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Assisted Reproductive TechnologyCXARDRNCT05404464

Construction of CITIC Xiangya Assisted Reproduction Data Repository

An observational study of Assisted Reproductive Technology and Infertility, run by Reproductive & Genetic Hospital of CITIC-Xiangya.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 16 to 66 years
Conditions the study is for
Assisted Reproductive Technology, Infertility
What is being tested?
Different baseline characteristics and clinical management
How many people
119,590 participants
Where
No sites listed yet
Study dates
1 Jan 2016to 30 Jun 2023
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 66 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • None.

About this study

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

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.

Being tested
Different baseline characteristics and clinical management
Keywords
Population-based database, Registry, Infertile couple and offspring, Longitudinal study
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Different baseline characteristics and clinical managementOther

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

Study groups in NCT05404464
Study groupRoleWhat they receive
Infertile couplesInfertile couples who came to the hospital for ART treatment
Receives: Other: Different baseline characteristics and clinical management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cleavage rate

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

    Measured: 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.

    Measured: Up to 30 days after transplantation

  3. Clinical pregnancy

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

    Measured: Up to 30 days after transplantation

  4. Miscarriage

    The spontaneous loss of an intrauterine pregnancy.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Up to 42 weeks after transplantation

  8. Height of offspring 1 year old

    Self-measurement

    Measured: Up to 1 year after delivery

  9. Weight of offspring 1 year old

    Self-measurement

    Measured: Up to 1 year after delivery

Secondary outcomes (9)

  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.

    Measured: 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).

    Measured: 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.

    Measured: Up to 7 days after insemination

  4. Proportion of good blastocysts

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

    Measured: Up to 7 days after insemination

  5. Ectopic pregnancy

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

    Measured: 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).

    Measured: Up to 30 weeks after transplantation

  7. Gestational hypertension

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

    Measured: 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.

    Measured: Up to 42 weeks after transplantation

  9. Neonatal mortality

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

    Measured: Up to 30 days after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2022
  2. Study start1 Jan 2016
  3. Primary completion1 Dec 2020
  4. Study completion30 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
119,590 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05404464
Sponsor's protocol ID
LL-SC-2022-014
Acronym
CXARDR
Status last verified
May 2022
First submitted
31 May 2022
Last updated
3 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Hu J, Ma S, Gao Y, Peng Y, Wang X, Wu IXY, Gong F. Elevated triglyceride glucose-body mass index is associated with a higher risk of reduced cumulative live birth and adverse pregnancy outcomes in women undergoing assisted reproductive technology: a retrospective cohort study. Front Endocrinol (Lausanne). 2026 Jun 17;17:1842023. doi: 10.3389/fendo.2026.1842023. eCollection 2026.

    PubMed 42388867

  • Ma S, Tan J, Xiong Y, Peng Y, Gong F, Hu L, Wang X, Tan L, Liu R, Hocher B, Sun X, Lin G. Cohort Profile: CITIC-Xiangya Assisted Reproductive Technology Cohort (CXART Cohort). Int J Epidemiol. 2024 Feb 1;53(1):dyad188. doi: 10.1093/ije/dyad188. No abstract available.

    PubMed 38205885

Questions about this trial

What is this clinical trial studying?

An observational study of Assisted Reproductive Technology and Infertility, run by Reproductive & Genetic Hospital of CITIC-Xiangya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cleavage rate (time frame: Up to 3 days after insemination). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05404464, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.

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