Construction of CITIC Xiangya Assisted Reproduction Data Repository

Infertility Clinical Trial

— CXARDR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05404464
• Other study ID #: LL-SC-2022-014
• Status: Active, not recruiting
• Start date: January 1, 2016
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2022
• Source: Reproductive & Genetic Hospital of CITIC-Xiangya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 119590
• Est. completion date: June 30, 2023
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 66 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Assisted Reproductive Technology
• Infertility

Intervention

Other:
• Different baseline characteristics and clinical management
Personal history, basic diseases, stimulation plan, type of ART, transplantation strategy, etc.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya	Central South University, West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Clinical pregnancy	A pregnancy diagnosed by ultrasonographic examination of at least one fetus with a discernible heartbeat.	Up to 30 days after transplantation
Primary	Miscarriage	The spontaneous loss of an intrauterine pregnancy.	Up to 42 weeks after transplantation
Primary	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
Primary	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
Primary	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
Primary	Height of offspring 1 year old	Self-measurement	Up to 1 year after delivery
Primary	Weight of offspring 1 year old	Self-measurement	Up to 1 year after delivery
Secondary	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
Secondary	1PN rate	The proportion of inseminated oocytes with one pronucleus on Day 1 (17 ± 1 h post-insemination).	Up to 2 days after insemination
Secondary	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
Secondary	Proportion of good blastocysts	The proportion of blastocysts with a grade of "good" or higher.	Up to 7 days after insemination
Secondary	Ectopic pregnancy	A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization, or histopathology.	Up to 30 days after transplantation
Secondary	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
Secondary	Gestational hypertension	Maternal systolic blood pressure = 140 mmHg and (or) diastolic pressure = 90 mmHg.	Up to 42 weeks after transplantation
Secondary	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
Secondary	Neonatal mortality	Death of a live born baby within 28 days of birth.	Up to 30 days after delivery