Construction of CITIC Xiangya Assisted Reproduction Data Repository

NCT05404464 | Unknown

• 1 other identifier: LL-SC-2022-014
• Study Type: observational
• Target: 119,590
• Locations: 0 countries
• Sites: N/A

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

Keywords

Population-based database; Registry; Infertile couple and offspring; Longitudinal study

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (9)

• Embryo development rate

  Up to 3 days after insemination

• 1PN rate

  Up to 2 days after insemination

• Blastocyst development rate

  Up to 7 days after insemination

• Proportion of good blastocysts

  Up to 7 days after insemination

• Ectopic pregnancy

  Up to 30 days after transplantation

Study Arms (1)

Infertile couples

Infertile couples who came to the hospital for ART treatment

Other: Different baseline characteristics and clinical management

Interventions

Different baseline characteristics and clinical management OTHER

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

Infertile couples

Eligibility Criteria

• Age: 16 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Reproductive & Genetic Hospital of CITIC-Xiangya: lead
• Central South University: collaborator
• West China Hospital: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

blood, semen, follicular fluid and granulosa cell

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Lin Ge, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 3, 2022
• Study Start: January 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: June 30, 2023
• Last Updated: June 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share