)
- Major congenital anomaly(Up to 42 weeks after transplantation)
- Blastocyst development rate(Up to 7 days after insemination)
- Gestational hypertension(Up to 42 weeks after transplantation)
- Embryo development rate(Up to 3 days after insemination)
- Ectopic pregnancy(Up to 30 days after transplantation)
- Neonatal mortality(Up to 30 days after delivery)