Clinical trial NCT05404464: Construction of CITIC Xiangya Assisted Reproduction Data Repository
Official title: CITIC Xiangya Assisted Reproduction Data Repository: a Real Medical Environment Based Research Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Assisted Reproductive Technology
Infertility
Keywords: Population-based database
Registry
Infertile couple and offspring
Longitudinal study
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
Collaborators: name: Central South University
name: West China Hospital
First posted: 2022-06-03
Enrollment: 119590
Sex: ALL
Minimum age (years): 16
Maximum age (years): 66
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile couples who received ART treatment in our hospital (CITIC-Xiangya).

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None.

Primary outcomes:
measure: Cleavage rate
timeFrame: Up to 3 days after insemination
measure: Implantation rate
timeFrame: Up to 30 days after transplantation
measure: Clinical pregnancy
timeFrame: Up to 30 days after transplantation
measure: Miscarriage
timeFrame: Up to 42 weeks after transplantation
measure: Live birth
timeFrame: Up to 42 weeks after transplantation
measure: Gestational age at birth
timeFrame: Up to 42 weeks after transplantation
measure: Birthweight
timeFrame: Up to 42 weeks after transplantation
measure: Height of offspring 1 year old
timeFrame: Up to 1 year after delivery
measure: Weight of offspring 1 year old
timeFrame: Up to 1 year after delivery
Secondary outcomes:
measure: Embryo development rate
timeFrame: Up to 3 days after insemination
measure: 1PN rate
timeFrame: Up to 2 days after insemination
measure: Blastocyst development rate
timeFrame: Up to 7 days after insemination
measure: Proportion of good blastocysts
timeFrame: Up to 7 days after insemination
measure: Ectopic pregnancy
timeFrame: Up to 30 days after transplantation
measure: Gestational diabetes
timeFrame: Up to 30 weeks after transplantation
measure: Gestational hypertension
timeFrame: Up to 42 weeks after transplantation
measure: Major congenital anomaly
timeFrame: Up to 42 weeks after transplantation
measure: Neonatal mortality
timeFrame: Up to 30 days after delivery
Other outcomes:
Locations:
Study officials:
affiliation: Reproductive & Genetic Hospital of CITIC-XIANGYA Changsha, Hunan China
name: Lin Ge, PhD
role: STUDY_DIRECTOR
References: