ClinicalTrials.gg
Status unknownNCT05404464CXARDRUpdated Jun 3, 2022

Construction of CITIC Xiangya Assisted Reproduction Data Repository

An observational study in Assisted Reproductive Technology and Infertility, sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya. Status unknown. Open to participants aged 16 Years to 66 Years. Per ClinicalTrials.gov, last updated 2022-06-03.

Sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
119,590
Ages
16 Years to 66 Years
Sex
All
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Study 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.

02

Conditions studied

  • Assisted Reproductive Technology
  • Infertility

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Keywords

  • Population-based database
  • Registry
  • Infertile couple and offspring
  • Longitudinal study
03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's enrollment of 119,590 is above the median of 200 across 592 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya is the lead sponsor of 26 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 66 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
119,590 participants (actual)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Infertile couples

    Infertile couples who came to the hospital for ART treatment

    Other: Different baseline characteristics and clinical management

Interventions

  • OtherDifferent baseline characteristics and clinical management

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

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What researchers measure

Primary outcomes

  1. Cleavage rate

    The proportion of zygotes that cleave to become embryos on Day 2 (44 ± 1 h post-insemination) .

    Time frame: Up to 3 days after insemination

  2. Implantation rate

    The number of gestational sacs divided by the total number of embryos transferred, irrespective of whether a pregnancy was established.

    Time frame: Up to 30 days after transplantation

  3. Clinical pregnancy

    A pregnancy diagnosed by ultrasonographic examination of at least one fetus with a discernible heartbeat.

    Time frame: Up to 30 days after transplantation

  4. Miscarriage

    The spontaneous loss of an intrauterine pregnancy.

    Time frame: Up to 42 weeks after transplantation

  5. Live birth

    The complete expulsion or extraction from a woman of a product of fertilization, after 20 completed weeks of gestational age.

    Time frame: Up to 42 weeks after transplantation

  6. Gestational age at birth

    The age of a fetus is calculated by the best obstetric estimate determined by assessments which may include early ultrasound.

    Time frame: Up to 42 weeks after transplantation

  7. Birthweight

    Birth weight should be collected within 24 hours of birth and assessed using a calibrated electronic scale with ten-gram resolution.

    Time frame: Up to 42 weeks after transplantation

  8. Height of offspring 1 year old

    Self-measurement

    Time frame: Up to 1 year after delivery

  9. Weight of offspring 1 year old

    Self-measurement

    Time frame: Up to 1 year after delivery

Secondary outcomes

  1. 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.

    Time frame: Up to 3 days after insemination

  2. 1PN rate

    The proportion of inseminated oocytes with one pronucleus on Day 1 (17 ± 1 h post-insemination).

    Time frame: Up to 2 days after insemination

  3. Blastocyst development rate

    The proportion of blastocysts observed at 116 ± 2 h post-insemination as a function of the number of normally fertilized oocytes.

    Time frame: Up to 7 days after insemination

  4. Proportion of good blastocysts

    The proportion of blastocysts with a grade of "good" or higher.

    Time frame: Up to 7 days after insemination

  5. Ectopic pregnancy

    A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization, or histopathology.

    Time frame: Up to 30 days after transplantation

  6. 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).

    Time frame: Up to 30 weeks after transplantation

  7. Gestational hypertension

    Maternal systolic blood pressure ≥ 140 mmHg and (or) diastolic pressure ≥ 90 mmHg.

    Time frame: Up to 42 weeks after transplantation

  8. 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.

    Time frame: Up to 42 weeks after transplantation

  9. Neonatal mortality

    Death of a live born baby within 28 days of birth.

    Time frame: Up to 30 days after delivery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05404464
Lead sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
Responsible party
Sponsor
First posted
Jun 3, 2022
Start date
Jan 1, 2016
Primary completion
Dec 1, 2020
Completion
Jun 30, 2023 (estimated)
Last update
Jun 3, 2022

Study contacts

Lin Ge, PhD
study director · Reproductive & Genetic Hospital of CITIC-XIANGYA Changsha, Hunan China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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