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Clinical Trials/NCT05404464
NCT05404464
Unknown
Not Applicable

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

Reproductive & Genetic Hospital of CITIC-Xiangya0 sites119,590 target enrollmentJanuary 1, 2016

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
June 30, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
Responsible Party
Sponsor

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)

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