Construction of CITIC Xiangya Assisted Reproduction Data Repository (CXARDR)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infertility; Assisted Reproductive Technology
• Intervention / Treatment: Other: Different baseline characteristics and clinical management

• Study Type: Observational
• Enrollment (Actual): 119590

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Infertile couples who received ART treatment in our hospital (CITIC-Xiangya).

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infertile couples; Infertile couples who came to the hospital for ART treatment	Other: Different baseline characteristics and clinical management; Personal history, basic diseases, stimulation plan, type of ART, transplantation strategy, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cleavage rate	The proportion of zygotes that cleave to become embryos on Day 2 (44 ± 1 h post-insemination) .	Up to 3 days after insemination
Implantation rate	The number of gestational sacs divided by the total number of embryos transferred, irrespective of whether a pregnancy was established.	Up to 30 days after transplantation
Clinical pregnancy	A pregnancy diagnosed by ultrasonographic examination of at least one fetus with a discernible heartbeat.	Up to 30 days after transplantation
Miscarriage	The spontaneous loss of an intrauterine pregnancy.	Up to 42 weeks after transplantation
Live birth	The complete expulsion or extraction from a woman of a product of fertilization, after 20 completed weeks of gestational age.	Up to 42 weeks after transplantation
Gestational age at birth	The age of a fetus is calculated by the best obstetric estimate determined by assessments which may include early ultrasound.	Up to 42 weeks after transplantation
Birthweight	Birth weight should be collected within 24 hours of birth and assessed using a calibrated electronic scale with ten-gram resolution.	Up to 42 weeks after transplantation
Height of offspring 1 year old	Self-measurement	Up to 1 year after delivery
Weight of offspring 1 year old	Self-measurement	Up to 1 year after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Embryo development rate	The proportion of cleaved embryos at the 4-cell stage on Day 2 (44 ± 1 h post-insemination) or at the 8-cell stage on Day 3 (68 ± 1 h post-insemination) per normally fertilized oocyte.	Up to 3 days after insemination
1PN rate	The proportion of inseminated oocytes with one pronucleus on Day 1 (17 ± 1 h post-insemination).	Up to 2 days after insemination
Blastocyst development rate	The proportion of blastocysts observed at 116 ± 2 h post-insemination as a function of the number of normally fertilized oocytes.	Up to 7 days after insemination
Proportion of good blastocysts	The proportion of blastocysts with a grade of "good" or higher.	Up to 7 days after insemination
Ectopic pregnancy	A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization, or histopathology.	Up to 30 days after transplantation
Gestational diabetes	By oral glucose tolerance test between 24 and 28 gestational weeks (fasting glucose ≥5.1 mmol/L, 1-h glucose ≥10.0 mmol/L, 2-h glucose ≥8.5 mmol/L; one abnormal result sufficient).	Up to 30 weeks after transplantation
Gestational hypertension	Maternal systolic blood pressure ≥ 140 mmHg and (or) diastolic pressure ≥ 90 mmHg.	Up to 42 weeks after transplantation
Major congenital anomaly	Structural, functional, and genetic anomalies, that occur during pregnancy, and identified antenatally, at birth, or later in life, and require surgical repair of a defect, or are visually evident, or are life-threatening, or cause death.	Up to 42 weeks after transplantation
Neonatal mortality	Death of a live born baby within 28 days of birth.	Up to 30 days after delivery

Collaborators and Investigators

• Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
• Collaborators: West China Hospital; Central South University
• Investigators: Study Director: Lin Ge, PhD, Reproductive & Genetic Hospital of CITIC-XIANGYA Changsha, Hunan China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Registry; Longitudinal study; Population-based database; Infertile couple and offspring
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: LL-SC-2022-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the policy of CITIC-Xiangya Reproductive and Genetic Hospital,research institutions could apply for data access by submitting a formal study protocol, subjected to approval by the hospital academic committee. Ethical review and research registration are mandatory for all studies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No