Construction of CITIC Xiangya Assisted Reproduction Data Repository

NCT ID: NCT05404464

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 119590 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2023-06-30

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.

Conditions

Assisted Reproductive Technology; Infertility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Infertile couples

Infertile couples who came to the hospital for ART treatment

Different baseline characteristics and clinical management

Intervention Type: OTHER

Personal history, basic diseases, stimulation plan, type of ART, transplantation strategy, etc.

Interventions

Different baseline characteristics and clinical management

Personal history, basic diseases, stimulation plan, type of ART, transplantation strategy, etc.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central South University

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Reproductive & Genetic Hospital of CITIC-Xiangya

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin Ge, PhD

Role: STUDY_DIRECTOR

Reproductive & Genetic Hospital of CITIC-XIANGYA Changsha, Hunan China

Other Identifiers

LL-SC-2022-014

Identifier Type: -

Identifier Source: org_study_id