Construction of CITIC Xiangya Assisted Reproduction Data Repository

Study Overview
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Brief Summary
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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.

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

Conditions
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Assisted Reproductive Technology, Infertility

Intervention / Treatment
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* Other: Different baseline characteristics and clinical management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All infertile couples undergoing ART treatment in our hospital (CITIC-Xiangya) were enrolled. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infertile couples<br>Infertile couples who came to the hospital for ART treatment | Other: Different baseline characteristics and clinical management<br>* Personal history, basic diseases, stimulation plan, type of ART, transplantation strategy, etc.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Population-based database, Registry, Infertile couple and offspring, Longitudinal study