跳至主要内容
临床试验/NCT05404464
NCT05404464Unknown不适用

CITIC Xiangya Assisted Reproduction Data Repository: a Real Medical Environment Based Research Database

Reproductive & Genetic Hospital of CITIC-Xiangya0 个研究点目标入组 119,590 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
119,590
主要终点
Cleavage rate

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 66 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All infertile couples undergoing ART treatment in our hospital (CITIC-Xiangya) were enrolled.

排除标准

  • 未提供

结局指标

主要结局

Cleavage rate

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Up to 1 year after delivery

Self-measurement

Miscarriage

时间窗: Up to 42 weeks after transplantation

The spontaneous loss of an intrauterine pregnancy.

Birthweight

时间窗: 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

时间窗: Up to 1 year after delivery

Self-measurement

Implantation rate

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Reproductive & Genetic Hospital of CITIC-Xiangya
申办方类型
Other
责任方
Sponsor

相似试验